CSIR-NCL makes fast track R & D roadmap for indigenous
chemical synthesis of drug intermediates
The Union Cabinet headed by Prime Minister Shri Narendra Modi approved on 21 March a special package for the Promotion of Bulk Drugs Parks to finance common infrastructural facilities and production-linked incentive schemes for the manufacture of key starting materials (KSMs)/ drug intermediates and active pharmaceutical ingredients (APIs) in the country, in response to the medical emergency situation which might arise due to COVID-19 lockdown for extended period. A list of 53 APIs / bulk drugs was identified, half of them are based on chemical synthesis on which CSIR-NCL is focussing. The Indian pharmaceutical industry is the third largest by volume but it is critically dependent on imports of raw materials or KSMs, in some cases to over 80% extent, mainly from China. Drug security, self-sufficiency and continuous supply of essential medicines are the need of the hour for national security and healthy population. India has the largest number of FDA approved manufacturing sites outside of USA.
The more than 27 or so bulk drugs covering different therapeutic classes such as anti-viral, retro-viral, antibiotics, anti-bacterial, anti-fungal, cardiovascular, diabetes, cholesterol lowering, anti-cancer to simple pain killer like paracetamol, are synthesized from about 10-12 simpler building blocks or KSMs/ drug intermediates. Self-sufficiency in drug supply chain for India means indigenous processes and platform technology to produce these important KSMs. In consultation with industry experts and from the list of essential APIs, the Organic Chemistry and Chemical Engineering scientists of CSIR-National Chemical Laboratory analysed the structures of chemical intermediates and the state of readiness employing synthetic routes which are scaleable and economical. For 3-4 drug intermediates/ bulk chemicals, R&D projects are already ongoing and these will be fast tracked. For remaining 4-5 molecules, the most efficient routes considering atom economy, novel catalysis, flow chemistry, process intensification, plant safety, cost of raw materials, reagents and solvents, and recycling of by-products, and energy management have been designed. These chemical processes will bring down the cost of production through continuous flow synthesis, process optimization and reaction engineering, an area in which CSIR-NCL has prior experience and expertise. CSIR-NCL scientists have reported a novel and economical chemical synthesis of cystic fibrosis drug Ivacaftor in 2018, which is one of the highest priced drugs for patients (US $300 000 per year per patient). CSIR-NCL has recently demonstrated flow synthesis with minimal or no solvent use which will make significant economic benefit when translated for the identified molecules. Apart from cost economics, minimal chemicals, process safety, and environment friendly, the biggest advantage of multi-step continuous flow technology is that the production can be carried out on smaller scale in a distributed model at several locations, a factor which will be important in the medical emergency situation facing the country.
Director Prof. Ashwini Kumar Nangia is hopeful that CSIR-NCL will be able to release the R&D reports to Govt. and chemicals and pharmaceutical industry bodies soon as each laboratory scale process is ready in the next few weeks and months to be taken up for manufacturing by Indian drug companies. The capability and infrastructure for further synthesis of final APIs from the intermediate KSMs largely exists in the country.
The Union Cabinet headed by Prime Minister Shri Narendra Modi approved on 21 March a special package for the Promotion of Bulk Drugs Parks to finance common infrastructural facilities and production-linked incentive schemes for the manufacture of key starting materials (KSMs)/ drug intermediates and active pharmaceutical ingredients (APIs) in the country, in response to the medical emergency situation which might arise due to COVID-19 lockdown for extended period. A list of 53 APIs / bulk drugs was identified, half of them are based on chemical synthesis on which CSIR-NCL is focussing. The Indian pharmaceutical industry is the third largest by volume but it is critically dependent on imports of raw materials or KSMs, in some cases to over 80% extent, mainly from China. Drug security, self-sufficiency and continuous supply of essential medicines are the need of the hour for national security and healthy population. India has the largest number of FDA approved manufacturing sites outside of USA.
The more than 27 or so bulk drugs covering different therapeutic classes such as anti-viral, retro-viral, antibiotics, anti-bacterial, anti-fungal, cardiovascular, diabetes, cholesterol lowering, anti-cancer to simple pain killer like paracetamol, are synthesized from about 10-12 simpler building blocks or KSMs/ drug intermediates. Self-sufficiency in drug supply chain for India means indigenous processes and platform technology to produce these important KSMs. In consultation with industry experts and from the list of essential APIs, the Organic Chemistry and Chemical Engineering scientists of CSIR-National Chemical Laboratory analysed the structures of chemical intermediates and the state of readiness employing synthetic routes which are scaleable and economical. For 3-4 drug intermediates/ bulk chemicals, R&D projects are already ongoing and these will be fast tracked. For remaining 4-5 molecules, the most efficient routes considering atom economy, novel catalysis, flow chemistry, process intensification, plant safety, cost of raw materials, reagents and solvents, and recycling of by-products, and energy management have been designed. These chemical processes will bring down the cost of production through continuous flow synthesis, process optimization and reaction engineering, an area in which CSIR-NCL has prior experience and expertise. CSIR-NCL scientists have reported a novel and economical chemical synthesis of cystic fibrosis drug Ivacaftor in 2018, which is one of the highest priced drugs for patients (US $300 000 per year per patient). CSIR-NCL has recently demonstrated flow synthesis with minimal or no solvent use which will make significant economic benefit when translated for the identified molecules. Apart from cost economics, minimal chemicals, process safety, and environment friendly, the biggest advantage of multi-step continuous flow technology is that the production can be carried out on smaller scale in a distributed model at several locations, a factor which will be important in the medical emergency situation facing the country.
Director Prof. Ashwini Kumar Nangia is hopeful that CSIR-NCL will be able to release the R&D reports to Govt. and chemicals and pharmaceutical industry bodies soon as each laboratory scale process is ready in the next few weeks and months to be taken up for manufacturing by Indian drug companies. The capability and infrastructure for further synthesis of final APIs from the intermediate KSMs largely exists in the country.
Biopharma Industry Movement on COVID-19 Outbreak
Diagnostics Update: The FDA has so far worked with 220 test developers. To date, 17 EUAs have been issued, including the AvellinoCoV2 test. The FDA has also been notified that more than 100 laboratories have begun testing.
3D Printing: The FDA entered into a Memorandum with various organizations that provides a framework for collaboration to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19.
Diagnostics: BGI Genomics received FDA EUA for its RT-PCR kit for SARS-CoV-2 detection. The test can return results for COVID-19 within three hours. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in bronchoalveolar lavage fluid and throat swabs.
Testing Therapies, Antivirals, and Vaccines: Sanofi Pasteur, the vaccines business for French pharma giant Sanofi, and Massachusetts-based Translate Bio have partnered to develop a novel messenger RNA (mRNA) vaccine for COVID-19, the disease caused by the novel coronavirus.
CytoDyn filed another round of modifications to its IND and protocol for a Phase II clinical trial with leronlimab in COVID-19 patients in severe condition. The company also reported that the drug had been tested in seven patients with severe COVID-19 under an Emergency IND granted by the FDA. The three-day results after treatment of the first four patients showed an improved immune profile, controlling the cytokine storm.
Vyripharm Biopharmaceuticals is repurposing the development of a novel theranostic platform for the diagnosis, monitoring, and treatment of viral infections such as SARS, MERS, and COVID-19. This theranostic approach will use radiopharmaceuticals for detection and diagnosis with the ability to incorporate combination therapies to interrupt the replication of the virus, the company said. The therapeutic application will begin with a CB1 antagonist, an anti-viral therapeutic formulation and followed by a short course of radiotherapeutic regimen in combination or in a dose-related response manner.
As reported by CNBC, the World Health Organization officials announced on Friday that the first patients in a “historic” drug trial to test treatments for the coronavirus have been enrolled in Norway and Spain.
Company Actions: BMS, Merck, Pfizer, and Enanta Pharmaceuticals join Eli Lilly, Galapagos, and other companies are pausing enrollment to some clinical trials during the COVID-19 pandemic. Other companies, such as AbbVie and Amgen, continue to closely monitor their trial sites.
Other Industry News: Cerus Corporation formed a collaborative research group with the aim of optimizing convalescent plasma therapy for COVID-19 patients. The research group seeks to define the key characteristics that influence the efficacy of convalescent plasma, including the level and nature of anti-COVID-19 antibodies, optimal collection timing, dosing and how these influence responses to the therapy regimen. Cerus’ INTERCEPT Blood System, a pathogen reduction technology, has approved label claims for SARS-CoV inactivation in both the US and Europe. SARS-CoV-2 is the causative agent of COVID-19 and the genetic sequence is at least 70% similar to that of SARS-CoV, the company said.
Ireland-based Medtronic launched a new online solution to assess, monitor, and triage support for patients concerned about COVID-19 and respiratory symptoms. The company’s new COVID-19 Virtual Care Evaluation and Monitoring solution uses a virtual assistant to evaluate patients through a Center for Disease Control and Prevention guideline-based survey for COVID-19 symptoms. If the user’s symptoms warrant it, the solution connects them to the Medtronic Care Management Services nurse command center, where registered nurses review the patient’s data and either identify recommendations or the need for additional care assessment, based on the CDC guidelines. This could include a recommendation to continue monitoring symptoms at home or to contact a healthcare provider directly.
Diagnostics Update: The FDA has so far worked with 220 test developers. To date, 17 EUAs have been issued, including the AvellinoCoV2 test. The FDA has also been notified that more than 100 laboratories have begun testing.
3D Printing: The FDA entered into a Memorandum with various organizations that provides a framework for collaboration to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19.
Diagnostics: BGI Genomics received FDA EUA for its RT-PCR kit for SARS-CoV-2 detection. The test can return results for COVID-19 within three hours. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in bronchoalveolar lavage fluid and throat swabs.
Testing Therapies, Antivirals, and Vaccines: Sanofi Pasteur, the vaccines business for French pharma giant Sanofi, and Massachusetts-based Translate Bio have partnered to develop a novel messenger RNA (mRNA) vaccine for COVID-19, the disease caused by the novel coronavirus.
CytoDyn filed another round of modifications to its IND and protocol for a Phase II clinical trial with leronlimab in COVID-19 patients in severe condition. The company also reported that the drug had been tested in seven patients with severe COVID-19 under an Emergency IND granted by the FDA. The three-day results after treatment of the first four patients showed an improved immune profile, controlling the cytokine storm.
Vyripharm Biopharmaceuticals is repurposing the development of a novel theranostic platform for the diagnosis, monitoring, and treatment of viral infections such as SARS, MERS, and COVID-19. This theranostic approach will use radiopharmaceuticals for detection and diagnosis with the ability to incorporate combination therapies to interrupt the replication of the virus, the company said. The therapeutic application will begin with a CB1 antagonist, an anti-viral therapeutic formulation and followed by a short course of radiotherapeutic regimen in combination or in a dose-related response manner.
As reported by CNBC, the World Health Organization officials announced on Friday that the first patients in a “historic” drug trial to test treatments for the coronavirus have been enrolled in Norway and Spain.
Company Actions: BMS, Merck, Pfizer, and Enanta Pharmaceuticals join Eli Lilly, Galapagos, and other companies are pausing enrollment to some clinical trials during the COVID-19 pandemic. Other companies, such as AbbVie and Amgen, continue to closely monitor their trial sites.
Other Industry News: Cerus Corporation formed a collaborative research group with the aim of optimizing convalescent plasma therapy for COVID-19 patients. The research group seeks to define the key characteristics that influence the efficacy of convalescent plasma, including the level and nature of anti-COVID-19 antibodies, optimal collection timing, dosing and how these influence responses to the therapy regimen. Cerus’ INTERCEPT Blood System, a pathogen reduction technology, has approved label claims for SARS-CoV inactivation in both the US and Europe. SARS-CoV-2 is the causative agent of COVID-19 and the genetic sequence is at least 70% similar to that of SARS-CoV, the company said.
Ireland-based Medtronic launched a new online solution to assess, monitor, and triage support for patients concerned about COVID-19 and respiratory symptoms. The company’s new COVID-19 Virtual Care Evaluation and Monitoring solution uses a virtual assistant to evaluate patients through a Center for Disease Control and Prevention guideline-based survey for COVID-19 symptoms. If the user’s symptoms warrant it, the solution connects them to the Medtronic Care Management Services nurse command center, where registered nurses review the patient’s data and either identify recommendations or the need for additional care assessment, based on the CDC guidelines. This could include a recommendation to continue monitoring symptoms at home or to contact a healthcare provider directly.
Sanofi Pasteur and Translate Bio Partnered Together to Develop COVID-19 Vaccine
Lyon, France: The vaccine business of French Pharma Company Sanofi – The Sanofi Pasteur, and Massachusetts-based Translate Bio have come to an agreement of developing a novel mRNA based COVID-19 vaccine.
On the outbreak of this global pandemic, these two companies are building on a two year old partnership to develop mRNA vaccines for infectious diseases. In 2018, the two companies partnered with the goal of developing five mRNA vaccines for infectious diseases. Now, Sanofi and Translate Bio are turning their research toward COVID-19.
Translate Bio will use its mRNA platform to discover, design, and manufacture SARS-CoV-2 vaccine candidates. Sanofi Pasteur, a vaccines expert, will aim its resources at advancing any candidate through developmental phases in hopes of bringing a desperately needed vaccine to the world. Depending on the final human dose, the mRNA platform of Translate Bio has excellent promise to meet the future demands for a pandemic response, Sanofi said.
For Sanofi, this marks the second collaboration in its efforts to develop a novel COVID-19 vaccine candidate. In February, Sanofi collaborated with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. The agreement with BARDA calls for Sanofi to initiate the development of a recombinant, protein-based vaccine candidate against COVID-19.
“We are committed to leveraging different ways to address the COVID-19 public health crisis by testing treatments, as well as two vaccines using different platforms. We believe the more approaches we explore, the better our likelihood of success in achieving this goal,” David Loew, Global Head of Vaccines at Sanofi said in a statement. “Having sufficient installed capacity will be key to satisfy the strong demand for vaccines we will probably see, and based on the experience we’ve had under the collaboration to date, we believe the Translate Bio mRNA platform could help us to meet that need.”
According to the release, Translate Bio has already begun to produce multiple mRNA constructs and is expanding its manufacturing capabilities through a partnership with a contract manufacturing partner to accommodate at least two 250 gram batches per month, the company said. Translate Bio already has 100-gram single-batch production capabilities with its clinical-stage mRNA therapeutics platform.
Translate Bio Chief Executive Officer Ronald Renaud said his company and Sanofi Pasteur have already generated "encouraging preclinical data across multiple infectious disease targets” through the existing collaboration. That work will serve as a strong foundation in developing a vaccine candidate for COVID-19, Renaud said. mRNA vaccines work by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential in order to create an immune response in the body. It is thought that mRNA vaccines will provide high potency against diseases and will also have the capacity for rapid development due to low-cost manufacture and safe administration using non-viral delivery.
Lyon, France: The vaccine business of French Pharma Company Sanofi – The Sanofi Pasteur, and Massachusetts-based Translate Bio have come to an agreement of developing a novel mRNA based COVID-19 vaccine.
On the outbreak of this global pandemic, these two companies are building on a two year old partnership to develop mRNA vaccines for infectious diseases. In 2018, the two companies partnered with the goal of developing five mRNA vaccines for infectious diseases. Now, Sanofi and Translate Bio are turning their research toward COVID-19.
Translate Bio will use its mRNA platform to discover, design, and manufacture SARS-CoV-2 vaccine candidates. Sanofi Pasteur, a vaccines expert, will aim its resources at advancing any candidate through developmental phases in hopes of bringing a desperately needed vaccine to the world. Depending on the final human dose, the mRNA platform of Translate Bio has excellent promise to meet the future demands for a pandemic response, Sanofi said.
For Sanofi, this marks the second collaboration in its efforts to develop a novel COVID-19 vaccine candidate. In February, Sanofi collaborated with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. The agreement with BARDA calls for Sanofi to initiate the development of a recombinant, protein-based vaccine candidate against COVID-19.
“We are committed to leveraging different ways to address the COVID-19 public health crisis by testing treatments, as well as two vaccines using different platforms. We believe the more approaches we explore, the better our likelihood of success in achieving this goal,” David Loew, Global Head of Vaccines at Sanofi said in a statement. “Having sufficient installed capacity will be key to satisfy the strong demand for vaccines we will probably see, and based on the experience we’ve had under the collaboration to date, we believe the Translate Bio mRNA platform could help us to meet that need.”
According to the release, Translate Bio has already begun to produce multiple mRNA constructs and is expanding its manufacturing capabilities through a partnership with a contract manufacturing partner to accommodate at least two 250 gram batches per month, the company said. Translate Bio already has 100-gram single-batch production capabilities with its clinical-stage mRNA therapeutics platform.
Translate Bio Chief Executive Officer Ronald Renaud said his company and Sanofi Pasteur have already generated "encouraging preclinical data across multiple infectious disease targets” through the existing collaboration. That work will serve as a strong foundation in developing a vaccine candidate for COVID-19, Renaud said. mRNA vaccines work by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential in order to create an immune response in the body. It is thought that mRNA vaccines will provide high potency against diseases and will also have the capacity for rapid development due to low-cost manufacture and safe administration using non-viral delivery.
Crowd Funding Platform Milaap Launched Campaign to Fight Covid-19
Mumbai, India: Covid-19, the disease caused by the novel coronavirus, has infected more than 4.9 lakh people worldwide, killing more than 22,000. In India alone, it has so far caused 17 deaths and infected at least 600 people across 27 states, as of 27th March 2020. In the past week, several states across India have put safety first by closing down schools, colleges, malls, theatres, restaurants, shops and non-essential workplaces, recommending working from home wherever possible. The country is now under a lockdown for 21 days.
However, there are many people in our society like doctors, nurses, delivery staff, conservancy workers (garbage/waste segregators) and field volunteers, among others, still working tirelessly to ensure our societal needs are met: often at the risk of their personal safety. Moreover, with the increasing number of people being tested positive worldwide, it’s also important to remember that not everyone can remain in quarantine without their lives being completely upturned. The financial impact of the pandemic, especially on blue-collar workers and families that survive on a daily wage, is far reaching.
This Sunday, on March 22 2020, Milaap, South Asia’s largest crowdfunding platform, opened itself up for fundraisers around Covid-19. In an attempt to help those whose lives have been worst affected by the pandemic, a separate page, www.milaap.org/covid19 has been launched. The causes range from providing essentials to nearby slums in bigger cities to equipping doctors / their social initiatives with protective gear, and even ventilators for smaller hospitals without the facility. While renowned people like Luis Miranda and Venkat Iyer have set up fundraisers on one hand, there are many regular individuals who are raising funds to support particular families in distress around them. In the spirit of global solidarity, Milaap has waived off their platform fee completely for all fundraisers under this cause.
Mayukh Choudhury, CEO and Co-founder of Milaap said, “This crowd funding project is to highlight citizen initiatives across India to mitigate the economic crisis faced by vulnerable families, as well as to support those who are in the frontlines, with the monetary resources they deserve. Our larger objective is to inspire each one of us to look within our circles, our neighbourhoods, and support the vulnerable in this hour of need. While it might take a while to get back to normalcy, even small acts of kindness can make this easier.”
“We have always stood by communities during natural calamities and disasters. This is no different. In this digital era, generosity can flow unhinged even when physical infrastructure crumbles. Many of our donors have reached out to us for verified, credible avenues to express their support for citizen-led fundraising initiatives. Within a week, nearly 6000 donors have supported fundraisers under the cause and the number is rising as we speak. Since the only way to fight a crisis at this scale is to do it together, Milaap is doing its best so that people can help each other. On our end, we are offering the platform at a zero percent fee so that people in need can get all the help coming their way.” he added.
Mumbai, India: Covid-19, the disease caused by the novel coronavirus, has infected more than 4.9 lakh people worldwide, killing more than 22,000. In India alone, it has so far caused 17 deaths and infected at least 600 people across 27 states, as of 27th March 2020. In the past week, several states across India have put safety first by closing down schools, colleges, malls, theatres, restaurants, shops and non-essential workplaces, recommending working from home wherever possible. The country is now under a lockdown for 21 days.
However, there are many people in our society like doctors, nurses, delivery staff, conservancy workers (garbage/waste segregators) and field volunteers, among others, still working tirelessly to ensure our societal needs are met: often at the risk of their personal safety. Moreover, with the increasing number of people being tested positive worldwide, it’s also important to remember that not everyone can remain in quarantine without their lives being completely upturned. The financial impact of the pandemic, especially on blue-collar workers and families that survive on a daily wage, is far reaching.
This Sunday, on March 22 2020, Milaap, South Asia’s largest crowdfunding platform, opened itself up for fundraisers around Covid-19. In an attempt to help those whose lives have been worst affected by the pandemic, a separate page, www.milaap.org/covid19 has been launched. The causes range from providing essentials to nearby slums in bigger cities to equipping doctors / their social initiatives with protective gear, and even ventilators for smaller hospitals without the facility. While renowned people like Luis Miranda and Venkat Iyer have set up fundraisers on one hand, there are many regular individuals who are raising funds to support particular families in distress around them. In the spirit of global solidarity, Milaap has waived off their platform fee completely for all fundraisers under this cause.
Mayukh Choudhury, CEO and Co-founder of Milaap said, “This crowd funding project is to highlight citizen initiatives across India to mitigate the economic crisis faced by vulnerable families, as well as to support those who are in the frontlines, with the monetary resources they deserve. Our larger objective is to inspire each one of us to look within our circles, our neighbourhoods, and support the vulnerable in this hour of need. While it might take a while to get back to normalcy, even small acts of kindness can make this easier.”
“We have always stood by communities during natural calamities and disasters. This is no different. In this digital era, generosity can flow unhinged even when physical infrastructure crumbles. Many of our donors have reached out to us for verified, credible avenues to express their support for citizen-led fundraising initiatives. Within a week, nearly 6000 donors have supported fundraisers under the cause and the number is rising as we speak. Since the only way to fight a crisis at this scale is to do it together, Milaap is doing its best so that people can help each other. On our end, we are offering the platform at a zero percent fee so that people in need can get all the help coming their way.” he added.
Global Biopharmaceutical Industry Pulling Out All the Stops to Address Coronavirus Public Health Crisis
Mumbai, India: The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), representing the world’s leading biopharmaceutical companies, has very recently confirmed that having already mobilized on an unprecedented scale to respond to the COVID-19 pandemic, they commit to do more. The biopharmaceutical industry commits to accelerate its effort to use its skills, technology, and resources to bring safe & effective diagnostics, treatments, and vaccines to patients around the world as a matter of urgency.
David Ricks, Chairman and CEO of Eli Lilly and Co, and IFPMA President, said: “We are sending a clear signal of how seriously industry is taking the pandemic and the need to act as one team. So, we are sharing our commitments on how we, as an industry, are stepping up to do all we can to fight this pandemic”.
The commitments demonstrate the combined will of leading companies in the field to share scientific expertise, technical skills and manufacturing capabilities to bring forward therapies and vaccines to protect humankind from this escalating pandemic. The biopharmaceutical industry is uniquely positioned to work in partnership with governments, the WHO and health systems across the world in a concerted, collective response.
Among the commitments are to:
Today, more than 80 clinical trials are underway to test new and existing medicines. At least nine IFPMA member companies are researching and developing new diagnostic tests, vaccines or treatments and testing existing medicines to treat those infected with the virus. Other companies are involved in fast-tracking diagnostic technology to help detect cases more rapidly.
There is an unprecedented level of collaboration taking place across the industry as it joins hands with public agencies to further accelerate the development of new diagnostic tests, vaccines and treatments for patients. Numerous collaborative research programmes have been agreed in order to fast-track the development of therapeutics and vaccines with institutions such as BARDA, CEPI, IMI and others. The biopharmaceutical industry commits to continue collaborating with government agencies, academia and other health care stakeholders to ensure patients get the care they need.
Thomas Cueni, IFPMA Director General, says the gravity of the COVID-19 pandemic demands extraordinary efforts across the board. He declares: “Society needs to know it can count on the biopharmaceutical industry to work to rapidly bring forward therapies, vaccines and diagnostics that protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises”.
He adds: “My first thoughts are obviously with all those impacted by the pandemic”. The gravity of the situation calls for an unprecedented one-team approach across the entire pharmaceutical industry: “We need to rally around this action plan that demonstrates our willingness to act”.
The profound global impact of the COVID-19 pandemic means business as usual is not an option. It is posing a serious threat to the functioning of healthcare systems and to healthcare professionals. If not contained, the expected impact of COVID-19 on all health systems, let alone weaker health systems in low- and middle-income countries, will be devastating.
Mumbai, India: The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), representing the world’s leading biopharmaceutical companies, has very recently confirmed that having already mobilized on an unprecedented scale to respond to the COVID-19 pandemic, they commit to do more. The biopharmaceutical industry commits to accelerate its effort to use its skills, technology, and resources to bring safe & effective diagnostics, treatments, and vaccines to patients around the world as a matter of urgency.
David Ricks, Chairman and CEO of Eli Lilly and Co, and IFPMA President, said: “We are sending a clear signal of how seriously industry is taking the pandemic and the need to act as one team. So, we are sharing our commitments on how we, as an industry, are stepping up to do all we can to fight this pandemic”.
The commitments demonstrate the combined will of leading companies in the field to share scientific expertise, technical skills and manufacturing capabilities to bring forward therapies and vaccines to protect humankind from this escalating pandemic. The biopharmaceutical industry is uniquely positioned to work in partnership with governments, the WHO and health systems across the world in a concerted, collective response.
Among the commitments are to:
- use Industry’s expertise and know-how to speed up the development of safe and effective vaccines, partnering with others to make it possible;
- use Industry’s medical expertise to support global healthcare systems to manage the unprecedented increase in pressure they face;
- share tools and insights to test potential therapies and vaccines as well as developing and scaling up capacity ofdiagnostics for testing for COVID-19 patients as much as possible;
- increase industry’s manufacturing capabilities and willingly share available capacity to ramp up production once a successful vaccine or treatment is developed;
- work to secure continuity of supply for all essential medicines, vaccines and diagnostics for patients with other life-threatening diseases, calling on governments to implement policies and decisions that facilitate access for those in need.
Today, more than 80 clinical trials are underway to test new and existing medicines. At least nine IFPMA member companies are researching and developing new diagnostic tests, vaccines or treatments and testing existing medicines to treat those infected with the virus. Other companies are involved in fast-tracking diagnostic technology to help detect cases more rapidly.
There is an unprecedented level of collaboration taking place across the industry as it joins hands with public agencies to further accelerate the development of new diagnostic tests, vaccines and treatments for patients. Numerous collaborative research programmes have been agreed in order to fast-track the development of therapeutics and vaccines with institutions such as BARDA, CEPI, IMI and others. The biopharmaceutical industry commits to continue collaborating with government agencies, academia and other health care stakeholders to ensure patients get the care they need.
Thomas Cueni, IFPMA Director General, says the gravity of the COVID-19 pandemic demands extraordinary efforts across the board. He declares: “Society needs to know it can count on the biopharmaceutical industry to work to rapidly bring forward therapies, vaccines and diagnostics that protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises”.
He adds: “My first thoughts are obviously with all those impacted by the pandemic”. The gravity of the situation calls for an unprecedented one-team approach across the entire pharmaceutical industry: “We need to rally around this action plan that demonstrates our willingness to act”.
The profound global impact of the COVID-19 pandemic means business as usual is not an option. It is posing a serious threat to the functioning of healthcare systems and to healthcare professionals. If not contained, the expected impact of COVID-19 on all health systems, let alone weaker health systems in low- and middle-income countries, will be devastating.
- Backgrounder: The biopharmaceutical industry is leading the way in developing vaccines and treatments for COVID-19 (March 2020).
Astellas Partnered with CytomX Therapeutics for Cancer Treatment
Tokyo, Japan: Astellas has entered into a new partnership with CytomX Therapeutics, in order to develop T-cell engaging bispecific antibodies targeting CD3 and tumour cell surface antigens for the treatment of cancer.
The companies have revealed that the deal, which is potentially worth more than USD 1.6 billion, will focus on several initial programmes, with CytomX leading research and discovery activities, up to clinical candidate selection, which will be funded by Astellas.
As part of the deal, Astellas has confirmed that it will make an upfront cash payment of $80 million to CytomX, with the latter eligible to receive future milestones of over $1.6 billion, plus tiered royalties on global net sales that range from high-single digits to mid-teens.
Further to the agreement, the businesses will utilise CytomX's Probody therapeutic technology platform, as well as its bispecific formats and CD3 modules.
The drugmakers noted that Probody therapeutics are designed to remain inactive until they are activated by proteases in the tumour microenvironment, thereby reducing toxicities and potentially creating safer, more effective therapies. The parties explained that Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells to tumour microenvironments, leading to cell-mediated anti-cancer activity.
"Immuno-oncology is a primary focus of our R&D strategy, and we are working on the development of next-generation cancer immuno-therapy using new modalities/technologies," commented Naoki Okamura, chief strategy officer at Astellas.
Tokyo, Japan: Astellas has entered into a new partnership with CytomX Therapeutics, in order to develop T-cell engaging bispecific antibodies targeting CD3 and tumour cell surface antigens for the treatment of cancer.
The companies have revealed that the deal, which is potentially worth more than USD 1.6 billion, will focus on several initial programmes, with CytomX leading research and discovery activities, up to clinical candidate selection, which will be funded by Astellas.
As part of the deal, Astellas has confirmed that it will make an upfront cash payment of $80 million to CytomX, with the latter eligible to receive future milestones of over $1.6 billion, plus tiered royalties on global net sales that range from high-single digits to mid-teens.
Further to the agreement, the businesses will utilise CytomX's Probody therapeutic technology platform, as well as its bispecific formats and CD3 modules.
The drugmakers noted that Probody therapeutics are designed to remain inactive until they are activated by proteases in the tumour microenvironment, thereby reducing toxicities and potentially creating safer, more effective therapies. The parties explained that Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells to tumour microenvironments, leading to cell-mediated anti-cancer activity.
"Immuno-oncology is a primary focus of our R&D strategy, and we are working on the development of next-generation cancer immuno-therapy using new modalities/technologies," commented Naoki Okamura, chief strategy officer at Astellas.
Novavax’ NanoFlu Achieved All Primary Endpoints in Phase 3 Clinical Trial
Gaithersburg, US: Novavax Inc, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has recently announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.
The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine.
NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs). “With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”
The trial’s key secondary endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents, which are expected to provide a more accurate assessment of clinically relevant HAI antibody responses against circulating wild-type viruses.
NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine : 24%-66% higher GMT responses and 11.4-20.4 higher SCR percentage points. NanoFlu also demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent for four tested drifted H3N2 strains not included in the vaccine but circulating this year: 34%-41% higher GMT responses, and 14.1-16.8 higher SCR percentage points.
“In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents,” said Gregory Glenn, M.D., President of Research and Development of Novavax. “NanoFlu demonstrated significant improvement against four drifted H3N2 strains that are co-circulating this year. These data, similar to what was shown in our Phase 2 clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift. We extend our sincere appreciation to those who volunteered for this important study and to our clinical partners who worked so quickly and diligently on this trial.”
Gaithersburg, US: Novavax Inc, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has recently announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.
The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine.
NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs). “With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”
The trial’s key secondary endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents, which are expected to provide a more accurate assessment of clinically relevant HAI antibody responses against circulating wild-type viruses.
NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine : 24%-66% higher GMT responses and 11.4-20.4 higher SCR percentage points. NanoFlu also demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent for four tested drifted H3N2 strains not included in the vaccine but circulating this year: 34%-41% higher GMT responses, and 14.1-16.8 higher SCR percentage points.
“In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents,” said Gregory Glenn, M.D., President of Research and Development of Novavax. “NanoFlu demonstrated significant improvement against four drifted H3N2 strains that are co-circulating this year. These data, similar to what was shown in our Phase 2 clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift. We extend our sincere appreciation to those who volunteered for this important study and to our clinical partners who worked so quickly and diligently on this trial.”
Eisai Submits Marketing Authorization Application for Anticancer Agent Denileukin Diftitox
Tokyo, Japan: Eisai Co Ltd has announced that it has submitted in Japan a marketing authorization application of the anticancer agent denileukin diftitox (genetic recombinant) (generic name, development code: E7777) for relapsed or refractory Cutaneous T-cell Lymphoma (CTCL) and Peripheral T-cell Lymphoma (PTCL).
This application is based on data from a multicenter, open-label, single-arm Phase II clinical study (study 205) conducted in Japan for patients with relapsed or refractory CTCL or PTCL to evaluate the efficacy and safety of this agent.
This study achieved the primary endpoint and exceeded a predetermined threshold with statistical significance: the objective response rate (ORR) of CTCL and PTCL patients in total (n=36) was 36.1 percent (95 percent confidence interval (CI): 20.8 - 53.8). The ORRs of each subtype were 31.6 percent (95 percent CI:12.6-56.6) for CTCL (n=19) and 41.2 percent (95 percent CI: 18.4-67.1) for PTCL (n=17).
The five most frequent adverse events observed in this study were increased aspartate aminotransferase (AST) (89.2 percent), increased alanine aminotransferase (ALT) (86.5 percent), hypoalbuminaemia (70.3 percent), lymphopenia (70.3 percent), and pyrexia (51.4 percent).
Denileukin diftitox (genetic recombinant) is a fusion protein of the receptor-binding portion of interleukin-2 (IL-2) and diphtheria toxin that specifically binds to the IL-2 receptor on the surface of tumoral lymphocyte. The antitumor effect of denileukin diftitox depends on the intracellular delivery of diphtheria toxin which inhibits protein synthesis and induces cell death. The agent has been evaluated as a drug with high medical need by the "Study Group for Unapproved Drugs/Off-Label Drugs for High Medical Needs"(1), and Eisai has been requested to develop it by the Ministry of Health, Labour and Welfare.
Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.
The Study Group set up within the Ministry of Health, Labour and Welfare with the purpose of contributing to enhancing the development of drugs and indications that have not been approved in Japan (unapproved drugs/off-label drugs) by pharmaceutical companies. In addition to evaluating the medical needs of unapproved drugs/off-label drugs, their responsibilities include evaluating the applicability of the drug to an Application with Public Knowledge, and the adequacy of additional clinical studies that need to be conducted for filing applications for approval, and so on.
Tokyo, Japan: Eisai Co Ltd has announced that it has submitted in Japan a marketing authorization application of the anticancer agent denileukin diftitox (genetic recombinant) (generic name, development code: E7777) for relapsed or refractory Cutaneous T-cell Lymphoma (CTCL) and Peripheral T-cell Lymphoma (PTCL).
This application is based on data from a multicenter, open-label, single-arm Phase II clinical study (study 205) conducted in Japan for patients with relapsed or refractory CTCL or PTCL to evaluate the efficacy and safety of this agent.
This study achieved the primary endpoint and exceeded a predetermined threshold with statistical significance: the objective response rate (ORR) of CTCL and PTCL patients in total (n=36) was 36.1 percent (95 percent confidence interval (CI): 20.8 - 53.8). The ORRs of each subtype were 31.6 percent (95 percent CI:12.6-56.6) for CTCL (n=19) and 41.2 percent (95 percent CI: 18.4-67.1) for PTCL (n=17).
The five most frequent adverse events observed in this study were increased aspartate aminotransferase (AST) (89.2 percent), increased alanine aminotransferase (ALT) (86.5 percent), hypoalbuminaemia (70.3 percent), lymphopenia (70.3 percent), and pyrexia (51.4 percent).
Denileukin diftitox (genetic recombinant) is a fusion protein of the receptor-binding portion of interleukin-2 (IL-2) and diphtheria toxin that specifically binds to the IL-2 receptor on the surface of tumoral lymphocyte. The antitumor effect of denileukin diftitox depends on the intracellular delivery of diphtheria toxin which inhibits protein synthesis and induces cell death. The agent has been evaluated as a drug with high medical need by the "Study Group for Unapproved Drugs/Off-Label Drugs for High Medical Needs"(1), and Eisai has been requested to develop it by the Ministry of Health, Labour and Welfare.
Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.
The Study Group set up within the Ministry of Health, Labour and Welfare with the purpose of contributing to enhancing the development of drugs and indications that have not been approved in Japan (unapproved drugs/off-label drugs) by pharmaceutical companies. In addition to evaluating the medical needs of unapproved drugs/off-label drugs, their responsibilities include evaluating the applicability of the drug to an Application with Public Knowledge, and the adequacy of additional clinical studies that need to be conducted for filing applications for approval, and so on.
e-Zest and Neurosynaptic Announced a Solution to Help Control the COVID-19 Pandemic
Pune, India: e-Zest Solutions and Neurosynaptic Communications has recently announced the ReMeDi® SCAN-CORONA platform, an innovative technology solution to help control the Novel COVID-19 pandemic.
As countries worldwide grapple to contain the spread and flatten the curve while treating the ones infected, the need of the hour is to deploy widespread screening and testing procedures to identify and isolate those showing symptoms.
The ReMeDi® SCAN-CORONA platform has a 3-pronged approach to controlling the Pandemic that makes the task of Screening, Testing, Tracking and Reporting extremely easy and manageable at a large scale.
Shree Shingane – Founder and Managing Director, e-Zest Solutions GmbH “Mass screening and testing is the need of the hour. With the scarcity of Healthcare Professionals, there is a need of technology enabled platforms to do this at a large scale with minimal to no human intervention. The ReMeDi® SCAN-CORONA brings together remote healthcare expertise and the power of emerging technology such as AI & ML, and promises to reduce the load on the healthcare system, so that timely care reaches the right set of people as fast as possible.”
The solution features a Corona-Screen Kit – a portable, lightweight kit that includes basic screening tools that seamlessly connect and feed data into a Patient Health Record (PHR) system without any manual intervention. It also features a geo-tagging powered Screening app that, by importing and analyzing data from the screening tools as well as travel and medical history. The input from a 3rd party COVID-19 rapid testing kit further enhances the accuracy of the outcome.
“ReMeDi® SCAN-CORONA helps front-line health workers to quickly assess the essential risk factors for a person digitally. It has the unique ability to track the progression of symptoms with time. The Tele-consultation facility allows individuals to obtain counselling as well as consult doctors independent of location, to access timely information and guidance. We are proud to present this solution in collaboration with e-Zest” said Sameer Sawarkar CEO -Neurosynaptic.
The beauty of this solution is that while it can bring a big relief for COVID-19 screening efforts, it is equally advantageous to heavily burdened Healthcare Providers in remotely treating the non-Corona health requirements as well.
The team acknowledges the valuable contribution in terms of clinical inputs for application development, from Dr. Nandakumar, a renowned Public Health expert.
e-Zest CEO Devendra Deshmukh said “e-Zest vision is to leverage Healthcare technologies to impact human life positively. We are happy to be part of this collaboration & look forward to it’s contribution to combat the pandemic challenge globally.”
Pune, India: e-Zest Solutions and Neurosynaptic Communications has recently announced the ReMeDi® SCAN-CORONA platform, an innovative technology solution to help control the Novel COVID-19 pandemic.
As countries worldwide grapple to contain the spread and flatten the curve while treating the ones infected, the need of the hour is to deploy widespread screening and testing procedures to identify and isolate those showing symptoms.
The ReMeDi® SCAN-CORONA platform has a 3-pronged approach to controlling the Pandemic that makes the task of Screening, Testing, Tracking and Reporting extremely easy and manageable at a large scale.
Shree Shingane – Founder and Managing Director, e-Zest Solutions GmbH “Mass screening and testing is the need of the hour. With the scarcity of Healthcare Professionals, there is a need of technology enabled platforms to do this at a large scale with minimal to no human intervention. The ReMeDi® SCAN-CORONA brings together remote healthcare expertise and the power of emerging technology such as AI & ML, and promises to reduce the load on the healthcare system, so that timely care reaches the right set of people as fast as possible.”
The solution features a Corona-Screen Kit – a portable, lightweight kit that includes basic screening tools that seamlessly connect and feed data into a Patient Health Record (PHR) system without any manual intervention. It also features a geo-tagging powered Screening app that, by importing and analyzing data from the screening tools as well as travel and medical history. The input from a 3rd party COVID-19 rapid testing kit further enhances the accuracy of the outcome.
“ReMeDi® SCAN-CORONA helps front-line health workers to quickly assess the essential risk factors for a person digitally. It has the unique ability to track the progression of symptoms with time. The Tele-consultation facility allows individuals to obtain counselling as well as consult doctors independent of location, to access timely information and guidance. We are proud to present this solution in collaboration with e-Zest” said Sameer Sawarkar CEO -Neurosynaptic.
The beauty of this solution is that while it can bring a big relief for COVID-19 screening efforts, it is equally advantageous to heavily burdened Healthcare Providers in remotely treating the non-Corona health requirements as well.
The team acknowledges the valuable contribution in terms of clinical inputs for application development, from Dr. Nandakumar, a renowned Public Health expert.
e-Zest CEO Devendra Deshmukh said “e-Zest vision is to leverage Healthcare technologies to impact human life positively. We are happy to be part of this collaboration & look forward to it’s contribution to combat the pandemic challenge globally.”
Neuberg Formally Joined the War Against Covid-19
Chennai, India: Neuberg Diagnostics Private Limited, a StartUp in the PathLab chain segment, has recently announced the commencement of COVID testing in its Neuberg Ehrlich Laboratory, Chennai post the approval from ICMR. Neuberg is the only Lab Chain in India, whose 4 facilities have been approved by ICMR and will offer COVID – 19 RT PCR tests through its laboratory in Ahmedabad (Neuberg Supratech), Bangalore (Neuberg Anand), Chennai (Neuberg Ehrlich) and Pune (Neuberg AG).
Commenting on the development, Dr. GSK Velu, Chairman & Managing Director, Neuberg Diagnostics Private Limited said “COVID-19 has been declared a global emergency by the World Health Organization, as the outbreak continues to spread beyond China. India is currently between Stage 2 and Stage 3 of the disease spread. The Government of India is taking the right measures to curtail its spread. Neuberg is happy to support its efforts towards testing of a symptomatic individual currently and later asymptomatic individuals, as it may be required to augment the travel ban, identify individuals with the infection, isolate them so that the virus can be curtailed.”
“We have also set up a special support fund for the weaker sections of the society. Through this we will offer free of cost testing to people with a BPL ration card and appropriate doctor prescriptions,” added Velu.
Neuberg will be scaling up its capacity up to 2000 to 2500 tests per day as per ICMR guidelines by next week.
Dr. Saranya Narayan, Technical Director & Chief Microbiologist, Neuberg Diagnostics Private Limited said, “Neuberg Ehrlich Laboratory, Chennai has started collecting COVID samples from the lab as well as home from 8 am to 4 pm. The mandatory requirement is the Identity and Address proof, Requisition/Prescription from Physician with their Medical registration number. Neuberg will provide reports within 24 hours in Ahmedabad, Bangalore, Chennai and Pune and within 48 hours from other cities subject to uninterrupted courier movements.”
“Reporting and sample acceptance will be strictly in accordance with the ICMR guidelines and will follow ICMR prescribed MRP of INR 4500,” she added.
Home pick will also be done through PPE equipped phlebotomists in these four cities.
The COVID-19 testing in Neuberg’s labs will follow guidelines by ICMR and other competent government agencies. COVID–19 samples from hospitals, nursing homes, and other healthcare providers can be tested in the labs. People who fall under the testing criteria set by ICMR can get themselves tested at Neuberg’s labs, but they need to contact the lab before visiting to ensure minimal risk of community spread and need to call on 04448505050 and 8939999215 (between 8 am and 8 pm). If the patient has no travel history but is in the hospital with symptoms of respiratory illness like pneumonia, she or he can also be tested.
As per the guidelines issued by ICMR for COVID-19 testing in private laboratories, Neuberg will provide the test to an individual only when prescribed by a qualified physician, while also adhering to the sample collection and testing guidelines set by ICMR. All COVID-19 positive samples will be transported to ICMR-NIV (National Institute of Virology), Pune under suitable Biosafety and Biosecurity precautions as laid down by ICMR.
Chennai, India: Neuberg Diagnostics Private Limited, a StartUp in the PathLab chain segment, has recently announced the commencement of COVID testing in its Neuberg Ehrlich Laboratory, Chennai post the approval from ICMR. Neuberg is the only Lab Chain in India, whose 4 facilities have been approved by ICMR and will offer COVID – 19 RT PCR tests through its laboratory in Ahmedabad (Neuberg Supratech), Bangalore (Neuberg Anand), Chennai (Neuberg Ehrlich) and Pune (Neuberg AG).
Commenting on the development, Dr. GSK Velu, Chairman & Managing Director, Neuberg Diagnostics Private Limited said “COVID-19 has been declared a global emergency by the World Health Organization, as the outbreak continues to spread beyond China. India is currently between Stage 2 and Stage 3 of the disease spread. The Government of India is taking the right measures to curtail its spread. Neuberg is happy to support its efforts towards testing of a symptomatic individual currently and later asymptomatic individuals, as it may be required to augment the travel ban, identify individuals with the infection, isolate them so that the virus can be curtailed.”
“We have also set up a special support fund for the weaker sections of the society. Through this we will offer free of cost testing to people with a BPL ration card and appropriate doctor prescriptions,” added Velu.
Neuberg will be scaling up its capacity up to 2000 to 2500 tests per day as per ICMR guidelines by next week.
Dr. Saranya Narayan, Technical Director & Chief Microbiologist, Neuberg Diagnostics Private Limited said, “Neuberg Ehrlich Laboratory, Chennai has started collecting COVID samples from the lab as well as home from 8 am to 4 pm. The mandatory requirement is the Identity and Address proof, Requisition/Prescription from Physician with their Medical registration number. Neuberg will provide reports within 24 hours in Ahmedabad, Bangalore, Chennai and Pune and within 48 hours from other cities subject to uninterrupted courier movements.”
“Reporting and sample acceptance will be strictly in accordance with the ICMR guidelines and will follow ICMR prescribed MRP of INR 4500,” she added.
Home pick will also be done through PPE equipped phlebotomists in these four cities.
The COVID-19 testing in Neuberg’s labs will follow guidelines by ICMR and other competent government agencies. COVID–19 samples from hospitals, nursing homes, and other healthcare providers can be tested in the labs. People who fall under the testing criteria set by ICMR can get themselves tested at Neuberg’s labs, but they need to contact the lab before visiting to ensure minimal risk of community spread and need to call on 04448505050 and 8939999215 (between 8 am and 8 pm). If the patient has no travel history but is in the hospital with symptoms of respiratory illness like pneumonia, she or he can also be tested.
As per the guidelines issued by ICMR for COVID-19 testing in private laboratories, Neuberg will provide the test to an individual only when prescribed by a qualified physician, while also adhering to the sample collection and testing guidelines set by ICMR. All COVID-19 positive samples will be transported to ICMR-NIV (National Institute of Virology), Pune under suitable Biosafety and Biosecurity precautions as laid down by ICMR.
Sartorius Supports the Development of the First Vaccine Candidate Against the Novel Coronavirus to Enter Clinical Trials
Shanghai, China: Sartorius, a leading international partner of life science research and the biopharmaceutical industry, has supported CanSino Biologics Inc. (“CanSinoBIO”) and Maj. Gen. Chen Wei’s team at the Institute of Bioengineering at the Academy of Military Medical Sciences (“Institute of Bioengineering”) in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimately saving time during development.
The BIOSTAT® STR single-use bioreactor system comes with updated BioPAT® toolbox for process monitoring, as well as Flexsafe® STR integrated, single-use bioprocess bags. It has been proven to be used for vaccine manufacturing because it offers rapid scalability and flexibility to adapt to fluctuating demand. The single use bags prevent cross-contamination, and reduce the time needed for washing and sanitation typical in stainless steel bioreactors. As such, the amount of time needed to prepare a vector for a vaccine is shortened from several months to (several) weeks.
“We are pleased that we can help our clients and partners accelerate vaccine development while maintaining compliance with safety protocols, thereby allowing us to contribute to better health for more people,” said Huang Xian, Head of Marketing at Sartorius BPS China. “The Sartorius team is making every effort to quickly allocate the staff and equipment needed to support the early stages of vaccine development during this high-risk period. We hope that Ad5-nCoV will achieve approval as early as possible, so it can help stop the spread of the novel coronavirus worldwide.”
This is the second collaboration from Sartorius, CanSinoBIO, and the Institute of Bioengineering to accelerate vaccine development. In October 2017, Sartorius’ BIOSTAT® STR50 bioreactor system was used during CanSinoBIO’s and the Institute of Bioengineering’s joint development of a recombinant vaccine against Ebola virus disease. This was the first registered Ebola vaccine in the world.
Shanghai, China: Sartorius, a leading international partner of life science research and the biopharmaceutical industry, has supported CanSino Biologics Inc. (“CanSinoBIO”) and Maj. Gen. Chen Wei’s team at the Institute of Bioengineering at the Academy of Military Medical Sciences (“Institute of Bioengineering”) in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimately saving time during development.
The BIOSTAT® STR single-use bioreactor system comes with updated BioPAT® toolbox for process monitoring, as well as Flexsafe® STR integrated, single-use bioprocess bags. It has been proven to be used for vaccine manufacturing because it offers rapid scalability and flexibility to adapt to fluctuating demand. The single use bags prevent cross-contamination, and reduce the time needed for washing and sanitation typical in stainless steel bioreactors. As such, the amount of time needed to prepare a vector for a vaccine is shortened from several months to (several) weeks.
“We are pleased that we can help our clients and partners accelerate vaccine development while maintaining compliance with safety protocols, thereby allowing us to contribute to better health for more people,” said Huang Xian, Head of Marketing at Sartorius BPS China. “The Sartorius team is making every effort to quickly allocate the staff and equipment needed to support the early stages of vaccine development during this high-risk period. We hope that Ad5-nCoV will achieve approval as early as possible, so it can help stop the spread of the novel coronavirus worldwide.”
This is the second collaboration from Sartorius, CanSinoBIO, and the Institute of Bioengineering to accelerate vaccine development. In October 2017, Sartorius’ BIOSTAT® STR50 bioreactor system was used during CanSinoBIO’s and the Institute of Bioengineering’s joint development of a recombinant vaccine against Ebola virus disease. This was the first registered Ebola vaccine in the world.
Cipla Receives Final Approval for Generic Version of AstraZeneca Pharmaceutical’s Nexium®
Mumbai, India: Cipla Limited has recently announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (US FDA). Cipla is the first company to file for the 10mg strength.
Cipla’s Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical’s Nexium®. It is a proton pump inhibitor indicated for the following:
Mumbai, India: Cipla Limited has recently announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (US FDA). Cipla is the first company to file for the 10mg strength.
Cipla’s Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical’s Nexium®. It is a proton pump inhibitor indicated for the following:
- Treatment of gastroesophageal reflux disease (GERD).
- Risk reduction of NSAID-associated gastric ulcer.
- H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
- Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Eisai's Discovery Research on Multikinase Inhibitor Lenvatinib Honored with PSJ Award for Drug Research and Development '20
Tokyo, Japan: Eisai Co Ltd has recently announced that drug discovery research conducted on lenvatinib mesylate (brand name: LENVIMA, lenvatinib), the orally available multikinase inhibitor discovered by Eisai, has been honored with The Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development '20 by the PSJ.
The PSJ Award for Drug Research and Development is one of a series of awards presented by the PSJ and is dedicated to researchers who have conducted outstanding research work that has contributed to medicine through the innovative development of a pharmaceutical drug or applicable technology related to the pharmaceutical sciences. Award recipients are evaluated by the PSJ based on the ingenuity of the research itself as well as the effectiveness and safety of the related pharmaceutical product(s) or the innovativeness of the related medical treatment or treatment technology. The PSJ Award for Drug Research and Development was introduced by the PSJ in 1988, with Eisai previously receiving the award for drug discovery research in 1998 on donepezil hydrochloride, an Alzheimer's disease treatment, and in 2013 on eribulin mesylate, an anti-cancer agent.
The reasons for the selection of this discovery research for the award are outlined by the PSJ as follows. First, Eisai researchers created lenvatinib as a new type of kinase inhibitor with type V binding mode through a creation of the original screening models reflecting human disease and refined optimization of leading compounds. Furthermore, lenvatinib mesylate demonstrated antitumor activity against various types of cancer in clinical trials, which was accomplished with strategic application of drug properties to selectively inhibit kinases associated with tumor growth and pathogenic angiogenesis. At the time of application for the award, lenvatinib mesylate received approval as a treatment for refractory thyroid cancer, unresectable hepatocellular carcinoma, and advanced renal cell carcinoma. Finally, lenvatinib discovery research realized an innovative drug that received the Breakthrough Therapy designation by the US Food and Drug Administration (FDA) and holds high potential to contribute to anticancer therapy worldwide.
Currently, lenvatinib has been approved as a treatment for refractory thyroid cancer in more than 60 countries including Japan, the United States, and in Europe; as a treatment for unresectable hepatocellular carcinoma in more than 55 countries including Japan, the United States, in Europe, China and in Asia; as well as in combination with everolimus as a treatment for advanced renal cell carcinoma (second-line) in more than 50 countries including the United States, in Europe and in Asia. Additionally, it is also approved in the combination treatment of lenvatinib plus KEYTRUDA (pembrolizumab) for advanced endometrial carcinoma in the United States, Australia, and Canada.
Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai is committed to exploring the potential clinical benefits of lenvatinib and aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.
Tokyo, Japan: Eisai Co Ltd has recently announced that drug discovery research conducted on lenvatinib mesylate (brand name: LENVIMA, lenvatinib), the orally available multikinase inhibitor discovered by Eisai, has been honored with The Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development '20 by the PSJ.
The PSJ Award for Drug Research and Development is one of a series of awards presented by the PSJ and is dedicated to researchers who have conducted outstanding research work that has contributed to medicine through the innovative development of a pharmaceutical drug or applicable technology related to the pharmaceutical sciences. Award recipients are evaluated by the PSJ based on the ingenuity of the research itself as well as the effectiveness and safety of the related pharmaceutical product(s) or the innovativeness of the related medical treatment or treatment technology. The PSJ Award for Drug Research and Development was introduced by the PSJ in 1988, with Eisai previously receiving the award for drug discovery research in 1998 on donepezil hydrochloride, an Alzheimer's disease treatment, and in 2013 on eribulin mesylate, an anti-cancer agent.
The reasons for the selection of this discovery research for the award are outlined by the PSJ as follows. First, Eisai researchers created lenvatinib as a new type of kinase inhibitor with type V binding mode through a creation of the original screening models reflecting human disease and refined optimization of leading compounds. Furthermore, lenvatinib mesylate demonstrated antitumor activity against various types of cancer in clinical trials, which was accomplished with strategic application of drug properties to selectively inhibit kinases associated with tumor growth and pathogenic angiogenesis. At the time of application for the award, lenvatinib mesylate received approval as a treatment for refractory thyroid cancer, unresectable hepatocellular carcinoma, and advanced renal cell carcinoma. Finally, lenvatinib discovery research realized an innovative drug that received the Breakthrough Therapy designation by the US Food and Drug Administration (FDA) and holds high potential to contribute to anticancer therapy worldwide.
Currently, lenvatinib has been approved as a treatment for refractory thyroid cancer in more than 60 countries including Japan, the United States, and in Europe; as a treatment for unresectable hepatocellular carcinoma in more than 55 countries including Japan, the United States, in Europe, China and in Asia; as well as in combination with everolimus as a treatment for advanced renal cell carcinoma (second-line) in more than 50 countries including the United States, in Europe and in Asia. Additionally, it is also approved in the combination treatment of lenvatinib plus KEYTRUDA (pembrolizumab) for advanced endometrial carcinoma in the United States, Australia, and Canada.
Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai is committed to exploring the potential clinical benefits of lenvatinib and aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.
Dr Mahendra Nayak Takes Over as Area Head for India, CIS, Middle East, Turkey, and Africa Takeda
Dr.Mahender Nayak has assumed responsibility as Area Head for the Company’s ICMEA (India, C.I.S., Middle East, Turkey, and Africa) Area. In his current capacity, Dr. Nayak will lead the company’s operations from Dubai, United Arab Emirates (UAE), where he will be based. Dr. Nayak has more than 20 years of performance-driven leadership experience in the biopharmaceutical industry, having worked in multi-national and regional companies. Before this role, he oversaw Portfolio Management for Takeda’s Growth and Emerging Markets Business Unit based in Singapore (2018 to 2020). Prior to that, Dr. Nayak was the General Manager of Takeda’s operations in Korea. Commenting on his new role, Dr. Nayak said, “This is an exciting time to move to a part of the world that is teeming with great opportunities to increase patient access to Takeda’s highly innovative medicines. We aim to do this through our commercial activities and commitments around our approaches to Access to Medicines across rare diseases, oncology, neuroscience and gastroenterology.” Across ICMEA, Takeda collaborates with governments and regulators, to ensure that its diverse portfolio of innovative medicines is made available to patients as quickly and safely as possible.
“These countries are open to innovation and partnering with world-leading R&D-led organizations like Takeda. Our diverse talent across the company’s presence in over 82 geographies bring many different experiences, backgrounds, cultures, and perspectives that help drive health innovation and ultimately benefit patients. This can only be done by nurturing and developing the best talents and ultimately becoming an employer of choice” added Dr. Nayak.
Dr.Mahender Nayak has assumed responsibility as Area Head for the Company’s ICMEA (India, C.I.S., Middle East, Turkey, and Africa) Area. In his current capacity, Dr. Nayak will lead the company’s operations from Dubai, United Arab Emirates (UAE), where he will be based. Dr. Nayak has more than 20 years of performance-driven leadership experience in the biopharmaceutical industry, having worked in multi-national and regional companies. Before this role, he oversaw Portfolio Management for Takeda’s Growth and Emerging Markets Business Unit based in Singapore (2018 to 2020). Prior to that, Dr. Nayak was the General Manager of Takeda’s operations in Korea. Commenting on his new role, Dr. Nayak said, “This is an exciting time to move to a part of the world that is teeming with great opportunities to increase patient access to Takeda’s highly innovative medicines. We aim to do this through our commercial activities and commitments around our approaches to Access to Medicines across rare diseases, oncology, neuroscience and gastroenterology.” Across ICMEA, Takeda collaborates with governments and regulators, to ensure that its diverse portfolio of innovative medicines is made available to patients as quickly and safely as possible.
“These countries are open to innovation and partnering with world-leading R&D-led organizations like Takeda. Our diverse talent across the company’s presence in over 82 geographies bring many different experiences, backgrounds, cultures, and perspectives that help drive health innovation and ultimately benefit patients. This can only be done by nurturing and developing the best talents and ultimately becoming an employer of choice” added Dr. Nayak.
Syntegon Technology Appointed Dr Michael Grosse as
Chief Executive Officer
Waiblingen, Germany: Syntegon Technology, a globally leading supplier of processing and packaging technology, has recently appointed Dr Michael Grosse as new Chief Executive Officer (CEO). Most recently, Michael Grosse was a member of the Management Board of Tetra Pak. He has relevant leadership and management experience in the international mechanical engineering industry, particularly in the areas of process and packaging technology for the food industry. Michael Grosse joined Tetra Pak in 2003 and was, among other things, responsible for expanding the global services business. Furthermore, he is an expert for new product development and process technologies. Thanks to his many years of experience, he has built an extensive network and close relationships within the food industry. Before joining Tetra Pak, he held several management positions in the automotive industry. Michael Grosse will take up his post on March 1, 2020.
He is going to succeed Dr Stefan Koenig, who spent a total of 24 years working for the Bosch Group, ten of which at Syntegon Technology, or Bosch Packaging respectively. Since 2017, he has been leading the company as CEO. In 2019, he was in charge of the company's spin-off from Robert Bosch GmbH and its subsequent sale.
"We are very pleased to have won Dr Michael Grosse, an extremely experienced and successful manager, for Syntegon Technology. Almost two decades of management experience in the packaging machinery industry and an international industry network are excellent prerequisites to further advance the successful development of Syntegon Technology. At the same time, I would like to express my sincere gratitude to Dr Stefan Koenig. He has done Syntegon Technology a great service - under his leadership, the company has not only become independent but also more profitable and more competitive," says Marc Strobel, Chairman of the Supervisory Board of Syntegon Technology.
"I am very much looking forward to my new position at Syntegon Technology. Because of its high standards in quality as well as its long tradition, Syntegon Technology is an outstanding company in the packaging industry. Together with the Syntegon Technology team, I will particularly focus on further improving customer satisfaction and profitability," says Dr Michael Grosse. "In addition, we want to offer our customers even more innovative and sustainable packaging solutions in the future and make full use of the opportunities offered by digitalisation".
In addition to the change at CEO level, Dr Walter Bickel will be appointed as a further Member of the Executive Board of Syntegon Technology as of March 1, 2020 . In his new position, he will be responsible for driving the Group’s transformation process forward decisively. Dr Walter Bickel has many years of leadership experience in top management positions within the mechanical engineering and automotive industry. He is a renowned expert in the implementation of holistic profit improvement programs, business model restructuring and leveraging additional growth potential. Between 2014 and 2018, he was CEO and CFO of the international foil manufacturer Treofan. Previous positions also include his role as COO and subsequently Member of the Supervisory Board of robotics manufacturer KUKA as
Waiblingen, Germany: Syntegon Technology, a globally leading supplier of processing and packaging technology, has recently appointed Dr Michael Grosse as new Chief Executive Officer (CEO). Most recently, Michael Grosse was a member of the Management Board of Tetra Pak. He has relevant leadership and management experience in the international mechanical engineering industry, particularly in the areas of process and packaging technology for the food industry. Michael Grosse joined Tetra Pak in 2003 and was, among other things, responsible for expanding the global services business. Furthermore, he is an expert for new product development and process technologies. Thanks to his many years of experience, he has built an extensive network and close relationships within the food industry. Before joining Tetra Pak, he held several management positions in the automotive industry. Michael Grosse will take up his post on March 1, 2020.
He is going to succeed Dr Stefan Koenig, who spent a total of 24 years working for the Bosch Group, ten of which at Syntegon Technology, or Bosch Packaging respectively. Since 2017, he has been leading the company as CEO. In 2019, he was in charge of the company's spin-off from Robert Bosch GmbH and its subsequent sale.
"We are very pleased to have won Dr Michael Grosse, an extremely experienced and successful manager, for Syntegon Technology. Almost two decades of management experience in the packaging machinery industry and an international industry network are excellent prerequisites to further advance the successful development of Syntegon Technology. At the same time, I would like to express my sincere gratitude to Dr Stefan Koenig. He has done Syntegon Technology a great service - under his leadership, the company has not only become independent but also more profitable and more competitive," says Marc Strobel, Chairman of the Supervisory Board of Syntegon Technology.
"I am very much looking forward to my new position at Syntegon Technology. Because of its high standards in quality as well as its long tradition, Syntegon Technology is an outstanding company in the packaging industry. Together with the Syntegon Technology team, I will particularly focus on further improving customer satisfaction and profitability," says Dr Michael Grosse. "In addition, we want to offer our customers even more innovative and sustainable packaging solutions in the future and make full use of the opportunities offered by digitalisation".
In addition to the change at CEO level, Dr Walter Bickel will be appointed as a further Member of the Executive Board of Syntegon Technology as of March 1, 2020 . In his new position, he will be responsible for driving the Group’s transformation process forward decisively. Dr Walter Bickel has many years of leadership experience in top management positions within the mechanical engineering and automotive industry. He is a renowned expert in the implementation of holistic profit improvement programs, business model restructuring and leveraging additional growth potential. Between 2014 and 2018, he was CEO and CFO of the international foil manufacturer Treofan. Previous positions also include his role as COO and subsequently Member of the Supervisory Board of robotics manufacturer KUKA as
B & R Introduces New Digital Output Module with Pulse Width Modulation
Pune, India: B & R's new digital output module X20DO4332-1 has integrated pulse width modulation and is a cost-effective alternative to motor modules. In addition, the module offers a dither function that prevents valves from sticking.
Pulse width modulation (PWM) is mainly used for controlling larger loads, such as motors. Instead of using electronics to regulate a continuous input voltage down to the desired motor voltage, the motor is controlled by the width of the switching pulses. This process saves a considerable amount of energy.
With its dither function, the module also prevents valves from sticking. This is particularly common when valves are held for extended times at a constant position, especially in liquids. The dither function oscillates the valve slightly around the position setpoint to prevent it from sticking. The X20 module is equipped with four outputs with three-wire connections and offers a nominal output current of 2 A.
Pune, India: B & R's new digital output module X20DO4332-1 has integrated pulse width modulation and is a cost-effective alternative to motor modules. In addition, the module offers a dither function that prevents valves from sticking.
Pulse width modulation (PWM) is mainly used for controlling larger loads, such as motors. Instead of using electronics to regulate a continuous input voltage down to the desired motor voltage, the motor is controlled by the width of the switching pulses. This process saves a considerable amount of energy.
With its dither function, the module also prevents valves from sticking. This is particularly common when valves are held for extended times at a constant position, especially in liquids. The dither function oscillates the valve slightly around the position setpoint to prevent it from sticking. The X20 module is equipped with four outputs with three-wire connections and offers a nominal output current of 2 A.
Cadila Celebrated World Cancer Day by Organizing a Bike Rally
Mumbai, India: Ahmedabad-based pharma major Cadila Pharmaceuticals and N. K. Dhabhar Foundation, organized a Bike Rally in Mumbai on Sunday 2nd February, ahead of World Cancer Day on February 4.
This bike rally was organized as a part of the ongoing campaign "I Am and I Will" where the aim is to not only raise cancer awareness and also to encourage people to take action in the fight against cancer. The campaign began on 28th January and scheduled to continue for a month. Cadila shares tips and messages on their digital channel related to cancer and how everyone can do their bits to defeat cancer. Multiple awareness rallies have been planned across the country in association with various organizations to sensitize people about cancer patients on the occasion of World Cancer Day.
More than 30 bikers of Bajaj Avenger Group took part in the awareness rally which started at 8:00 am at Shivaji Park, and culminated at Nariman Point after passing through Worli, Mahalaxmi, and Girgaum Chowpatty.
"We all need to come together against cancer and not let it win. We need to make sure that the cancer patients and survivors feel safe and know that they are not alone in the difficult journey of cancer. Cancer if detected early is curable. It can be defeated if the right support and environment is provided to the patient. We all have a huge part to play in this", said Dr Dhabhar, Head of N K Dhabhar foundation.
Cadila Pharmaceuticals has been actively taking action to spread awareness towards various diseases. The activities are aimed at sensitizing people about various illnesses such as iron deficiency, Cancer, Schizophrenia, Epilepsy, and Depression. These campaigns are meant to help people to understand the ailments better and to support them to provide care to their loved ones.
Cadila Pharmaceuticals Ltd is one of the largest privately held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused, research-driven company, we are committed to comply the highest ethical standard in clinical research and medical practice.
Mumbai, India: Ahmedabad-based pharma major Cadila Pharmaceuticals and N. K. Dhabhar Foundation, organized a Bike Rally in Mumbai on Sunday 2nd February, ahead of World Cancer Day on February 4.
This bike rally was organized as a part of the ongoing campaign "I Am and I Will" where the aim is to not only raise cancer awareness and also to encourage people to take action in the fight against cancer. The campaign began on 28th January and scheduled to continue for a month. Cadila shares tips and messages on their digital channel related to cancer and how everyone can do their bits to defeat cancer. Multiple awareness rallies have been planned across the country in association with various organizations to sensitize people about cancer patients on the occasion of World Cancer Day.
More than 30 bikers of Bajaj Avenger Group took part in the awareness rally which started at 8:00 am at Shivaji Park, and culminated at Nariman Point after passing through Worli, Mahalaxmi, and Girgaum Chowpatty.
"We all need to come together against cancer and not let it win. We need to make sure that the cancer patients and survivors feel safe and know that they are not alone in the difficult journey of cancer. Cancer if detected early is curable. It can be defeated if the right support and environment is provided to the patient. We all have a huge part to play in this", said Dr Dhabhar, Head of N K Dhabhar foundation.
Cadila Pharmaceuticals has been actively taking action to spread awareness towards various diseases. The activities are aimed at sensitizing people about various illnesses such as iron deficiency, Cancer, Schizophrenia, Epilepsy, and Depression. These campaigns are meant to help people to understand the ailments better and to support them to provide care to their loved ones.
Cadila Pharmaceuticals Ltd is one of the largest privately held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused, research-driven company, we are committed to comply the highest ethical standard in clinical research and medical practice.
Catalent Acquired Premier European Product Launch Site from Bristol-Myers Squibb
Anagni, Italy: Catalent recently announced the completion of its acquisition of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility in Anagni, Italy.
The state-of-the-art facility, designed for late-phase tech transfers and commercial product launches, has a track record of launching hundreds of new products across many therapies including cardiovascular, cancer, and hepatitis treatments. The facility provides Catalent customers the access to:
Anagni, Italy: Catalent recently announced the completion of its acquisition of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility in Anagni, Italy.
The state-of-the-art facility, designed for late-phase tech transfers and commercial product launches, has a track record of launching hundreds of new products across many therapies including cardiovascular, cancer, and hepatitis treatments. The facility provides Catalent customers the access to:
- Comprehensive commercial packaging solutions, with blister and bottling capabilities
- Serialization solutions to ensure product traceability throughout the global supply chain
- Integrated digital printing and RFID tracking
- Automated warehousing
Jubilant Life Sciences Announced Q3 & 9M'FY 20 Results
Noida, India: The Board of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company has recently announced their financial results for the quarter ended December 31, 2019. Commenting on the Company's performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said: “We reported stable performance Y-o-Y and growth in EBITDA with better margins sequentially and PAT was lower due to certain exceptional charges. Demand conditions across all Pharma businesses, Specialty Intermediates and Nutritional Products are strong. Overall we are confident of delivering strong performance going forward.
Pharmaceutical segment reported steady revenue growth during the quarter. We witnessed healthy growth in Allergy Therapy Products and API businesses with stable performance in Radiopharma, CMO and Generics. EBITDA at 411 Crore was up 6 percent Y-o-Y and 7 percent Q-o-Q with margin of 28.4 percent, an improvement of 112 bps Y-o-Y and 180 bps Q-o-Q. Adjusted EBITDA of Pharmaceutical segment at 414 Crore was 8 percent higher YoY with a margin of 28.6 percent.
LSI segment revenue at 797 Crore was lower 11 percent Y-o-Y, but up 6 percent Q-o-Q led by growth in Specialty Intermediates and Nutritional Products. Life Science Chemicals business’ revenue at 381 Crore was down 30 percent Y-o-Y due to lower input prices of Acetic Acid. LSI EBITDA at 100 Crore was down 21 percent Y-o-Y, but up 10 percent sequentially with margins of 12.6 percent.
The Drug Discovery Services business reported robust growth of 26 percent YoY in revenue and a ~2.7x increase in EBITDA with margin of 25 percent during the quarter. In view of the strong demand, we are making significant investments in this business to double capacities over the next 2-3 years.
In our Proprietary Drug Discovery business, we are working on more than six programs targeting small molecule therapies in the area of oncology and auto-immune disorders with potential to fast track promising assets from discovery to clinical stage".
Noida, India: The Board of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company has recently announced their financial results for the quarter ended December 31, 2019. Commenting on the Company's performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said: “We reported stable performance Y-o-Y and growth in EBITDA with better margins sequentially and PAT was lower due to certain exceptional charges. Demand conditions across all Pharma businesses, Specialty Intermediates and Nutritional Products are strong. Overall we are confident of delivering strong performance going forward.
Pharmaceutical segment reported steady revenue growth during the quarter. We witnessed healthy growth in Allergy Therapy Products and API businesses with stable performance in Radiopharma, CMO and Generics. EBITDA at 411 Crore was up 6 percent Y-o-Y and 7 percent Q-o-Q with margin of 28.4 percent, an improvement of 112 bps Y-o-Y and 180 bps Q-o-Q. Adjusted EBITDA of Pharmaceutical segment at 414 Crore was 8 percent higher YoY with a margin of 28.6 percent.
LSI segment revenue at 797 Crore was lower 11 percent Y-o-Y, but up 6 percent Q-o-Q led by growth in Specialty Intermediates and Nutritional Products. Life Science Chemicals business’ revenue at 381 Crore was down 30 percent Y-o-Y due to lower input prices of Acetic Acid. LSI EBITDA at 100 Crore was down 21 percent Y-o-Y, but up 10 percent sequentially with margins of 12.6 percent.
The Drug Discovery Services business reported robust growth of 26 percent YoY in revenue and a ~2.7x increase in EBITDA with margin of 25 percent during the quarter. In view of the strong demand, we are making significant investments in this business to double capacities over the next 2-3 years.
In our Proprietary Drug Discovery business, we are working on more than six programs targeting small molecule therapies in the area of oncology and auto-immune disorders with potential to fast track promising assets from discovery to clinical stage".
Piramal Pharma Solutions Invested CA$25 Million to Expand its Aurora, Canada Facility
Aurora, Canada: Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has recently announced their plans to expand the Aurora facility in Canada with the addition of a new stateof- the-art wing dedicated to manufacture Active Pharmaceutical Ingredients (APIs). A total investment of ~CA$25 million will be infused towards this expansion.
Known for its world-class lab services and production plants, the Piramal Pharma Solutions’ (PPS) Aurora facility will enhance its offerings to customers with this new addition that features ~10,500 sq. ft. of new manufacturing space. The additional capacity will cater to increasing customer demand as well as support the facility's ability to provide APIs and HPAPIs down to an Occupational Exposure Limit (OEL) of 1mcg/m3. It will also include filtration and drying capabilities that will enhance service offerings at Piramal Pharma Solutions’ Aurora facility.
Peter DeYoung, CEO, Piramal Pharma Solutions said, “We are delighted to announce the capacity expansion at our Aurora facility in Canada. This additional capacity will help us to strengthen our presence in Canada as well as service other geographies such as North America and Europe, whilst enabling us to support our customer’s API requirements and market demand for integrated solutions. As a Patient Centric organization, Piramal Pharma Solutions is committed to serving the patient community and reducing the burden of disease."
Apart from the existing production scale reactors, this expansion will include two new reactor suites as well as a dedicated filter dryer room and a portable filter dryer. The expansion is expected to be completed and running by April 30, 2021. With successful inspections by the US FDA, the UK MHRA and the PMDA, Piramal Pharma Solutions’ Aurora facility has a stellar track record of regulatory compliance and is committed to maintaining gold standards of environmental performance, health & safety This upcoming facility has been designed to meet the highest standards of global compliance and will employ highly qualified scientific, technical and professional staff, building on a business that has already seen staff numbers grow almost 2-fold to ~200 in recent years.
Aurora, Canada: Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has recently announced their plans to expand the Aurora facility in Canada with the addition of a new stateof- the-art wing dedicated to manufacture Active Pharmaceutical Ingredients (APIs). A total investment of ~CA$25 million will be infused towards this expansion.
Known for its world-class lab services and production plants, the Piramal Pharma Solutions’ (PPS) Aurora facility will enhance its offerings to customers with this new addition that features ~10,500 sq. ft. of new manufacturing space. The additional capacity will cater to increasing customer demand as well as support the facility's ability to provide APIs and HPAPIs down to an Occupational Exposure Limit (OEL) of 1mcg/m3. It will also include filtration and drying capabilities that will enhance service offerings at Piramal Pharma Solutions’ Aurora facility.
Peter DeYoung, CEO, Piramal Pharma Solutions said, “We are delighted to announce the capacity expansion at our Aurora facility in Canada. This additional capacity will help us to strengthen our presence in Canada as well as service other geographies such as North America and Europe, whilst enabling us to support our customer’s API requirements and market demand for integrated solutions. As a Patient Centric organization, Piramal Pharma Solutions is committed to serving the patient community and reducing the burden of disease."
Apart from the existing production scale reactors, this expansion will include two new reactor suites as well as a dedicated filter dryer room and a portable filter dryer. The expansion is expected to be completed and running by April 30, 2021. With successful inspections by the US FDA, the UK MHRA and the PMDA, Piramal Pharma Solutions’ Aurora facility has a stellar track record of regulatory compliance and is committed to maintaining gold standards of environmental performance, health & safety This upcoming facility has been designed to meet the highest standards of global compliance and will employ highly qualified scientific, technical and professional staff, building on a business that has already seen staff numbers grow almost 2-fold to ~200 in recent years.
Agilent Teamed with IIT Delhi to Enhance Bio-therapeutics
New Delhi, India: Agilent Technologies Inc has recently announced its association with Indian Institute of Technology Delhi (IIT Delhi) to promote biopharmaceutical research. Agilent and IIT Delhi signed a memorandum of understanding(MoU). Under the scope of this MoU, Agilent, a leader in the biopharma space, is going to contribute funds to support the incubator at IIT New Delhi to support researchers at the institute in establishing global best practices for identifying and characterizing biopharmaceuticals. The research conducted by IIT Delhi examines and reports on the quality of bio-therapeutic products for the Indian market.
Visiting the campus, Agilent CEO, Mike McMullen, spoke about Agilent's history of innovation, focus on research and academia, and vision for the future. Likewise, the institute's Director, Prof. V. Ramgopal Rao, spoke about the institute's mission and role in promoting collaborations between academia and industry.
Agilent will be contributing funds to the IIT Delhi incubator site, as a part of its corporate social responsibility initiative, with the goal of enhancing the quality and safety of bio-therapeutics. The aim is to offer world-class training to researchers from academia and industry on protein characterization. The setup will be under the DBT Center of Excellence for Biopharmaceutical Technology (CBT) and will support incubated startups at IIT Delhi performing protein analysis, the result of which will provide critical information to policy makers for ensuring safe and efficacious bio-therapeutic products in India.
"We are happy to be associated with Agilent," said Prof. Anurag S. Rathore (IIT Delhi), Coordinator of the CBT. "Agilent's broad range of technologies will further boost our efforts at the Centre of Excellence for Biopharmaceutical Technology. This mutually constructive and productive partnership will hopefully lead to promising results for the entire biotherapeutics ecosystem."
"We are excited to embark on this initiative with IIT Delhi, an institute with the country's brightest minds engaged in research and technology," said Bharat Bhardwaj, country general manager, Agilent India. "Agilent's relationship with IIT Delhi goes back decades. The new memorandum of understanding that we have signed will further strengthen our relationship and will enhance the ability to do cutting-edge research, which can be used to improve the quality of life for the community at large, through the application of new innovations."
New Delhi, India: Agilent Technologies Inc has recently announced its association with Indian Institute of Technology Delhi (IIT Delhi) to promote biopharmaceutical research. Agilent and IIT Delhi signed a memorandum of understanding(MoU). Under the scope of this MoU, Agilent, a leader in the biopharma space, is going to contribute funds to support the incubator at IIT New Delhi to support researchers at the institute in establishing global best practices for identifying and characterizing biopharmaceuticals. The research conducted by IIT Delhi examines and reports on the quality of bio-therapeutic products for the Indian market.
Visiting the campus, Agilent CEO, Mike McMullen, spoke about Agilent's history of innovation, focus on research and academia, and vision for the future. Likewise, the institute's Director, Prof. V. Ramgopal Rao, spoke about the institute's mission and role in promoting collaborations between academia and industry.
Agilent will be contributing funds to the IIT Delhi incubator site, as a part of its corporate social responsibility initiative, with the goal of enhancing the quality and safety of bio-therapeutics. The aim is to offer world-class training to researchers from academia and industry on protein characterization. The setup will be under the DBT Center of Excellence for Biopharmaceutical Technology (CBT) and will support incubated startups at IIT Delhi performing protein analysis, the result of which will provide critical information to policy makers for ensuring safe and efficacious bio-therapeutic products in India.
"We are happy to be associated with Agilent," said Prof. Anurag S. Rathore (IIT Delhi), Coordinator of the CBT. "Agilent's broad range of technologies will further boost our efforts at the Centre of Excellence for Biopharmaceutical Technology. This mutually constructive and productive partnership will hopefully lead to promising results for the entire biotherapeutics ecosystem."
"We are excited to embark on this initiative with IIT Delhi, an institute with the country's brightest minds engaged in research and technology," said Bharat Bhardwaj, country general manager, Agilent India. "Agilent's relationship with IIT Delhi goes back decades. The new memorandum of understanding that we have signed will further strengthen our relationship and will enhance the ability to do cutting-edge research, which can be used to improve the quality of life for the community at large, through the application of new innovations."
Conduent Market-Leading Disease Surveillance and Outbreak Management System to Fight Corona Virus
Bengaluru, India: Conduent Incorporated has announced a version of its disease surveillance and outbreak management platform, Maven®, to securely track, manage and report on cases of the coronavirus, 2019-nCov.
Maven is a software platform developed for organizations, including government agencies, to manage cases of more than 90 communicable diseases. Its flexible design gives organizations the capability to customize disease tracking most prevalent in specific geographies or communities.
Conduent will host the platform’s coronavirus-enabled version of Maven in the company's secure cloud so public health agencies and other organizations can get immediate access to use it. Conduent expects its coronavirus module to be available within the month. Additionally, those with advanced training also can leverage the solution's flexibility to customize the Maven platform on their own to track coronavirus.
Based on an organization's need, Maven has the capability to track diseases such as influenza, tuberculosis and Ebola. More than 40 organizations are currently using Maven, and some have already taken advantage of the platform's flexibility by configuring it to track the coronavirus's spread within their respective locations. Conduent is also actively facilitating sharing of best practices between clients as they configure their systems to track the outbreak.
"Maven is a valuable tool that organizations can use to identify and follow up on people who may have come into contact with a person infected with a communicable or infectious disease," said Mark Brewer, President, Global Public Sector Solutions, Conduent. "In the absence of a vaccine, tracking and analyzing who is at risk from contact with an infected person is one of the most important methods available to contain diseases like the coronavirus and prevent widespread outbreaks.
"Maven's technology is scalable and can be quickly and easily configured to changing technologies, protocols and geographic locations - all of which are keys to effective disease outbreak response. It is also designed to allow for easier data sharing and integration among health agencies on the front lines of battling the disease."
Designed with rich contact tracing, outbreak management and detection, state and local health organizations can collaborate to quickly and effectively contain public health crises. Epidemiologists can use Maven's reporting capability to search and analyze the centralized data collected to discover trends and patterns. Maven can also be used to report externally, supporting the need for automatic case reporting to the Centers for Disease Control and Prevention in the United States, the World Health Organization, or local authorities.
Bengaluru, India: Conduent Incorporated has announced a version of its disease surveillance and outbreak management platform, Maven®, to securely track, manage and report on cases of the coronavirus, 2019-nCov.
Maven is a software platform developed for organizations, including government agencies, to manage cases of more than 90 communicable diseases. Its flexible design gives organizations the capability to customize disease tracking most prevalent in specific geographies or communities.
Conduent will host the platform’s coronavirus-enabled version of Maven in the company's secure cloud so public health agencies and other organizations can get immediate access to use it. Conduent expects its coronavirus module to be available within the month. Additionally, those with advanced training also can leverage the solution's flexibility to customize the Maven platform on their own to track coronavirus.
Based on an organization's need, Maven has the capability to track diseases such as influenza, tuberculosis and Ebola. More than 40 organizations are currently using Maven, and some have already taken advantage of the platform's flexibility by configuring it to track the coronavirus's spread within their respective locations. Conduent is also actively facilitating sharing of best practices between clients as they configure their systems to track the outbreak.
"Maven is a valuable tool that organizations can use to identify and follow up on people who may have come into contact with a person infected with a communicable or infectious disease," said Mark Brewer, President, Global Public Sector Solutions, Conduent. "In the absence of a vaccine, tracking and analyzing who is at risk from contact with an infected person is one of the most important methods available to contain diseases like the coronavirus and prevent widespread outbreaks.
"Maven's technology is scalable and can be quickly and easily configured to changing technologies, protocols and geographic locations - all of which are keys to effective disease outbreak response. It is also designed to allow for easier data sharing and integration among health agencies on the front lines of battling the disease."
Designed with rich contact tracing, outbreak management and detection, state and local health organizations can collaborate to quickly and effectively contain public health crises. Epidemiologists can use Maven's reporting capability to search and analyze the centralized data collected to discover trends and patterns. Maven can also be used to report externally, supporting the need for automatic case reporting to the Centers for Disease Control and Prevention in the United States, the World Health Organization, or local authorities.
B & R's Blackout Mode Enables High Machine Availability
Pune, India: The B & R drive technology portfolio now offers a Blackout mode that ensures safe machine control in the event of a network failure. Machine downtime can be avoided without costly redundancy solutions to ensure maximum machine availability.
The Blackout function enables the safe variants of B & R servo drives (ACOPOSmulti, ACOPOSmotor or ACOPOS P3) to continue operation in the event of a network failure. Safety functionality remains intact.
Controlled shutdown - Blackout mode allows configuration of simple safety sequences. Applications in lower-level systems continue execution even after a network failure. For example, axes can be brought to a stop or moved to a defined position.
Pune, India: The B & R drive technology portfolio now offers a Blackout mode that ensures safe machine control in the event of a network failure. Machine downtime can be avoided without costly redundancy solutions to ensure maximum machine availability.
The Blackout function enables the safe variants of B & R servo drives (ACOPOSmulti, ACOPOSmotor or ACOPOS P3) to continue operation in the event of a network failure. Safety functionality remains intact.
Controlled shutdown - Blackout mode allows configuration of simple safety sequences. Applications in lower-level systems continue execution even after a network failure. For example, axes can be brought to a stop or moved to a defined position.
Acquisition Positions Catalent as Premier Partner for
Advanced Biotherapeutics, Now Including Cell Therapy
New Jersey, USA: Catalent Inc., the leading global provider of advanced delivery technologies, development, and manufacturing solutions has announced agreement to acquire MaSTherCell, a leading, technologyfocused cell therapy development and manufacturing partner.
In combination with Catalent's deep experience in viral vector scale-up and production, MaSTherCell's expertise in both autologous and allogeneic cell therapy development and manufacturing, will allow Catalent to be a fullservice partner for CAR-T immunotherapies and beyond.
MaSTherCell's advanced capabilities will supplement Catalent's industry-leading platform in biotechnologies including gene therapy, biomanufacturing, fill finish, clinical logistics and commercial supply, creating a comprehensive solution for advanced biotherapeutics.
New Jersey, USA: Catalent Inc., the leading global provider of advanced delivery technologies, development, and manufacturing solutions has announced agreement to acquire MaSTherCell, a leading, technologyfocused cell therapy development and manufacturing partner.
In combination with Catalent's deep experience in viral vector scale-up and production, MaSTherCell's expertise in both autologous and allogeneic cell therapy development and manufacturing, will allow Catalent to be a fullservice partner for CAR-T immunotherapies and beyond.
MaSTherCell's advanced capabilities will supplement Catalent's industry-leading platform in biotechnologies including gene therapy, biomanufacturing, fill finish, clinical logistics and commercial supply, creating a comprehensive solution for advanced biotherapeutics.
Glenmark's Consolidated Net Profit Rises by 64 percent to 1,908.39 Mn. in Q3 FY 2019-20
Mumbai, India: Glenmark Pharmaceuticals Limited, a researchled global integrated pharmaceutical company, has recently announced its financial results for the third quarter ended December 31 of the financial year 2019-20.
In the third quarter ended December 31, 2019, Glenmark's consolidated revenue was at 27,355.61 Mn (USD 385.64 Mn) as against 25,550.45 Mn (USD 355.87 Mn) in the previous corresponding quarter, recording an increase of 7.07 percent. Consolidated Net Profit was at 1,908.39 Mn for the quarter ended December 31, 2019 as compared to 1,163.41 Mn in the previous corresponding quarter, registering an increase of 64.03 percent.
Consolidated EBITDA was at 4,400.75 Mn in the quarter ended December 31, 2019 as against 4,346.80 Mn in the previous corresponding quarter, an increase of 1.2 percent.
"While the US business lost some of its momentum in the third quarter, the India business continued to grow at a healthy pace, consistently outperforming industry growth. We expect the ROW region and the European business to gain traction in the coming few quarters", said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals. He further added, "Despite the challenging macro- economic environment globally, the organization still continued to record high single digit revenue growth and we hope that we can consistently grow the business every year."
India Formulations: Sales from the formulation business in India was at 7,888.39 Mn (USD 111.08 Mn) for the third quarter ended December 31, 2018, as against 6,675.30 Mn (USD 92.49 Mn) in the previous corresponding quarter, recording a growth of 18.17 percent.
The India business continued to outperform the industry growth; as per IQVIA Q3 FY 2019-20, Glenmark's India business recorded growth of 13.65 percent compared to IPM growth of 9.03 percent. As per IQVIA MAT December 2019, the India business recorded growth of 12.98 percent compared to IPM growth of 10.10 percent. Glenmark's India formulation business is ranked 14th, with market share of 2.21 percent. Glenmark has 9 brands among the 'Top 300 Brands in the IPM.'
USA Formulations: Glenmark Pharmaceuticals Inc. U.S.A registered revenue from sale of finished dosage formulations of 7,998.28 Mn (USD 112.70 Mn) for the quarter ended December 31, 2019 as against revenue of 8,556.75 Mn (USD 119.36 Mn ) for the previous corresponding quarter, recording a de-growth of (6.53 percent).
In the nine months of FY 2019-20, the Company has received 13 ANDA approvals including 11 final approvals and 2 tentative approval.
Glenmark has 5 US FDA approved formulation manufacturing facilities (Goa, Indore, Baddi, Aurangabad and Monroe). In Sep 2019, the US FDA inspected the manufacturing facility in Goa, India. We have received an EIR regarding that inspection. In Sep 2019, the US FDA also inspected the manufacturing facility in Indore, India and we received an EIR regarding that inspection. The Baddi facility was inspected by SUKL (State Institute for Drug control), Czech Republic and was issued a certificate of compliance for the audit in Oct, 2019.
Europe Formulations: Glenmark Europe's revenue for the third quarter of FY 2019 -20 was at 3,089.36 Mn (USD 43.59 Mn) as against 3,217.39 Mn (USD 45.09 Mn) in the previous corresponding quarter, recording a de- growth of (3.98 percent).
Glenmark Europe operations recorded strong growth in the third quarter of the previous financial year. Thus in the current third quarter, the growth is suppressed to that extent. However we still expect the European business to grow at a steady pace in the coming quarters. The European business however recorded growth quarter-over-quarter. Despite the high base effect, the Central Eastern and the Western European business recorded moderate growth as compared to the previous corresponding quarter.
Africa, Asia and CIS Region (ROW) : For the third quarter of FY 2019-20, revenue from Africa, Asia and CIS region was at 3,413.74 Mn (USD 48.15 Mn) as against 3,401.21 Mn (USD 47.57 Mn) in the previous corresponding quarter, an increase of 0.37 percent.
Latin America: Glenmark's revenue from its Latin American and Caribbean operations was at 1,563.18 Mn (USD 22.10 Mn) for the third quarter of FY 2019-20 , as against 1,014.33 Mn (USD 14.11 Mn), recording an increase of 54.11 percent. Glenmark Life Sciences (GLS) : For the third quarter of FY 2019-20, external sales for Glenmark Life Sciences was at 2,621.56 Mn (USD 36.95 Mn) as against 2,392.48 Mn(USD 33.29 Mn), recording growth of 9.58 percent over the corresponding period last year.
US and Emerging markets led the growth in the third quarter, with the US growing at excess 125 percent over the corresponding quarter in the last financial year and 60 percent over the previous quarter. The emerging markets sales grew at 25 percent. In the US market, the growth was led by key products such as Aprepitant.
Highlights for Q3 FY 2019-20
Mumbai, India: Glenmark Pharmaceuticals Limited, a researchled global integrated pharmaceutical company, has recently announced its financial results for the third quarter ended December 31 of the financial year 2019-20.
In the third quarter ended December 31, 2019, Glenmark's consolidated revenue was at 27,355.61 Mn (USD 385.64 Mn) as against 25,550.45 Mn (USD 355.87 Mn) in the previous corresponding quarter, recording an increase of 7.07 percent. Consolidated Net Profit was at 1,908.39 Mn for the quarter ended December 31, 2019 as compared to 1,163.41 Mn in the previous corresponding quarter, registering an increase of 64.03 percent.
Consolidated EBITDA was at 4,400.75 Mn in the quarter ended December 31, 2019 as against 4,346.80 Mn in the previous corresponding quarter, an increase of 1.2 percent.
"While the US business lost some of its momentum in the third quarter, the India business continued to grow at a healthy pace, consistently outperforming industry growth. We expect the ROW region and the European business to gain traction in the coming few quarters", said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals. He further added, "Despite the challenging macro- economic environment globally, the organization still continued to record high single digit revenue growth and we hope that we can consistently grow the business every year."
India Formulations: Sales from the formulation business in India was at 7,888.39 Mn (USD 111.08 Mn) for the third quarter ended December 31, 2018, as against 6,675.30 Mn (USD 92.49 Mn) in the previous corresponding quarter, recording a growth of 18.17 percent.
The India business continued to outperform the industry growth; as per IQVIA Q3 FY 2019-20, Glenmark's India business recorded growth of 13.65 percent compared to IPM growth of 9.03 percent. As per IQVIA MAT December 2019, the India business recorded growth of 12.98 percent compared to IPM growth of 10.10 percent. Glenmark's India formulation business is ranked 14th, with market share of 2.21 percent. Glenmark has 9 brands among the 'Top 300 Brands in the IPM.'
USA Formulations: Glenmark Pharmaceuticals Inc. U.S.A registered revenue from sale of finished dosage formulations of 7,998.28 Mn (USD 112.70 Mn) for the quarter ended December 31, 2019 as against revenue of 8,556.75 Mn (USD 119.36 Mn ) for the previous corresponding quarter, recording a de-growth of (6.53 percent).
In the nine months of FY 2019-20, the Company has received 13 ANDA approvals including 11 final approvals and 2 tentative approval.
Glenmark has 5 US FDA approved formulation manufacturing facilities (Goa, Indore, Baddi, Aurangabad and Monroe). In Sep 2019, the US FDA inspected the manufacturing facility in Goa, India. We have received an EIR regarding that inspection. In Sep 2019, the US FDA also inspected the manufacturing facility in Indore, India and we received an EIR regarding that inspection. The Baddi facility was inspected by SUKL (State Institute for Drug control), Czech Republic and was issued a certificate of compliance for the audit in Oct, 2019.
Europe Formulations: Glenmark Europe's revenue for the third quarter of FY 2019 -20 was at 3,089.36 Mn (USD 43.59 Mn) as against 3,217.39 Mn (USD 45.09 Mn) in the previous corresponding quarter, recording a de- growth of (3.98 percent).
Glenmark Europe operations recorded strong growth in the third quarter of the previous financial year. Thus in the current third quarter, the growth is suppressed to that extent. However we still expect the European business to grow at a steady pace in the coming quarters. The European business however recorded growth quarter-over-quarter. Despite the high base effect, the Central Eastern and the Western European business recorded moderate growth as compared to the previous corresponding quarter.
Africa, Asia and CIS Region (ROW) : For the third quarter of FY 2019-20, revenue from Africa, Asia and CIS region was at 3,413.74 Mn (USD 48.15 Mn) as against 3,401.21 Mn (USD 47.57 Mn) in the previous corresponding quarter, an increase of 0.37 percent.
Latin America: Glenmark's revenue from its Latin American and Caribbean operations was at 1,563.18 Mn (USD 22.10 Mn) for the third quarter of FY 2019-20 , as against 1,014.33 Mn (USD 14.11 Mn), recording an increase of 54.11 percent. Glenmark Life Sciences (GLS) : For the third quarter of FY 2019-20, external sales for Glenmark Life Sciences was at 2,621.56 Mn (USD 36.95 Mn) as against 2,392.48 Mn(USD 33.29 Mn), recording growth of 9.58 percent over the corresponding period last year.
US and Emerging markets led the growth in the third quarter, with the US growing at excess 125 percent over the corresponding quarter in the last financial year and 60 percent over the previous quarter. The emerging markets sales grew at 25 percent. In the US market, the growth was led by key products such as Aprepitant.
Highlights for Q3 FY 2019-20
- India Business grew by 18.17 percent to 7,888.39 Mn
- US Business de-grew by 6.53 percent to 7,998.28 Mn
- Latin America Business grew by 54.11 percent to 1,563.18 Mn
- API Business grew by 9.58 percent to 2,621.56 Mn
Breakthrough Study Makes Cancer Detection Possible
with a Simple Blood Test; Introduces a New Systemic Hallmark of Cancer
Mumbai, India: A new study by scientists from India, USA, and UK has presented clinical evidence for an innovative test that can detect clusters of cancer cells in the blood of asymptomatic individuals as a non-invasive screening and diagnostic method. The test makes cancer screening easier, efficient and affordable, and can potentially be a breakthrough in cancer detection and diagnosis. The test will soon be available commercially.
Commenting on the study, principal author Dr. Dadasaheb Akolkar, who is the Research Director at Datar Cancer Genetics, said, "This is the first study of its kind to investigate the prevalence of circulating tumor emboli or C-ETACs (Circulating Ensembles of Tumor Associated Cells) in over 16,000 participants, to establish the definitive new systemic hallmark of cancer. The technique we have used is a breakthrough innovation. When clusters of cells break off from an early stage tumor and enter the bloodstream, we can efficiently and accurately isolate a few hundred malignant cells from more than 100 million cells, using just 10 ml of blood. While almost all cancer samples had these cell clusters, they were seen in very few of the samples which were apparently without cancer."
Speaking on the breakthrough study and technique, Mr. Rajan Datar, Chairman and Managing Director, Datar Cancer Genetics, said, "Cancer is rapidly becoming a civilizational challenge. Importantly, cancer deaths are mainly because of late detection. We believe that this innovative blood-based test is a breakthrough in cancer screening and will impact outcomes through easy, patient-friendly detection and diagnosis in apparently healthy people who may have a silent malignancy in their bodies! It has the potential to eliminate the need for invasive biopsies and the risks associated with it. In the near future, a simple, inexpensive blood test that could be all that is required to reliably detect and diagnose cancer, even before any symptoms are seen."
The study involved 16,134 participants, including 5,509 patients with cancer (TrueBlood study) and 10,625 individuals with no symptoms (RESOLUTE study) and the test has shown an accuracy of more than 94 percent. The C-ETACs were seen in 89.8 percent of cancer cases and in only 3 percent of apparently healthy, asymptomatic individuals who had no abnormal ? ndings in presently used screening tests. The study was the largest of its kind in the world.
Datar Cancer Genetics has also presented further data at several leading international conferences including AACR, ASCO and ESMO Early detection of cancer is crucial but challenging, because of the lack of efficient and reliable screening methods. Most of the commercially available cancer-screening tests are invasive and expensive. Also, currently available cancer screening techniques such as mammograms and low-dose CT scans (LDCT) carry radiation risks, colonoscopies are invasive, blood based markers are non-specific and tissue biopsies for diagnosis have the same risks as general surgical procedures.
Mumbai, India: A new study by scientists from India, USA, and UK has presented clinical evidence for an innovative test that can detect clusters of cancer cells in the blood of asymptomatic individuals as a non-invasive screening and diagnostic method. The test makes cancer screening easier, efficient and affordable, and can potentially be a breakthrough in cancer detection and diagnosis. The test will soon be available commercially.
Commenting on the study, principal author Dr. Dadasaheb Akolkar, who is the Research Director at Datar Cancer Genetics, said, "This is the first study of its kind to investigate the prevalence of circulating tumor emboli or C-ETACs (Circulating Ensembles of Tumor Associated Cells) in over 16,000 participants, to establish the definitive new systemic hallmark of cancer. The technique we have used is a breakthrough innovation. When clusters of cells break off from an early stage tumor and enter the bloodstream, we can efficiently and accurately isolate a few hundred malignant cells from more than 100 million cells, using just 10 ml of blood. While almost all cancer samples had these cell clusters, they were seen in very few of the samples which were apparently without cancer."
Speaking on the breakthrough study and technique, Mr. Rajan Datar, Chairman and Managing Director, Datar Cancer Genetics, said, "Cancer is rapidly becoming a civilizational challenge. Importantly, cancer deaths are mainly because of late detection. We believe that this innovative blood-based test is a breakthrough in cancer screening and will impact outcomes through easy, patient-friendly detection and diagnosis in apparently healthy people who may have a silent malignancy in their bodies! It has the potential to eliminate the need for invasive biopsies and the risks associated with it. In the near future, a simple, inexpensive blood test that could be all that is required to reliably detect and diagnose cancer, even before any symptoms are seen."
The study involved 16,134 participants, including 5,509 patients with cancer (TrueBlood study) and 10,625 individuals with no symptoms (RESOLUTE study) and the test has shown an accuracy of more than 94 percent. The C-ETACs were seen in 89.8 percent of cancer cases and in only 3 percent of apparently healthy, asymptomatic individuals who had no abnormal ? ndings in presently used screening tests. The study was the largest of its kind in the world.
Datar Cancer Genetics has also presented further data at several leading international conferences including AACR, ASCO and ESMO Early detection of cancer is crucial but challenging, because of the lack of efficient and reliable screening methods. Most of the commercially available cancer-screening tests are invasive and expensive. Also, currently available cancer screening techniques such as mammograms and low-dose CT scans (LDCT) carry radiation risks, colonoscopies are invasive, blood based markers are non-specific and tissue biopsies for diagnosis have the same risks as general surgical procedures.
Sun Pharma and Rockwell Medical Entered into Licensing Agreement for Triferic in India
Mumbai, India: Sun Pharmaceutical Industries Ltd has recently announced that one of its wholly owned subsidiaries has entered into exclusive licensing and supply agreements with Rockwell Medical Inc. (Rockwell), to commercialize Rockwell's Triferic, a proprietary iron replacement and haemoglobin maintenance drug, for treating anaemia in hemodialysis patients in India. Triferic is approved in USA. As per the terms of the agreement, Sun Pharma will be the exclusive development and commercialization partner for Triferic during the term of the agreement, subject to its approval in India. In consideration for the license, Rockwell will be eligible for upfront and milestone payments as well as royalty on net sales. The financial terms of the agreement are confidential.
Kirti Ganorkar, CEO of India business, Sun Pharma, said, "We are excited to build a partnership with Rockwell who has developed an innovative product, Triferic for haemodialysis patients. Triferic is an innovative anaemia therapy for the patients who are undergoing haemodialysis and offers a unique treatment option. Triferic will help Sun Pharma expand its portfolio in its core therapy areas."
According to the 2017 Global Burden of Disease Study, chronic kidney disease was the 10th leading cause of mortality in India, having risen from 14th rank in 20071. In India, there are approximately 130,000 patients receiving hemodialysis, and the number is increasing by about 232 per million population.
Mumbai, India: Sun Pharmaceutical Industries Ltd has recently announced that one of its wholly owned subsidiaries has entered into exclusive licensing and supply agreements with Rockwell Medical Inc. (Rockwell), to commercialize Rockwell's Triferic, a proprietary iron replacement and haemoglobin maintenance drug, for treating anaemia in hemodialysis patients in India. Triferic is approved in USA. As per the terms of the agreement, Sun Pharma will be the exclusive development and commercialization partner for Triferic during the term of the agreement, subject to its approval in India. In consideration for the license, Rockwell will be eligible for upfront and milestone payments as well as royalty on net sales. The financial terms of the agreement are confidential.
Kirti Ganorkar, CEO of India business, Sun Pharma, said, "We are excited to build a partnership with Rockwell who has developed an innovative product, Triferic for haemodialysis patients. Triferic is an innovative anaemia therapy for the patients who are undergoing haemodialysis and offers a unique treatment option. Triferic will help Sun Pharma expand its portfolio in its core therapy areas."
According to the 2017 Global Burden of Disease Study, chronic kidney disease was the 10th leading cause of mortality in India, having risen from 14th rank in 20071. In India, there are approximately 130,000 patients receiving hemodialysis, and the number is increasing by about 232 per million population.
Cipla Foundation Sets Up a Dedicated State-ofthe-Art Chemistry Laboratory at IISER Pune
Pune, India: In continuance of its efforts to advance quality education and promote industry-academia collaboration, Cipla Foundation, the social responsibility arm of Cipla Ltd, has funded the set-up of a world class chemistry research laboratory at the Indian Institute of Science Education and Research (IISER) Pune.
The lab aims to provide practical training in Chemistry to undergraduates and researchers in the varsity campus along with support to the national outreach programme for school children. The centre and the labs will help strengthen science education in India by engaging with various stakeholders, including students, academicians, scientists, teachers of schools and undergraduate level science and mathematics.
Dr. Y. K. Hamied, Chairman, Cipla, Ms. Rumana Hamied, Managing Trustee, Cipla Foundation and Prof. Jayant B Udgaonkar, Director, IISER Pune were present at the campus for the unveiling of the facility along with senior leaders from Cipla and IISER Pune.
The expansive 27,000 square feet, ground plus two floor facility has been constructed in an eco-friendly zone in adherence with the green building GRIHA standards. In line with the international standards of chemistry practicals, four state-of-the-art four laboratories have been set up, each appointed with best-in-class equipment including virtual reality functionalities, interactive gadgets, demonstration facilities and more. In addition to academic learning, the facilities will also be utilized for reallife industry driven research projects and contribute to the latest scientific innovation taking place in the country.
Pune, India: In continuance of its efforts to advance quality education and promote industry-academia collaboration, Cipla Foundation, the social responsibility arm of Cipla Ltd, has funded the set-up of a world class chemistry research laboratory at the Indian Institute of Science Education and Research (IISER) Pune.
The lab aims to provide practical training in Chemistry to undergraduates and researchers in the varsity campus along with support to the national outreach programme for school children. The centre and the labs will help strengthen science education in India by engaging with various stakeholders, including students, academicians, scientists, teachers of schools and undergraduate level science and mathematics.
Dr. Y. K. Hamied, Chairman, Cipla, Ms. Rumana Hamied, Managing Trustee, Cipla Foundation and Prof. Jayant B Udgaonkar, Director, IISER Pune were present at the campus for the unveiling of the facility along with senior leaders from Cipla and IISER Pune.
The expansive 27,000 square feet, ground plus two floor facility has been constructed in an eco-friendly zone in adherence with the green building GRIHA standards. In line with the international standards of chemistry practicals, four state-of-the-art four laboratories have been set up, each appointed with best-in-class equipment including virtual reality functionalities, interactive gadgets, demonstration facilities and more. In addition to academic learning, the facilities will also be utilized for reallife industry driven research projects and contribute to the latest scientific innovation taking place in the country.
Clariant Partners to Bring New Biotransformation Technology to India
The team at the signing ceremony with Shri P. Raghavendra Rao, Secretary, Department of Chemicals & Petrochemicals.
Mumbai, India: Clariant, a focused and innovative specialty chemical company and Polymateria, has been developing a new standard in biodegradation of plastics, signed a partnership agreement with the Central Institute of Plastic Engineering & Technology (CIPET), Department of Chemical and Petrochemical, Ministry of Chemicals & Fertilizers, Government of India. This partnership entails bringing Polymateria's Biotransformation technology to market in India through Clariant's Masterbatches.
Clariant's Masterbatches and Polymateria will work with CIPET's world class testing facilities to apply the biotransformation technology to the local brands and packaging companies, who want to validate solutions for the most highly littered forms of plastic.
At the signing ceremony, Shri P. Raghavendra Rao, Secretary, Department of Chemicals & Petrochemicals, said, "India has world leading ambitions to tackle plastic waste. With new innovations such as Biotransformation emerging, we can work with the industry to address these issues."
Niall Dunne, CEO of Polymateria, said, "This partnership agreement reflects that the only way to solve global problems is to accelerate the impact of disruptive technology through meaningful collaboration."
Sambit Roy, Head of LBL India, BU MB, Clariant, said, "We are happy with this agreement and keen to support our clear strategy towards Sustainability. Clariant has an important role to play in creating solutions for recycling and now with this new technology we will also be able to offer biodegradation solutions for fugitive plastics which are left over in recycling stream. This agreement gives us access to the global technology from Polymateria to bring the biodegradation capabilities to the Indian market; while working with CIPET's testing facilities."
The team at the signing ceremony with Shri P. Raghavendra Rao, Secretary, Department of Chemicals & Petrochemicals.
Mumbai, India: Clariant, a focused and innovative specialty chemical company and Polymateria, has been developing a new standard in biodegradation of plastics, signed a partnership agreement with the Central Institute of Plastic Engineering & Technology (CIPET), Department of Chemical and Petrochemical, Ministry of Chemicals & Fertilizers, Government of India. This partnership entails bringing Polymateria's Biotransformation technology to market in India through Clariant's Masterbatches.
Clariant's Masterbatches and Polymateria will work with CIPET's world class testing facilities to apply the biotransformation technology to the local brands and packaging companies, who want to validate solutions for the most highly littered forms of plastic.
At the signing ceremony, Shri P. Raghavendra Rao, Secretary, Department of Chemicals & Petrochemicals, said, "India has world leading ambitions to tackle plastic waste. With new innovations such as Biotransformation emerging, we can work with the industry to address these issues."
Niall Dunne, CEO of Polymateria, said, "This partnership agreement reflects that the only way to solve global problems is to accelerate the impact of disruptive technology through meaningful collaboration."
Sambit Roy, Head of LBL India, BU MB, Clariant, said, "We are happy with this agreement and keen to support our clear strategy towards Sustainability. Clariant has an important role to play in creating solutions for recycling and now with this new technology we will also be able to offer biodegradation solutions for fugitive plastics which are left over in recycling stream. This agreement gives us access to the global technology from Polymateria to bring the biodegradation capabilities to the Indian market; while working with CIPET's testing facilities."
Metropolis Healthcare Ltd signs binding agreement to acquire lab in Ahmedabad
Ahmedabad, India: Metropolis Healthcare Ltd, the leading pan -India pathology specialist, has recently signed a binding agreement to acquire Ahmedabad based Shraddha Diagnostics Pvt Ltd.
With this acquisition, Metropolis has expanded its lab footprint from 17 to 20 in nine cities and towns of Gujarat; Ahmedabad, Surat, Baroda, Mehsana, Rajkot, Navsari, Jamnagar, Bharuch and Gandhidham. Besides, presently, the company has 300 patient service network centers across Gujarat and services over 1500+ clients through its robust B2B network.
Ameera Shah, Promoter and Managing Director, Metropolis Healthcare Ltd said, "Gujarat has always been an important market for us. In October 2019, we acquired 4 laboratories in Surat that increased our market share and we are now leaders in the region. With the Ahmedabad acquisition, we are aiming to gain profitable market share by building better leadership, operational capabilities, and expanding our test menu. Our immediate focus would be to fully integrate and modernize these laboratories and in terms of diagnosis, deliver on our promise of integrity, empathy, and accuracy."
Shraddha Diagnostic Pvt Ltd was started by Dr. Hiren Shah and Dr.Dushyant Patel. With these two young and dynamic pathologists joining the Metropolis Family, it is the right launchpad for modern and integrated laboratory services in Ahmedabad.
Metropolis has a track record of acquiring and successfully integrating companies by bringing in industry best practices to these acquired businesses including standardized machines and standard operating procedures, in a phased manner, resulting in efficiency and quality enhancement. Metropolis, since 2002 has successfully used its brand strength to established large networks through acquisitions in Chennai, Rajkot, Surat, Bangalore, Pune as well as outside India.
Ahmedabad, India: Metropolis Healthcare Ltd, the leading pan -India pathology specialist, has recently signed a binding agreement to acquire Ahmedabad based Shraddha Diagnostics Pvt Ltd.
With this acquisition, Metropolis has expanded its lab footprint from 17 to 20 in nine cities and towns of Gujarat; Ahmedabad, Surat, Baroda, Mehsana, Rajkot, Navsari, Jamnagar, Bharuch and Gandhidham. Besides, presently, the company has 300 patient service network centers across Gujarat and services over 1500+ clients through its robust B2B network.
Ameera Shah, Promoter and Managing Director, Metropolis Healthcare Ltd said, "Gujarat has always been an important market for us. In October 2019, we acquired 4 laboratories in Surat that increased our market share and we are now leaders in the region. With the Ahmedabad acquisition, we are aiming to gain profitable market share by building better leadership, operational capabilities, and expanding our test menu. Our immediate focus would be to fully integrate and modernize these laboratories and in terms of diagnosis, deliver on our promise of integrity, empathy, and accuracy."
Shraddha Diagnostic Pvt Ltd was started by Dr. Hiren Shah and Dr.Dushyant Patel. With these two young and dynamic pathologists joining the Metropolis Family, it is the right launchpad for modern and integrated laboratory services in Ahmedabad.
Metropolis has a track record of acquiring and successfully integrating companies by bringing in industry best practices to these acquired businesses including standardized machines and standard operating procedures, in a phased manner, resulting in efficiency and quality enhancement. Metropolis, since 2002 has successfully used its brand strength to established large networks through acquisitions in Chennai, Rajkot, Surat, Bangalore, Pune as well as outside India.
Indian Society for Clinical Research (ISCR) to Host 13th Annual Conference in Mumbai
Mumbai, India: Beyond new regulations, increasing participation and enhancing patient safety is the theme of the 13th Annual Conference of Indian Society for Clinical Research (ISCR) to be held in Mumbai from January 24-25. Held against the backdrop of the New Drugs and Clinical Trials Rules, 2019 launched around a year ago, the event will bring clinical research professionals from academia, healthcare institutions, not for profit organisations and the industry together to deliberate on the road ahead for clinical research in India, as well as new and emerging areas in clinical research. Dr. V G Somani, Drug Controller General India, CDSCO, will deliver the Chief Guest address. Dr. Gagandeep Kang, Executive Director, Translational Health Science Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT), Ministry of Science & Technology, Govt. of India, will deliver the late Prof Ranjit Roy Chaudhury Oration.
"This year's Conference provides the right opportunity for clinical research professionals to reflect on the year that has gone by and look forward at what more we need to be doing to move the clinical research agenda in the country forward so that our patients have access to treatment for the many unmet medical needs in our country," said Dr Chirag Trivedi, President, ISCR. "India has 16% of the world’s population and 20% of the world's disease burden and yet less than 1.2% of global clinical trials are done in India (source: www.clinicaltrials.gov)." The Conference has four tracks covering Clinical Operations, Medical Writing, Biostatistics and Data Management.
Leading up to the annual conference, six pre-conference workshops have been scheduled for clinical researcher professionals, investigators and students on January 23rd. The workshops will cover Real World Evidence, Risk-based Implementation Strategy, PV Audits and Inspections and Enhancing Site and Investigator Capability among other topics.
Mumbai, India: Beyond new regulations, increasing participation and enhancing patient safety is the theme of the 13th Annual Conference of Indian Society for Clinical Research (ISCR) to be held in Mumbai from January 24-25. Held against the backdrop of the New Drugs and Clinical Trials Rules, 2019 launched around a year ago, the event will bring clinical research professionals from academia, healthcare institutions, not for profit organisations and the industry together to deliberate on the road ahead for clinical research in India, as well as new and emerging areas in clinical research. Dr. V G Somani, Drug Controller General India, CDSCO, will deliver the Chief Guest address. Dr. Gagandeep Kang, Executive Director, Translational Health Science Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology (DBT), Ministry of Science & Technology, Govt. of India, will deliver the late Prof Ranjit Roy Chaudhury Oration.
"This year's Conference provides the right opportunity for clinical research professionals to reflect on the year that has gone by and look forward at what more we need to be doing to move the clinical research agenda in the country forward so that our patients have access to treatment for the many unmet medical needs in our country," said Dr Chirag Trivedi, President, ISCR. "India has 16% of the world’s population and 20% of the world's disease burden and yet less than 1.2% of global clinical trials are done in India (source: www.clinicaltrials.gov)." The Conference has four tracks covering Clinical Operations, Medical Writing, Biostatistics and Data Management.
Leading up to the annual conference, six pre-conference workshops have been scheduled for clinical researcher professionals, investigators and students on January 23rd. The workshops will cover Real World Evidence, Risk-based Implementation Strategy, PV Audits and Inspections and Enhancing Site and Investigator Capability among other topics.
Wockhardt: 1st Indian Company to Achieve Approval for Newly Discovered Antibiotics
Mumbai, India: Indian drug regulator, DCGI has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).
The size of Indian Antibiotic market is approx. 16,000 Crore, growing at 7 percent and is one of the largest therapeutic segment, with a 12 percent market share of the Indian Pharmaceutical Market1.
"By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over the currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality"- said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group.
Antimicrobial Resistance is a medical challenge with 38 percent resistance in India. AMR is a major public health problem globally. India carries one of the largest burdens of drug resistant pathogens worldwide. Infections caused by drug -resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health -care systems, and hinder the goals of sustainable development. Two million deaths are projected to occur in India due to AMR by the year 20502.
World Health Organisation (WHO) in 2017 has listed Methicillin resistant S. aureus (MRSA) as a 'high' priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings3. In 2018, a national study conducted by the Indian council of Medical research (ICMR ) and Anti-microbial resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6% of MRSA in India4. A recent Indian study reports that 1 in 6 patients infected with multidrug resistant Gram positive infections die in intensive care units5.
Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts, muscle pain, to name a few6; which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. The patient management is further complicated due to increasing resistance to these agents and drying antimicrobial pipeline.
EMROK / EMROK O are the modern gram positive antibiotic against methicillin resistant Staphylococcus Aureus infections. EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. While the non-clinical and Phase 1 studies have been undertaken in U.S. Europe and India, the Phase 2 and Phase 3 clinical studies have been successfully completed in India. More than 50 international publications/posters in top-notch journals/scientific conferences and studies by leading international experts have established that EMROK/EMROK-O represents a truly multi-spectrum MRSA drug with potent bactericidal action against Gram positive, quinolone susceptible Gram negative, anaerobic and atypical bacteria.
Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs vancomycin, teicoplanin, daptomycin and linezolid which are beset with unfavourable features of nephrotoxicity, bone-marrow toxicity and muscle toxicity therefore cannot be given in patients with impaired kidney/liver function and seriously ill patients requiring for longer duration therapy.
After a significant gap of 14 years, a new anti-MRSA agent will be made available by Wockhardt as 'EMROK' for the management of resistant superbug.
Due to the combination of complexity of resistance mechanisms expressed by bacteria as well as lack of financial resources to fund antibiotic research, many major pharmaceutical firms have steered away from the antibiotic research in the last 30 years. In such challenging scenarios, Wockhardt Ltd. has invested for more than two decades in developing a strong antibiotic pipeline catering both multi drug resistant Gram positive and Gram negative pathogens and is the only company in the world having five antibiotics against superbugs in the late phase of clinical development. All these antibiotics, because of their promising activity against MDR pathogens, have received US FDA-QIDP status for expediting the drug development cycle. Out of the five, the first two antibiotics -EMROK and EMROK-O have been approved by DCGI recently and will be launched soon.
Mumbai, India: Indian drug regulator, DCGI has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).
The size of Indian Antibiotic market is approx. 16,000 Crore, growing at 7 percent and is one of the largest therapeutic segment, with a 12 percent market share of the Indian Pharmaceutical Market1.
"By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over the currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality"- said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group.
Antimicrobial Resistance is a medical challenge with 38 percent resistance in India. AMR is a major public health problem globally. India carries one of the largest burdens of drug resistant pathogens worldwide. Infections caused by drug -resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health -care systems, and hinder the goals of sustainable development. Two million deaths are projected to occur in India due to AMR by the year 20502.
World Health Organisation (WHO) in 2017 has listed Methicillin resistant S. aureus (MRSA) as a 'high' priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings3. In 2018, a national study conducted by the Indian council of Medical research (ICMR ) and Anti-microbial resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6% of MRSA in India4. A recent Indian study reports that 1 in 6 patients infected with multidrug resistant Gram positive infections die in intensive care units5.
Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts, muscle pain, to name a few6; which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. The patient management is further complicated due to increasing resistance to these agents and drying antimicrobial pipeline.
EMROK / EMROK O are the modern gram positive antibiotic against methicillin resistant Staphylococcus Aureus infections. EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. While the non-clinical and Phase 1 studies have been undertaken in U.S. Europe and India, the Phase 2 and Phase 3 clinical studies have been successfully completed in India. More than 50 international publications/posters in top-notch journals/scientific conferences and studies by leading international experts have established that EMROK/EMROK-O represents a truly multi-spectrum MRSA drug with potent bactericidal action against Gram positive, quinolone susceptible Gram negative, anaerobic and atypical bacteria.
Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs vancomycin, teicoplanin, daptomycin and linezolid which are beset with unfavourable features of nephrotoxicity, bone-marrow toxicity and muscle toxicity therefore cannot be given in patients with impaired kidney/liver function and seriously ill patients requiring for longer duration therapy.
After a significant gap of 14 years, a new anti-MRSA agent will be made available by Wockhardt as 'EMROK' for the management of resistant superbug.
Due to the combination of complexity of resistance mechanisms expressed by bacteria as well as lack of financial resources to fund antibiotic research, many major pharmaceutical firms have steered away from the antibiotic research in the last 30 years. In such challenging scenarios, Wockhardt Ltd. has invested for more than two decades in developing a strong antibiotic pipeline catering both multi drug resistant Gram positive and Gram negative pathogens and is the only company in the world having five antibiotics against superbugs in the late phase of clinical development. All these antibiotics, because of their promising activity against MDR pathogens, have received US FDA-QIDP status for expediting the drug development cycle. Out of the five, the first two antibiotics -EMROK and EMROK-O have been approved by DCGI recently and will be launched soon.
Glenmark Pharmaceuticals Receives ANDA Approval for Deferasirox Tablets
Mumbai, India: Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration(USFDA) for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, the generic version of Exjade®1 Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.
According to IQVIATM sales data for the 12- month period ending November 2019, the Exjade® Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg market2 achieved annual sales of approximately $106.4 million*.
Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 43 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Mumbai, India: Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food & Drug Administration(USFDA) for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, the generic version of Exjade®1 Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.
According to IQVIATM sales data for the 12- month period ending November 2019, the Exjade® Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg market2 achieved annual sales of approximately $106.4 million*.
Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 43 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Bosch Packaging Technology is Now Syntegon
Waiblingen, Germany: Syntegon Technology is the new name amongst the market leaders in the processing and packaging industry. Known as Bosch Packaging Technology until late 2019, the former Bosch division has recently presented itself as an independent enterprise at the company headquarters in Waiblingen (Germany). Syntegon Technology's business focus is on intelligent and sustainable technologies for the pharmaceutical and food industries. Extending the service range is a priority for the company. Syntegon Technology employs 6,100 people at more than 30 locations worldwide. It posted 1.3 billion euros in sales in 2019. Bosch disclosed its plans to sell the packaging machinery division to a newly incorporated entity managed by CVC Capital Partners, a leading private equity and investment advisory firm, in July 2019. The transaction was completed according to plan, with the company gaining full independence at the turn of the year.
Transaction wrapped up on schedule as business development remains stable. The sale of Bosch Packaging Technology was completed on January 2, 2020, as envisioned. Bosch had announced in June 2018 that it intended to sell its packaging division, finding a buyer a year later in CVC Capital Partners (CVC). Bosch Packaging Technology then expanded its headquarters in Waiblingen, Germany, augmenting it with new departments required for the switch. Business developments remained stable in the interim, bucking the trend in the sluggish machine engineering sector. Sales in 2019 came to 1.3 billion euros, matching the previous year's figure.
The new owner, CVC, aims to vigorously develop the company as a whole and expand intra-group synergies. Commenting on the closing of the sale, Marc Strobel, a partner at CVC Capital Partners said, "CVC is delighted to see the transaction completed on schedule. Syntegon Technology has a strong presence in many market segments, great technological know-how, and innovative power. We want to build on these strengths jointly with management and the entire workforce."
Into the future with a new brand : "Processing and packaging technology for a better life!" This is Syntegon's mission statement. The company is determined to improve the lives of consumers and patients with intelligent and sustainable processing and packaging solutions. A new corporate brand was developed over the past few months. The name Syntegon stands for synergy, technology, and focus on the future. The new corporate color green underscores the importance of sustainability and health. The square in the newly designed logo symbolizes a package as well as packaging technology's ability to protect products.
The entire workforce will celebrate the independent company's launch with management on January 16, 2020. The ceremony at the Waiblingen headquarters, broadcasted live around the world, will be followed by events held at the individual locations. Syntegon Technology will share the news with its business partners today. Chairman of the Executive Board Dr. Stefan König takes this opportunity to send an emphatic message: "We are building on 150 years of experience and the 64,000 machines deployed by our customers, and pursuing new avenues of business. Now, more than ever before, we are working on intelligent and sustainable technologies and embracing the collaboration with our business partners in the true spirit of partnership."
Greater flexibility and focus on caring partnerships: This newly gained independence enables Syntegon Technology to be even more flexible. And newly added departments at the headquarters such as Purchasing and IT shorten the distances between in-house units and facilitating interaction with customers and suppliers. Whereas the company had been part of a large corporation with diverse divisions, it can now create a business framework that is an even better fit for the industry. This new setup will enable the company to enhance its profile as a leading processing and packaging company.
Syntegon Technology aims to set new priorities for services. Impelled by the spirit of partnership with its customers, the company is striving to improve its processes. One goal is to reduce response times to customer enquiries; another is to further increase the availability of service technicians. Syntegon Technology is also investing in a customer and technology center at its Waiblingen headquarters. The processing and packaging technology company collaborates with global corporations and regional market leaders, and is determined to offer even more attractive services for mediumsized enterprises and startups.
Intelligent and sustainable technologies: Syntegon Technology has intensified its efforts to develop intelligent and sustainable technologies. Drawing on a deep well of experience in developing and integrating software solutions, the company uses connected components as well as components enhanced with artificial intelligence to this end. It puts a premium on ensuring sophisticated technologies are simple to use. The greater goal is to collect and evaluate data to avoid machine downtime, maximize product quality, and optimize overall plant efficiency.
The enterprise is pursuing two approaches to produce sustainable packaging - one is to use mono materials rather than conventional multilayer films, and the other is to use paper packaging as an alternative to plastic. Syntegon Technology supports its customers on the path to a sustainable future with material testing, machine applications, and innovative packaging designed to meet the requirements of products, transport modes, and regional circumstances. The company has also significantly reduced its machines' energy consumption.
The numbers speak for themselves : A campaign to train the spotlight on Syntegon Technology's new brand is underway. The company is letting the numbers tell the story. Featuring prominently on the website at www.syntegon.com/numbers, these persuasive figures show what Syntegon is all about. The next highlight on the agenda is the Düsseldorf interpack trade fair, where the company will present its fresh, new brand identity to customers in May 2020.
Waiblingen, Germany: Syntegon Technology is the new name amongst the market leaders in the processing and packaging industry. Known as Bosch Packaging Technology until late 2019, the former Bosch division has recently presented itself as an independent enterprise at the company headquarters in Waiblingen (Germany). Syntegon Technology's business focus is on intelligent and sustainable technologies for the pharmaceutical and food industries. Extending the service range is a priority for the company. Syntegon Technology employs 6,100 people at more than 30 locations worldwide. It posted 1.3 billion euros in sales in 2019. Bosch disclosed its plans to sell the packaging machinery division to a newly incorporated entity managed by CVC Capital Partners, a leading private equity and investment advisory firm, in July 2019. The transaction was completed according to plan, with the company gaining full independence at the turn of the year.
Transaction wrapped up on schedule as business development remains stable. The sale of Bosch Packaging Technology was completed on January 2, 2020, as envisioned. Bosch had announced in June 2018 that it intended to sell its packaging division, finding a buyer a year later in CVC Capital Partners (CVC). Bosch Packaging Technology then expanded its headquarters in Waiblingen, Germany, augmenting it with new departments required for the switch. Business developments remained stable in the interim, bucking the trend in the sluggish machine engineering sector. Sales in 2019 came to 1.3 billion euros, matching the previous year's figure.
The new owner, CVC, aims to vigorously develop the company as a whole and expand intra-group synergies. Commenting on the closing of the sale, Marc Strobel, a partner at CVC Capital Partners said, "CVC is delighted to see the transaction completed on schedule. Syntegon Technology has a strong presence in many market segments, great technological know-how, and innovative power. We want to build on these strengths jointly with management and the entire workforce."
Into the future with a new brand : "Processing and packaging technology for a better life!" This is Syntegon's mission statement. The company is determined to improve the lives of consumers and patients with intelligent and sustainable processing and packaging solutions. A new corporate brand was developed over the past few months. The name Syntegon stands for synergy, technology, and focus on the future. The new corporate color green underscores the importance of sustainability and health. The square in the newly designed logo symbolizes a package as well as packaging technology's ability to protect products.
The entire workforce will celebrate the independent company's launch with management on January 16, 2020. The ceremony at the Waiblingen headquarters, broadcasted live around the world, will be followed by events held at the individual locations. Syntegon Technology will share the news with its business partners today. Chairman of the Executive Board Dr. Stefan König takes this opportunity to send an emphatic message: "We are building on 150 years of experience and the 64,000 machines deployed by our customers, and pursuing new avenues of business. Now, more than ever before, we are working on intelligent and sustainable technologies and embracing the collaboration with our business partners in the true spirit of partnership."
Greater flexibility and focus on caring partnerships: This newly gained independence enables Syntegon Technology to be even more flexible. And newly added departments at the headquarters such as Purchasing and IT shorten the distances between in-house units and facilitating interaction with customers and suppliers. Whereas the company had been part of a large corporation with diverse divisions, it can now create a business framework that is an even better fit for the industry. This new setup will enable the company to enhance its profile as a leading processing and packaging company.
Syntegon Technology aims to set new priorities for services. Impelled by the spirit of partnership with its customers, the company is striving to improve its processes. One goal is to reduce response times to customer enquiries; another is to further increase the availability of service technicians. Syntegon Technology is also investing in a customer and technology center at its Waiblingen headquarters. The processing and packaging technology company collaborates with global corporations and regional market leaders, and is determined to offer even more attractive services for mediumsized enterprises and startups.
Intelligent and sustainable technologies: Syntegon Technology has intensified its efforts to develop intelligent and sustainable technologies. Drawing on a deep well of experience in developing and integrating software solutions, the company uses connected components as well as components enhanced with artificial intelligence to this end. It puts a premium on ensuring sophisticated technologies are simple to use. The greater goal is to collect and evaluate data to avoid machine downtime, maximize product quality, and optimize overall plant efficiency.
The enterprise is pursuing two approaches to produce sustainable packaging - one is to use mono materials rather than conventional multilayer films, and the other is to use paper packaging as an alternative to plastic. Syntegon Technology supports its customers on the path to a sustainable future with material testing, machine applications, and innovative packaging designed to meet the requirements of products, transport modes, and regional circumstances. The company has also significantly reduced its machines' energy consumption.
The numbers speak for themselves : A campaign to train the spotlight on Syntegon Technology's new brand is underway. The company is letting the numbers tell the story. Featuring prominently on the website at www.syntegon.com/numbers, these persuasive figures show what Syntegon is all about. The next highlight on the agenda is the Düsseldorf interpack trade fair, where the company will present its fresh, new brand identity to customers in May 2020.
Transgene and NEC Start Two Clinical Trials with
TG4050, an AI-Powered Cancer Vaccine for Ovarian and Head & Neck Cancers
Tokyo, Japan: Transgene is a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation is a leader in IT and network technologies. They both has recently announced that the first patients have been enrolled in the first-in-human trials evaluating TG4050, a therapeutic vaccine based on the myvac technology and powered by NEC's cutting-edge AI capabilities. In these Phase 1 trials, TG4050 is being administered to patients with head and neck cancer who have a high risk of relapse after surgery and patients with ovarian cancer after surgery and adjuvant therapy.
Transgene's highly innovative myvac technology allows the generation of virus-based immunotherapy within a very short time frame while encoding patient-specific mutations identified and selected by NEC's Neoantigen Prediction System. TG4050 has been designed to target up to 30 patientspecific neoantigens (cancer cell mutations). They are selected using NEC's Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary immune data, allowing it to accurately prioritize and select the most immunogenic sequences.
Transgene uses its expertise in viral vectorization via myvac to incorporate the selected neoantigen sequences in the genome of the Modified Vaccinia virus Ankara (MVA) viral vector. The Company has also set up a unique in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the clinical development of this novel therapeutic vaccine.
"As each patient's cancer is unique, we have developed a therapy that turns their solid tumor's genetic signature into a powerful highly specific anticancer weapon. TG4050 is based on an MVA viral vector that has proven biological activity and has the ability to elicit an immune response against tumor antigens. Our partnership with NEC ensures that TG4050 is benefitting from its world-leading expertise in artificial intelligence and its unique algorithm that is used to select up to 30 patient-specific antigens that allow this novel vaccine to induce a strong immune response. We are convinced that TG4050, which is at the crossroad of immunotherapy and big data sciences, will herald the start of a new era in the fight against cancer," explained Philippe Archinard, Chairman and Chief Executive Officer of Transgene.
"We are excited to enroll our first patients in these trials and see TG4050 advance to the clinic. This is another step closer towards the realization of an AI-driven individualized immunotherapy for each patient. Our unique partnership with Transgene enables us to leverage its significant clinical development know-how and proven viral vector delivery platform. We are hopeful that TG4050 will make a significant difference for patients throughout the world," commented Osamu Fujikawa, Senior Vice President, NEC Corporation. A Phase 1 clinical trial of TG4050 is enrolling patients with ovarian cancer after surgery and first-line chemotherapy. This multi-center, one-arm trial will recruit patients in the USA and in France. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. Dr. Matthew Block, MD, PhD, immunologist and medical oncologist at the Mayo Clinic, is conducting the trial in the USA; in France, the trial will be conducted by Dr. Martinez at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie.
Another Phase 1 clinical trial of TG4050 is enrolling patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN) that have received an adjuvant (first-line) therapy after surgery. This multi-center, open-label, randomized two arms trial will include patients in the UK and in France. Patients will receive either TG4050 monotherapy after completion of the adjuvant therapy or in combination with the standard of care at the time of recurrence. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. In France, the trial is being conducted by Pr. Delord at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie; in the UK, the trial is coordinated by Pr. Ottensmeier from Southampton University. Both studies are sponsored by Transgene and are co-financed by Transgene and NEC.
Tokyo, Japan: Transgene is a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation is a leader in IT and network technologies. They both has recently announced that the first patients have been enrolled in the first-in-human trials evaluating TG4050, a therapeutic vaccine based on the myvac technology and powered by NEC's cutting-edge AI capabilities. In these Phase 1 trials, TG4050 is being administered to patients with head and neck cancer who have a high risk of relapse after surgery and patients with ovarian cancer after surgery and adjuvant therapy.
Transgene's highly innovative myvac technology allows the generation of virus-based immunotherapy within a very short time frame while encoding patient-specific mutations identified and selected by NEC's Neoantigen Prediction System. TG4050 has been designed to target up to 30 patientspecific neoantigens (cancer cell mutations). They are selected using NEC's Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary immune data, allowing it to accurately prioritize and select the most immunogenic sequences.
Transgene uses its expertise in viral vectorization via myvac to incorporate the selected neoantigen sequences in the genome of the Modified Vaccinia virus Ankara (MVA) viral vector. The Company has also set up a unique in-house good manufacturing practice (GMP) unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the clinical development of this novel therapeutic vaccine.
"As each patient's cancer is unique, we have developed a therapy that turns their solid tumor's genetic signature into a powerful highly specific anticancer weapon. TG4050 is based on an MVA viral vector that has proven biological activity and has the ability to elicit an immune response against tumor antigens. Our partnership with NEC ensures that TG4050 is benefitting from its world-leading expertise in artificial intelligence and its unique algorithm that is used to select up to 30 patient-specific antigens that allow this novel vaccine to induce a strong immune response. We are convinced that TG4050, which is at the crossroad of immunotherapy and big data sciences, will herald the start of a new era in the fight against cancer," explained Philippe Archinard, Chairman and Chief Executive Officer of Transgene.
"We are excited to enroll our first patients in these trials and see TG4050 advance to the clinic. This is another step closer towards the realization of an AI-driven individualized immunotherapy for each patient. Our unique partnership with Transgene enables us to leverage its significant clinical development know-how and proven viral vector delivery platform. We are hopeful that TG4050 will make a significant difference for patients throughout the world," commented Osamu Fujikawa, Senior Vice President, NEC Corporation. A Phase 1 clinical trial of TG4050 is enrolling patients with ovarian cancer after surgery and first-line chemotherapy. This multi-center, one-arm trial will recruit patients in the USA and in France. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. Dr. Matthew Block, MD, PhD, immunologist and medical oncologist at the Mayo Clinic, is conducting the trial in the USA; in France, the trial will be conducted by Dr. Martinez at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie.
Another Phase 1 clinical trial of TG4050 is enrolling patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN) that have received an adjuvant (first-line) therapy after surgery. This multi-center, open-label, randomized two arms trial will include patients in the UK and in France. Patients will receive either TG4050 monotherapy after completion of the adjuvant therapy or in combination with the standard of care at the time of recurrence. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine. In France, the trial is being conducted by Pr. Delord at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie; in the UK, the trial is coordinated by Pr. Ottensmeier from Southampton University. Both studies are sponsored by Transgene and are co-financed by Transgene and NEC.
Change in Management in Sanner Group: Ralf Tiemann is
the New CEO and Dr Johannis Willem van Vliet is the New CTO
Bensheim/Germany: Sanner – the international supplier of high -quality plastic packaging and components for pharmaceutical, medical and healthcare products - renewed its organizational structure. Ralf Tiemann was appointed as the CEO of the entire Sanner Group. He is supported by a three-member team consisting of the new CTO and Managing Director of Sanner GmbH, Dr. Johannis Willem van Vliet, the vacant position of CSO and the long-standing CFO Claudia Tonhäuser.
Sanner is set for further growth. Accordingly, the Bensheim-based company has decided to reallocate responsibilities within the organization. Ralf Tiemann, who has headed the subsidiary Sanner Pharmaceutical & Medical Packaging Materials Co. Ltd. based in Kunshan, China since 2008, took over the newly created position of CEO of the entire Sanner Group on January 1, 2020. "Sanner is in an excellent international position to continue on its growth path," says Tiemann. "In addition to investments in the different locations, we will also successively expand our portfolio in the coming years. This includes intelligent solutions for greater therapeutic adherence as well as sustainable, biobased plastic packaging".
Dirk Mähr, member of the management board of Sanner GmbH since August 2015, left the company at the end of 2019. Therefore Sanner GmbH appointed Dr. Johannis Willem van Vliet to the management board last summer. As CTO, he is responsible for production, development and quality. Until the position of CSO is filled, van Vliet will also temporarily assume responsibility for sales, marketing, product management and personnel. As Vice President of Ottobock healthcare products GmbH, van Vliet most recently headed the development department for 2 medical products in Vienna. He holds a PhD in mechanical engineering and has many years of experience in research and development as well as production and automation. "This is ideally in line with Sanner's strategic orientation: we want to further strengthen the company in international competition with higher investments in development activities, Industry 4.0 and the expansion of the medtech portfolio," says van Vliet.
Claudia Tonhäuser will continue to be responsible for finance, controlling, purchasing and IT. The business informatics graduate has been with Sanner GmbH for many years and has held the position of CFO since 2010.
Bensheim/Germany: Sanner – the international supplier of high -quality plastic packaging and components for pharmaceutical, medical and healthcare products - renewed its organizational structure. Ralf Tiemann was appointed as the CEO of the entire Sanner Group. He is supported by a three-member team consisting of the new CTO and Managing Director of Sanner GmbH, Dr. Johannis Willem van Vliet, the vacant position of CSO and the long-standing CFO Claudia Tonhäuser.
Sanner is set for further growth. Accordingly, the Bensheim-based company has decided to reallocate responsibilities within the organization. Ralf Tiemann, who has headed the subsidiary Sanner Pharmaceutical & Medical Packaging Materials Co. Ltd. based in Kunshan, China since 2008, took over the newly created position of CEO of the entire Sanner Group on January 1, 2020. "Sanner is in an excellent international position to continue on its growth path," says Tiemann. "In addition to investments in the different locations, we will also successively expand our portfolio in the coming years. This includes intelligent solutions for greater therapeutic adherence as well as sustainable, biobased plastic packaging".
Dirk Mähr, member of the management board of Sanner GmbH since August 2015, left the company at the end of 2019. Therefore Sanner GmbH appointed Dr. Johannis Willem van Vliet to the management board last summer. As CTO, he is responsible for production, development and quality. Until the position of CSO is filled, van Vliet will also temporarily assume responsibility for sales, marketing, product management and personnel. As Vice President of Ottobock healthcare products GmbH, van Vliet most recently headed the development department for 2 medical products in Vienna. He holds a PhD in mechanical engineering and has many years of experience in research and development as well as production and automation. "This is ideally in line with Sanner's strategic orientation: we want to further strengthen the company in international competition with higher investments in development activities, Industry 4.0 and the expansion of the medtech portfolio," says van Vliet.
Claudia Tonhäuser will continue to be responsible for finance, controlling, purchasing and IT. The business informatics graduate has been with Sanner GmbH for many years and has held the position of CFO since 2010.
Clarivate Analytics Highlighted India as an Emerging
Hub for Biologics and Biosimilars
New Delhi, India: Clarivate Analytics plc, a global leader in providing trusted insights and analytics to accelerate the pace of innovation, has released a new report together with the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC) and ABLE (Association of Biotechnology Led Enterprises). Entitled 'India: The emerging hub for biologics and biosimilars', the report features analysis based on insights from Cortellis Deals Intelligence™ and Cortellis Competitive Intelligence™, and it can be downloaded.
The report examines the transformation of the pharmaceutical/ biotech industry from small molecule therapeutics to biotherapeutics (biologics and biosimilars), driven by unmet clinical needs, the inherent advantages of biotherapeutics, and commercial potential. Of the top 10 blockbuster molecules in 2018, only two were small molecule therapeutics and eight were biological therapeutics.
The report was released at the Global Bio-India 2019 in New Delhi by Dr. Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Shri. Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel, Dr. Renu Swarup, Secretary, DBT and other luminaries including Prof. Vinod K. Paul, Member NITI Aayog and Dr. Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon Limited.
Dr. Renu Swarup, Secretary, Department of Biotechnology said, "India has 95 approved biosimilars in the domestic market, more than any other country, and market penetration, which is currently relatively low and expected to increase quickly in coming years with the increase in demand by middle class patients."
The Indian pharmaceutical/biotech industry is well placed to capitalize on the substantial opportunity offered by biotherapeutics and includes companies with an extensive pipeline of biosimilars under active development.
Kiran Mazumdar, Chairperson and Managing Director, Biocon Limited, said, "Technological innovation, coupled with economies of scale, are driving India's emergence as a global hub for biologics and biosimilars. In enabling affordable access to high quality biosimilars worldwide, India's biopharma sector can emulate the global leadership achieved in generic drugs and vaccines." Dr. Cyrus S. Poonawalla, Chairman and Managing Director, Serum Institute of India, said, "India's contribution and heft in the health sector is growing through novel technologies and innovative science, supported by economies of scale and cutting-edge manufacturing infrastructure to drive new frontiers in health science."
So far, Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. It is likely that drug development will continue to accelerate thanks to the steps taken by the government of India to support the biopharmaceutical industry with the necessary infrastructure, funding, global collaborations to bridge the technical knowledge gap, and further development of regulatory guidelines.
"Efforts by industry and the government will help position India as a leader in biotechnology-based research and a hub for biotech innovation and commercialization," concluded Arvind Pachhapur, Vice President, Clarivate Analytics.
New Delhi, India: Clarivate Analytics plc, a global leader in providing trusted insights and analytics to accelerate the pace of innovation, has released a new report together with the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC) and ABLE (Association of Biotechnology Led Enterprises). Entitled 'India: The emerging hub for biologics and biosimilars', the report features analysis based on insights from Cortellis Deals Intelligence™ and Cortellis Competitive Intelligence™, and it can be downloaded.
The report examines the transformation of the pharmaceutical/ biotech industry from small molecule therapeutics to biotherapeutics (biologics and biosimilars), driven by unmet clinical needs, the inherent advantages of biotherapeutics, and commercial potential. Of the top 10 blockbuster molecules in 2018, only two were small molecule therapeutics and eight were biological therapeutics.
The report was released at the Global Bio-India 2019 in New Delhi by Dr. Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Shri. Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel, Dr. Renu Swarup, Secretary, DBT and other luminaries including Prof. Vinod K. Paul, Member NITI Aayog and Dr. Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon Limited.
Dr. Renu Swarup, Secretary, Department of Biotechnology said, "India has 95 approved biosimilars in the domestic market, more than any other country, and market penetration, which is currently relatively low and expected to increase quickly in coming years with the increase in demand by middle class patients."
The Indian pharmaceutical/biotech industry is well placed to capitalize on the substantial opportunity offered by biotherapeutics and includes companies with an extensive pipeline of biosimilars under active development.
Kiran Mazumdar, Chairperson and Managing Director, Biocon Limited, said, "Technological innovation, coupled with economies of scale, are driving India's emergence as a global hub for biologics and biosimilars. In enabling affordable access to high quality biosimilars worldwide, India's biopharma sector can emulate the global leadership achieved in generic drugs and vaccines." Dr. Cyrus S. Poonawalla, Chairman and Managing Director, Serum Institute of India, said, "India's contribution and heft in the health sector is growing through novel technologies and innovative science, supported by economies of scale and cutting-edge manufacturing infrastructure to drive new frontiers in health science."
So far, Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. It is likely that drug development will continue to accelerate thanks to the steps taken by the government of India to support the biopharmaceutical industry with the necessary infrastructure, funding, global collaborations to bridge the technical knowledge gap, and further development of regulatory guidelines.
"Efforts by industry and the government will help position India as a leader in biotechnology-based research and a hub for biotech innovation and commercialization," concluded Arvind Pachhapur, Vice President, Clarivate Analytics.
Kilitch Drugs to Set-Up Second Green Field Project in
Ethiopia at an Investment of USD 5 Mn
Mumbai, India: Government of Ethiopia in its endeavor to become self-sufficient has invited Kilitch to explore supply of Liquid injectables. Kilitch Drugs, is setting up its second green field project in Ethiopia to manufacture liquid injectables and at a capital investment of USD 5 million. In this regard, the Company has accepted the request of Ethiopian government for one hector land near Addis Ababa.
Commenting on the company's project status, Mr. Bhavin Mehta, Whole time Director of Kilitch Drugs said, "We are happy to announce our second manufacturing venture in Ethiopia as also for the maiden unit which is now at a very critical stage of our project implementation cycle. Once the validation process is satisfactorily done, Kilitch Drugs plans to commence operations at the first unit in the first quarter of FY2020-21. We are confident that manufacturing base in Ethiopia will strengthen our presence in the African continent."
At the same time, the Company's first manufacturing plant has also reached a decisive stage of the completion process. Kilitch Drugs has begun installing machinery at the first Addis Ababa manufacturing unit and is all scheduled to commence the validation process in December. Process validation being an important tool in quality management of pharmaceuticals is a significant parameter of GMPs.
Kilitch Drugs has registered over 300 products in key African countries and another 250+ products are under registration. It has been having a presence in Africa for over three decades now and during this period has gained a strong advantage. The company's hopes to replicate its Ethiopian business model to the rest of Africa, going forward.
Mumbai, India: Government of Ethiopia in its endeavor to become self-sufficient has invited Kilitch to explore supply of Liquid injectables. Kilitch Drugs, is setting up its second green field project in Ethiopia to manufacture liquid injectables and at a capital investment of USD 5 million. In this regard, the Company has accepted the request of Ethiopian government for one hector land near Addis Ababa.
Commenting on the company's project status, Mr. Bhavin Mehta, Whole time Director of Kilitch Drugs said, "We are happy to announce our second manufacturing venture in Ethiopia as also for the maiden unit which is now at a very critical stage of our project implementation cycle. Once the validation process is satisfactorily done, Kilitch Drugs plans to commence operations at the first unit in the first quarter of FY2020-21. We are confident that manufacturing base in Ethiopia will strengthen our presence in the African continent."
At the same time, the Company's first manufacturing plant has also reached a decisive stage of the completion process. Kilitch Drugs has begun installing machinery at the first Addis Ababa manufacturing unit and is all scheduled to commence the validation process in December. Process validation being an important tool in quality management of pharmaceuticals is a significant parameter of GMPs.
Kilitch Drugs has registered over 300 products in key African countries and another 250+ products are under registration. It has been having a presence in Africa for over three decades now and during this period has gained a strong advantage. The company's hopes to replicate its Ethiopian business model to the rest of Africa, going forward.
Eris Lifesciences Acquired Zomelis from Novartis
Mumbai, India: Eris Lifesciences has announced the acquisition of the trademark Zomelis and its associated trademarks from Novartis AG, Switzerland for a consideration of USD 13 million. Zomelis is used in the treatment of type 2 diabetes and comes under a new class of anti-diabetic drugs known as DPP 4 inhibitors. Amit Bakshi, Chairman and Managing Director, Eris Lifesciences, said, "The acquisition of Zomelis will help us strengthen our position in the diabetes care market in India. Zomelis is a strong brand amongst the super speciality prescriptions and has been promoted for close to 10 years. Our inorganic growth strategy continues as we explore good opportunities to strengthen our product offering for patients.:
Mumbai, India: Eris Lifesciences has announced the acquisition of the trademark Zomelis and its associated trademarks from Novartis AG, Switzerland for a consideration of USD 13 million. Zomelis is used in the treatment of type 2 diabetes and comes under a new class of anti-diabetic drugs known as DPP 4 inhibitors. Amit Bakshi, Chairman and Managing Director, Eris Lifesciences, said, "The acquisition of Zomelis will help us strengthen our position in the diabetes care market in India. Zomelis is a strong brand amongst the super speciality prescriptions and has been promoted for close to 10 years. Our inorganic growth strategy continues as we explore good opportunities to strengthen our product offering for patients.:
Siddharth Mittal Took Over as CEO and Joint Managing
Director of Biocon Limited
Bengaluru, India: Biocon Ltd an innovation-led global biopharmaceuticals company, announced that Siddharth Mittal has taken over as Chief Executive Officer & Joint Managing Director of the Company starting December 1, 2019. Mr. Mittal has been serving as Biocon's Chief Financial Officer (CFO) since August 2014.
Welcoming Mr. Mittal, Kiran Mazumdar-Shaw, CMD, Biocon, said, " am very pleased to welcome Siddharth as CEO & Joint MD of Biocon. Siddharth's strong leadership qualities, comprehensive understanding of various aspects of the business, deep financial insights and robust operational experience make him an excellent fit for the role of CEO to lead Biocon through its next phase of growth. I am confident that in this new role he will build immense value for Biocon and its stakeholders." Mr. Mittal takes over from Dr. Arun Chandavarkar who retired as Chief Executive Officer & Joint Managing Director of Biocon on November 30, 2019, after 29 years of outstanding contribution to the evolution and success of Biocon.
Mr. Mittal has been a core member of the leadership team at Biocon since May 2013 and has played an instrumental role in the biosimilars success story so far including restructuring of the biosimilars business into Biocon Biologics with an objective to unlock value for Biocon’s shareholders. He also played a pivotal role in managing global collaborations. As the CFO, he has successfully created a compelling Shareholder Value Proposition for Biocon over the last 6 years, including value unlocking of Syngene which was listed on the Indian capital markets in 2015.
Siddharth Mittal, CEO & Joint Managing Director, Biocon, said, "I am honoured to take over as the CEO & Joint MD of Biocon, which has a strong legacy as an innovation-led biopharmaceuticals company. It is at an inflection point where it is well positioned to create value for its shareholders by unlocking the potential of various business segments. I now look forward to generating value for our stakeholders by focusing on our Small Molecules business with an aim to further strengthen our portfolio of complex APIs and Generic Formulations in key global markets."
Bengaluru, India: Biocon Ltd an innovation-led global biopharmaceuticals company, announced that Siddharth Mittal has taken over as Chief Executive Officer & Joint Managing Director of the Company starting December 1, 2019. Mr. Mittal has been serving as Biocon's Chief Financial Officer (CFO) since August 2014.
Welcoming Mr. Mittal, Kiran Mazumdar-Shaw, CMD, Biocon, said, " am very pleased to welcome Siddharth as CEO & Joint MD of Biocon. Siddharth's strong leadership qualities, comprehensive understanding of various aspects of the business, deep financial insights and robust operational experience make him an excellent fit for the role of CEO to lead Biocon through its next phase of growth. I am confident that in this new role he will build immense value for Biocon and its stakeholders." Mr. Mittal takes over from Dr. Arun Chandavarkar who retired as Chief Executive Officer & Joint Managing Director of Biocon on November 30, 2019, after 29 years of outstanding contribution to the evolution and success of Biocon.
Mr. Mittal has been a core member of the leadership team at Biocon since May 2013 and has played an instrumental role in the biosimilars success story so far including restructuring of the biosimilars business into Biocon Biologics with an objective to unlock value for Biocon’s shareholders. He also played a pivotal role in managing global collaborations. As the CFO, he has successfully created a compelling Shareholder Value Proposition for Biocon over the last 6 years, including value unlocking of Syngene which was listed on the Indian capital markets in 2015.
Siddharth Mittal, CEO & Joint Managing Director, Biocon, said, "I am honoured to take over as the CEO & Joint MD of Biocon, which has a strong legacy as an innovation-led biopharmaceuticals company. It is at an inflection point where it is well positioned to create value for its shareholders by unlocking the potential of various business segments. I now look forward to generating value for our stakeholders by focusing on our Small Molecules business with an aim to further strengthen our portfolio of complex APIs and Generic Formulations in key global markets."
Piramal Pharma Solutions Announced Collaboration with
BerGenBio
Mumbai, India: Piramal Enterprises Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO) announced that the company will be partnering with BerGenBio ASA on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.
According to Peter DeYoung, CEO, Piramal Pharma Solutions, "BerGenBio's decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients."
To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions™ platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry's growing need for preferred partner relationships, has been successfully applied to more than eighty programs.
Richard Godfrey, Chief Executive Officer of BerGenBio, stated that "Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions' capabilities - especially the Xcelerate Integrated Solutions platform - represent an ideal solution for BerGenBio."
The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.
Mumbai, India: Piramal Enterprises Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO) announced that the company will be partnering with BerGenBio ASA on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.
According to Peter DeYoung, CEO, Piramal Pharma Solutions, "BerGenBio's decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients."
To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions™ platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry's growing need for preferred partner relationships, has been successfully applied to more than eighty programs.
Richard Godfrey, Chief Executive Officer of BerGenBio, stated that "Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions' capabilities - especially the Xcelerate Integrated Solutions platform - represent an ideal solution for BerGenBio."
The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.
Granules India Limited to Divest its Stake
in its Joint Venture Located in China
Hyderabad, India: Granules India Limited announced its intention to divest its entire equity shareholding in Granules Biocause Pharmaceuticals Co. Ltd. by selling its stake to joint venture partner. Granules Biocause Pharmaceuticals Co. Ltd. is an equal joint venture between Granules India Limited and Hubei Biocause Heilen Pharmaceutical Co. Ltd. The manufacturing facility of the joint venture is in Jingmen, China.
Granules formed the JV in 2007 to ensure a regular supply of Ibuprofen API to support its requirements for manufacturing Pharmaceutical Formulation Intermediates and Finished Dosages. Granules cited the environmental issues as one of the key reason for exiting the JV. Environmental issues have created an atmosphere of business uncertainty in China. To comply with regulatory issues on pollution, Granules Biocause Pharmaceuticals' production facility had invested and will continue to invest substantial capex, which is contrary to Granules India's strategy of reducing Capex outflow and Free Cash Flow generation. Also several existing Ibuprofen API manufacturers have expanded capacity or stated their intention to increase capacity. In addition, several companies have announced their intention to enter the Ibuprofen API market. Granules believes the additional API supply will enable it to have more supply options and having a JV is not necessary to ensure Ibuprofen API continuity. Granules India's decision to dilute the stake will not impact its commitment of achieving the profitability target provided for the year even without any additional JV's contribution in the consolidated Net Profit.
Hyderabad, India: Granules India Limited announced its intention to divest its entire equity shareholding in Granules Biocause Pharmaceuticals Co. Ltd. by selling its stake to joint venture partner. Granules Biocause Pharmaceuticals Co. Ltd. is an equal joint venture between Granules India Limited and Hubei Biocause Heilen Pharmaceutical Co. Ltd. The manufacturing facility of the joint venture is in Jingmen, China.
Granules formed the JV in 2007 to ensure a regular supply of Ibuprofen API to support its requirements for manufacturing Pharmaceutical Formulation Intermediates and Finished Dosages. Granules cited the environmental issues as one of the key reason for exiting the JV. Environmental issues have created an atmosphere of business uncertainty in China. To comply with regulatory issues on pollution, Granules Biocause Pharmaceuticals' production facility had invested and will continue to invest substantial capex, which is contrary to Granules India's strategy of reducing Capex outflow and Free Cash Flow generation. Also several existing Ibuprofen API manufacturers have expanded capacity or stated their intention to increase capacity. In addition, several companies have announced their intention to enter the Ibuprofen API market. Granules believes the additional API supply will enable it to have more supply options and having a JV is not necessary to ensure Ibuprofen API continuity. Granules India's decision to dilute the stake will not impact its commitment of achieving the profitability target provided for the year even without any additional JV's contribution in the consolidated Net Profit.
Biocon and Mylan Launched Trastuzumab
Biosimilar, Ogivri™ in the U.S.
Bengaluru, India: Biocon Ltd. announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). This FDA-approved product, co-developed by Biocon Biologics and Mylan, was unanimously recommended by the FDA Oncologic Drugs Advisory Committee. Mylan to offer Ogivri in both the 420mg and 150mg strengths, increasing access to treatment for thousands of HER2-positive breast and gastric cancer patients.
Dr Christiane Hamacher, CEO, Biocon Biologics, said: "The U.S. launch of Ogivri marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multiuse vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S. Ogivri is the second biosimilar from our partnered portfolio being commercialized by Mylan in the U.S. Last year, through the launch of Fulphila we helped in expanding patient access to biosimilar Pegfilgrastim". FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.
Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.
Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila®, a biosimilar to Neulasta®. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products. Mylan President Rajiv Malik added, "As one of the largest suppliers of oncology medicines in the U.S., we are proud to offer Ogivri, and help increase more affordable access to this important treatment option for breast and gastric cancer patients. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients."
Bengaluru, India: Biocon Ltd. announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). This FDA-approved product, co-developed by Biocon Biologics and Mylan, was unanimously recommended by the FDA Oncologic Drugs Advisory Committee. Mylan to offer Ogivri in both the 420mg and 150mg strengths, increasing access to treatment for thousands of HER2-positive breast and gastric cancer patients.
Dr Christiane Hamacher, CEO, Biocon Biologics, said: "The U.S. launch of Ogivri marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multiuse vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S. Ogivri is the second biosimilar from our partnered portfolio being commercialized by Mylan in the U.S. Last year, through the launch of Fulphila we helped in expanding patient access to biosimilar Pegfilgrastim". FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.
Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.
Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila®, a biosimilar to Neulasta®. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products. Mylan President Rajiv Malik added, "As one of the largest suppliers of oncology medicines in the U.S., we are proud to offer Ogivri, and help increase more affordable access to this important treatment option for breast and gastric cancer patients. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients."
Sweden Announced Launch of India-Sweden Healthcare Innovation Centre in India
New Delhi, India: The Swedish Trade Commissioner's Office in collaboration with the All India Institute of Medical Sciences, New Delhi (AIIMS, New Delhi) and All India Institute of Medical Sciences, Jodhpur (AIIMS, Jodhpur) announced the launch of India-Sweden Healthcare Innovation Centre in India at the India- Sweden Business Summit Inauguration held recently.
The announcement was made in the presence of His Majesties King Carl XVI Gustaf of Sweden and in the presence of the Ministers Nirmala Sitharaman, Finance, Government of India and Ibrahim Baylan, Ministry of Enterprise and Innovation, Government of Sweden. The knowledge partner was represented by Mr. Leif Johansson, Chairman of the Board, AstraZeneca who reinforced the importance of innovation to achieve the ambition of providing affordable and accessible healthcare to all in the country.
The signing of the Memorandum of Intent (MoI) took place at the event that marked the 10 years of India Sweden health cooperation in the presence of Dr. Harsh Vardhan, Union Minister of Health and Family Welfare and Dr. Maja Fjaestad, State Secretary, Ministry of Health and Social Affairs, Government of Sweden. AIIMS Delhi was represented by Dr. Randeep Guleria, Director and AIIMS Jodhpur by Dr. Sanjeev Misra, Director and Swedish Trade Commissioner's Office by Anders Wickberg, Swedish Trade Commissioner to India.
New Delhi, India: The Swedish Trade Commissioner's Office in collaboration with the All India Institute of Medical Sciences, New Delhi (AIIMS, New Delhi) and All India Institute of Medical Sciences, Jodhpur (AIIMS, Jodhpur) announced the launch of India-Sweden Healthcare Innovation Centre in India at the India- Sweden Business Summit Inauguration held recently.
The announcement was made in the presence of His Majesties King Carl XVI Gustaf of Sweden and in the presence of the Ministers Nirmala Sitharaman, Finance, Government of India and Ibrahim Baylan, Ministry of Enterprise and Innovation, Government of Sweden. The knowledge partner was represented by Mr. Leif Johansson, Chairman of the Board, AstraZeneca who reinforced the importance of innovation to achieve the ambition of providing affordable and accessible healthcare to all in the country.
The signing of the Memorandum of Intent (MoI) took place at the event that marked the 10 years of India Sweden health cooperation in the presence of Dr. Harsh Vardhan, Union Minister of Health and Family Welfare and Dr. Maja Fjaestad, State Secretary, Ministry of Health and Social Affairs, Government of Sweden. AIIMS Delhi was represented by Dr. Randeep Guleria, Director and AIIMS Jodhpur by Dr. Sanjeev Misra, Director and Swedish Trade Commissioner's Office by Anders Wickberg, Swedish Trade Commissioner to India.
Sanofi Acquired Synthorx for USD 2.5 Billion
Parish, France: Sanofi announced that it will acquire Synthorx, a clinical-stage biotechnology company headquartered in La Jolla, CA, for $68 per share in cash, totaling to approximately $2.5 billion. Through the agreement, Sanofi will obtain all outstanding shares of Synthorx common stock for $68 per share, which represents a 172 percent premium to Synthorx’s closing price, according to a Sanofi press release. The transaction is expected to be completed in the first quarter of 2020.
The acquisition will give Sanofi access to Synthorx's lead immuno-oncology product candidate, THOR-707, a variant of interleukin-2 (IL-2), which is currently in clinical development in solid tumor types as a single agent and in combination with immune checkpoint inhibitors. Additionally, Synthorx's Expanded Genetic Alphabet platform will work in conjunction with Sanofi's Nanobody technology and other existing platforms to expand Sanofi's novel biologics, protein fusions, and multispecific biologics.
"Synthorx's exceptionally novel discovery platform has already produced a molecule that has the potential to become a foundation of the next generation of immuno-oncology combination therapies," said John Reed, MD, PhD, global head of Research and Development at Sanofi, in the press release.
Parish, France: Sanofi announced that it will acquire Synthorx, a clinical-stage biotechnology company headquartered in La Jolla, CA, for $68 per share in cash, totaling to approximately $2.5 billion. Through the agreement, Sanofi will obtain all outstanding shares of Synthorx common stock for $68 per share, which represents a 172 percent premium to Synthorx’s closing price, according to a Sanofi press release. The transaction is expected to be completed in the first quarter of 2020.
The acquisition will give Sanofi access to Synthorx's lead immuno-oncology product candidate, THOR-707, a variant of interleukin-2 (IL-2), which is currently in clinical development in solid tumor types as a single agent and in combination with immune checkpoint inhibitors. Additionally, Synthorx's Expanded Genetic Alphabet platform will work in conjunction with Sanofi's Nanobody technology and other existing platforms to expand Sanofi's novel biologics, protein fusions, and multispecific biologics.
"Synthorx's exceptionally novel discovery platform has already produced a molecule that has the potential to become a foundation of the next generation of immuno-oncology combination therapies," said John Reed, MD, PhD, global head of Research and Development at Sanofi, in the press release.
ZETA Engineering for LONZA's Mega Project IbexTM Solutions
Homer Glen, USA: Lonza is investing400 million Swiss francs in its biopark in Visp, Switzerland. This expansion of IbexTMSolutions makes it possible to manage the entire production cycle at one site. ZETA is providing the detailed layout for the single-use plant in which upstream, midstream and downstream processes are integrated in a single module. The complex multi-purpose plant is designed for the utmost flexibility to map a wide range of processes at different scales. Based on the R & Is, a 3D model was designed in the shortest possible time that ensures space-saving design to meet the requirements of the limited package space.
Homer Glen, USA: Lonza is investing400 million Swiss francs in its biopark in Visp, Switzerland. This expansion of IbexTMSolutions makes it possible to manage the entire production cycle at one site. ZETA is providing the detailed layout for the single-use plant in which upstream, midstream and downstream processes are integrated in a single module. The complex multi-purpose plant is designed for the utmost flexibility to map a wide range of processes at different scales. Based on the R & Is, a 3D model was designed in the shortest possible time that ensures space-saving design to meet the requirements of the limited package space.
ICRA Maintained Stable Outlook for Indian Pharma Companies
Gurugram, India: ICRA has maintained a stable outlook on the Indian pharmaceutical industry. The abating headwinds from pricing pressure in largest regulated markets USA, stable growth for the Indian market driven by increasing healthcare spend and better accessibility are likely to drive healthy growth for the Indian Pharma companies, coupled with comfortable balance sheet structure. However increased cost related to regulatory compliances especially for US market, price controls across markets and mandatory genericisation for Indian market remains key risks. The domestic pharmaceutical industry has gained adequate scale and generic drug development capabilities over a decade of growth which will keep them in good stead to capture bigger opportunities especially in the Specialty/niche segments in the regulated market. The FY2019-2022 CAGR is expected to be around 10-12percent for domestic Pharmaceutical companies.
The credit metrics of leading pharma companies are likely to remain stable in view of steady growth prospects in regulated markets and limited dependence of Indian pharmaceutical companies on bank borrowings. The OPBITDA/Interest and TD/OPBITDA for ICRA set of 21 entities in Indian pharmaceutical industry has been healthy at 10.0x and 2.1x for FY2019. They are expected to remain in similar range in medium term despite some pressure on profitability and marginal rise in debt levels, given inorganic investments. The key sensitivity to our outlook remains productivity of R & D expenditure, operational risk related to increased level of due diligence by regulatory agencies and price controls.
The growth from US picked up in FY2019 to 12.1 percent after seeing a decline of -13.1 percent in FY2018. The growth was supported by higher market share for Indian players as several generic MNC players optimised product portfolios along with new product launches. While the US growth is expected to remain at high single digit to low double digit, it will face headwinds given the relatively moderate proportion of large size drugs going off patent, generic adoption reaching saturation levels in the US market and increased regulatory scrutiny as reflected in increased issuance of warning letters/import alerts. The pricing pressure led by consolidation of supply chain in US market and faster ANDA approvals is abating and is expected to remain in mid-single digit in FY2020 compared to low teens in FY2018.
ICRA expects the industry profitability to remain healthy supported by cost optimization undertaken by several players though variables such as increased regulatory compliance costs, R&D costs for commercialising specialty product pipeline and currency volatility related challenges in emerging markets (EM)s may have an adverse impact. Overall, company specific factors would continue to play a pivotal role with quality of product pipeline (i.e. higher share of limited competition launches in the U.S.) being the single most differentiating factor. Companies with growing portfolio comprising of niche/complex products in regulated markets, diversified geographic-mix and established brands in EMs would be better placed to manage some of the headwinds.
With R&D optimization efforts underway to counter US pricing pressure, we expect aggregate R&D spend to maintain at current levels despite requirements arising from expanding presence in complex therapy segment such as injectables, inhalers, dermatology, controlled-release substances and even biosimilars. Companies will opt for co-development of biosimilars that need expensive clinical trials to diversify their risk across portfolio of such products while benefitting from commercial and marketing prowess of their JV partners.
Gurugram, India: ICRA has maintained a stable outlook on the Indian pharmaceutical industry. The abating headwinds from pricing pressure in largest regulated markets USA, stable growth for the Indian market driven by increasing healthcare spend and better accessibility are likely to drive healthy growth for the Indian Pharma companies, coupled with comfortable balance sheet structure. However increased cost related to regulatory compliances especially for US market, price controls across markets and mandatory genericisation for Indian market remains key risks. The domestic pharmaceutical industry has gained adequate scale and generic drug development capabilities over a decade of growth which will keep them in good stead to capture bigger opportunities especially in the Specialty/niche segments in the regulated market. The FY2019-2022 CAGR is expected to be around 10-12percent for domestic Pharmaceutical companies.
The credit metrics of leading pharma companies are likely to remain stable in view of steady growth prospects in regulated markets and limited dependence of Indian pharmaceutical companies on bank borrowings. The OPBITDA/Interest and TD/OPBITDA for ICRA set of 21 entities in Indian pharmaceutical industry has been healthy at 10.0x and 2.1x for FY2019. They are expected to remain in similar range in medium term despite some pressure on profitability and marginal rise in debt levels, given inorganic investments. The key sensitivity to our outlook remains productivity of R & D expenditure, operational risk related to increased level of due diligence by regulatory agencies and price controls.
The growth from US picked up in FY2019 to 12.1 percent after seeing a decline of -13.1 percent in FY2018. The growth was supported by higher market share for Indian players as several generic MNC players optimised product portfolios along with new product launches. While the US growth is expected to remain at high single digit to low double digit, it will face headwinds given the relatively moderate proportion of large size drugs going off patent, generic adoption reaching saturation levels in the US market and increased regulatory scrutiny as reflected in increased issuance of warning letters/import alerts. The pricing pressure led by consolidation of supply chain in US market and faster ANDA approvals is abating and is expected to remain in mid-single digit in FY2020 compared to low teens in FY2018.
ICRA expects the industry profitability to remain healthy supported by cost optimization undertaken by several players though variables such as increased regulatory compliance costs, R&D costs for commercialising specialty product pipeline and currency volatility related challenges in emerging markets (EM)s may have an adverse impact. Overall, company specific factors would continue to play a pivotal role with quality of product pipeline (i.e. higher share of limited competition launches in the U.S.) being the single most differentiating factor. Companies with growing portfolio comprising of niche/complex products in regulated markets, diversified geographic-mix and established brands in EMs would be better placed to manage some of the headwinds.
With R&D optimization efforts underway to counter US pricing pressure, we expect aggregate R&D spend to maintain at current levels despite requirements arising from expanding presence in complex therapy segment such as injectables, inhalers, dermatology, controlled-release substances and even biosimilars. Companies will opt for co-development of biosimilars that need expensive clinical trials to diversify their risk across portfolio of such products while benefitting from commercial and marketing prowess of their JV partners.
Panacea Biotec Announced the Launch of Diabetes Drug in India
New Delhi, India: Panacea Biotec is pleased to announce launch of brand ViLACT in India. ViLACT is used in the treatment of Uncontrolled Type 2 Diabetes Mellitus patients with HbA1c >6.5 percent. The total market size of this molecule and its combination is 969 Crore as per AIOCD MAT October '2019 and is growing at the rate of 4 percent. Vildagliptin product patent (IN 212815) in India has expired on 09th December '2019. Vildagliptin is a new oral antidiabetic agent that enhances pancreatic islet cell responsiveness to glucose, is an incretin enhancer, a potent and selective inhibitor of dipeptidyl peptidase-4 (DPP-4), the enzyme responsible for the rapid degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). This activity increases levels of active incretins and enhances pancreatic islet a- and ß-cell responsiveness to glucose, thus improving insulin secretion and reducing inappropriate glucagon production, improving insulin sensitivity, improving postprandial lipid and lipoprotein metabolism, and reducing fasting and prandial glucose and HbA1c.
Susheel Umesh, Chief Executive, Domestic Formulation said the VilACT brand will be an affordable, high quality medicine in the armamentarium of a physician treating patients with Diabetes. The patients have always been and will continue to be the center of our business. The Physician needs a lot of options to bring down the burden of Diabetes and we with the VilACT range will continue to support the patient and physician in this journey.”
New Delhi, India: Panacea Biotec is pleased to announce launch of brand ViLACT in India. ViLACT is used in the treatment of Uncontrolled Type 2 Diabetes Mellitus patients with HbA1c >6.5 percent. The total market size of this molecule and its combination is 969 Crore as per AIOCD MAT October '2019 and is growing at the rate of 4 percent. Vildagliptin product patent (IN 212815) in India has expired on 09th December '2019. Vildagliptin is a new oral antidiabetic agent that enhances pancreatic islet cell responsiveness to glucose, is an incretin enhancer, a potent and selective inhibitor of dipeptidyl peptidase-4 (DPP-4), the enzyme responsible for the rapid degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). This activity increases levels of active incretins and enhances pancreatic islet a- and ß-cell responsiveness to glucose, thus improving insulin secretion and reducing inappropriate glucagon production, improving insulin sensitivity, improving postprandial lipid and lipoprotein metabolism, and reducing fasting and prandial glucose and HbA1c.
Susheel Umesh, Chief Executive, Domestic Formulation said the VilACT brand will be an affordable, high quality medicine in the armamentarium of a physician treating patients with Diabetes. The patients have always been and will continue to be the center of our business. The Physician needs a lot of options to bring down the burden of Diabetes and we with the VilACT range will continue to support the patient and physician in this journey.”
HRS PSL Exhibited Energy Efficient Heat Transfer
Solutions for Pharmaceutical Industry at P-mec /CPHI 2019
Pune, India: HRS PSL has recently participated at P-mec/ CPHI 2019, organized by Informa Markets at India Expo Centre, Greater Noida, Delhi NCR, held from 26th - 28th November 2019. This was Asia's biggest exhibition and conference held for sharing latest information and developments in pharma processing technology and ingredients industries.
HRS presented its flagship ECOFLUX* corrugated tube heat exchangers (CTHE), in the exhibition. ECOCLUX* is one of the most trusted heat exchangers in the process industry today, having a track record of over 2 decades in service. Also exhibited the energy efficient HRS FUNKE plate heat exchangers (PHE) and range of heat exchanger based systems to enable customers to achieve better productivity and efficiency in process plants. Many visitors from pharma, healthcare and allied industries have visited our stall to understand the heat transfer solutions from HRS for pharmaceutical industry. In an interview with Informa Markets, Mr. Naresh Agarwal (Vice President - Heat Exchangers BU, HRS PSL) explained role of advanced Heat Transfer technology to achieve better productivity. He also emphasized HRS' expertise to design and manufacture heat exchangers in exotic material like AL6XN, C22, C276, C2000, Titanium, Tantalum, Duplex, Super Duplex, Alloy 20, Copper, Cu-Ni, alloys, Inconel, Monel, SMO grades of SS which are increasingly proving beneficial for critical applications for the pharmaceutical industry.
It is a great opportunity to interact with many of our partners in the pharmaceutical industry. An opportune event to show case the company, meet new clients and generate business opportunities. Our esteemed customers like Cipla, Teva, Emcure, Biocon, Aurobindo, Jubilant Life Sciences, Dr. Reddy, Deccan, Granules, Sartorius, Mylan, Hetero, Unichem Laboratories limited, Sun Pharma, Lupin, Biocon, Aurobindo, Divis, Baxter, Cadila healthcare limited, Rakshit Drugs, Sriram, Neclife, Suven Life Sciences, Pharmazail and many more have visited the stall and shown great deal of interest in our energy efficient range of heat exchanger for pharmaceutical industry.
Pune, India: HRS PSL has recently participated at P-mec/ CPHI 2019, organized by Informa Markets at India Expo Centre, Greater Noida, Delhi NCR, held from 26th - 28th November 2019. This was Asia's biggest exhibition and conference held for sharing latest information and developments in pharma processing technology and ingredients industries.
HRS presented its flagship ECOFLUX* corrugated tube heat exchangers (CTHE), in the exhibition. ECOCLUX* is one of the most trusted heat exchangers in the process industry today, having a track record of over 2 decades in service. Also exhibited the energy efficient HRS FUNKE plate heat exchangers (PHE) and range of heat exchanger based systems to enable customers to achieve better productivity and efficiency in process plants. Many visitors from pharma, healthcare and allied industries have visited our stall to understand the heat transfer solutions from HRS for pharmaceutical industry. In an interview with Informa Markets, Mr. Naresh Agarwal (Vice President - Heat Exchangers BU, HRS PSL) explained role of advanced Heat Transfer technology to achieve better productivity. He also emphasized HRS' expertise to design and manufacture heat exchangers in exotic material like AL6XN, C22, C276, C2000, Titanium, Tantalum, Duplex, Super Duplex, Alloy 20, Copper, Cu-Ni, alloys, Inconel, Monel, SMO grades of SS which are increasingly proving beneficial for critical applications for the pharmaceutical industry.
It is a great opportunity to interact with many of our partners in the pharmaceutical industry. An opportune event to show case the company, meet new clients and generate business opportunities. Our esteemed customers like Cipla, Teva, Emcure, Biocon, Aurobindo, Jubilant Life Sciences, Dr. Reddy, Deccan, Granules, Sartorius, Mylan, Hetero, Unichem Laboratories limited, Sun Pharma, Lupin, Biocon, Aurobindo, Divis, Baxter, Cadila healthcare limited, Rakshit Drugs, Sriram, Neclife, Suven Life Sciences, Pharmazail and many more have visited the stall and shown great deal of interest in our energy efficient range of heat exchanger for pharmaceutical industry.
Arctoris Ltd Successfully Moved into Its New Global Headquarter in Oxford, UK
Oxford, UK: Arctoris Ltd, the developer of the world's first fully automated drug discovery platform, has recently opened the doors to its new global headquarters and state-of-the-art research and development (R & D) facility in Oxford, UK. Housing the company's proprietary technology and providing space for its rapidly growing commercial and scientific teams, the facility will enable Arctoris to continue to support its research partners around the world with its structured, automated approach to drug discovery.
At the heart of the new scientific facility is the next-generation, fully automated platform developed by the drug discovery experts, engineers and roboticists at Arctoris. The platform efficiently generates reproducible data from biochemical, cellbased and molecular biology assays. The rapid turnaround enables shorter cycle times - and therefore more design-maketest- analyse iterations - for their drug discovery partners. This end-to-end robotic platform provides biotechnology companies, pharmaceutical corporations and academic centres with costeffective and reproducible drug discovery data – all through an online portal that streamlines experiment planning, ordering, tracking and data analysis.
Martin-Immanuel Bittner MD DPhil, Chief Executive Officer and Co- Founder of Arctoris, said, "Investing in new global headquarters and greatly enhanced R & D facility in our home city of Oxford, UK, an internationally-renowned centre of scientific excellence, demonstrates our continued commitment to delivering the highest standards of data available to our partners. This state-of-the-art home for our next-generation robotic platform enables our growing team of experts to provide scientists across the globe with access to reproducible data through a rapid and fully-validated approach to drug discovery."
Having settled into its new headquarters, Arctoris will continue delivering high quality, reproducible drug discovery data to its customers through access to a library of validated drug discovery protocols designed to support hit-to-lead analysis, lead optimisation, mechanistic profiling and additional preclinical studies. This will enable scientists to make rapid, informed decision-making in basic biology, target validation, toxicology and phenotypic screening for drug characterisation, optimisation and selection.
Oxford, UK: Arctoris Ltd, the developer of the world's first fully automated drug discovery platform, has recently opened the doors to its new global headquarters and state-of-the-art research and development (R & D) facility in Oxford, UK. Housing the company's proprietary technology and providing space for its rapidly growing commercial and scientific teams, the facility will enable Arctoris to continue to support its research partners around the world with its structured, automated approach to drug discovery.
At the heart of the new scientific facility is the next-generation, fully automated platform developed by the drug discovery experts, engineers and roboticists at Arctoris. The platform efficiently generates reproducible data from biochemical, cellbased and molecular biology assays. The rapid turnaround enables shorter cycle times - and therefore more design-maketest- analyse iterations - for their drug discovery partners. This end-to-end robotic platform provides biotechnology companies, pharmaceutical corporations and academic centres with costeffective and reproducible drug discovery data – all through an online portal that streamlines experiment planning, ordering, tracking and data analysis.
Martin-Immanuel Bittner MD DPhil, Chief Executive Officer and Co- Founder of Arctoris, said, "Investing in new global headquarters and greatly enhanced R & D facility in our home city of Oxford, UK, an internationally-renowned centre of scientific excellence, demonstrates our continued commitment to delivering the highest standards of data available to our partners. This state-of-the-art home for our next-generation robotic platform enables our growing team of experts to provide scientists across the globe with access to reproducible data through a rapid and fully-validated approach to drug discovery."
Having settled into its new headquarters, Arctoris will continue delivering high quality, reproducible drug discovery data to its customers through access to a library of validated drug discovery protocols designed to support hit-to-lead analysis, lead optimisation, mechanistic profiling and additional preclinical studies. This will enable scientists to make rapid, informed decision-making in basic biology, target validation, toxicology and phenotypic screening for drug characterisation, optimisation and selection.
OneLife - Live It Right, Raised Pre-Series A Funding of INR 50 Mn from High Networth Individuals (HNIs)
Mumbai, India: Onelife Nutriscience Pvt. Ltd. ("Onelife") which owns the consumer healthcare brand "Onelife - Live it right" has raised Pre -Series A funding of INR 50 Mn from a group of HNIs from Pharma / Healthcare & Chemicals Industry. Onelife has over 100 products in the nutrition, wellness and beauty space with presence in more than 15 cities across West and North India. Onelife is geared up for its next level of growth post this round of capital. It will leverage the infused funds for geographical expansion, online & offline expansion, marketing and team building. The Company is founded by Gaurav Aggarwal who has over 20 years of experience in the Nutrition Industry. Hailing from a family who has been one of the leading producers of Vitamin B3 in the World, this is a natural progression for Gaurav to leverage his extensive experience and network to develop a promising B2C Healthcare Brand.
Commenting on the capital raised, Gaurav Aggarwal, Founder, Onelife said, "We are very happy to have experienced an early acceptance of our products from the customers at a time when the Nutraceuticals Industry is looking at an exponential growth. The funds raised will help us strengthen our product range, expand geographies, increase online & offline presence, invest in marketing & brand building and add further talent. We are targeting to achieve 3x growth over next 18 months from our current levels."
Mumbai based Nyuleaf Advisors were the exclusive advisors on this transaction.
Mumbai, India: Onelife Nutriscience Pvt. Ltd. ("Onelife") which owns the consumer healthcare brand "Onelife - Live it right" has raised Pre -Series A funding of INR 50 Mn from a group of HNIs from Pharma / Healthcare & Chemicals Industry. Onelife has over 100 products in the nutrition, wellness and beauty space with presence in more than 15 cities across West and North India. Onelife is geared up for its next level of growth post this round of capital. It will leverage the infused funds for geographical expansion, online & offline expansion, marketing and team building. The Company is founded by Gaurav Aggarwal who has over 20 years of experience in the Nutrition Industry. Hailing from a family who has been one of the leading producers of Vitamin B3 in the World, this is a natural progression for Gaurav to leverage his extensive experience and network to develop a promising B2C Healthcare Brand.
Commenting on the capital raised, Gaurav Aggarwal, Founder, Onelife said, "We are very happy to have experienced an early acceptance of our products from the customers at a time when the Nutraceuticals Industry is looking at an exponential growth. The funds raised will help us strengthen our product range, expand geographies, increase online & offline presence, invest in marketing & brand building and add further talent. We are targeting to achieve 3x growth over next 18 months from our current levels."
Mumbai based Nyuleaf Advisors were the exclusive advisors on this transaction.
CAS Launched Formulus®: Largest Collection of Formulations Data in India
Mumbai, India: CAS, a division of the American Chemical Society that specializes in scientific information solutions, has recently launched Formulus® in India, the world's largest collection of formulations sourced from journals, patents and product inserts. Formulus is the new one-stop shop for research scientists looking to search through millions of formulations quickly and efficiently. This product can be a potential gamechanger for India's pharmaceutical and agrochemical sector because it streamlines and simplifies the time-consuming process of formulating new products and can help new innovations get to market faster. CAS will be holding workshops this week in Mumbai, Hyderabad and Bangalore to demonstrate its capabilities for formulators and researchers.
Formulation is a critical component of drug or product development. However, current formulation resources and solutions are lacking, data sources are disparate and existing libraries are small. This causes 60 percent of companies to experience a project delay or failure due to formulation challenges. In response to this situation, CAS has invested millions of dollars over the past 3 years and conducted over 500 research sessions with formulation scientists in order to develop this tool.
Speaking about the launch, Molly Strausbaugh, Assistant Director, CAS, said: "The new CAS collection of formulations has been curated from information found by hundreds of scientists from numerous sources. This data clearly identifies formulation ingredients and their roles and provides users with critical insights, decreasing development time. By speeding up this process, formulators are able to receive reliable information more quickly, allowing them more time to spend on the real-world challenges they're trying to solve."
Over 70 percent of formulators that tested Formulus confirmed that it helped them narrow focus more quickly and 73 percent of formulators agreed that it helped them get up to speed about a new product. CAS formulations content can also be licensed for in-house projects and applications. Formulus is integrated with CAS substance collection, detailed supplier specifications and regulatory resources and the data is also being made available in leading CAS solutions STNext® and SciFindern.
Mumbai, India: CAS, a division of the American Chemical Society that specializes in scientific information solutions, has recently launched Formulus® in India, the world's largest collection of formulations sourced from journals, patents and product inserts. Formulus is the new one-stop shop for research scientists looking to search through millions of formulations quickly and efficiently. This product can be a potential gamechanger for India's pharmaceutical and agrochemical sector because it streamlines and simplifies the time-consuming process of formulating new products and can help new innovations get to market faster. CAS will be holding workshops this week in Mumbai, Hyderabad and Bangalore to demonstrate its capabilities for formulators and researchers.
Formulation is a critical component of drug or product development. However, current formulation resources and solutions are lacking, data sources are disparate and existing libraries are small. This causes 60 percent of companies to experience a project delay or failure due to formulation challenges. In response to this situation, CAS has invested millions of dollars over the past 3 years and conducted over 500 research sessions with formulation scientists in order to develop this tool.
Speaking about the launch, Molly Strausbaugh, Assistant Director, CAS, said: "The new CAS collection of formulations has been curated from information found by hundreds of scientists from numerous sources. This data clearly identifies formulation ingredients and their roles and provides users with critical insights, decreasing development time. By speeding up this process, formulators are able to receive reliable information more quickly, allowing them more time to spend on the real-world challenges they're trying to solve."
Over 70 percent of formulators that tested Formulus confirmed that it helped them narrow focus more quickly and 73 percent of formulators agreed that it helped them get up to speed about a new product. CAS formulations content can also be licensed for in-house projects and applications. Formulus is integrated with CAS substance collection, detailed supplier specifications and regulatory resources and the data is also being made available in leading CAS solutions STNext® and SciFindern.
Abzena Showcased Discovery and Developability Services at PEGS Europe 2019
Cambridge, UK: Abzena has recently showcased its discovery and developability Services, enabling biopharmaceutical companies to generate high affinity antibodies and select lead candidates with the highest chances of clinical success at the 11th Annual Protein & Antibody Engineering Summit (PEGS Europe) being held 18–22 November, on Booth #121 at the Lisbon Congress Centre, Lisbon, Portugal.
Abzena offers a Discovery Service that harnesses murine immunisation to generate antibodies with high affinity and desired functional properties. This is integrated with full Developability Services to assesses the fundamental characteristics of drug design – specificity, functionality, safety and manufacturability - to ensure the probability of identifying antibodies with appropriate therapeutic utility and maximise the chances of clinical success.
Campbell Bunce PhD, Chief Scientific Officer at Abzena, commented: "The development of biologics takes time, is expensive and subject to safety, functionality, stability and scalability liabilities. Having worked with hundreds of drug candidates, Abzena’s Discovery and Developability Services offer a defined approach that applies our expertise to guide the discovery and selection of the best drug candidates and reduce the risks that can significantly impact the time and cost typically associated with biopharmaceutical R& D."
"Maximising the chances of therapeutic utility and clinical success drives our Discovery and Developability Services: from providing custom strategies for generating high affinity antibodies, to our Developability Service for selecting lead candidates and identifying measures that will mitigate risks," added Rob Holgate PhD, Senior Director of Protein Engineering at Abzena.
Cambridge, UK: Abzena has recently showcased its discovery and developability Services, enabling biopharmaceutical companies to generate high affinity antibodies and select lead candidates with the highest chances of clinical success at the 11th Annual Protein & Antibody Engineering Summit (PEGS Europe) being held 18–22 November, on Booth #121 at the Lisbon Congress Centre, Lisbon, Portugal.
Abzena offers a Discovery Service that harnesses murine immunisation to generate antibodies with high affinity and desired functional properties. This is integrated with full Developability Services to assesses the fundamental characteristics of drug design – specificity, functionality, safety and manufacturability - to ensure the probability of identifying antibodies with appropriate therapeutic utility and maximise the chances of clinical success.
Campbell Bunce PhD, Chief Scientific Officer at Abzena, commented: "The development of biologics takes time, is expensive and subject to safety, functionality, stability and scalability liabilities. Having worked with hundreds of drug candidates, Abzena’s Discovery and Developability Services offer a defined approach that applies our expertise to guide the discovery and selection of the best drug candidates and reduce the risks that can significantly impact the time and cost typically associated with biopharmaceutical R& D."
"Maximising the chances of therapeutic utility and clinical success drives our Discovery and Developability Services: from providing custom strategies for generating high affinity antibodies, to our Developability Service for selecting lead candidates and identifying measures that will mitigate risks," added Rob Holgate PhD, Senior Director of Protein Engineering at Abzena.
SCHOTT Inaugurated New Production Facility at Its Gujarat Plant, Production Capacity to Increase by 50 percent
Mainz, Germany; Jambusar, India: SCHOTT AG, a global leader in pharmaceutical glass manufacturing, has recently inaugurated its new glass tank facility in Jambusar, Gujarat following an investment of €21 million last year. The company forecasts a rapid growth trend for high quality glass material in the pharma industry, and has thus committed additional investments of €26 million for yet another tank facility in 2020.
Each of the new production facilities with a combined investment of €47 million, will double the capacity of SCHOTT Glass India's manufacturing plant, allowing the group to produce its highly specialised FIOLAX® tubing material for both domestic and export demands.
SCHOTT began the construction of its first new facility last year on the occasion of completing two decades of operations in India. The facility finished construction within a record time of one year, enabling employment of another 100 skilled local workforce. The new set-up brings together SCHOTT's state-of-the-art technology and Indian ingenuity together to produce pharmaceutical packaging and tubing equipment in line with 'Industry 4.0' standards.
Talking about SCHOTT Glass India's future plans, Managing Director, Georg Sparschuh shared, "While domestic market remains our key focus, our India plant also caters to the Asian market, thereby contributing to pharmaceutical industry exports and the Indian government's vision of becoming a global pharmaceutical hub. SCHOTT also takes cognizance of the Indian Health Ministry's initiative to provide affordable and accessible healthcare to its citizens. In this regard, we wish to be part of such initiatives by contributing to the pharmaceutical value chains and by providing high-quality glass products for pharma packaging, ensuring highest global safety standards."
SCHOTT’s success story runs parallel to India’s phenomenal performance in the World Bank's Ease of Doing Business Rankings, where India jumped 14 places this year to be ranked 63rd out of 190 countries. "We are among the benefactors of the efforts made by the Government of India in creating an environment conducive for international businesses to invest and set up manufacturing facilities. We plan to continue investing in India as a part of Make in India, as we believe there is great potential in our Indian facilities becoming the hub for providing pharmaceutical equipment for global pharmaceutical supply chains as well.
SCHOTT is also collaborating with Indian universities and training institutes to focus on skilling, preparing trainees to match the demands of future industry 4.0 requirements," said Dr Patrick Markschläger, Executive Vice President, SCHOTT AG, Business Unit Tubing. Dignitaries from the German Consulate, Mumbai, key partners and industry associations such as the CII also graced the inauguration of the new facility.
On the occasion, Marja Einig - Deputy German Counsel commended the efforts and said, "SCHOTT is playing a pivotal role in giving a fillip to our efforts in strengthening the Indo- German partnership. Time and again, SCHOTT has showcased its commitment towards India. With its expanded operations in the country, it is catering to the needs of the Indian health industry and contributing to the Indian government's initiatives such as Make in India and Pharma Vision 2020."
SCHOTT's India plant functions as a production hub for SCHOTT pharmaceutical tubing in Asia and produces the branded FIOLAX® pharmaceutical tubing. FIOLAX® glass exists since 1911 and provides an unprecedented quality standard in the industry through SCHOTT's perfeXion® process since 2017. perfeXion® stands for the transition from statistical quality control to 100 percent automated inspection of each individual FIOLAX® tube - based on big data. Hence, it is introducing Germany's Industry 4.0 to its Indian factory in the most effective manner.
Mainz, Germany; Jambusar, India: SCHOTT AG, a global leader in pharmaceutical glass manufacturing, has recently inaugurated its new glass tank facility in Jambusar, Gujarat following an investment of €21 million last year. The company forecasts a rapid growth trend for high quality glass material in the pharma industry, and has thus committed additional investments of €26 million for yet another tank facility in 2020.
Each of the new production facilities with a combined investment of €47 million, will double the capacity of SCHOTT Glass India's manufacturing plant, allowing the group to produce its highly specialised FIOLAX® tubing material for both domestic and export demands.
SCHOTT began the construction of its first new facility last year on the occasion of completing two decades of operations in India. The facility finished construction within a record time of one year, enabling employment of another 100 skilled local workforce. The new set-up brings together SCHOTT's state-of-the-art technology and Indian ingenuity together to produce pharmaceutical packaging and tubing equipment in line with 'Industry 4.0' standards.
Talking about SCHOTT Glass India's future plans, Managing Director, Georg Sparschuh shared, "While domestic market remains our key focus, our India plant also caters to the Asian market, thereby contributing to pharmaceutical industry exports and the Indian government's vision of becoming a global pharmaceutical hub. SCHOTT also takes cognizance of the Indian Health Ministry's initiative to provide affordable and accessible healthcare to its citizens. In this regard, we wish to be part of such initiatives by contributing to the pharmaceutical value chains and by providing high-quality glass products for pharma packaging, ensuring highest global safety standards."
SCHOTT’s success story runs parallel to India’s phenomenal performance in the World Bank's Ease of Doing Business Rankings, where India jumped 14 places this year to be ranked 63rd out of 190 countries. "We are among the benefactors of the efforts made by the Government of India in creating an environment conducive for international businesses to invest and set up manufacturing facilities. We plan to continue investing in India as a part of Make in India, as we believe there is great potential in our Indian facilities becoming the hub for providing pharmaceutical equipment for global pharmaceutical supply chains as well.
SCHOTT is also collaborating with Indian universities and training institutes to focus on skilling, preparing trainees to match the demands of future industry 4.0 requirements," said Dr Patrick Markschläger, Executive Vice President, SCHOTT AG, Business Unit Tubing. Dignitaries from the German Consulate, Mumbai, key partners and industry associations such as the CII also graced the inauguration of the new facility.
On the occasion, Marja Einig - Deputy German Counsel commended the efforts and said, "SCHOTT is playing a pivotal role in giving a fillip to our efforts in strengthening the Indo- German partnership. Time and again, SCHOTT has showcased its commitment towards India. With its expanded operations in the country, it is catering to the needs of the Indian health industry and contributing to the Indian government's initiatives such as Make in India and Pharma Vision 2020."
SCHOTT's India plant functions as a production hub for SCHOTT pharmaceutical tubing in Asia and produces the branded FIOLAX® pharmaceutical tubing. FIOLAX® glass exists since 1911 and provides an unprecedented quality standard in the industry through SCHOTT's perfeXion® process since 2017. perfeXion® stands for the transition from statistical quality control to 100 percent automated inspection of each individual FIOLAX® tube - based on big data. Hence, it is introducing Germany's Industry 4.0 to its Indian factory in the most effective manner.
Texila American University Announced Scholarship for PG Medical Aspirants
New Delhi, India: Texila American University (TAU) has announced a scholarship program for post-graduation (PG) medical aspirants for the year 2020. Students can register for any TAU's PG program on or before December 31, 2019, and avail 10% scholarship on their first-year tuition fees. TAU offers an opportunity for students to upgrade their qualifications without disturbing their clinical practice.
The shortage of skilled doctors and specialists continues to be a pressing issue across the globe, especially in developing countries like India. An extreme shortage of specialist doctors in India poses a serious threat to the nation's health sector. Shortage prevails in almost all disciplines. India demands 230,000 pediatricians, whereas it has only 23,000. Besides, we have only 650 specialists in endocrinology to treat 70 million diabetic patients. The demand for specialized doctors is growing at a faster pace, whereas the supply cannot meet the demand.
Upon understanding the demand, TAU, in association with Universidad Central de Nicaragua (UCN), offers a range of PG fellowship, PG upgradation, and research programs for medical professionals. These programs will help students to upgrade their knowledge and skills in their respective fields.
TAU offers a few PG programs for working professionals to get specialized in the area of interest without compromising clinical commitments. One of them, Fellowship (MMSc) that offers specializations ranging from Critical Care, Endocrinology, Diabetology, Preventive Cardiology, Family Medicine, Oncology, Nuclear Medicine, Cosmetology, to Reproductive Health.
Other one is Master of Medicine/Master of Surgery that provides a premier learning experience, both in theoretical and clinical aspects. It enables to learn unique skills, get trained, and gain extensive knowledge. They can also upgrade on General Surgery, Orthopaedics, Obstetrics and Gynaecology, Dermatology, Paediatrics, Internal Medicine, Anaesthesia, Pathology, ENT, and so on.
Ph.D. in Medical Science program is designed for individuals who want to do extensive research on their specialized studies and enhance their academic career without leaving their job.
New Delhi, India: Texila American University (TAU) has announced a scholarship program for post-graduation (PG) medical aspirants for the year 2020. Students can register for any TAU's PG program on or before December 31, 2019, and avail 10% scholarship on their first-year tuition fees. TAU offers an opportunity for students to upgrade their qualifications without disturbing their clinical practice.
The shortage of skilled doctors and specialists continues to be a pressing issue across the globe, especially in developing countries like India. An extreme shortage of specialist doctors in India poses a serious threat to the nation's health sector. Shortage prevails in almost all disciplines. India demands 230,000 pediatricians, whereas it has only 23,000. Besides, we have only 650 specialists in endocrinology to treat 70 million diabetic patients. The demand for specialized doctors is growing at a faster pace, whereas the supply cannot meet the demand.
Upon understanding the demand, TAU, in association with Universidad Central de Nicaragua (UCN), offers a range of PG fellowship, PG upgradation, and research programs for medical professionals. These programs will help students to upgrade their knowledge and skills in their respective fields.
TAU offers a few PG programs for working professionals to get specialized in the area of interest without compromising clinical commitments. One of them, Fellowship (MMSc) that offers specializations ranging from Critical Care, Endocrinology, Diabetology, Preventive Cardiology, Family Medicine, Oncology, Nuclear Medicine, Cosmetology, to Reproductive Health.
Other one is Master of Medicine/Master of Surgery that provides a premier learning experience, both in theoretical and clinical aspects. It enables to learn unique skills, get trained, and gain extensive knowledge. They can also upgrade on General Surgery, Orthopaedics, Obstetrics and Gynaecology, Dermatology, Paediatrics, Internal Medicine, Anaesthesia, Pathology, ENT, and so on.
Ph.D. in Medical Science program is designed for individuals who want to do extensive research on their specialized studies and enhance their academic career without leaving their job.
Cadila Pharma Showcased Its Might at CPhI Frankfurt
Ahmedabad, India: Cadila Pharmaceuticals, one of the biggest pharma companies in India and known for innovation and quality, participated in the recently concluded CPhI Worldwide event held in Frankfurt, Germany.
CPhI is one of the biggest pharmaceutical industry buyer-seller meet where pharma stakeholders can come and interact to grow their business. Cadila's International Formulations team and the Active Pharmaceutical Ingredient (API) team participated in the event where they talked about their products and expertise. Their products which are heavily based on research and development, got a great response from the buyers. The event was held from 5 to 7 November, 2019 in Messi, Frankfurt.
Leading Cadila's International formulations team at the event, Mr Mahidhwaj Sisodia, Executive Vice President, International Business, said "We are excited to be at CPhI Frankfurt. We are very well poised to serve the growing finished formulations market across the globe. We met delegates from multiple countries and the feedback throughout has been very encouraging."
The next CPhI event will be hosted in Delhi, India from 26 to 28 November, 2019 expecting to see multiple stakeholders attend the event.
Ahmedabad, India: Cadila Pharmaceuticals, one of the biggest pharma companies in India and known for innovation and quality, participated in the recently concluded CPhI Worldwide event held in Frankfurt, Germany.
CPhI is one of the biggest pharmaceutical industry buyer-seller meet where pharma stakeholders can come and interact to grow their business. Cadila's International Formulations team and the Active Pharmaceutical Ingredient (API) team participated in the event where they talked about their products and expertise. Their products which are heavily based on research and development, got a great response from the buyers. The event was held from 5 to 7 November, 2019 in Messi, Frankfurt.
Leading Cadila's International formulations team at the event, Mr Mahidhwaj Sisodia, Executive Vice President, International Business, said "We are excited to be at CPhI Frankfurt. We are very well poised to serve the growing finished formulations market across the globe. We met delegates from multiple countries and the feedback throughout has been very encouraging."
The next CPhI event will be hosted in Delhi, India from 26 to 28 November, 2019 expecting to see multiple stakeholders attend the event.
Natural Product Synthesis: One Step Closer to
Entering Your Medicine Cabinet
Molecules isolated from natural sources have a wide range of biological effects: caffeine in coffee gives you an energy boost, morphine from poppy seeds alleviates pain, and muscarine in fly agarics is a dangerous poison. In order to study and apply such natural products as medicine, we have to synthesize them in the laboratory.
In his organic chemistry PhD thesis Juha Siitonen from Department of Chemnistry at the University of Jyväskylä, Finland has focused on syntheses of natural products isolated from Stemona- and Cephalotaxus-plants. Stemona derived natural products have a wide variety of applications, ranging all the way from antitussive effects to insecticidal properties. Cephalotaxus natural products, on the other hand, have proven effective against cancer.
"Half of world's drugs are either natural products or take their inspiration from natural products. For example, willow tree bark contains salicylic acid which is a precursor to aspirin", Siitonen points out.
Serves pharmaceutical and agrochemical industries
The PhD thesis presents synthetic pathways to three different Stemona natural products, as well as a significantly shorter method to access the core structure of Cephalotaxus natural products. Several new synthetic methods had to be developed to accomplish these goals. In the future, the developed methods can find use in synthesis of new drugs, agrochemicals as well as new materials.
"Molecular structures of natural products are intriguing. The complex structures can be seen as synthetic challenges that very quickly reveal the shortcomings and limitations of our current methods for chemical synthesis", Siitonen explains.
MSc Juha Siitonen defends his doctoral dissertation in organic chemistry "Synthetic Studies on 1-Azabicyclo[5.3.0]decane Alkaloids" on Thursday 4th of October 2018 at noon 12:00 in lecture hall YlistöKem4. Opponent professor Annette Bayer (University of Tromsø - The Arctic University of Norway) and custos professor Petri Pihko (University of Jyväskylä). The doctoral dissertation is held in English.
Molecules isolated from natural sources have a wide range of biological effects: caffeine in coffee gives you an energy boost, morphine from poppy seeds alleviates pain, and muscarine in fly agarics is a dangerous poison. In order to study and apply such natural products as medicine, we have to synthesize them in the laboratory.
In his organic chemistry PhD thesis Juha Siitonen from Department of Chemnistry at the University of Jyväskylä, Finland has focused on syntheses of natural products isolated from Stemona- and Cephalotaxus-plants. Stemona derived natural products have a wide variety of applications, ranging all the way from antitussive effects to insecticidal properties. Cephalotaxus natural products, on the other hand, have proven effective against cancer.
"Half of world's drugs are either natural products or take their inspiration from natural products. For example, willow tree bark contains salicylic acid which is a precursor to aspirin", Siitonen points out.
Serves pharmaceutical and agrochemical industries
The PhD thesis presents synthetic pathways to three different Stemona natural products, as well as a significantly shorter method to access the core structure of Cephalotaxus natural products. Several new synthetic methods had to be developed to accomplish these goals. In the future, the developed methods can find use in synthesis of new drugs, agrochemicals as well as new materials.
"Molecular structures of natural products are intriguing. The complex structures can be seen as synthetic challenges that very quickly reveal the shortcomings and limitations of our current methods for chemical synthesis", Siitonen explains.
MSc Juha Siitonen defends his doctoral dissertation in organic chemistry "Synthetic Studies on 1-Azabicyclo[5.3.0]decane Alkaloids" on Thursday 4th of October 2018 at noon 12:00 in lecture hall YlistöKem4. Opponent professor Annette Bayer (University of Tromsø - The Arctic University of Norway) and custos professor Petri Pihko (University of Jyväskylä). The doctoral dissertation is held in English.
Ashland announces price increases for composites
products in India
Ashland announced it will increase the price of its portfolio of all composites products in India by 7.5 INR per kilo (+/-100US$ per ton). This increase will take effect immediately, or as soon as possible thereafter as contracts allow. This increase is primarily driven by continued escalation of costs in key raw materials. Ashland continues to make these decisions with the intent to ensure we are servicing our customers with the utmost quality and performance and the ability to continue reinvesting in our product line.
Ashland announced it will increase the price of its portfolio of all composites products in India by 7.5 INR per kilo (+/-100US$ per ton). This increase will take effect immediately, or as soon as possible thereafter as contracts allow. This increase is primarily driven by continued escalation of costs in key raw materials. Ashland continues to make these decisions with the intent to ensure we are servicing our customers with the utmost quality and performance and the ability to continue reinvesting in our product line.
Sun Pharma Announces Receipt of European Commission
Approval For ILUMETRI® (tildrakizumab)
Sun Pharmaceutical Industries Ltd. announced that Almirall has received the European Commission (EC) approval for ILUMETRI®(tildrakizumab) for the treatment of adults with moderate-tosevere chronic plaque psoriasis who are candidates for systemic therapy. As indicated by Almirall, roll out of ILUMETRI® in Europe will start in the next few weeks. In July 2016, Sun Pharma outlicensed tildrakizumab to Almirall, for the development and commercialization of the product for psoriasis in Europe.
Tildrakizumab is a humanized high-affinity anti-IL-23p19 monoclonal antibody1. Due to its specific mechanism of action, it selectively blocks interleukin-23 (IL-23), an upstream inflammatory mediator cytokine, and acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system .
Its approval in Europe is based on the positive results from reSURFACE 1 and 2 phase-3 clinical trials3, presented for the first time in October 2016 at the 25th European Academy of Dermatology and Venerology (EADV) Congress in Vienna (Austria). Both pivotal phase-3 clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed ILUMETRI® has a high level of safety and efficacy.
According to both studies data, an average of 63% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 78% at week 28. Moreover, an average of 59% of patients achieved PASI 90 and an average of 30% reached PASI 100 at week 28. Over a year, more than 92% of patients who responded to ILUMETRI® within 28 weeks maintained a PASI 75 response.
Moreover, the results of a pooled analysis through three years2 from resurface 1 and 2 phase-3 trials show the consistent maintenance of efficacy and safety over three years of ILUMETRI® in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with ILUMETRI® in 90% of patients up to week 1482. ILUMETRI® was well-tolerated with very low drug-related serious adverse events and discontinuation rates.
Sun Pharmaceutical Industries Ltd. announced that Almirall has received the European Commission (EC) approval for ILUMETRI®(tildrakizumab) for the treatment of adults with moderate-tosevere chronic plaque psoriasis who are candidates for systemic therapy. As indicated by Almirall, roll out of ILUMETRI® in Europe will start in the next few weeks. In July 2016, Sun Pharma outlicensed tildrakizumab to Almirall, for the development and commercialization of the product for psoriasis in Europe.
Tildrakizumab is a humanized high-affinity anti-IL-23p19 monoclonal antibody1. Due to its specific mechanism of action, it selectively blocks interleukin-23 (IL-23), an upstream inflammatory mediator cytokine, and acts by modifying the pathogenesis of the disease with limited impact on the rest of the immune system .
Its approval in Europe is based on the positive results from reSURFACE 1 and 2 phase-3 clinical trials3, presented for the first time in October 2016 at the 25th European Academy of Dermatology and Venerology (EADV) Congress in Vienna (Austria). Both pivotal phase-3 clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed ILUMETRI® has a high level of safety and efficacy.
According to both studies data, an average of 63% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 78% at week 28. Moreover, an average of 59% of patients achieved PASI 90 and an average of 30% reached PASI 100 at week 28. Over a year, more than 92% of patients who responded to ILUMETRI® within 28 weeks maintained a PASI 75 response.
Moreover, the results of a pooled analysis through three years2 from resurface 1 and 2 phase-3 trials show the consistent maintenance of efficacy and safety over three years of ILUMETRI® in patients with moderate-to-severe chronic plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with ILUMETRI® in 90% of patients up to week 1482. ILUMETRI® was well-tolerated with very low drug-related serious adverse events and discontinuation rates.
LifeCell launches 'Transformational' Newborn
Screening Program
LifeCell International, India's premier stem cell bank and mother & baby diagnostics company today announced the launch of "RightStart" - the world's first Integrated DNA testing for Newborn Screening to detect over 50 medical conditions. This technology has been proven to be more accurate than current screening methods and has also been found to drastically reduce the false-positive reporting thereby avoiding unnecessary follow-up tests and anxiety of the parents.
In current process of newborn screening, a few drops of blood are obtained through heel prick from the baby's heel, usually 48 hours after childbirth, and is analysed by profiling a specific set of metabolites present in the blood. If an abnormal metabolic profile is found further testing is recommended for confirmation.
The confirmatory test would need an additional sample to be taken once again from the child. Since most routine screening labs do not have DNA testing capabilities, the child is referred to specialised labs leading to further delays in diagnosis & treatment apart from causing further agony for the parents. The DNA based test is considered a gold standard and is most reliable for confirmation as it does not get impacted by interferences such as medications, nutrition, temperature, or preterm status.
LifeCell's "RightStart" Newborn screening, which adopts an integrated DNA testing approach, does not require an additional sample since a portion of the sample collected initially can be used. Also, no additional costs would need to be incurred by the parents. "RightStart" provides more accurate results and also saves time & effort enabling a speedy diagnosis to initiate treatment. More importantly, the parents are alerted to the risk only if the DNA tests are positive thereby reducing parental anxiety.
LifeCell International, India's premier stem cell bank and mother & baby diagnostics company today announced the launch of "RightStart" - the world's first Integrated DNA testing for Newborn Screening to detect over 50 medical conditions. This technology has been proven to be more accurate than current screening methods and has also been found to drastically reduce the false-positive reporting thereby avoiding unnecessary follow-up tests and anxiety of the parents.
In current process of newborn screening, a few drops of blood are obtained through heel prick from the baby's heel, usually 48 hours after childbirth, and is analysed by profiling a specific set of metabolites present in the blood. If an abnormal metabolic profile is found further testing is recommended for confirmation.
The confirmatory test would need an additional sample to be taken once again from the child. Since most routine screening labs do not have DNA testing capabilities, the child is referred to specialised labs leading to further delays in diagnosis & treatment apart from causing further agony for the parents. The DNA based test is considered a gold standard and is most reliable for confirmation as it does not get impacted by interferences such as medications, nutrition, temperature, or preterm status.
LifeCell's "RightStart" Newborn screening, which adopts an integrated DNA testing approach, does not require an additional sample since a portion of the sample collected initially can be used. Also, no additional costs would need to be incurred by the parents. "RightStart" provides more accurate results and also saves time & effort enabling a speedy diagnosis to initiate treatment. More importantly, the parents are alerted to the risk only if the DNA tests are positive thereby reducing parental anxiety.
Dr. Reddy's Laboratories announces the sale of
Cloderm® (clocortolone pivalate) Cream, 0.1% Franchise to EPI Health, LLC
Dr. Reddy's Laboratories Ltd announced that its wholly owned subsidiary Promius Pharma, LLC, has sold its rights of Cloderm®(clocortolone pivalate) Cream, 0.1% and its authorized generic to EPI Health, LLC, an affiliate of EPI Group, LLC. Under the terms of the agreement, Promius Pharma is eligible to receive an upfront payment followed by future royalties as the consideration for Cloderm® Cream and its authorized generic in the United States, effective immediately. "We look forward to EPI continuing to support Cloderm, a brand that providers have prescribed for several decades and find as an important treatment option for their patients." says Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma.
Dr. Reddy's Laboratories Ltd announced that its wholly owned subsidiary Promius Pharma, LLC, has sold its rights of Cloderm®(clocortolone pivalate) Cream, 0.1% and its authorized generic to EPI Health, LLC, an affiliate of EPI Group, LLC. Under the terms of the agreement, Promius Pharma is eligible to receive an upfront payment followed by future royalties as the consideration for Cloderm® Cream and its authorized generic in the United States, effective immediately. "We look forward to EPI continuing to support Cloderm, a brand that providers have prescribed for several decades and find as an important treatment option for their patients." says Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma.
New Single Quadrupole Mass Spectrometry Technology
Designed for Chromatographers Performing LC-MS Routine Analysis
Driven by industry demand for a robust, easy to implement system, Thermo Fisher Scientific designed the Thermo Scientific ISQ EM single quadrupole mass spectrometer for high performance and productivity standards in laboratories. With a mass range of 10–2000 m/z, the system offers the power to detect and quantify small and large molecules, and supports analytical needs across an extensive range of applications - from drug development to manufacturing support and quality control. The system's highperforming heated electrospray ionization (HESI) and dual HESI/atmospheric pressure chemical ionization (APCI) probes facilitate the measurement of polar and non-polar analytes, enabling application flexibility. Chromatographers looking for bold confidence in their samples can now benefit from a single quadrupole mass spectrometer designed for ease-of-use while offering application flexibility and reliable results for challenging mass confirmation analyses.
The ISQ EM is integrated with HPLC systems and fully controlled by Thermo Scientific Chromeleon Chromatography Data System (CDS), which offers tools to guide users through LC-MS method development and select appropriate source conditions. Thermo Scientific Chromeleon XPS Open Access software also supports the ISQ EM with walk-up workflows for simple daily operation. Additionally, full integration with native control in Chromeleon CDS enables users to benefit from the entire productivity suite, from method creation through final reporting. A built-in reference standard also automates instrument calibration for a userfriendly experience.
Driven by industry demand for a robust, easy to implement system, Thermo Fisher Scientific designed the Thermo Scientific ISQ EM single quadrupole mass spectrometer for high performance and productivity standards in laboratories. With a mass range of 10–2000 m/z, the system offers the power to detect and quantify small and large molecules, and supports analytical needs across an extensive range of applications - from drug development to manufacturing support and quality control. The system's highperforming heated electrospray ionization (HESI) and dual HESI/atmospheric pressure chemical ionization (APCI) probes facilitate the measurement of polar and non-polar analytes, enabling application flexibility. Chromatographers looking for bold confidence in their samples can now benefit from a single quadrupole mass spectrometer designed for ease-of-use while offering application flexibility and reliable results for challenging mass confirmation analyses.
The ISQ EM is integrated with HPLC systems and fully controlled by Thermo Scientific Chromeleon Chromatography Data System (CDS), which offers tools to guide users through LC-MS method development and select appropriate source conditions. Thermo Scientific Chromeleon XPS Open Access software also supports the ISQ EM with walk-up workflows for simple daily operation. Additionally, full integration with native control in Chromeleon CDS enables users to benefit from the entire productivity suite, from method creation through final reporting. A built-in reference standard also automates instrument calibration for a userfriendly experience.
State-of-the art cancer screening systems for over 17
lakh women
TAKE Solutions Ltd a globally recognized domain intensive services provider in Life Sciences, today announced its support for Preventive Oncology with Cancer Institute (WIA) in Chennai as part of its CSR initiative. This project is particularly important as this aligns with TAKE’s core expertise in Oncology and is fitting that it is being initiated in the Breast Cancer Awareness Month. Navitas Life Sciences, a TAKE Solutions Enterprise has supported over 650 oncology studies with some of the largest players in the therapeutic area. Cervical cancer and breast cancer are the most common cause of cancer deaths among women in India, but early detection and proper treatment can improve this prognosis and can make cancer curable. A study conducted by E&Y and FICCI has reported that in India, 2,000 women are newly diagnosed with cancer every day. 1,200 of these cases are detected in late stages, which reduces the 5-year survival rate by 3 to 17 times for breast and cervical cancer. This late detection also raises the cost of treatment by 1.5 to 2 times that for early-stage cancers.
The major thrust in cancer control is early detection and prevention. Towards this, the Cancer Institute has a functional preventive oncology department set- up for early detection screening, education centres in Villupuram, Gummidipoondi, Pudukkottai and Thiruvannamaalai and a Cancer Exhibition and mammomobile for breast cancer screening. The department also functions as the training centre to train staff and coordinate the activities at the different centres. Through their efforts, the Cancer Institute has covered nearly 2,18,000 households across 260 villages in Tamil Nadu and enabled early detection screening for over 90,820 women and men.
TAKE Solutions Ltd a globally recognized domain intensive services provider in Life Sciences, today announced its support for Preventive Oncology with Cancer Institute (WIA) in Chennai as part of its CSR initiative. This project is particularly important as this aligns with TAKE’s core expertise in Oncology and is fitting that it is being initiated in the Breast Cancer Awareness Month. Navitas Life Sciences, a TAKE Solutions Enterprise has supported over 650 oncology studies with some of the largest players in the therapeutic area. Cervical cancer and breast cancer are the most common cause of cancer deaths among women in India, but early detection and proper treatment can improve this prognosis and can make cancer curable. A study conducted by E&Y and FICCI has reported that in India, 2,000 women are newly diagnosed with cancer every day. 1,200 of these cases are detected in late stages, which reduces the 5-year survival rate by 3 to 17 times for breast and cervical cancer. This late detection also raises the cost of treatment by 1.5 to 2 times that for early-stage cancers.
The major thrust in cancer control is early detection and prevention. Towards this, the Cancer Institute has a functional preventive oncology department set- up for early detection screening, education centres in Villupuram, Gummidipoondi, Pudukkottai and Thiruvannamaalai and a Cancer Exhibition and mammomobile for breast cancer screening. The department also functions as the training centre to train staff and coordinate the activities at the different centres. Through their efforts, the Cancer Institute has covered nearly 2,18,000 households across 260 villages in Tamil Nadu and enabled early detection screening for over 90,820 women and men.
Glenmark Pharmaceuticals receives ANDA approval for
Hydrocortisone Valerate Cream USP, 0.2%
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort®1 Cream, 0.2%, of Sun Pharmaceutical Industries Inc. Glenmark's current portfolio consists of 139 products authorized for distribution in the U.S. marketplace and 60 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort®1 Cream, 0.2%, of Sun Pharmaceutical Industries Inc. Glenmark's current portfolio consists of 139 products authorized for distribution in the U.S. marketplace and 60 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Strand Life Sciences Acquires India Diagnostics
Business from Quest Diagnostics
Strand Life Sciences, a Bangalore-based specialized research and diagnostics company today announced an agreement to acquire the India medical diagnostics business of Quest Diagnostics, the world's leading provider of diagnostic information services. "This acquisition is an important addition to our network of 24 diagnostic labs across India, especially as we continue to expand our work in oncology, genomics, and precision medicine. It adds strong North India presence and marquee clientele that includes leading hospital chains, corporates and pharmaceutical clients to our portfolio, making us India's leading specialized diagnostics company", said Dr. Ramesh Hariharan, Chief Executive Officer, Strand Life Sciences. Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics, commented: "We have built a diagnostic laboratory in India with a reputation for quality over the past 10 years. As our business model has evolved, we believe Strand Life Sciences is well positioned to continue the important work of empowering the people of India to improve their health with diagnostic insights." The two companies will work together to manage the transition, and aim to close the sale by the end of first quarter 2019. Terms of this transaction were not disclosed.
Strand Life Sciences, a Bangalore-based specialized research and diagnostics company today announced an agreement to acquire the India medical diagnostics business of Quest Diagnostics, the world's leading provider of diagnostic information services. "This acquisition is an important addition to our network of 24 diagnostic labs across India, especially as we continue to expand our work in oncology, genomics, and precision medicine. It adds strong North India presence and marquee clientele that includes leading hospital chains, corporates and pharmaceutical clients to our portfolio, making us India's leading specialized diagnostics company", said Dr. Ramesh Hariharan, Chief Executive Officer, Strand Life Sciences. Steve Rusckowski, Chairman, President and CEO, Quest Diagnostics, commented: "We have built a diagnostic laboratory in India with a reputation for quality over the past 10 years. As our business model has evolved, we believe Strand Life Sciences is well positioned to continue the important work of empowering the people of India to improve their health with diagnostic insights." The two companies will work together to manage the transition, and aim to close the sale by the end of first quarter 2019. Terms of this transaction were not disclosed.
Neurimmune Achieves Milestone in Collaboration with
Ono Pharmaceutical
Neurimmune has the achieved a key preclinical milestone in the ongoing collaboration with Ono Pharmaceutical Co., Ltd. In November 2017, the parties entered into a collaboration focused on the development of human-derived antibodies against a novel therapeutic target for neurodegenerative diseases. Under the terms of the collaboration agreement Neurimmune conducts research to generate and validate human-derived monoclonal antibodies using its proprietary Reverse Translational Medicine™ (RTM™) technology platform. The milestone triggers a pre-agreed milestone payment to Neurimmune. "We highly appreciate a key success in drug discovery of human-derived monoclonal antibodies with Neurimmune’s proprietary platform.", said Hiromu Habashita, Ph.D., Corporate Officer and Executive Director, Discovery and Research of Ono. "We believe this progress will lead to the delivery of a novel and innovative treatment for patients with neurodegenerative diseases."
Neurimmune has the achieved a key preclinical milestone in the ongoing collaboration with Ono Pharmaceutical Co., Ltd. In November 2017, the parties entered into a collaboration focused on the development of human-derived antibodies against a novel therapeutic target for neurodegenerative diseases. Under the terms of the collaboration agreement Neurimmune conducts research to generate and validate human-derived monoclonal antibodies using its proprietary Reverse Translational Medicine™ (RTM™) technology platform. The milestone triggers a pre-agreed milestone payment to Neurimmune. "We highly appreciate a key success in drug discovery of human-derived monoclonal antibodies with Neurimmune’s proprietary platform.", said Hiromu Habashita, Ph.D., Corporate Officer and Executive Director, Discovery and Research of Ono. "We believe this progress will lead to the delivery of a novel and innovative treatment for patients with neurodegenerative diseases."
Dr. Reddy's Laboratories receives approval for
Aspirin and Extended-Release Dipyridamole Capsules in the U.S. Market
Dr. Reddy's Laboratories Ltd has received approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extendedrelease dipyridamole) Capsules in the United States market from the U.S. Food and Drug Administration (USFDA). The Company is working towards launching the product. The Aggrenox brand and generic had U.S. sales of approximately $183 million MAT for the most recent twelve months ending in August 2018 according to IMS Health*. Dr. Reddy's Aspirin and Extended-Release Dipyridamole Capsules is available in 25 mg/200 mg strength with 60 count bottle size. Aggrenox is a registered trademark of Boehringer Ingelheim.
Dr. Reddy's Laboratories Ltd has received approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extendedrelease dipyridamole) Capsules in the United States market from the U.S. Food and Drug Administration (USFDA). The Company is working towards launching the product. The Aggrenox brand and generic had U.S. sales of approximately $183 million MAT for the most recent twelve months ending in August 2018 according to IMS Health*. Dr. Reddy's Aspirin and Extended-Release Dipyridamole Capsules is available in 25 mg/200 mg strength with 60 count bottle size. Aggrenox is a registered trademark of Boehringer Ingelheim.
Dr Reddy's Laboratories announces the launch of
Neostigmine Methylsulfate Injection, USP in the U.S. Market
Dr Reddy's Laboratories Ltd announced the launch of Neostigmine Methylsulfate Injection, USP, a therapeutic equivalent generic version of Bloxiverz (Neostigmine Methylsulfate) Injection approved by the U.S. Food and Drug Administration (USFDA).
The Bloxiverz brand and generic had U.S. sales of approximately $111 million MAT for the most recent twelve months ending in July 2018 according to IMS Health*.
Dr Reddy's Neostigmine Methylsulfate Injection, USP is available in 5 mg/10 mL and 10 mg/10 mL multi-dose vials.
Dr Reddy's Laboratories Ltd announced the launch of Neostigmine Methylsulfate Injection, USP, a therapeutic equivalent generic version of Bloxiverz (Neostigmine Methylsulfate) Injection approved by the U.S. Food and Drug Administration (USFDA).
The Bloxiverz brand and generic had U.S. sales of approximately $111 million MAT for the most recent twelve months ending in July 2018 according to IMS Health*.
Dr Reddy's Neostigmine Methylsulfate Injection, USP is available in 5 mg/10 mL and 10 mg/10 mL multi-dose vials.
SOTIO and PPF Complete Acquisition of Cytune Pharma
SOTIO, a biotechnology company owned by the PPF Group, announced the completion of the acquisition of Cytune Pharma by PPF. SOTIO will continue to develop the lead program SO-C101 (RLI-15) within its pipeline and intends to initiate first-in-human clinical trials in early 2019. SOTIO is spearheading all of PPF's activities in the biotech sector and closely cooperated during Cytune's acquisition process. All Cytune projects will be developed as part of SOTIO's pipeline.
Cytune Pharma develops IL-15 based therapies for the treatment of cancer. The lead molecule of Cytune’s pipeline, SO-C101 (RLI-15), is a human fusion protein of IL-15 and the high-affinity binding domain of IL-15Rα and acts as a specific IL-2/IL-15Rβγ agonist.
The deal announced in 2015 between PPF Group and Cytune involved investments into Cytune and a staged-acquisition of the company, which has now been completed with the acquisition of all outstanding shares of Cytune. Cytune becomes an important part of SOTIO's activities in the biotech sector and will also closely collaborate with its affiliate Accord Research on the future development of the lead program SO-C101, and other earlier-stage targeted RLI-15 programs. SOTIO is planning to initiate a first-inhuman study with SO-C101 in selected European countries and the US in early 2019. A key part of this early clinical program is the combination with immune checkpoint inhibitors.
"We are excited about the completion of the acquisition and welcome Cytune to the PPF Group. Cytune and SOTIO have been closely and very successfully collaborating over the course of the last few years and we very much look forward to initiating the first clinical trials with SO-C101 in a few months," commented Radek Spisek, CEO of SOTIO. "SO-C101 will become a core program of our pipeline, together with our clinical programs in ovarian, lung and prostate cancer based on our autologous dendritic cell therapy platform DCVAC."
"I'm proud that our products, originating from INSERM and the University of Nantes and supported by Bpifrance and Atlanpole Biotherapies, hold the potential to lead to new therapeutic options for the treatment of cancer patients. Such IL-2/IL-15Rβγ agonists represent a new and very promising class of drugs in the immune-oncology segment as they have shown to re-induce responses in patients after failure to checkpoint inhibitors treatment," adds David Bechard, President and COO of Cytune. "The continued financial support by PPF combined with SOTIO's clinical development expertise will be instrumental in accelerating the development of SO-C101 in multiple clinical trials, ultimately for the benefit of cancer patients."
The financial terms of the transaction are not disclosed.
SOTIO, a biotechnology company owned by the PPF Group, announced the completion of the acquisition of Cytune Pharma by PPF. SOTIO will continue to develop the lead program SO-C101 (RLI-15) within its pipeline and intends to initiate first-in-human clinical trials in early 2019. SOTIO is spearheading all of PPF's activities in the biotech sector and closely cooperated during Cytune's acquisition process. All Cytune projects will be developed as part of SOTIO's pipeline.
Cytune Pharma develops IL-15 based therapies for the treatment of cancer. The lead molecule of Cytune’s pipeline, SO-C101 (RLI-15), is a human fusion protein of IL-15 and the high-affinity binding domain of IL-15Rα and acts as a specific IL-2/IL-15Rβγ agonist.
The deal announced in 2015 between PPF Group and Cytune involved investments into Cytune and a staged-acquisition of the company, which has now been completed with the acquisition of all outstanding shares of Cytune. Cytune becomes an important part of SOTIO's activities in the biotech sector and will also closely collaborate with its affiliate Accord Research on the future development of the lead program SO-C101, and other earlier-stage targeted RLI-15 programs. SOTIO is planning to initiate a first-inhuman study with SO-C101 in selected European countries and the US in early 2019. A key part of this early clinical program is the combination with immune checkpoint inhibitors.
"We are excited about the completion of the acquisition and welcome Cytune to the PPF Group. Cytune and SOTIO have been closely and very successfully collaborating over the course of the last few years and we very much look forward to initiating the first clinical trials with SO-C101 in a few months," commented Radek Spisek, CEO of SOTIO. "SO-C101 will become a core program of our pipeline, together with our clinical programs in ovarian, lung and prostate cancer based on our autologous dendritic cell therapy platform DCVAC."
"I'm proud that our products, originating from INSERM and the University of Nantes and supported by Bpifrance and Atlanpole Biotherapies, hold the potential to lead to new therapeutic options for the treatment of cancer patients. Such IL-2/IL-15Rβγ agonists represent a new and very promising class of drugs in the immune-oncology segment as they have shown to re-induce responses in patients after failure to checkpoint inhibitors treatment," adds David Bechard, President and COO of Cytune. "The continued financial support by PPF combined with SOTIO's clinical development expertise will be instrumental in accelerating the development of SO-C101 in multiple clinical trials, ultimately for the benefit of cancer patients."
The financial terms of the transaction are not disclosed.
XchangePoint, an integrated workflow management
system for medication optimization
EXILANT Technologies, a QuEST Global Company, has successfully partnered with PharmaPoint, a technology-enabled pharmacy management and software company in the United States, to unveil the latest version of XchangePoint, an integrated workflow management system for medication optimization.
The new release includes real-time video conferencing capabilities to extend a pharmacist's reach to patients in need of a medication consultation. XchangePoint's analytical engine has also been enhanced to include socio-economic factors as an option for targeting potentially at-risk patients in need of additional services.
“We are proud to partner with EXILANT, a QuEST Global company," said Bobby Middleton, Vice President of Product Operations for PharmaPoint. "Their work on product development for XchangePoint allows us to efficiently roll out enhancements and new features to our clients in a timely manner. We look forward to continuing to disrupt the healthcare industry together with innovative solutions that result in the highest quality of patient care."
XchangePoint prioritizes high risk patient populations, operationalizes "meds to beds" workflow, provides complete and accurate pharmacyled medication reconciliation, and offers customized discharge medication instructions. Essentially, XchangePoint serves as the process communicator and enabler that converts analytics into action - resulting in improved outcomes and optimal staff productivity.
Commenting on the successful release of the latest version of XchangePoint, Krish Kupathil, Head - Digital and Hi-Tech, QuEST Global, said, "Analytics is playing a crucial role by helping organizations in different industries to ensure accurate planning, make better business decisions and improve customer satisfaction. We are excited to partner with PharmaPoint to integrate data from various sources to provide effective bedside programs, medication reconciliation, post follow-up and coordinated transition of care via the XchangePoint solution. At QuEST Global, we support customers to enhance their product experience and lead their industries by co-innovating products using the latest software and digital technologies."
EXILANT Technologies, a QuEST Global Company, has successfully partnered with PharmaPoint, a technology-enabled pharmacy management and software company in the United States, to unveil the latest version of XchangePoint, an integrated workflow management system for medication optimization.
The new release includes real-time video conferencing capabilities to extend a pharmacist's reach to patients in need of a medication consultation. XchangePoint's analytical engine has also been enhanced to include socio-economic factors as an option for targeting potentially at-risk patients in need of additional services.
“We are proud to partner with EXILANT, a QuEST Global company," said Bobby Middleton, Vice President of Product Operations for PharmaPoint. "Their work on product development for XchangePoint allows us to efficiently roll out enhancements and new features to our clients in a timely manner. We look forward to continuing to disrupt the healthcare industry together with innovative solutions that result in the highest quality of patient care."
XchangePoint prioritizes high risk patient populations, operationalizes "meds to beds" workflow, provides complete and accurate pharmacyled medication reconciliation, and offers customized discharge medication instructions. Essentially, XchangePoint serves as the process communicator and enabler that converts analytics into action - resulting in improved outcomes and optimal staff productivity.
Commenting on the successful release of the latest version of XchangePoint, Krish Kupathil, Head - Digital and Hi-Tech, QuEST Global, said, "Analytics is playing a crucial role by helping organizations in different industries to ensure accurate planning, make better business decisions and improve customer satisfaction. We are excited to partner with PharmaPoint to integrate data from various sources to provide effective bedside programs, medication reconciliation, post follow-up and coordinated transition of care via the XchangePoint solution. At QuEST Global, we support customers to enhance their product experience and lead their industries by co-innovating products using the latest software and digital technologies."
Eisai's LENVIMA (LENVATINIB) Capsules Approved for
First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South
Korea
Eisai Co, Ltd announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) from the Ministry of Food and Drug Safety (MFDS) in South Korea. An application seeking approval of LENVIMA for use in the treatment of unresectable HCC was submitted in South Korea in March 2018. This approval for LENVIMA in South Korea marks the second in Asia following approval in Japan. LENVIMA is the first new treatment option approved in ten years as a first-line systemic treatment for HCC in South Korea.
In March 2018, Eisai and Merck & Co, Inc, Kenilworth, N.J, U.S.A, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. The companies are expected to commence co-commercialization efforts for LENVIMA in South Korea by the end of 2018.
This approval was based on results from REFLECT (Study 304), an open-label, Phase III trial where LENVIMA demonstrated a treatment effect on overall survival (OS)(1) by statistical confirmation of noninferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC. LENVIMA also demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS)(2) and objective response rate (ORR)(3).
REFLECT showed that LENVIMA achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio [HR]: 0.92; 95% Confidence Interval [CI]: 0.79-1.06). The OS analysis was conducted as prespecified in the statistical analysis plan when 351 events had occurred in the LENVIMA arm and 350 events had occurred in the sorafenib arm. Regarding secondary efficacy endpoints, according to independent imaging review based on mRECIST criteria, LENVIMA showed statistically significant superiority and clinically meaningful improvements as compared to sorafenib in median PFS: LENVIMA 7.3 months versus sorafenib 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; )
Liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions.(1) HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.
LENVIMA has been approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a secondline treatment for RCC in over 45 countries including the United States and in Europe.
Since the initial launch, more than 10,000 patients have been treated with LENVIMA, which is approved in more than 50 countries worldwide. In Japan, approximately 3,000 HCC patients have been treated with LENVIMA since the approval of the HCC indication in March 2018.
Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of LENVIMA, in collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A., as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to cancer patients, their families, and healthcare providers worldwide.
(1) Overall Survival (OS): The time period from the commencement of cancer treatment up until death by any cause. Whether the cause of death is cancer or not is not taken into consideration for this variable.
(2) Progression Free Survival (PFS): PFS is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression, or date of death from any cause, whichever occurs first.
(3) Objective Response Rate (ORR): ORR is the combined proportion of patients whose tumor was eliminated (complete response) and whose tumor was reduced by over 30% in size (partial response) as verified by imaging assessment.
REFLECT Trial (Study 304) was a large (n=954) Phase III, randomized, multicenter, open-label trial conducted by Eisai to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma (HCC). Patients at 154 trial sites in 20 countries were randomized to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (>/=60 kg or
In addition, LENVIMA showed statistically significant superiority and clinically meaningful improvements in the secondary efficacy endpoints of PFS and ORR, as confirmed by a blinded independent imaging review (IIR).
Median PFS was doubled with LENVIMA compared to sorafenib: 7.3 months versus 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; p
In addition, median time to progression (TTP) was doubled with LENVIMA compared to sorafenib: 7.4 months versus 3.7 months (HR: 0.60; 95% CI: 0.51-0.71; p
The results of the REFLECT trial were published in The Lancet 2018, 391 (10126), 1163-1173 (published online on February 9, 2018).
Eisai Co, Ltd announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) from the Ministry of Food and Drug Safety (MFDS) in South Korea. An application seeking approval of LENVIMA for use in the treatment of unresectable HCC was submitted in South Korea in March 2018. This approval for LENVIMA in South Korea marks the second in Asia following approval in Japan. LENVIMA is the first new treatment option approved in ten years as a first-line systemic treatment for HCC in South Korea.
In March 2018, Eisai and Merck & Co, Inc, Kenilworth, N.J, U.S.A, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. The companies are expected to commence co-commercialization efforts for LENVIMA in South Korea by the end of 2018.
This approval was based on results from REFLECT (Study 304), an open-label, Phase III trial where LENVIMA demonstrated a treatment effect on overall survival (OS)(1) by statistical confirmation of noninferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC. LENVIMA also demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS)(2) and objective response rate (ORR)(3).
REFLECT showed that LENVIMA achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio [HR]: 0.92; 95% Confidence Interval [CI]: 0.79-1.06). The OS analysis was conducted as prespecified in the statistical analysis plan when 351 events had occurred in the LENVIMA arm and 350 events had occurred in the sorafenib arm. Regarding secondary efficacy endpoints, according to independent imaging review based on mRECIST criteria, LENVIMA showed statistically significant superiority and clinically meaningful improvements as compared to sorafenib in median PFS: LENVIMA 7.3 months versus sorafenib 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; )
Liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions.(1) HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.
LENVIMA has been approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a secondline treatment for RCC in over 45 countries including the United States and in Europe.
Since the initial launch, more than 10,000 patients have been treated with LENVIMA, which is approved in more than 50 countries worldwide. In Japan, approximately 3,000 HCC patients have been treated with LENVIMA since the approval of the HCC indication in March 2018.
Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of LENVIMA, in collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A., as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to cancer patients, their families, and healthcare providers worldwide.
(1) Overall Survival (OS): The time period from the commencement of cancer treatment up until death by any cause. Whether the cause of death is cancer or not is not taken into consideration for this variable.
(2) Progression Free Survival (PFS): PFS is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression, or date of death from any cause, whichever occurs first.
(3) Objective Response Rate (ORR): ORR is the combined proportion of patients whose tumor was eliminated (complete response) and whose tumor was reduced by over 30% in size (partial response) as verified by imaging assessment.
REFLECT Trial (Study 304) was a large (n=954) Phase III, randomized, multicenter, open-label trial conducted by Eisai to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma (HCC). Patients at 154 trial sites in 20 countries were randomized to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (>/=60 kg or
In addition, LENVIMA showed statistically significant superiority and clinically meaningful improvements in the secondary efficacy endpoints of PFS and ORR, as confirmed by a blinded independent imaging review (IIR).
Median PFS was doubled with LENVIMA compared to sorafenib: 7.3 months versus 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; p
In addition, median time to progression (TTP) was doubled with LENVIMA compared to sorafenib: 7.4 months versus 3.7 months (HR: 0.60; 95% CI: 0.51-0.71; p
The results of the REFLECT trial were published in The Lancet 2018, 391 (10126), 1163-1173 (published online on February 9, 2018).
Pushing the Boundaries in Automation - Lonza's Next
-Generation Robotic Solution for Endotoxin Detection
Consistent with the FDA's Process Analytical Technology (PAT) initiative,
Lonza is introducing a new generation of automated endotoxin detection
driven by its market leading WinKQCL Endotoxin Detection Software.
A few of the highlighted features include:
Consistent with the FDA's Process Analytical Technology (PAT) initiative,
Lonza is introducing a new generation of automated endotoxin detection
driven by its market leading WinKQCL Endotoxin Detection Software.A few of the highlighted features include:
- Adapting to changes: WinKQCL Software can generate robotic scripts and adapt to changing sample dilution requirements.
- Offering a "walk-away" solution: The WinKQCL Software can control the procedure from start to finish.
- Saving time and reducing risk: WinKQCL Software can import sample test worklists from a sample management system and export the results back out to the same system, preventing transcription errors and saving time over manually entering data.
Markus Regner takes over as MD of Romaco
Pharmatechnik GmbH at the Karlsruhe facility
The Romaco Group has just appointed Markus Regner (51) as new Managing Director of Romaco Pharmatechnik GmbH, the facility where Romaco's Noack and Siebler brands are manufactured in Karlsruhe (Germany). Amongst other things, Regner will be responsible for sales, customer service, operations and engineering. He will work alongside Carsten Strenger, who will remain CFO/COO of Romaco Holding GmbH as well as joint Managing Director of Romaco Pharmatechnik GmbH.
A graduate in Aerospace Engineering, Markus Regner began his career in the solar technology sector in the mid-nineties. He switched to the pharmaceutical packaging industry, which has remained his professional home to this day, at the turn of the millennium. He has held various executive positions with pharmaceutical technology groups over the past 20 years, most recently as Technical Manager at a supplier of customised machines for filling liquids.
Markus Regner explains his move to Romaco as: "I believe Romaco has everything it takes to be very successful. My aim is to systematically strengthen this innovation capability and drive those technologies forward. It's an exciting challenge and I’m looking forward to it immensely."
The Romaco Group has just appointed Markus Regner (51) as new Managing Director of Romaco Pharmatechnik GmbH, the facility where Romaco's Noack and Siebler brands are manufactured in Karlsruhe (Germany). Amongst other things, Regner will be responsible for sales, customer service, operations and engineering. He will work alongside Carsten Strenger, who will remain CFO/COO of Romaco Holding GmbH as well as joint Managing Director of Romaco Pharmatechnik GmbH.
A graduate in Aerospace Engineering, Markus Regner began his career in the solar technology sector in the mid-nineties. He switched to the pharmaceutical packaging industry, which has remained his professional home to this day, at the turn of the millennium. He has held various executive positions with pharmaceutical technology groups over the past 20 years, most recently as Technical Manager at a supplier of customised machines for filling liquids.
Markus Regner explains his move to Romaco as: "I believe Romaco has everything it takes to be very successful. My aim is to systematically strengthen this innovation capability and drive those technologies forward. It's an exciting challenge and I’m looking forward to it immensely."
Sun Pharma launches Volini Maxx, India's Strongest
Pain Relief Spray
Sun Pharma Consumer Healthcare, a division of Sun Pharmaceutical Industries Ltd announced the launch of Volini Maxx, India's strongest pain relief spray*. The company has signed Virat Kohli, Captain of Indian Cricket Team as the new brand ambassador of Volini. A 3600 marketing campaign featuring Virat Kohli goes live today.
Volini Maxx is a new variant of Sun Pharma’s popular brand, Volini - the No.1 pain relief spray in India#. Its unique formulation of 2% diclofenac makes it 100% stronger than the existing 1% diclofenac sprays available in the Indian market. Volini Maxx is targeted for severe pains including musculoskeletal, joint and low back. Its 3600 technology ensures standardised drug delivery at all angles.
"Volini has been a trusted pain relief partner for over two decades. We are happy to introduce Volini Maxx spray which is stronger than any other topical pain relief spray available in India*. It will provide effective relief to people suffering from back and joint pain and also in sports injuries," said Kal Sundaram, CEO - India, Emerging Markets & Consumer Healthcare, Sun Pharma. "Known for pushing the limits of physical endurance, Virat echoes the brand vision of constantly improving performance and not letting pain come in the way of going that extra mile," he added.
The overall topical analgesic market in India is valued at 3380 crores growing at 11% (AC Nielsen MAT June 18). Out of this, the spray category is around ` 356 crores growing at 18% (AC Nielsen MAT June 18).
Sun Pharma Consumer Healthcare, a division of Sun Pharmaceutical Industries Ltd announced the launch of Volini Maxx, India's strongest pain relief spray*. The company has signed Virat Kohli, Captain of Indian Cricket Team as the new brand ambassador of Volini. A 3600 marketing campaign featuring Virat Kohli goes live today.
Volini Maxx is a new variant of Sun Pharma’s popular brand, Volini - the No.1 pain relief spray in India#. Its unique formulation of 2% diclofenac makes it 100% stronger than the existing 1% diclofenac sprays available in the Indian market. Volini Maxx is targeted for severe pains including musculoskeletal, joint and low back. Its 3600 technology ensures standardised drug delivery at all angles.
"Volini has been a trusted pain relief partner for over two decades. We are happy to introduce Volini Maxx spray which is stronger than any other topical pain relief spray available in India*. It will provide effective relief to people suffering from back and joint pain and also in sports injuries," said Kal Sundaram, CEO - India, Emerging Markets & Consumer Healthcare, Sun Pharma. "Known for pushing the limits of physical endurance, Virat echoes the brand vision of constantly improving performance and not letting pain come in the way of going that extra mile," he added.
The overall topical analgesic market in India is valued at 3380 crores growing at 11% (AC Nielsen MAT June 18). Out of this, the spray category is around ` 356 crores growing at 18% (AC Nielsen MAT June 18).
Get ready to witness the best of pharmaceutical
machinery and allied technologies in Hyderabad
Under the new management of Messe Muenchen India, the leading exhibition on pharma processing & packaging machineries - PHARMA Pro & Pack 2018 is expected to feature over 100 exhibitors and attract more than 3,000 quality trade visitors from 6-8 September 2018 at HITEX Exhibition Centre in Hyderabad.
Taking place at the pharmaceutical hub of India- Hyderabad, which is home to about 1000+ pharmaceutical companies, the exhibition will be attended by top decision makers. Having a rich experience of organizing professional events on various industries, Messe Muenchen India is also organizing analytica Anacon India and India Lab Expo simultaneously with the trade fair which is expected to attract over 300 exhibitors and more than 8500 trade visitors.
In order to ensure high potential buyers, Pharma Pro & Pack 2018 will be hosting top buyers from across country via the hosted buyer program.
Bhupinder Singh, CEO of Messe Muenchen India said: "We are delighted to offer one solid trade platform for the domestic & international suppliers and buyers. In order to expand our reach and network, we are organizing promotional roadshows across India, well ahead of the trade fairs at Ahmedabad, Bengaluru, Chennai, Puducherry, Visakhapatnam and Hyderabad."
Mahendra Mehta, President of Indian Pharma Machinery Manufacturers Association (IPMMA) stated: "The response of the industry has been overwhelming and we have participation from all key industry leaders. To ensure high-quality buyers at the show, we are organizing a hosted buyer program this year as well. Our synergies with analytica Anacon India and India Lab Expo will also benefit our participants."
The exhibition has garnered whole-hearted support from leading trade associations and media publications in the country. Some of the distinguished personalities namely Mr. Kaushik Desai (Chairperson- FAPA & Secretary General- IPEC India), Mr. Chakravarthi AVPS (CEO & MD - Ecobliss India Pvt Ltd), Dr. S. B. Rijhwani (MD- Preomed Laboratories Pvt Ltd), Mr. S V Veerramani (Chairman & MD- Fourrts Laboratories Pvt Ltd), Mr. Sanjit Singh Lamba (MD - Eisai Knowledge Centre), Mr. Daara Patel (Secretary General - IDMA) & Mr. S.M. Mudda (Chairman – Regulatory Affairs Committee at IDMA) are the advisory committee members of Pharma Pro & Pack 2018.
"This year, we have a wider participation and encourage all industry professionals to come and join the trade fairs and take business to new heights this year." Concluded Singh.
Organized by Messe Muenchen India, PHARMA Pro & Pack Expo will take place from September 6-8, 2018 at HITEX Exhibition Center in Hyderabad. The event is co-located with analytica Anacon India, India Lab Expo.
Under the new management of Messe Muenchen India, the leading exhibition on pharma processing & packaging machineries - PHARMA Pro & Pack 2018 is expected to feature over 100 exhibitors and attract more than 3,000 quality trade visitors from 6-8 September 2018 at HITEX Exhibition Centre in Hyderabad.
Taking place at the pharmaceutical hub of India- Hyderabad, which is home to about 1000+ pharmaceutical companies, the exhibition will be attended by top decision makers. Having a rich experience of organizing professional events on various industries, Messe Muenchen India is also organizing analytica Anacon India and India Lab Expo simultaneously with the trade fair which is expected to attract over 300 exhibitors and more than 8500 trade visitors.
In order to ensure high potential buyers, Pharma Pro & Pack 2018 will be hosting top buyers from across country via the hosted buyer program.
Bhupinder Singh, CEO of Messe Muenchen India said: "We are delighted to offer one solid trade platform for the domestic & international suppliers and buyers. In order to expand our reach and network, we are organizing promotional roadshows across India, well ahead of the trade fairs at Ahmedabad, Bengaluru, Chennai, Puducherry, Visakhapatnam and Hyderabad."
Mahendra Mehta, President of Indian Pharma Machinery Manufacturers Association (IPMMA) stated: "The response of the industry has been overwhelming and we have participation from all key industry leaders. To ensure high-quality buyers at the show, we are organizing a hosted buyer program this year as well. Our synergies with analytica Anacon India and India Lab Expo will also benefit our participants."
The exhibition has garnered whole-hearted support from leading trade associations and media publications in the country. Some of the distinguished personalities namely Mr. Kaushik Desai (Chairperson- FAPA & Secretary General- IPEC India), Mr. Chakravarthi AVPS (CEO & MD - Ecobliss India Pvt Ltd), Dr. S. B. Rijhwani (MD- Preomed Laboratories Pvt Ltd), Mr. S V Veerramani (Chairman & MD- Fourrts Laboratories Pvt Ltd), Mr. Sanjit Singh Lamba (MD - Eisai Knowledge Centre), Mr. Daara Patel (Secretary General - IDMA) & Mr. S.M. Mudda (Chairman – Regulatory Affairs Committee at IDMA) are the advisory committee members of Pharma Pro & Pack 2018.
"This year, we have a wider participation and encourage all industry professionals to come and join the trade fairs and take business to new heights this year." Concluded Singh.
Organized by Messe Muenchen India, PHARMA Pro & Pack Expo will take place from September 6-8, 2018 at HITEX Exhibition Center in Hyderabad. The event is co-located with analytica Anacon India, India Lab Expo.
New supporting programs at analytica Anacon
India and India Lab Expo this year in Hyderabad
More than 300 companies will be exhibiting at India's leading trade fair for laboratory technology, analysis, biotechnology and diagnostics industry displaying the best of the technologies. It comprehensively covers the entire value chain for pharma, food, chemical, industrial and research laboratories. The trade fair is accompanied by compelling supporting programs to further enhance the visitor experience.
Co-Location brings benefits
For the second time in a row, the co-location with PHARMA Pro & Pack Expo brings a pool of manufacturers and suppliers of pharmaceutical machinery, laboratory and analytical equipment to analytica Anacon India and India Lab Expo.
Buyers and trade visitors of analytica Anacon India and India Lab Expo will benefit from attending product segments of PHARMA Pro & Pack Expo and vice-versa. This cross-display of technology will allow visitors to witness a wider range of exhibits and thus, will position the three trade fairs as the most important gathering for the pharmaceutical machinery, analysis and laboratory industry.
New: Smart Lab Summit
Visitors to analytica Anacon India and India Lab Expo have the opportunity to engage themselves in a knowledge based forum – Smart Lab Summit, which will be a talking point with respect to latest products, technologies and innovations concerning the laboratory and research & development sector. This will be a top notch forum with a gathering of scientists and key industry experts sharing deep insights about their industry enabling a strong interactive and engaging platform with the audience.
Growing interest for Buyer-Seller Forum: 1,000 meetings expected
The buyer seller forum has been an integral supporting program at the trade fair as it involves focused business discussions between the buyers and sellers of the technology. The one-to-one meetings facilitate direct contact between exhibitors and buyers from domestic and international markets through prescheduled meetings.
This tailored match-making platform allows exhibitors to connect with possible business partners filtered by branch, position or companies. In return, it allows visitors to search for specific applications or brands. In this edition, more than 1,000 meetings are expected to take place during the show days.
Seminar: Analytical Solutions for Life Sciences Research
Attendees will also benefit from an additional supporting program at the analytica Anacon India and India Lab Expo. The seminar on Analytical Solutions for Life Sciences Research will lead to informative sessions and discussions pertaining to key analytical solutions compatible with life sciences and research. The attendees to the seminar will take away important insights about the latest technologies and the best of their applications.
More than 300 companies will be exhibiting at India's leading trade fair for laboratory technology, analysis, biotechnology and diagnostics industry displaying the best of the technologies. It comprehensively covers the entire value chain for pharma, food, chemical, industrial and research laboratories. The trade fair is accompanied by compelling supporting programs to further enhance the visitor experience.
Co-Location brings benefits
For the second time in a row, the co-location with PHARMA Pro & Pack Expo brings a pool of manufacturers and suppliers of pharmaceutical machinery, laboratory and analytical equipment to analytica Anacon India and India Lab Expo.
Buyers and trade visitors of analytica Anacon India and India Lab Expo will benefit from attending product segments of PHARMA Pro & Pack Expo and vice-versa. This cross-display of technology will allow visitors to witness a wider range of exhibits and thus, will position the three trade fairs as the most important gathering for the pharmaceutical machinery, analysis and laboratory industry.
New: Smart Lab Summit
Visitors to analytica Anacon India and India Lab Expo have the opportunity to engage themselves in a knowledge based forum – Smart Lab Summit, which will be a talking point with respect to latest products, technologies and innovations concerning the laboratory and research & development sector. This will be a top notch forum with a gathering of scientists and key industry experts sharing deep insights about their industry enabling a strong interactive and engaging platform with the audience.
Growing interest for Buyer-Seller Forum: 1,000 meetings expected
The buyer seller forum has been an integral supporting program at the trade fair as it involves focused business discussions between the buyers and sellers of the technology. The one-to-one meetings facilitate direct contact between exhibitors and buyers from domestic and international markets through prescheduled meetings.
This tailored match-making platform allows exhibitors to connect with possible business partners filtered by branch, position or companies. In return, it allows visitors to search for specific applications or brands. In this edition, more than 1,000 meetings are expected to take place during the show days.
Seminar: Analytical Solutions for Life Sciences Research
Attendees will also benefit from an additional supporting program at the analytica Anacon India and India Lab Expo. The seminar on Analytical Solutions for Life Sciences Research will lead to informative sessions and discussions pertaining to key analytical solutions compatible with life sciences and research. The attendees to the seminar will take away important insights about the latest technologies and the best of their applications.
Filling and closing machine from Bosch honored with
Red Dot Award
The filling and closing machine AFG 5000 from Bosch Packaging Technology recently received the internationally renowned "Red Dot Award" from the Design Zentrum Nordrhein-Westfalen in the category product design. The assessment was carried out by a 40-member international expert jury based on criteria such as degree of innovation, functionality, formal quality, ergonomics and durability. Designers and manufacturers from 59 nations submitted more than 6,300 objects.
The filling and closing machine from Bosch was awarded in the category product design.
"We are very happy to receive this award. The independent jury verdict shows that our approach to focus on the customer right from the beginning proves successful," said Dieter Bandtel, product manager at Bosch Packaging Technology, during the award ceremony at the Red Dot Gala in Essen, Germany. "The AFG 5000 was developed and designed according to customer requirements. The result is a machine with a compact and space-saving design, easy handling and a small number of format parts."
Successful market introduction and ongoing development
In autumn 2017, the AFG 5000 was first presented to a selected audience. The flexible machine platform allows the exact dosing of both small and large amounts of powder with an output of up to 480 vials per minute. Customers can choose between statistical or 100% in-process control of dosing weights. While the vials are continuously fed into the filling machine, the transport system adjusts the feed rate to precisely match the rhythm of the individual workstations. Shuttle carrier systems, which can quickly switch between infeed and outfeed, prevent bottlenecks and idle times. "Since its introduction, the machine has been successfully established on the market within a very short time ," said Bandtel.
Flexible aseptic parts changeover
The close exchange with customers, as well as their feedback made it possible to add new features to the AFG. For instance, pharmaceutical manufacturers can now also aseptically incorporate powder-handling parts before the start of production with closed RABS (Restricted Access Barrier System). The parts are introduced via transfer lock and then mounted with the aid of gloves. "Parts handling is usually a complicated process," Bandtel explained. "This is why the product-handling parts of the AFG 5000 are light-weighted and easy to handle, so employees can install them with little effort. Thanks to the vertical, ergonomically accessible design, the system can be operated completely from one side." Alternatively, operators can exchange parts when the RABS is open and then sterilize the assembled essential parts with a CIP/SIP process.
Continuous gas flushing reduces residual oxygen
To increase pharmaceutical products' durability, manufacturers must keep the residual oxygen content in the vial as low as possible. Hence the glass containers are gassed with nitrogen prior to closing. "However, when nitrogen is rapidly and forcefully blown into the vial, there is a risk of powder particles whirling up and out of the vial," Bandtel explained. "We prevent this risk by integrating the gassing channels of the AFG 5000 directly into the stoppering wheel." The rotation of the wheel creates a continuous flow of nitrogen at the bottle opening right up to closing and ensures consistently low residual oxygen levels. "The continuous transportation of the vials within the gassing area optimally supports this process," said Bandtel. "This way, the functionalities of the machine complement each other even more effectively."
The filling and closing machine AFG 5000 from Bosch Packaging Technology recently received the internationally renowned "Red Dot Award" from the Design Zentrum Nordrhein-Westfalen in the category product design. The assessment was carried out by a 40-member international expert jury based on criteria such as degree of innovation, functionality, formal quality, ergonomics and durability. Designers and manufacturers from 59 nations submitted more than 6,300 objects.
The filling and closing machine from Bosch was awarded in the category product design.
"We are very happy to receive this award. The independent jury verdict shows that our approach to focus on the customer right from the beginning proves successful," said Dieter Bandtel, product manager at Bosch Packaging Technology, during the award ceremony at the Red Dot Gala in Essen, Germany. "The AFG 5000 was developed and designed according to customer requirements. The result is a machine with a compact and space-saving design, easy handling and a small number of format parts."
Successful market introduction and ongoing development
In autumn 2017, the AFG 5000 was first presented to a selected audience. The flexible machine platform allows the exact dosing of both small and large amounts of powder with an output of up to 480 vials per minute. Customers can choose between statistical or 100% in-process control of dosing weights. While the vials are continuously fed into the filling machine, the transport system adjusts the feed rate to precisely match the rhythm of the individual workstations. Shuttle carrier systems, which can quickly switch between infeed and outfeed, prevent bottlenecks and idle times. "Since its introduction, the machine has been successfully established on the market within a very short time ," said Bandtel.
Flexible aseptic parts changeover
The close exchange with customers, as well as their feedback made it possible to add new features to the AFG. For instance, pharmaceutical manufacturers can now also aseptically incorporate powder-handling parts before the start of production with closed RABS (Restricted Access Barrier System). The parts are introduced via transfer lock and then mounted with the aid of gloves. "Parts handling is usually a complicated process," Bandtel explained. "This is why the product-handling parts of the AFG 5000 are light-weighted and easy to handle, so employees can install them with little effort. Thanks to the vertical, ergonomically accessible design, the system can be operated completely from one side." Alternatively, operators can exchange parts when the RABS is open and then sterilize the assembled essential parts with a CIP/SIP process.
Continuous gas flushing reduces residual oxygen
To increase pharmaceutical products' durability, manufacturers must keep the residual oxygen content in the vial as low as possible. Hence the glass containers are gassed with nitrogen prior to closing. "However, when nitrogen is rapidly and forcefully blown into the vial, there is a risk of powder particles whirling up and out of the vial," Bandtel explained. "We prevent this risk by integrating the gassing channels of the AFG 5000 directly into the stoppering wheel." The rotation of the wheel creates a continuous flow of nitrogen at the bottle opening right up to closing and ensures consistently low residual oxygen levels. "The continuous transportation of the vials within the gassing area optimally supports this process," said Bandtel. "This way, the functionalities of the machine complement each other even more effectively."
Agilent to Showcase Latest Analytical Solutions
at Two Scientific Symposiums in India
Agilent Technologies Inc. will be hosting two scientific symposiums in India this summer, both featuring industry speakers, interactive workshops, and Agilent's latest analytical solutions.
The first edition of the Total Agilent Experience, held in Mumbai last year, drew 300 scientists and researchers from across the country.
This year's symposiums took place in Ahmedabad, 13th June, and Hyderabad, 20th June.
"The Total Agilent Experience offers unparalleled opportunities for scientists and industry leaders to talk about new ways to solve problems and make their laboratories more efficient," said Bharat Bhardwaj, country manager for Agilent in India.
On display at the two symposiums was Agilent's latest chromatography, mass spectrometry, and spectroscopy platforms, including:
Agilent Technologies Inc. will be hosting two scientific symposiums in India this summer, both featuring industry speakers, interactive workshops, and Agilent's latest analytical solutions.
The first edition of the Total Agilent Experience, held in Mumbai last year, drew 300 scientists and researchers from across the country.
This year's symposiums took place in Ahmedabad, 13th June, and Hyderabad, 20th June.
"The Total Agilent Experience offers unparalleled opportunities for scientists and industry leaders to talk about new ways to solve problems and make their laboratories more efficient," said Bharat Bhardwaj, country manager for Agilent in India.
On display at the two symposiums was Agilent's latest chromatography, mass spectrometry, and spectroscopy platforms, including:
- The Agilent Intuvo 9000 GC system, which features click-andrun connections that eliminate ferrules, guard-chip technology that extends column life, and a trim-free column that eliminates retention time shifts due to trimming.
- The Agilent Ultivo Triple Quadrupole LC/MS system, which delivers robust performance, superior uptime, and easier serviceability, in a footprint that is 70% smaller than previous instruments.
- A suite of innovative Raman spectroscopy instruments, acquired last year when Agilent bought Cobalt Light Systems, a UK-based developer of innovative technologies for non-invasive, throughbarrier chemical analysis for use in pharmaceutical and publicsafety applications.
Metropolis Healthcare launches new test to screen and
diagnose Preeclampsia
Metropolis Healthcare has launched sFlt-1/PlGF ratio, a new tool for the diagnosis of preeclampsia by discriminating between preeclamptic pregnancies and other forms of pregnancy-related hypertensive disorders. Its uniqueness lies in the fact that it has been conceptualized as a simple blood test to deliver clear , reliable results with a specificity of 95% and a sensitivity of 82% to help identify patients at risk for potentially life threatening complications. It is believed that Preeclampsia may be caused by an imbalance of angiogenic factors. It has been demonstrated that high serum levels of sFlt-1, an anti-angiogenic protein (inhibits growth of new blood vessels) and low levels of PlGF, a pro -angiogenic protein (promotes growth of new blood vessels) predict subsequent development of preeclampsia.
Speaking on the launch of this new test, Dr Sushil Shah, Founder & Chairman, Metropolis Healthcare said "Metropolis is proud to launch this test to diagnose preeclampsia and we truly believe that this will greatly help clinicians manage their patients accordingly. This new test could be a life saver for moms at risk ."
Adding to it, Dr Deepak Sanghavi, Head of Department, Clinical Chemistry said "Clinical criteria alone (blood pressure and proteinuria) may be inadequate to predict adverse outcomes. This test for preeclampsia allows for early and precise diagnosis leading to effective clinical management and improving the outcome for mother and child."
Though it may sound complicated, Indians have been aware of preeclampsia over several decades. The need for developing high-accuracy diagnostic pathways have prompted doctors to start monitoring blood pressure from early pregnancy periods to ensure the close monitoring of high-risk pregnancies.
Metropolis Healthcare has launched sFlt-1/PlGF ratio, a new tool for the diagnosis of preeclampsia by discriminating between preeclamptic pregnancies and other forms of pregnancy-related hypertensive disorders. Its uniqueness lies in the fact that it has been conceptualized as a simple blood test to deliver clear , reliable results with a specificity of 95% and a sensitivity of 82% to help identify patients at risk for potentially life threatening complications. It is believed that Preeclampsia may be caused by an imbalance of angiogenic factors. It has been demonstrated that high serum levels of sFlt-1, an anti-angiogenic protein (inhibits growth of new blood vessels) and low levels of PlGF, a pro -angiogenic protein (promotes growth of new blood vessels) predict subsequent development of preeclampsia.
Speaking on the launch of this new test, Dr Sushil Shah, Founder & Chairman, Metropolis Healthcare said "Metropolis is proud to launch this test to diagnose preeclampsia and we truly believe that this will greatly help clinicians manage their patients accordingly. This new test could be a life saver for moms at risk ."
Adding to it, Dr Deepak Sanghavi, Head of Department, Clinical Chemistry said "Clinical criteria alone (blood pressure and proteinuria) may be inadequate to predict adverse outcomes. This test for preeclampsia allows for early and precise diagnosis leading to effective clinical management and improving the outcome for mother and child."
Though it may sound complicated, Indians have been aware of preeclampsia over several decades. The need for developing high-accuracy diagnostic pathways have prompted doctors to start monitoring blood pressure from early pregnancy periods to ensure the close monitoring of high-risk pregnancies.
Senior Marketing Director - Biocon, Vasudev Tribhuvan
, joins Wellthy Therapeutics
Wellthy Therapeutics (Wellthy) has announced the appointment of Vasudev V. Tribhuvan as Vice President, Partnerships & Alliances effective May 2018.
Commenting on the appointment, Abhishek Shah, Co-Founder and CEO of Wellthy Therapeutics said, "We have reached a point where digital pills greatly augment conventional drugs to target outcomes which were previously unheard of. Wellthy has already been pioneering outcomes beyond the pill in India. Vasudev's rich experience in understanding of healthcare stakeholder problems, coupled with Wellthy's world-class platform to solve for them has incredible potential to accelerate our impact goals, both in India and in Asia".
Vasudev's previous role was at Biocon, where he was the Senior Director, Marketing and led strategic initiatives for the metabolic unit while guiding the team on patient programs. Prior to Biocon, Vasudev held sales and marketing leadership roles with AstraZeneca, Boehringer Ingelheim and Novo Nordisk, and is an alumni of the University of California, Los Angeles.
Commenting on his new role, Vasudev V. Tribhuvan said, "For years, there has been a push within the pharmaceutical industry to move 'beyond the pill', to improve outcomes in chronic metabolic disorders. The impetus to move beyond the pill typically arises from the realizations that drugs alone do not suffice for patients to achieve optimal clinical outcomes. Pharma companies should consider integrating beyond-the-pill solutions as a differentiated package offering in chronic disease categories, also ensuring better outcomes."
Wellthy Therapeutics (Wellthy) has announced the appointment of Vasudev V. Tribhuvan as Vice President, Partnerships & Alliances effective May 2018.
Commenting on the appointment, Abhishek Shah, Co-Founder and CEO of Wellthy Therapeutics said, "We have reached a point where digital pills greatly augment conventional drugs to target outcomes which were previously unheard of. Wellthy has already been pioneering outcomes beyond the pill in India. Vasudev's rich experience in understanding of healthcare stakeholder problems, coupled with Wellthy's world-class platform to solve for them has incredible potential to accelerate our impact goals, both in India and in Asia".
Vasudev's previous role was at Biocon, where he was the Senior Director, Marketing and led strategic initiatives for the metabolic unit while guiding the team on patient programs. Prior to Biocon, Vasudev held sales and marketing leadership roles with AstraZeneca, Boehringer Ingelheim and Novo Nordisk, and is an alumni of the University of California, Los Angeles.
Commenting on his new role, Vasudev V. Tribhuvan said, "For years, there has been a push within the pharmaceutical industry to move 'beyond the pill', to improve outcomes in chronic metabolic disorders. The impetus to move beyond the pill typically arises from the realizations that drugs alone do not suffice for patients to achieve optimal clinical outcomes. Pharma companies should consider integrating beyond-the-pill solutions as a differentiated package offering in chronic disease categories, also ensuring better outcomes."
Lupin Gets FDA approval for generic Nystatin
and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram
Pharma major Lupin announced that it has received final approval for its Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram , from the United States Food and Drug Administration (FDA) to market a generic version of Delcor Asset Corporation's (Delcor) Mycolog®-II Cream.
Lupin's Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, is the generic equivalent of Delcor's Mycolog®-II Cream. It is indicated for the treatment of cutaneous candidiasis.
Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, had annual sales of approximately USD 62.2 million in the US (IQVIA MAT April 2018).
Pharma major Lupin announced that it has received final approval for its Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram , from the United States Food and Drug Administration (FDA) to market a generic version of Delcor Asset Corporation's (Delcor) Mycolog®-II Cream.
Lupin's Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, is the generic equivalent of Delcor's Mycolog®-II Cream. It is indicated for the treatment of cutaneous candidiasis.
Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, had annual sales of approximately USD 62.2 million in the US (IQVIA MAT April 2018).
US FDA Approves Mylan and Biocon's Fulphila, the
First Biosimilar to Neulasta
Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) has announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphila (pegfilgrastimjmbd), a biosimilar to Neulasta (pegfilgrastim), co -developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.
Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S.Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment. As a global leader in the development and manufacturing of complex products, Mylan has a portfolio of 20 biosimilar and insulin analog products - one of the industry's largest and most diverse portfolios -and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.
Mylan was the first company to receive FDA approval of Ogivri, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.
The approval for Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.
Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.
Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Do not administer Fulphila to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic rupture and sickle cell crisis, including fatal cases, can occur following the administration of Fulphila. Discontinue Fulphila in patients with Acute Respiratory Distress Syndrome and consider dose reduction or interruption in patients with glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity.
Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) has announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphila (pegfilgrastimjmbd), a biosimilar to Neulasta (pegfilgrastim), co -developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.
Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S.Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment. As a global leader in the development and manufacturing of complex products, Mylan has a portfolio of 20 biosimilar and insulin analog products - one of the industry's largest and most diverse portfolios -and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.
Mylan was the first company to receive FDA approval of Ogivri, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.
The approval for Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.
Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.
Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Do not administer Fulphila to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic rupture and sickle cell crisis, including fatal cases, can occur following the administration of Fulphila. Discontinue Fulphila in patients with Acute Respiratory Distress Syndrome and consider dose reduction or interruption in patients with glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity.
2018 China International Pharma 4.0 Summit
Successfully Ended At the Longemont Shanghai
During May 17-18, 2018, 2018 China International Pharma 4.0 Summit held by Borscon Group was ceremoniously convened in The Longemont Shanghai. This summit was strongly supported by important institutions at home and abroad such as Ministry of industry and information technology, China Chemical Pharmaceutical Industry Association, ISPE member unit -Lachman Consultants, Fraunhofer IPK Research Institute, China Pharmaceutical City, Optics Valley Bio City, etc. and related leaders.
Mr. Wu Haidong, deputy director of the consumer products division of the Ministry of industry and information technology, Mr. Pan Guangcheng, executive chairman of China Chemical Pharmaceutical Industry Association came to the meeting, taking a deep interpretation of the nineteen largest party of the party and the strategic planning of manufacturing in China for the high quality development of the pharmaceutical industry in 2025; the summit also successfully invited the experts and scholars of Pfizer, GSK, Yang Sen, Sanofi, and Tian Shi Li, separately taking a discussion of multi angle and deep level for the application and development of advanced pharmaceutical technology such as continuous manufacturing, PCMM system, innovation driven, virtualization, modularization, informatization and digitalization and so on, as well as the intelligent upgrading and transformation of Chinese traditional medicine. In addition, many top smart technology suppliers such as Cheng Yi Tong, CHIEFTAIN, SIEMENS, Swisslog, Rockwell Automation and so on brought solutions of Landing and realizing the customization, efficiency, flexibility and precision of pharmaceutical 4.0 and actual cases.
The thematic sharing that unusually brilliant -- with high lights of the above made the 153 representatives present have receive a great deal of outstanding especially 80 executives, directors and managers from the pharmaceutical development, manufacturing, and quality control departments of the pharmaceutical factory. In addition to the topic speech in the field, the site was also integrated into a variety of communication links such as round table discussion, tea break and outdoor display and so on, for providing the possibility of more opportunities for cooperation for the participants.
During May 17-18, 2018, 2018 China International Pharma 4.0 Summit held by Borscon Group was ceremoniously convened in The Longemont Shanghai. This summit was strongly supported by important institutions at home and abroad such as Ministry of industry and information technology, China Chemical Pharmaceutical Industry Association, ISPE member unit -Lachman Consultants, Fraunhofer IPK Research Institute, China Pharmaceutical City, Optics Valley Bio City, etc. and related leaders.
Mr. Wu Haidong, deputy director of the consumer products division of the Ministry of industry and information technology, Mr. Pan Guangcheng, executive chairman of China Chemical Pharmaceutical Industry Association came to the meeting, taking a deep interpretation of the nineteen largest party of the party and the strategic planning of manufacturing in China for the high quality development of the pharmaceutical industry in 2025; the summit also successfully invited the experts and scholars of Pfizer, GSK, Yang Sen, Sanofi, and Tian Shi Li, separately taking a discussion of multi angle and deep level for the application and development of advanced pharmaceutical technology such as continuous manufacturing, PCMM system, innovation driven, virtualization, modularization, informatization and digitalization and so on, as well as the intelligent upgrading and transformation of Chinese traditional medicine. In addition, many top smart technology suppliers such as Cheng Yi Tong, CHIEFTAIN, SIEMENS, Swisslog, Rockwell Automation and so on brought solutions of Landing and realizing the customization, efficiency, flexibility and precision of pharmaceutical 4.0 and actual cases.
The thematic sharing that unusually brilliant -- with high lights of the above made the 153 representatives present have receive a great deal of outstanding especially 80 executives, directors and managers from the pharmaceutical development, manufacturing, and quality control departments of the pharmaceutical factory. In addition to the topic speech in the field, the site was also integrated into a variety of communication links such as round table discussion, tea break and outdoor display and so on, for providing the possibility of more opportunities for cooperation for the participants.
AstraZeneca expands its GMD Centre in India
Global science-led biopharmaceutical company AstraZeneca officially opened its new Global Medicines Development (GMD) Centre in Bengaluru, India. This unit is one of AstraZeneca's nine GMD centres around the world that transform breakthrough molecules into medicines and monitor their use and safety. With this opening, India will now play an even bigger role in AstraZeneca's global operations.
Globally, GMD works with AstraZeneca's two biotech units- Innovative Medicines and Early Development (IMED) and MedImmune - and the Global Portfolio and Product Strategy (GPPS) organisation to understand where there is unmet medical need, to shape AstraZeneca's therapy area strategies from early development through to commercialisation.
The GMD Bengaluru team will focus on supporting AstraZeneca's medicines, which covers treatments across a range of therapy areas, including oncology, respiratory and cardiovascular and metabolic diseases. GMD Bengaluru plays a key role supporting 51 of AstraZeneca's mature brands which are used by patients around the world. During the last year, the team has recruited scientific experts in the fields of regulatory science, clinical, and patient safety, and has grown from 30 to 70 people. The expansion will see a further increase to more than 100 specialists.
Global science-led biopharmaceutical company AstraZeneca officially opened its new Global Medicines Development (GMD) Centre in Bengaluru, India. This unit is one of AstraZeneca's nine GMD centres around the world that transform breakthrough molecules into medicines and monitor their use and safety. With this opening, India will now play an even bigger role in AstraZeneca's global operations.
Globally, GMD works with AstraZeneca's two biotech units- Innovative Medicines and Early Development (IMED) and MedImmune - and the Global Portfolio and Product Strategy (GPPS) organisation to understand where there is unmet medical need, to shape AstraZeneca's therapy area strategies from early development through to commercialisation.
The GMD Bengaluru team will focus on supporting AstraZeneca's medicines, which covers treatments across a range of therapy areas, including oncology, respiratory and cardiovascular and metabolic diseases. GMD Bengaluru plays a key role supporting 51 of AstraZeneca's mature brands which are used by patients around the world. During the last year, the team has recruited scientific experts in the fields of regulatory science, clinical, and patient safety, and has grown from 30 to 70 people. The expansion will see a further increase to more than 100 specialists.
LifeCell launches "Pentastic"
LifeCell, India's premier mother & baby diagnostics company and stem cell bank, has launched "Pentastic" - an ultrasound and biochemistry based blood test undertaken in the first trimester of pregnancy between 11 to 13 weeks 6 days to screen for genetic abnormalities, structural malformations in the fetus and serious high blood pressure in pregnancy.
Compared to conventional screening tests that use only 2 analytes[PAPP-A + free hCGß], the new Pentastic test incorporates 5 analytes [PAPP-A + free hCGß + AFP + Inhibin-A + PIGF] to predict the risk. Addition of these new analytes can significantly improve the detection of these abnormalities whilst simultaneously lowering the number of false alarms raised. This would lead to substantial improvements in health outcomes whilst providing a higher level of reassurance for expectant parents.
The screening will be performed on a platform accredited by Fetal Medical Foundation (FMF), the flagship international organisation for fetal diagnostics.
LifeCell, India's premier mother & baby diagnostics company and stem cell bank, has launched "Pentastic" - an ultrasound and biochemistry based blood test undertaken in the first trimester of pregnancy between 11 to 13 weeks 6 days to screen for genetic abnormalities, structural malformations in the fetus and serious high blood pressure in pregnancy.
Compared to conventional screening tests that use only 2 analytes[PAPP-A + free hCGß], the new Pentastic test incorporates 5 analytes [PAPP-A + free hCGß + AFP + Inhibin-A + PIGF] to predict the risk. Addition of these new analytes can significantly improve the detection of these abnormalities whilst simultaneously lowering the number of false alarms raised. This would lead to substantial improvements in health outcomes whilst providing a higher level of reassurance for expectant parents.
The screening will be performed on a platform accredited by Fetal Medical Foundation (FMF), the flagship international organisation for fetal diagnostics.
Sanofi Genzyme partners with MSSI to support the
multiple sclerosis community in the country
Sanofi Genzyme, the specialty care global business unit of Sanofi, and Multiple Sclerosis Society of India (MSSI) join hands to raise awareness and to provide better treatment solutions for the 130,000 people living with Multiple Sclerosis (MS) in India.
Sanofi Genzyme and MSSI are working together to ensure that people affected with multiple sclerosis can continue to live fuller lives through support programs that enhance their quality of life. The eight MSSI chapters in - Delhi, Mumbai, Bengaluru, Chennai, Hyderabad, Kolkata, Indore and Pune, along with Sanofi Genzyme are rolling out this year's campaign #bringinguscloser, through various awareness programs such as symposiums, MS camps, MS walks, medical seminars, photo exhibitions, and laughter & music therapy sessions. These programs will help bring the multiple sclerosis (MS) community together to share stories and raise awareness about the condition.
Sanofi Genzyme in India is focused on treatment for multiple sclerosis, rare diseases, and immunology. Through its partnership with the MSSI in India, Sanofi Genzyme is playing a critical role in enabling and empowering the lives of people with multiple sclerosis. Globally, Sanofi Genzyme is continuously working to advance multiple sclerosis treatment and care with therapies, portfolio of research and development-stage programs, and MS research collaborations.
Sanofi Genzyme, the specialty care global business unit of Sanofi, and Multiple Sclerosis Society of India (MSSI) join hands to raise awareness and to provide better treatment solutions for the 130,000 people living with Multiple Sclerosis (MS) in India.
Sanofi Genzyme and MSSI are working together to ensure that people affected with multiple sclerosis can continue to live fuller lives through support programs that enhance their quality of life. The eight MSSI chapters in - Delhi, Mumbai, Bengaluru, Chennai, Hyderabad, Kolkata, Indore and Pune, along with Sanofi Genzyme are rolling out this year's campaign #bringinguscloser, through various awareness programs such as symposiums, MS camps, MS walks, medical seminars, photo exhibitions, and laughter & music therapy sessions. These programs will help bring the multiple sclerosis (MS) community together to share stories and raise awareness about the condition.
Sanofi Genzyme in India is focused on treatment for multiple sclerosis, rare diseases, and immunology. Through its partnership with the MSSI in India, Sanofi Genzyme is playing a critical role in enabling and empowering the lives of people with multiple sclerosis. Globally, Sanofi Genzyme is continuously working to advance multiple sclerosis treatment and care with therapies, portfolio of research and development-stage programs, and MS research collaborations.
Syngene International Announces Partnership with
Zumutor Biologics for Biotherapeutic Antibody Discovery Services
Syngene International, a leading global Contract Research Services Company, has entered into a non-exclusive partnering agreement with Zumutor Biologics, an emerging immuno-oncology Company, to access Zumutor's proprietary naïve human phage/yeast display library. This collaboration further enhances Syngene's marketleading capabilities in Discovery Biology, providing its scientists with additional tools to help solve complex biology problems in biotherapeutic drug discovery.
Under the terms of the agreement, Syngene will screen target antigens against Zumutor's proprietary human antibody libraries to identify and characterize novel antibody clones, which will be further developed by Syngene towards novel biotherapeutics programs for its partners.
Kavitha Iyer Rodrigues, Founder-CEO, Zumutor Biologics said, "Zumutor will use its proprietary antibody display platform to enhance Syngene's discovery programmes. Our antibody engineering expertise and experience enables us to optimize any lead to evolve into a best-in-class differentiated molecule".
Commenting on the collaboration, Dr. Manoj Nerurkar, Chief Operating Officer, Syngene International, said, "Syngene has been a pioneer in discovery research and we see Discovery Biology as one of our growth drivers. This partnership will expand our existing portfolio of therapeutic antibody discovery platforms for our clients".
Syngene International, a leading global Contract Research Services Company, has entered into a non-exclusive partnering agreement with Zumutor Biologics, an emerging immuno-oncology Company, to access Zumutor's proprietary naïve human phage/yeast display library. This collaboration further enhances Syngene's marketleading capabilities in Discovery Biology, providing its scientists with additional tools to help solve complex biology problems in biotherapeutic drug discovery.
Under the terms of the agreement, Syngene will screen target antigens against Zumutor's proprietary human antibody libraries to identify and characterize novel antibody clones, which will be further developed by Syngene towards novel biotherapeutics programs for its partners.
Kavitha Iyer Rodrigues, Founder-CEO, Zumutor Biologics said, "Zumutor will use its proprietary antibody display platform to enhance Syngene's discovery programmes. Our antibody engineering expertise and experience enables us to optimize any lead to evolve into a best-in-class differentiated molecule".
Commenting on the collaboration, Dr. Manoj Nerurkar, Chief Operating Officer, Syngene International, said, "Syngene has been a pioneer in discovery research and we see Discovery Biology as one of our growth drivers. This partnership will expand our existing portfolio of therapeutic antibody discovery platforms for our clients".
ZIM Laboratories Limited to List on BSE Main Board
ZIM Laboratories Limited (ZIM) – is a unique R & D centered pharmaceutical company focused on developing and supply of complex generics products based on proprietary Novel Drug Delivery Solutions (NDDS).
ZIM got listed on OTC Exchange of India in 1994, following the SEBI guidelines the company will be listing on BSE and will have a price discovery as per trading on the bourses.
Promoted by Technocrat Dr. Anwar Daud, the company has a Unique R & D focused business model helping customers with product development, co-development, out licensing, manufacturing, supplies and marketing support with a strong IP base - 26 inventions with 53 patent filings and 174 clients across 45 countries.
Incepted in 1989, ZIM has made a significant mark as a pharma innovator. Throughout all these years constantly penetrating newer areas of pharmaceutical technology and business, ZIM has established itself as a preferred healthcare solution provider in the field of New Drug Delivery Systems.
ZIM Laboratories Limited (ZIM) – is a unique R & D centered pharmaceutical company focused on developing and supply of complex generics products based on proprietary Novel Drug Delivery Solutions (NDDS).
ZIM got listed on OTC Exchange of India in 1994, following the SEBI guidelines the company will be listing on BSE and will have a price discovery as per trading on the bourses.
Promoted by Technocrat Dr. Anwar Daud, the company has a Unique R & D focused business model helping customers with product development, co-development, out licensing, manufacturing, supplies and marketing support with a strong IP base - 26 inventions with 53 patent filings and 174 clients across 45 countries.
Incepted in 1989, ZIM has made a significant mark as a pharma innovator. Throughout all these years constantly penetrating newer areas of pharmaceutical technology and business, ZIM has established itself as a preferred healthcare solution provider in the field of New Drug Delivery Systems.
Digital therapeutics improves self-monitoring of
blood glucose adherence in India
Clinical data published in the latest edition of Endocrine Practice, the AACE Journal established the role of Wellthy Care, a digital therapeutic platform by Wellthy Therapeutics, in improving self-monitoring of blood glucose (SMBG) for patients with Type II Diabetes.
As per clinical guidelines, a Type 2 diabetic patient should check his blood glucose daily. Real World studies in India indicate, that the average educated diabetes patient checks blood glucose less than once a month.
The data reported from 104 patients that recorded a total of 1288 blood glucose readings (12.38 measurements per patient on average) shows how Wellthy Care can potentially help physicians and HCPs personalize care for their patients by knowing the glycaemic variability. On completion of the 16 weeks program, 56% and 50% of patients reported a reduction in their fasting blood sugar and post prandial blood sugar values respectively, with significantly more readings than average at the time of the next physician appointment.
"There is an unmet need for personalised care in between doctor visits. In emerging markets like India, SMBG still remains relatively affordable versus other blood sugar measuring diagnostic tools. Real time feedback and guidance plays a crucial role for SMBG adherence and value creation, which needs tools like chat bots and self learning logic systems like those that Wellthy Therapeutics provides for patients. Better and more data leads to personalised decision support for both the doctor and the patient, which is of utmost importance to enable the respective stakeholder to action decisions leading to better outcomes, and enables patients to unlock more value from their device" said Abhishek Shah, Co-Founder and CEO, Wellthy Therapeutics.
Dr Rajiv Kovil, Consultant Diabetologist, commented "It is really great to see a tool that not just stresses on the importance of SMBG, but is effectively improving the adherence of and value to patients. SMBG is an essential tool in the optimal management of diabetes, and am glad to see clinically validated real time responses helping patients manage their blood sugar levels better".
Stressing on the importance of improved SMBG among people with diabetes, Dr. Banshi Saboo (MD. PhD), Chairman, Dia-Care Ahmedabad, Hon. Sec of Diabetes India said, "In-spite of the advice given by physicians to patients with Type 2 diabetes, compliance with SMBG in patients living in India is very low. There is a need to help, encourage and empower patients beyond the test, to enable better compliance and better glycaemic variability. Digital Therapeutics like Wellthy Care provides data that is acquired, integrated, analysed, and presented in a selfexplanatory manner to patients, while highlighting important trends that require attention for physicians, and am glad to see such encouraging results."
Clinical data published in the latest edition of Endocrine Practice, the AACE Journal established the role of Wellthy Care, a digital therapeutic platform by Wellthy Therapeutics, in improving self-monitoring of blood glucose (SMBG) for patients with Type II Diabetes.
As per clinical guidelines, a Type 2 diabetic patient should check his blood glucose daily. Real World studies in India indicate, that the average educated diabetes patient checks blood glucose less than once a month.
The data reported from 104 patients that recorded a total of 1288 blood glucose readings (12.38 measurements per patient on average) shows how Wellthy Care can potentially help physicians and HCPs personalize care for their patients by knowing the glycaemic variability. On completion of the 16 weeks program, 56% and 50% of patients reported a reduction in their fasting blood sugar and post prandial blood sugar values respectively, with significantly more readings than average at the time of the next physician appointment.
"There is an unmet need for personalised care in between doctor visits. In emerging markets like India, SMBG still remains relatively affordable versus other blood sugar measuring diagnostic tools. Real time feedback and guidance plays a crucial role for SMBG adherence and value creation, which needs tools like chat bots and self learning logic systems like those that Wellthy Therapeutics provides for patients. Better and more data leads to personalised decision support for both the doctor and the patient, which is of utmost importance to enable the respective stakeholder to action decisions leading to better outcomes, and enables patients to unlock more value from their device" said Abhishek Shah, Co-Founder and CEO, Wellthy Therapeutics.
Dr Rajiv Kovil, Consultant Diabetologist, commented "It is really great to see a tool that not just stresses on the importance of SMBG, but is effectively improving the adherence of and value to patients. SMBG is an essential tool in the optimal management of diabetes, and am glad to see clinically validated real time responses helping patients manage their blood sugar levels better".
Stressing on the importance of improved SMBG among people with diabetes, Dr. Banshi Saboo (MD. PhD), Chairman, Dia-Care Ahmedabad, Hon. Sec of Diabetes India said, "In-spite of the advice given by physicians to patients with Type 2 diabetes, compliance with SMBG in patients living in India is very low. There is a need to help, encourage and empower patients beyond the test, to enable better compliance and better glycaemic variability. Digital Therapeutics like Wellthy Care provides data that is acquired, integrated, analysed, and presented in a selfexplanatory manner to patients, while highlighting important trends that require attention for physicians, and am glad to see such encouraging results."
Dr. Cyrus Poonawalla conferred with "Doctor of
Science Hon." By the University of Massachusetts
The University of Massachusetts conferred Dr. Cyrus Poonawalla, with the Honorary Degree of "Doctor of Science Hon" for his commendable work in the field of vaccines. Known as one of the 'seven vaccine heroes of the world' by Bill & Melinda Gates Foundation, Dr.Poonawalla is the Founder of Serum Institute of India, world's largest vaccine manufacturer producing 1.5 billion doses annually that are administered in 170 countries.
Dr. Poonawalla said, "I am grateful to the University of Massachusetts for recognising our work. I strongly feel that we need to treat the field of vaccination with the respect it deserves. It's not just another field related to medical science. But one of the most important ones. We need more precautionary measures than cures for betterment of human life and vaccination is one such measure".
In the past, this degree has been awarded to Barack Obama, in the year 2006, Anthony S. Fauci, Director of National Institute of Allergy and Infectious Disease in the year 2008 and Her Excellency Ellen Johnson Sirleaf, President of Liberia and the 2011 co-recipient of the Nobel Peace Prize in 2012.
Along with Dr. Poonawallah, physician-scientist Huda Y. Zoghbi and Duke University nursing leader Marion E. Broome were conferred with the Honorary Degree if "Doctor of Science Hon." for their accomplishments as well.
Dr. Poonawalla is also the first Indian to receive the award for "Excellence in Inter-American Public Health" by the Pan American Health Organization (PAHO) and the Pan American Health and Education Foundation (PAHEF).
The University of Massachusetts conferred Dr. Cyrus Poonawalla, with the Honorary Degree of "Doctor of Science Hon" for his commendable work in the field of vaccines. Known as one of the 'seven vaccine heroes of the world' by Bill & Melinda Gates Foundation, Dr.Poonawalla is the Founder of Serum Institute of India, world's largest vaccine manufacturer producing 1.5 billion doses annually that are administered in 170 countries.
Dr. Poonawalla said, "I am grateful to the University of Massachusetts for recognising our work. I strongly feel that we need to treat the field of vaccination with the respect it deserves. It's not just another field related to medical science. But one of the most important ones. We need more precautionary measures than cures for betterment of human life and vaccination is one such measure".
In the past, this degree has been awarded to Barack Obama, in the year 2006, Anthony S. Fauci, Director of National Institute of Allergy and Infectious Disease in the year 2008 and Her Excellency Ellen Johnson Sirleaf, President of Liberia and the 2011 co-recipient of the Nobel Peace Prize in 2012.
Along with Dr. Poonawallah, physician-scientist Huda Y. Zoghbi and Duke University nursing leader Marion E. Broome were conferred with the Honorary Degree if "Doctor of Science Hon." for their accomplishments as well.
Dr. Poonawalla is also the first Indian to receive the award for "Excellence in Inter-American Public Health" by the Pan American Health Organization (PAHO) and the Pan American Health and Education Foundation (PAHEF).
Takeda to Buy Shire for USD 62 billion
Takeda Pharmaceutical agreed to buy London-listed Shire for 45.3 billion pounds (USD 62 billion), the biggest yet in a wave of deals sweeping the drugs industry.
Assuming it wins the backing of shareholders, the deal will be the largest overseas purchase by a Japanese company and propel Takeda, led by Frenchman Christophe Weber, into the top 10 rankings of global drugmakers.
The tie-up crowns a hectic few months of M & A activity as big drugmakers, including Novartis and Sanofi, have brought in promising medicines developed by younger firms.
The enlarged group will be a Japanese national champion in pharmaceuticals and a leader in gastroenterology, neuroscience, oncology, rare diseases and blood-derived therapies, used for serious conditions such as hemophilia.
Shire has profitable businesses selling drugs for hyperactivity and rare disorders but the size of the deal will make Takeda one of the most indebted drugmakers, prompting Standard & Poor's to warn of a potential credit downgrade.
To pay off debts quickly, Takeda plans to slash thousands of jobs and cut back on duplicated drug research.
The deal, struck on the last day Takeda had to make a firm bid, is around 46 percent cash and 54 percent stock, leaving Shire shareholders owning around half of the combination.
Shire had rejected four previous offers, due to price concerns and the fact that the Japanese company is proposing to pay for much of the acquisition in stock.
Shire investors will receive $30.33 in cash and either 0.839 new Takeda shares or 1.678 Takeda American depositary shares for each share, valuing the offer at 48.17 pounds a share based on the latest price and exchange rate.
That is a 60 percent premium to the price before Takeda first declared its interest six weeks ago.
Takeda Pharmaceutical agreed to buy London-listed Shire for 45.3 billion pounds (USD 62 billion), the biggest yet in a wave of deals sweeping the drugs industry.
Assuming it wins the backing of shareholders, the deal will be the largest overseas purchase by a Japanese company and propel Takeda, led by Frenchman Christophe Weber, into the top 10 rankings of global drugmakers.
The tie-up crowns a hectic few months of M & A activity as big drugmakers, including Novartis and Sanofi, have brought in promising medicines developed by younger firms.
The enlarged group will be a Japanese national champion in pharmaceuticals and a leader in gastroenterology, neuroscience, oncology, rare diseases and blood-derived therapies, used for serious conditions such as hemophilia.
Shire has profitable businesses selling drugs for hyperactivity and rare disorders but the size of the deal will make Takeda one of the most indebted drugmakers, prompting Standard & Poor's to warn of a potential credit downgrade.
To pay off debts quickly, Takeda plans to slash thousands of jobs and cut back on duplicated drug research.
The deal, struck on the last day Takeda had to make a firm bid, is around 46 percent cash and 54 percent stock, leaving Shire shareholders owning around half of the combination.
Shire had rejected four previous offers, due to price concerns and the fact that the Japanese company is proposing to pay for much of the acquisition in stock.
Shire investors will receive $30.33 in cash and either 0.839 new Takeda shares or 1.678 Takeda American depositary shares for each share, valuing the offer at 48.17 pounds a share based on the latest price and exchange rate.
That is a 60 percent premium to the price before Takeda first declared its interest six weeks ago.
Boehringer Ingelheim Opens New Veterinary
R & D Centre in China
Boehringer Ingelheim, the world’s second largest animal health company, has been boosting its investment in China by expanding the Asian Veterinary Research & Development (R & D) Center to enhance its research and innovation capacity. The company’s new integrated R & D Center has been officially inaugurated. Located in Shanghai's Zhangjiang Hi-tech Park, the R & D Center is currently the country's largest integrated animal health R & D facility in terms of investment value, and is equipped with world-class R & D capabilities. Initially put into operation in March 2012, Boehringer Ingelheim’s Asian Veterinary R & D Center, the largest of its kind established by a multinational pharmaceutical company in China, has been dedicated to discovering and developing innovative solutions to address specific livestock diseases in China and Asia. Therefore, it has set the high starting point of the new integrated R & D center and its long-term leading strength. In January 2017, Boehringer Ingelheim and Merial officially merged, and have been going through integration since. With the inauguration of the new integrated R & D center, the teams from both companies have now joined their forces in the R & D center, which will leverage the broad R & D expertise to create powerful collaboration in veterinary R & D capabilities.
The new integrated R & D center has a total investment of 19 million euros, covering a total area of 3,300 square meters. More than 110 researchers work at the center, led by eight international experts and 19 scholar returnees from overseas. In the meantime, Boehringer Ingelheim's 8,000-square-meter Veterinary Trial Center (VTC) in Taizhou, with an investment of 16 million euros, has come into operation. As part of the new integrated Asian Veterinary R & D Center, VTC is the base to conduct animal trials during veterinary R & D. Up till today, the accumulated operation cost of the new integrated Asian Veterinary R & D center has reached 125 million euros.
Boehringer Ingelheim, the world’s second largest animal health company, has been boosting its investment in China by expanding the Asian Veterinary Research & Development (R & D) Center to enhance its research and innovation capacity. The company’s new integrated R & D Center has been officially inaugurated. Located in Shanghai's Zhangjiang Hi-tech Park, the R & D Center is currently the country's largest integrated animal health R & D facility in terms of investment value, and is equipped with world-class R & D capabilities. Initially put into operation in March 2012, Boehringer Ingelheim’s Asian Veterinary R & D Center, the largest of its kind established by a multinational pharmaceutical company in China, has been dedicated to discovering and developing innovative solutions to address specific livestock diseases in China and Asia. Therefore, it has set the high starting point of the new integrated R & D center and its long-term leading strength. In January 2017, Boehringer Ingelheim and Merial officially merged, and have been going through integration since. With the inauguration of the new integrated R & D center, the teams from both companies have now joined their forces in the R & D center, which will leverage the broad R & D expertise to create powerful collaboration in veterinary R & D capabilities.
The new integrated R & D center has a total investment of 19 million euros, covering a total area of 3,300 square meters. More than 110 researchers work at the center, led by eight international experts and 19 scholar returnees from overseas. In the meantime, Boehringer Ingelheim's 8,000-square-meter Veterinary Trial Center (VTC) in Taizhou, with an investment of 16 million euros, has come into operation. As part of the new integrated Asian Veterinary R & D Center, VTC is the base to conduct animal trials during veterinary R & D. Up till today, the accumulated operation cost of the new integrated Asian Veterinary R & D center has reached 125 million euros.
Chugai Pharma Receives Taiwan FDA Approval for
Alecensa
Chugai Pharmaceutical Co., Ltd. announced that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for "Alecensa," anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of "patients with ALK-positive, advanced non-small cell lung cancer (NSCLC)."
“The results of the J-ALEX study conducted by Chugai and the ALEX study conducted overseas showed that Alecensa will greatly contribute to the treatment of patients who receive at an early stage." said Dr. Yasushi Ito, Chugai's senior vice president, co-head of project & lifecycle management unit. "Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region."
This approval is based on results from the phase III ALEX study. The ALEX study evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line).
In the study, Alecensa significantly reduced the risk of disease worsening or death by 47% (primary endpoint, HR=0.53, 95%CI: 0.38-0.73, stratified log-rank test, p <0.0001) compared to crizotinib as assessed by independent review committee. Median progressionfree survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib.
The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.
Chugai Pharmaceutical Co., Ltd. announced that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for "Alecensa," anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of "patients with ALK-positive, advanced non-small cell lung cancer (NSCLC)."
“The results of the J-ALEX study conducted by Chugai and the ALEX study conducted overseas showed that Alecensa will greatly contribute to the treatment of patients who receive at an early stage." said Dr. Yasushi Ito, Chugai's senior vice president, co-head of project & lifecycle management unit. "Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region."
This approval is based on results from the phase III ALEX study. The ALEX study evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line).
In the study, Alecensa significantly reduced the risk of disease worsening or death by 47% (primary endpoint, HR=0.53, 95%CI: 0.38-0.73, stratified log-rank test, p <0.0001) compared to crizotinib as assessed by independent review committee. Median progressionfree survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib.
The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.
Hikma Pharma Launches Basilea's Hospital Antibiotic
Zevtera in Saudi Arabia
Basilea Pharmaceutica Ltd. announced that its partner Hikma Pharmaceuticals LLC has launched Basilea's hospital antibiotic Zevtera (ceftobiprole) in Saudi Arabia.
Adesh Kaul, chief corporate development officer, said: "We are very pleased with the launch of Zevtera in Saudi Arabia. This is the first launch by our partner Hikma, a leading pharmaceutical company in the Middle East and North Africa region. Infections with bacteria resistant to established antibiotics remain a major health care concern across this region. Following the market entry in Saudi Arabia we are therefore looking forward to Hikma expanding the availability of Zevtera to further countries in the Middle East and North Africa."
Zevtera is approved in Saudi Arabia for the treatment of adult patients with hospital-acquired pneumonia (HAP), excluding ventilatorassociated pneumonia (VAP), and for the treatment of communityacquired pneumonia (CAP).
Basilea entered into a distribution and license agreement for Zevtera with Hikma in 2015 and for the antifungal Cresemba (isavuconazole) in 2016. Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillinsusceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.1 Ceftobiprole is approved for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).1 It is marketed in major European countries, Argentina, Canada and Saudi Arabia. Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. Ceftobiprole is currently in a phase 3 clinical program for registration in the US.
Basilea Pharmaceutica Ltd. announced that its partner Hikma Pharmaceuticals LLC has launched Basilea's hospital antibiotic Zevtera (ceftobiprole) in Saudi Arabia.
Adesh Kaul, chief corporate development officer, said: "We are very pleased with the launch of Zevtera in Saudi Arabia. This is the first launch by our partner Hikma, a leading pharmaceutical company in the Middle East and North Africa region. Infections with bacteria resistant to established antibiotics remain a major health care concern across this region. Following the market entry in Saudi Arabia we are therefore looking forward to Hikma expanding the availability of Zevtera to further countries in the Middle East and North Africa."
Zevtera is approved in Saudi Arabia for the treatment of adult patients with hospital-acquired pneumonia (HAP), excluding ventilatorassociated pneumonia (VAP), and for the treatment of communityacquired pneumonia (CAP).
Basilea entered into a distribution and license agreement for Zevtera with Hikma in 2015 and for the antifungal Cresemba (isavuconazole) in 2016. Ceftobiprole is a cephalosporin antibiotic for intravenous administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillinsusceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.1 Ceftobiprole is approved for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).1 It is marketed in major European countries, Argentina, Canada and Saudi Arabia. Basilea has entered into license and distribution agreements for the brand in Europe, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) region. Ceftobiprole is currently in a phase 3 clinical program for registration in the US.
Pfizer's Biosimilar Retacrit Gets US FDA Nod
Pfizer Inc. announced the US Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen and Procrit (epoetin alfa), for all indications of the reference product. Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the US.
"As the first approved epoetin alfa biosimilar in the US, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients," said Berk Gurdogan, US Institutions President, Pfizer Essential Health. "We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community."
The FDA approval was based on a comprehensive data package submitted by Pfizer demonstrating a high degree of similarity between Retacrit and its US reference product, Epogen and Procrit.
In the US, Retacrit is indicated for: Treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis; Zidovudine in HIV-infected patients; The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy; Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Pfizer Inc. announced the US Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen and Procrit (epoetin alfa), for all indications of the reference product. Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the US.
"As the first approved epoetin alfa biosimilar in the US, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients," said Berk Gurdogan, US Institutions President, Pfizer Essential Health. "We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community."
The FDA approval was based on a comprehensive data package submitted by Pfizer demonstrating a high degree of similarity between Retacrit and its US reference product, Epogen and Procrit.
In the US, Retacrit is indicated for: Treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis; Zidovudine in HIV-infected patients; The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy; Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
HedgePath Pharma Receives Expanded US Patent Coverage
HedgePath Pharmaceuticals, Inc. (HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialise innovative therapeutics for patients with cancer, announced that the US Patent and Trademark Office (USPTO) has issued a new patent to HPPI which expands the company’s patent portfolio.
The new patent is entitled "Treatment and Prognostic Monitoring of Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors." The claims covered by the patent relate to the use of the already FDA-approved anti-fungal drug itraconazole being re-purposed by HPPI to treat cancer. A patented formulation of itraconazole is being studied by HPPI as a product candidate for the treatment of cancer.
Nicholas Virca, HPPI’s president and chief executive officer, stated, "This new patent, which has 21 claims, relates to methods for treating cancer by orally administering a formulation of itraconazole that confers superior bio availability compared to conventional formulations of itraconazole. The patent covers treatment of hematologic cancers, such as leukemia or lymphoma, as well as non-hematologic cancers including lung, ovarian, breast, brain and pancreatic cancers. The patent claims also cover treatment of prostate cancer, basal cell carcinoma, and other cancers, and monitoring subjects undergoing such treatments based on biomarkers and other criteria predictive of efficacy. Issuance of this patent strengthens and expands the scope of patent protection provided by our first patent, US Patent No. 9,192,609, which issued on November 24, 2015."
The basic premise behind HPPI’s proposed therapy is that in certain cancers, the Hedgehog pathway, a major regulator of many fundamental cellular processes, malfunctions, thus leading to the formation of cancerous cells. Itraconazole appears to act on the essential Hedgehog pathway component called Smoothened (SMO) in a manner that is different than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by Hedgehog stimulation. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it has less side effects than vismodegib
HedgePath Pharmaceuticals, Inc. (HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialise innovative therapeutics for patients with cancer, announced that the US Patent and Trademark Office (USPTO) has issued a new patent to HPPI which expands the company’s patent portfolio.
The new patent is entitled "Treatment and Prognostic Monitoring of Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors." The claims covered by the patent relate to the use of the already FDA-approved anti-fungal drug itraconazole being re-purposed by HPPI to treat cancer. A patented formulation of itraconazole is being studied by HPPI as a product candidate for the treatment of cancer.
Nicholas Virca, HPPI’s president and chief executive officer, stated, "This new patent, which has 21 claims, relates to methods for treating cancer by orally administering a formulation of itraconazole that confers superior bio availability compared to conventional formulations of itraconazole. The patent covers treatment of hematologic cancers, such as leukemia or lymphoma, as well as non-hematologic cancers including lung, ovarian, breast, brain and pancreatic cancers. The patent claims also cover treatment of prostate cancer, basal cell carcinoma, and other cancers, and monitoring subjects undergoing such treatments based on biomarkers and other criteria predictive of efficacy. Issuance of this patent strengthens and expands the scope of patent protection provided by our first patent, US Patent No. 9,192,609, which issued on November 24, 2015."
The basic premise behind HPPI’s proposed therapy is that in certain cancers, the Hedgehog pathway, a major regulator of many fundamental cellular processes, malfunctions, thus leading to the formation of cancerous cells. Itraconazole appears to act on the essential Hedgehog pathway component called Smoothened (SMO) in a manner that is different than the FDA-approved drug vismodegib by preventing the ciliary accumulation of SMO normally caused by Hedgehog stimulation. Itraconazole also has a much shorter half-life than vismodegib, which may be the reason it has less side effects than vismodegib
Daiichi Sankyo Introduces Naruvein Injection in Japan
to Treat Cancer Pain
Daiichi Sankyo Company, Limited has launched in Japan Naruvein injection 2 mg • 20 mg (generic name: hydromorphone hydrochloride) for cancer pain treatment.
Hydromorphone hydrochloride is an opium-based narcotic analgesic that has been sold for more than 80 years outside Japan and positioned as the standard drug for pain management in the World Health Organization (WHO) guidelines for cancer pain treatment.
Joining the currently marketed extended-release formulation, Narusus tablets, and immediate-release formulation, Narurapid tablets, the injection formulation, Naruvein injection, is a new addition to Daiichi Sankyo’s analgesic line-up to help meet the diverse needs of patients and health care professionals in Japan.
Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs. Daiichi Sankyo decided to develop the drug in 2012, and received a grant from the Pharmaceutical Development Support Center for its development.
Daiichi Sankyo is committed to making unapproved and off-label drugs with high medical needs available to the patients who are waiting for them.
Daiichi Sankyo Company, Limited has launched in Japan Naruvein injection 2 mg • 20 mg (generic name: hydromorphone hydrochloride) for cancer pain treatment.
Hydromorphone hydrochloride is an opium-based narcotic analgesic that has been sold for more than 80 years outside Japan and positioned as the standard drug for pain management in the World Health Organization (WHO) guidelines for cancer pain treatment.
Joining the currently marketed extended-release formulation, Narusus tablets, and immediate-release formulation, Narurapid tablets, the injection formulation, Naruvein injection, is a new addition to Daiichi Sankyo’s analgesic line-up to help meet the diverse needs of patients and health care professionals in Japan.
Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs. Daiichi Sankyo decided to develop the drug in 2012, and received a grant from the Pharmaceutical Development Support Center for its development.
Daiichi Sankyo is committed to making unapproved and off-label drugs with high medical needs available to the patients who are waiting for them.
Premas Life Sciences Announces Partnership with
Leading Secondary Analysis Provider Edico Genome
Premas Life Sciences and Edico Genome has announced a new sales distribution agreement, appointing Premas Life Sciences as the sole distributor of Edico Genome's DRAGEN Bio-IT Platform in India. DRAGEN delivers industry leading speed and accuracy, earning top marks for its accuracy in the latest PrecisionFDA Challenge and two Guinness World Recordsâ„¢ for its speed.
Through this partnership, Premas Life Sciences will bring Edico Genome's best-in-class DRAGEN Bio-IT Platform and comprehensive suite of DRAGEN pipelines to life science organizations throughout India.
"We are proud of our association as the sole distributor for the leading secondary analysis solution provider for next-generation sequencing (NGS)," said Praveen Gupta, Managing Director of Premas Life Sciences. "Genome Centers and Researchers in India will greatly benefit from the flexibility, speed and accuracy that the DRAGEN platform delivers for their projects."
Leveraging field-programmable gate array (FPGA) technology, DRAGEN can process an entire human genome at 30x coverage in 20 minutes, as compared to over 20 hours using traditional CPU based message. The DRAGEN platform offers accuracy, speed and scalability allowing customers of all sizes to emphasize on what is most significant- delivering breakthrough results. The all-inclusive set of DRAGEN pipelines can be run onsite, in the Cloud or through a seamless hybrid cloud blend, facilitating organizations to scale as their throughput fluctuates.
Premas Life Sciences and Edico Genome has announced a new sales distribution agreement, appointing Premas Life Sciences as the sole distributor of Edico Genome's DRAGEN Bio-IT Platform in India. DRAGEN delivers industry leading speed and accuracy, earning top marks for its accuracy in the latest PrecisionFDA Challenge and two Guinness World Recordsâ„¢ for its speed.
Through this partnership, Premas Life Sciences will bring Edico Genome's best-in-class DRAGEN Bio-IT Platform and comprehensive suite of DRAGEN pipelines to life science organizations throughout India.
"We are proud of our association as the sole distributor for the leading secondary analysis solution provider for next-generation sequencing (NGS)," said Praveen Gupta, Managing Director of Premas Life Sciences. "Genome Centers and Researchers in India will greatly benefit from the flexibility, speed and accuracy that the DRAGEN platform delivers for their projects."
Leveraging field-programmable gate array (FPGA) technology, DRAGEN can process an entire human genome at 30x coverage in 20 minutes, as compared to over 20 hours using traditional CPU based message. The DRAGEN platform offers accuracy, speed and scalability allowing customers of all sizes to emphasize on what is most significant- delivering breakthrough results. The all-inclusive set of DRAGEN pipelines can be run onsite, in the Cloud or through a seamless hybrid cloud blend, facilitating organizations to scale as their throughput fluctuates.
AstraZeneca Sells Seroquel to Luye Pharma
British pharma company AstraZeneca said it had sold the rights for Seroquel, a treatment for schizophrenia and bipolar disease, to Luye Pharma Group for USD 538 million, as part of a strategy to focus on other therapy areas.
AstraZeneca said it had sold the rights for the treatments, named Seroquel and Seroquel XR, in the UK, China and other international markets, in a deal which will give it USD 260 million once the transaction closes, followed by future payments.
"The agreement with Luye Pharma is in line with AstraZeneca's strategy to focus on three main therapy areas while maximising the value from our legacy medicines like Seroquel," said Astra's executive vice president Mark Mallon in a statement
British pharma company AstraZeneca said it had sold the rights for Seroquel, a treatment for schizophrenia and bipolar disease, to Luye Pharma Group for USD 538 million, as part of a strategy to focus on other therapy areas.
AstraZeneca said it had sold the rights for the treatments, named Seroquel and Seroquel XR, in the UK, China and other international markets, in a deal which will give it USD 260 million once the transaction closes, followed by future payments.
"The agreement with Luye Pharma is in line with AstraZeneca's strategy to focus on three main therapy areas while maximising the value from our legacy medicines like Seroquel," said Astra's executive vice president Mark Mallon in a statement
Sciformix Launches Safety and Risk Management
Technology Platform for Life Science Customers
Sciformix Corporation, a leading scientific knowledge-based services organization, has launched a platform of new technology solutions to greatly expand its capabilities to offer end-to-end solutions in the area of Safety & Risk Management. This expansion is part of Sciformix's strategy to address today's unmet technology services needs for life sciences customers.
For life science organizations, the journey from pharmacovigilance (PV) system selection to a production-ready, optimized PV technology platform is a time consuming, costly process that requires significant experience and knowledge. As the requirements of technology infrastructure and regulatory compliance increase in complexity, the effort required to implement and maintain PV information systems also expands.To reduce this complexity, Sciformix has enhanced its capabilities by launching the Sciformix Safety and Risk Management Technology Platform. The platform includes best in class industry solutions, internally developed integrations and automations, proprietary IT QMS processes, and expertise to provide end-to-end safety services.
Sciformix is now hosting and offering 3 new market leading solutions that can be deployed as a standalone or an integrated solution set. These gold standard solutions are cloud based, compliant and secure making them easy to deploy, scale and maintain for today's ever changing environments.
Sciformix Corporation, a leading scientific knowledge-based services organization, has launched a platform of new technology solutions to greatly expand its capabilities to offer end-to-end solutions in the area of Safety & Risk Management. This expansion is part of Sciformix's strategy to address today's unmet technology services needs for life sciences customers.
For life science organizations, the journey from pharmacovigilance (PV) system selection to a production-ready, optimized PV technology platform is a time consuming, costly process that requires significant experience and knowledge. As the requirements of technology infrastructure and regulatory compliance increase in complexity, the effort required to implement and maintain PV information systems also expands.To reduce this complexity, Sciformix has enhanced its capabilities by launching the Sciformix Safety and Risk Management Technology Platform. The platform includes best in class industry solutions, internally developed integrations and automations, proprietary IT QMS processes, and expertise to provide end-to-end safety services.
Sciformix is now hosting and offering 3 new market leading solutions that can be deployed as a standalone or an integrated solution set. These gold standard solutions are cloud based, compliant and secure making them easy to deploy, scale and maintain for today's ever changing environments.
US FDA Approves Granules Generic Methylergonovine
Tablets
Granules India Ltd. announced that the US FDA has approved its Abbreviated New Drug Applications (ANDA) for methylergonovine 0.2 mg tablets. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited. The approved ANDA is the bioequivalent to the reference listed drug product (RLD), Methergine 0.2 mg.
Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage.
"Granules Pharmaceuticals Inc., our R & D and manufacturing subsidiary in Virginia was established with an objective to foray into the development and manufacture of products that are niche, on several levels. Our first product approval from this site is a "first generic," to the market and is a testimony to our objectives and execution capabilities," said Krishna Prasad Chigurupati, chairman and managing director, Granules India Limited.
Granules India is a growing pharmaceutical manufacturing company with best in class facilities and is committed to operational excellence, quality and customer service.
Granules India Ltd. announced that the US FDA has approved its Abbreviated New Drug Applications (ANDA) for methylergonovine 0.2 mg tablets. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited. The approved ANDA is the bioequivalent to the reference listed drug product (RLD), Methergine 0.2 mg.
Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage.
"Granules Pharmaceuticals Inc., our R & D and manufacturing subsidiary in Virginia was established with an objective to foray into the development and manufacture of products that are niche, on several levels. Our first product approval from this site is a "first generic," to the market and is a testimony to our objectives and execution capabilities," said Krishna Prasad Chigurupati, chairman and managing director, Granules India Limited.
Granules India is a growing pharmaceutical manufacturing company with best in class facilities and is committed to operational excellence, quality and customer service.
Epygen to Raise 300 Cr to Propel
Biosimilars in India
After having spent seven years on technology incubation in India and more than a decade of Biotechnology research abroad, Epygen Biotech, one of the leading privately held biotechnology companies in India plans to raise 300 crore in the next three years to fuel launch of its exciting Biosimilar pipeline.
The funding will provide Epygen with the best possible conditions to propel clinical trial programs of its pipeline molecules in the field of Oncology and Cardiology, which are showing substantial promise in protein expression and purification.
With several decades of recombinant protein background, the company aims to take a lead role in the biosimilar field in the region. From a pipeline full with E Coli and mammalian proteins, the company has chosen to launch a stepping stone Biosimilar Recombinant Streptokinase (rSK) for the cardiovascular segment in India by 2019. This product is of utmost national interest as 17 lakh people die of heart attack in India every year and other thrombolytic proteins is more than ten times in cost. This technology is befitting to the current programme assuring "Healtahcare for all".
The company is upgrading its R & D capabilities setting up a 1,00,000 sqft Biopharmaceutical facility in Patalganga, Maharashtra, where Phase-I of the Project is dedicated to E Coli based biosimilars for Cardiovascular, Oncology and Rheumatology and Phase-II to make mammalian cell based monoclonal antibodies for Oncology, jointly targeting more than $ 10 billion market. The fresh fund infusion would be utlilized for clinical trials of the pipeline molecules and securing intellectual property (IP) for a range of medium and late stage technologies for Novel Biological Entities in Oncology and CNS segments.
After having spent seven years on technology incubation in India and more than a decade of Biotechnology research abroad, Epygen Biotech, one of the leading privately held biotechnology companies in India plans to raise 300 crore in the next three years to fuel launch of its exciting Biosimilar pipeline.
The funding will provide Epygen with the best possible conditions to propel clinical trial programs of its pipeline molecules in the field of Oncology and Cardiology, which are showing substantial promise in protein expression and purification.
With several decades of recombinant protein background, the company aims to take a lead role in the biosimilar field in the region. From a pipeline full with E Coli and mammalian proteins, the company has chosen to launch a stepping stone Biosimilar Recombinant Streptokinase (rSK) for the cardiovascular segment in India by 2019. This product is of utmost national interest as 17 lakh people die of heart attack in India every year and other thrombolytic proteins is more than ten times in cost. This technology is befitting to the current programme assuring "Healtahcare for all".
The company is upgrading its R & D capabilities setting up a 1,00,000 sqft Biopharmaceutical facility in Patalganga, Maharashtra, where Phase-I of the Project is dedicated to E Coli based biosimilars for Cardiovascular, Oncology and Rheumatology and Phase-II to make mammalian cell based monoclonal antibodies for Oncology, jointly targeting more than $ 10 billion market. The fresh fund infusion would be utlilized for clinical trials of the pipeline molecules and securing intellectual property (IP) for a range of medium and late stage technologies for Novel Biological Entities in Oncology and CNS segments.
Intas Pharmaceuticals brings down Cancer treatment
cost by 60%
Intas Pharmaceuticals Limited, India's one of the fastest growing pharmaceutical company, is pleased to announce a big step which will bring relief to large number of cancer patients in the country for whom the drug - Bevacizumab was out of reach till today. Intas's bevacizumab therapy is priced at Rs. 39995 for the dose strength of 400 mg variant which makes it 60% less than the currently available options.
Every year over 7 lakh patients die due to various types of cancer in India. At Intas we believe in the philosophy of "Patient First". Hence, in order to relieve the patients from the financial burden associated with the treatment, this cost effective measure is implemented by the organisation. The step is entirely focussed in making the drug treatment accessible to cancer patients in India thus, providing them with a beacon of hope in their fight against the disease.
Bevacizumab is a drug which works by slowing the growth of new blood vessels and is used in treating multiple-cancers like colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma (a type of brain tumour). The drug has been available in India since 2004 but the cost has been so prohibitive that as per eminent clinicians of the country they have been able to give this drug to very few eligible patients.
Intas Pharmaceuticals Limited, India's one of the fastest growing pharmaceutical company, is pleased to announce a big step which will bring relief to large number of cancer patients in the country for whom the drug - Bevacizumab was out of reach till today. Intas's bevacizumab therapy is priced at Rs. 39995 for the dose strength of 400 mg variant which makes it 60% less than the currently available options.
Every year over 7 lakh patients die due to various types of cancer in India. At Intas we believe in the philosophy of "Patient First". Hence, in order to relieve the patients from the financial burden associated with the treatment, this cost effective measure is implemented by the organisation. The step is entirely focussed in making the drug treatment accessible to cancer patients in India thus, providing them with a beacon of hope in their fight against the disease.
Bevacizumab is a drug which works by slowing the growth of new blood vessels and is used in treating multiple-cancers like colorectal cancer, ovarian cancer, cervical cancer, lung cancer and recurrent glioblastoma (a type of brain tumour). The drug has been available in India since 2004 but the cost has been so prohibitive that as per eminent clinicians of the country they have been able to give this drug to very few eligible patients.
Cipla to Market MannKind's Afrezza in India
Cipla, a 14,280 crore plus fourth largest pharma major, has entered into an exclusive marketing and distribution agreement with USbased MannKind Corporation for Afrezza in India. Afrezza is the only US FDA approved inhaled insulin available for patients suffering from diabetes.
Available by prescription, Afrezza (insulin human) inhalation powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.
Cipla, a 14,280 crore plus fourth largest pharma major, has entered into an exclusive marketing and distribution agreement with USbased MannKind Corporation for Afrezza in India. Afrezza is the only US FDA approved inhaled insulin available for patients suffering from diabetes.
Available by prescription, Afrezza (insulin human) inhalation powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.
Intelligent Upgrade Wisdom Pharmacy
2018 China International Pharma 4.0 Summit Successfully Ended At the Longemont Shanghaion May 18th
During May 17-18, 2018, 2018 China International Pharma 4.0 Summit held by Borscon Group was ceremoniously convened in The Longemont Shanghai. This summit was strongly supported by important institutions at home and abroad such as Ministry of industry and information technology, China Chemical Pharmaceutical Industry Association, ISPE member unit -Lachman Consultants, Fraunhofer IPK Research Institute, China Pharmaceutical City, Optics Valley Bio City, etc. and related leaders.
The splendor of the occasion surpassed anything heretofore seen, the world's top pharmaceutical companies and world-renowned smart pharmaceutical solutions providers gathered in Shanghai, to create a high-end technology and information exchange feast for the pharmaceutical industry.
Mr. Wu Haidong, deputy director of the consumer products division of the Ministry of industry and information technology, Mr. Pan Guangcheng, executive chairman of China Chemical Pharmaceutical Industry Association came to the meeting, taking a deep interpretation of the nineteen largest party of the party and the strategic planning of manufacturing in China for the high quality development of the pharmaceutical industry in 2025; the summit also successfully invited the experts and scholars of Pfizer, GSK, Yang Sen, Sanofi, and Tian Shi Li, separately taking a discussion of multi angle and deep level for the application and development of advanced pharmaceutical technology such as continuous manufacturing, PCMM system, innovation driven, virtualization, modularization, informatization and digitalization and so on, as well as the intelligent upgrading and transformation of Chinese traditional medicine. In addition, many top smart technology suppliers such as Cheng Yi Tong, CHIEFTAIN, SIEMENS, Swisslog, Rockwell Automation and so on brought solutions of Landing and realizing the customization, efficiency, flexibility and precision of pharmaceutical 4.0 and actual cases. The thematic sharing that unusually brilliant -- with high lights of the above made the 153 representatives present have receive a great deal of outstanding especially 80 executives, directors and managers from the pharmaceutical development, manufacturing, and quality control departments of the pharmaceutical factory. In addition to the topic speech in the field, the site was also integrated into a variety of communication links such as round table discussion, tea break and outdoor display and so on, for providing the possibility of more opportunities for cooperation for the participants.
With the help of the big background of China's manufacture of 2025, combined with the German industry 4.0 and the advanced manufacturing in the United States , based on the actual situation of the development of Chinese pharmaceutical enterprises, it aims to build the best communication platform for industrial upgrading, and promote international exchange and cooperation in China's pharmaceutical industry.
2018 China International Pharma 4.0 Summit Successfully Ended At the Longemont Shanghaion May 18th
During May 17-18, 2018, 2018 China International Pharma 4.0 Summit held by Borscon Group was ceremoniously convened in The Longemont Shanghai. This summit was strongly supported by important institutions at home and abroad such as Ministry of industry and information technology, China Chemical Pharmaceutical Industry Association, ISPE member unit -Lachman Consultants, Fraunhofer IPK Research Institute, China Pharmaceutical City, Optics Valley Bio City, etc. and related leaders.
The splendor of the occasion surpassed anything heretofore seen, the world's top pharmaceutical companies and world-renowned smart pharmaceutical solutions providers gathered in Shanghai, to create a high-end technology and information exchange feast for the pharmaceutical industry.
Mr. Wu Haidong, deputy director of the consumer products division of the Ministry of industry and information technology, Mr. Pan Guangcheng, executive chairman of China Chemical Pharmaceutical Industry Association came to the meeting, taking a deep interpretation of the nineteen largest party of the party and the strategic planning of manufacturing in China for the high quality development of the pharmaceutical industry in 2025; the summit also successfully invited the experts and scholars of Pfizer, GSK, Yang Sen, Sanofi, and Tian Shi Li, separately taking a discussion of multi angle and deep level for the application and development of advanced pharmaceutical technology such as continuous manufacturing, PCMM system, innovation driven, virtualization, modularization, informatization and digitalization and so on, as well as the intelligent upgrading and transformation of Chinese traditional medicine. In addition, many top smart technology suppliers such as Cheng Yi Tong, CHIEFTAIN, SIEMENS, Swisslog, Rockwell Automation and so on brought solutions of Landing and realizing the customization, efficiency, flexibility and precision of pharmaceutical 4.0 and actual cases. The thematic sharing that unusually brilliant -- with high lights of the above made the 153 representatives present have receive a great deal of outstanding especially 80 executives, directors and managers from the pharmaceutical development, manufacturing, and quality control departments of the pharmaceutical factory. In addition to the topic speech in the field, the site was also integrated into a variety of communication links such as round table discussion, tea break and outdoor display and so on, for providing the possibility of more opportunities for cooperation for the participants.
With the help of the big background of China's manufacture of 2025, combined with the German industry 4.0 and the advanced manufacturing in the United States , based on the actual situation of the development of Chinese pharmaceutical enterprises, it aims to build the best communication platform for industrial upgrading, and promote international exchange and cooperation in China's pharmaceutical industry.
Apitope phase 1 trial to treat Graves' disease
reports positive results
first-in-class antigen-specific immunotherapies targeting autoimmune diseases, announced positive results from the Phase I first in man clinical trial of its product candidate, ATX-GD-59, in development for the treatment of Graves' disease.
Graves' disease is one of the most common autoimmune diseases with approximately 10 million patients across Europe and the US and yet there have been no innovative treatments in more than 60 years. With Graves' disease, the immune system mistakenly attacks the thyroid gland and causes it to become overactive. Symptoms can include an enlargement of the thyroid gland, swelling of the neck, localised abnormalities of skin, tremors, heat intolerance and sweating, significant weight loss, osteoporosis, atrial fibrillation and ocular changes in patients. Each year 20-30 out of every 100,000 people are newly diagnosed with Graves' disease. The ratio of women versus men diagnosed with Graves' disease is 6:1 and around 2 percent of all women will develop Graves' disease during their lifetime.
The phase I clinical study met the primary endpoint to assess the safety and tolerability of ATX-GD-59 in 12 patients with Graves' disease. The majority of the per protocol subjects were either euthyroid, the clinical objective of therapy, or close to being euthyroid by the end of treatment; the effect was maintained during the 3 months follow up off therapy. Importantly, TSHR antibody levels were also reduced with close correlations between percentage decreases in antibody and thyroid hormone levels in line with the mechanism of action.
The investigational product was administered intradermally (ID) every two weeks over a period of 18 weeks in male and female patients that were not otherwise being treated with anti-thyroid therapy. Following a titration period of 25, 50, 100, 400 and 800 μg in the initial eight weeks of treatment, a dose of 800 μg was administered fortnightly for an additional 10 weeks, comparable to the regime followed in the successful ATX-MS-1467 multiple sclerosis (MS) trials.
first-in-class antigen-specific immunotherapies targeting autoimmune diseases, announced positive results from the Phase I first in man clinical trial of its product candidate, ATX-GD-59, in development for the treatment of Graves' disease.
Graves' disease is one of the most common autoimmune diseases with approximately 10 million patients across Europe and the US and yet there have been no innovative treatments in more than 60 years. With Graves' disease, the immune system mistakenly attacks the thyroid gland and causes it to become overactive. Symptoms can include an enlargement of the thyroid gland, swelling of the neck, localised abnormalities of skin, tremors, heat intolerance and sweating, significant weight loss, osteoporosis, atrial fibrillation and ocular changes in patients. Each year 20-30 out of every 100,000 people are newly diagnosed with Graves' disease. The ratio of women versus men diagnosed with Graves' disease is 6:1 and around 2 percent of all women will develop Graves' disease during their lifetime.
The phase I clinical study met the primary endpoint to assess the safety and tolerability of ATX-GD-59 in 12 patients with Graves' disease. The majority of the per protocol subjects were either euthyroid, the clinical objective of therapy, or close to being euthyroid by the end of treatment; the effect was maintained during the 3 months follow up off therapy. Importantly, TSHR antibody levels were also reduced with close correlations between percentage decreases in antibody and thyroid hormone levels in line with the mechanism of action.
The investigational product was administered intradermally (ID) every two weeks over a period of 18 weeks in male and female patients that were not otherwise being treated with anti-thyroid therapy. Following a titration period of 25, 50, 100, 400 and 800 μg in the initial eight weeks of treatment, a dose of 800 μg was administered fortnightly for an additional 10 weeks, comparable to the regime followed in the successful ATX-MS-1467 multiple sclerosis (MS) trials.
Temasek to buy 31 million shares of Bayer
Bayer announced that Temasek, an investment company headquartered in Singapore, signed an agreement to subscribe to 31 million new shares of Bayer, corresponding to around 3.6 percent of the capital stock, for total gross proceeds of 3 billion euros. With the consent of the Supervisory Board, the Board of Management of Bayer AG resolved to execute the capital increase out of authorized capital against cash contributions and excluding the subscription rights of existing Bayer shareholders.
Under the agreement, Bayer is to issue to a subsidiary of Temasek at an at -market price the new registered (no-par value) shares with an entitlement to dividends as of January 1, 2017.
On completion of the capital increase, together with its existing shareholdings in Bayer, Temasek will hold approximately 4 percent of the issued capital stock of Bayer. The shares issued to Temasek will not be subject to any lock-up period .
The proceeds from this placement will be taken into account when determining the size of the previously announced share capital increase through a rights offering with subscription rights to existing shareholders to finance the proposed acquisition of Monsanto.
Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.
Incorporated in 1974, Temasek is an investment company headquartered in Singapore. Supported by 11 offices internationally, Temasek owns a portfolio of 275 billion Singapore dollars (184 billion euros) as of March 31, 2017, mainly in Singapore and the rest of Asia.
Bayer announced that Temasek, an investment company headquartered in Singapore, signed an agreement to subscribe to 31 million new shares of Bayer, corresponding to around 3.6 percent of the capital stock, for total gross proceeds of 3 billion euros. With the consent of the Supervisory Board, the Board of Management of Bayer AG resolved to execute the capital increase out of authorized capital against cash contributions and excluding the subscription rights of existing Bayer shareholders.
Under the agreement, Bayer is to issue to a subsidiary of Temasek at an at -market price the new registered (no-par value) shares with an entitlement to dividends as of January 1, 2017.
On completion of the capital increase, together with its existing shareholdings in Bayer, Temasek will hold approximately 4 percent of the issued capital stock of Bayer. The shares issued to Temasek will not be subject to any lock-up period .
The proceeds from this placement will be taken into account when determining the size of the previously announced share capital increase through a rights offering with subscription rights to existing shareholders to finance the proposed acquisition of Monsanto.
Bayer is a global enterprise with core competencies in the life science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.
Incorporated in 1974, Temasek is an investment company headquartered in Singapore. Supported by 11 offices internationally, Temasek owns a portfolio of 275 billion Singapore dollars (184 billion euros) as of March 31, 2017, mainly in Singapore and the rest of Asia.
PRAC to review risk of dosing errors with methotrexate
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.
When used for inflammatory diseases, methotrexate is taken once a week, whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some patients incorrectly receiving a dose every day instead of every week, with serious consequences in some cases.
The Spanish Agency for Medicines and Health ProductsExternal link icon therefore asked the PRAC to further investigate the reasons why dosing errors continue to occur in order to identify and put in place measures to prevent them.
PRAC to further consider unmet medical needs for hydroxyethylstarch (HES) solutions for infusion
Following the PRAC recommendation in January 2018 to suspend the marketing authorisations for HES solutions for infusion across the EU, the European Commission has requested that the committee further consider any possible unmet medical need that could result from the suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.
The PRAC is now looking at these specific aspects and will discuss its recommendation at its May meeting. The PRAC's revised recommendation will then be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt a final position.
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.
When used for inflammatory diseases, methotrexate is taken once a week, whereas for some types of cancer, the dose is higher and the medicine is used more frequently. Mistakes have led to some patients incorrectly receiving a dose every day instead of every week, with serious consequences in some cases.
The Spanish Agency for Medicines and Health ProductsExternal link icon therefore asked the PRAC to further investigate the reasons why dosing errors continue to occur in order to identify and put in place measures to prevent them.
PRAC to further consider unmet medical needs for hydroxyethylstarch (HES) solutions for infusion
Following the PRAC recommendation in January 2018 to suspend the marketing authorisations for HES solutions for infusion across the EU, the European Commission has requested that the committee further consider any possible unmet medical need that could result from the suspension, as well as the feasibility and likely effectiveness of additional risk minimisation measures.
The PRAC is now looking at these specific aspects and will discuss its recommendation at its May meeting. The PRAC's revised recommendation will then be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt a final position.
Alcon launches new age monthly
disposable contact lens
Alcon, the global leader in eye care and a division of Novartis, launched their new age monthly disposable contact lens 'Air Optix plus HydraGlyde.' recently. 'Air Optix plus HydraGlyde', has a unique technology called 'SmartShield' that repels dust and grime and ensures clarity of vision through your long day.
Alcon has combined two advanced technologies, ie, SmartShield Technology and HydraGlyde Moisture Matrix, to help provide excellent deposit protection and support long-lasting lens surface moisture. SmartShield Technology helps deliver superior resistance to lipid deposits throughout the lens, through an ultra-thin protective layer to help shield the contact lens wearer. Air Optix plus HydraGlyde contact lenses are made with a highly breathable material that allows nourishing oxygen to flow continuously through the lens, keeping the lenses with longer-lasting hydration for 16 hours for white, healthy-looking eyes.
The contact lenses enable you to focus on your goals through your long day without the hiccups of itching, burning or watering in your eyes and ensure clarity of vision all month long. Now even spectacle users who have resisted contact lenses due to discomfort can try New Air Optix plus HydraGlyde contact lenses. Air Optix plus HydraGlyde are monthly disposable lenses, ideal for those with an active lifestylewhether you have a busy day at the office or play sports.
Alcon, the global leader in eye care and a division of Novartis, launched their new age monthly disposable contact lens 'Air Optix plus HydraGlyde.' recently. 'Air Optix plus HydraGlyde', has a unique technology called 'SmartShield' that repels dust and grime and ensures clarity of vision through your long day.
Alcon has combined two advanced technologies, ie, SmartShield Technology and HydraGlyde Moisture Matrix, to help provide excellent deposit protection and support long-lasting lens surface moisture. SmartShield Technology helps deliver superior resistance to lipid deposits throughout the lens, through an ultra-thin protective layer to help shield the contact lens wearer. Air Optix plus HydraGlyde contact lenses are made with a highly breathable material that allows nourishing oxygen to flow continuously through the lens, keeping the lenses with longer-lasting hydration for 16 hours for white, healthy-looking eyes.
The contact lenses enable you to focus on your goals through your long day without the hiccups of itching, burning or watering in your eyes and ensure clarity of vision all month long. Now even spectacle users who have resisted contact lenses due to discomfort can try New Air Optix plus HydraGlyde contact lenses. Air Optix plus HydraGlyde are monthly disposable lenses, ideal for those with an active lifestylewhether you have a busy day at the office or play sports.
US FDA approves Roche’s cobas CT/NG to detect
Chlamydia trachomatis & Neisseria gonorrhoeae DNA
Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas CT/NG for use on the cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.
cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinicianinstructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens (all collected in cobas PCR media) and cervical specimens collected in PreservCyt Solution. Other STI assays are in development and will further allow laboratories to consolidate high volume STI testing on a single platform. In addition to cobas CT/NG, cobas 6800/8800 Systems menu in the US includes viral load monitoring tests for HIV, HBV, HCV and CMV, as well as MPX, WNV, DPX and Zika for use in screening blood donations. Since its introduction in 2015, the fully automated cobas 6800/8800 Systems have offered labs the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.
Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD), with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the longterm consequences of untreated disease, as well as lowering the financial burden on the healthcare system. The Centers for Disease Control and Prevention (CDC) recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.1 Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity, providing users with greater flexibility to consolidate their testing to a single system while increasing overall workflow efficiencies.
Roche, a global pioneer in pharmaceuticals and diagnostics company, announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas CT/NG for use on the cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.
cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinicianinstructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens (all collected in cobas PCR media) and cervical specimens collected in PreservCyt Solution. Other STI assays are in development and will further allow laboratories to consolidate high volume STI testing on a single platform. In addition to cobas CT/NG, cobas 6800/8800 Systems menu in the US includes viral load monitoring tests for HIV, HBV, HCV and CMV, as well as MPX, WNV, DPX and Zika for use in screening blood donations. Since its introduction in 2015, the fully automated cobas 6800/8800 Systems have offered labs the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.
Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD), with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the longterm consequences of untreated disease, as well as lowering the financial burden on the healthcare system. The Centers for Disease Control and Prevention (CDC) recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.1 Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity, providing users with greater flexibility to consolidate their testing to a single system while increasing overall workflow efficiencies.
Novartis helps to preserve kidney function in heart
failure patients with diabetes
Novartis announced a new post hoc analysis of the pivotal phase III heart failure study, PARADIGM-HF, demonstrating that treatment with Entresto (sacubitril/valsartan) helped to preserve kidney function, as assessed by estimated glomerular filtration rate (eGFR), in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril. In a sub group of patients who had both HFrEF and diabetes, the magnitude of benefit was twice as high. The findings of the analysis are published in The Lancet Diabetes & Endocrinology.
Non-diabetic HFrEF patients in the PARADIGM-HF study were shown to lose kidney function twice as fast as the general population. This was further accelerated in HFrEF patients with diabetes, who experienced a decline in kidney function that was twice as fast as the non-diabetic patients. When compared with enalapril, treatment with Entresto significantly slowed this decline in all HFrEF patients (-1.3 vs -1.8 ml/min/1.73 m per year).In HFrEF patients who also had diabetes, the benefit of treatment with Entresto was doubled vs. those without diabetes (+0.6 (0.4, 0.8) vs. +0.3 (0.2, 0.5) ml/min/1.73m per year).
Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Other common heart failure medicines, called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.
Novartis announced a new post hoc analysis of the pivotal phase III heart failure study, PARADIGM-HF, demonstrating that treatment with Entresto (sacubitril/valsartan) helped to preserve kidney function, as assessed by estimated glomerular filtration rate (eGFR), in patients with heart failure with reduced ejection fraction (HFrEF). HFrEF patients treated with Entresto had a slower rate of decline in eGFR than those treated with ACE inhibitor enalapril. In a sub group of patients who had both HFrEF and diabetes, the magnitude of benefit was twice as high. The findings of the analysis are published in The Lancet Diabetes & Endocrinology.
Non-diabetic HFrEF patients in the PARADIGM-HF study were shown to lose kidney function twice as fast as the general population. This was further accelerated in HFrEF patients with diabetes, who experienced a decline in kidney function that was twice as fast as the non-diabetic patients. When compared with enalapril, treatment with Entresto significantly slowed this decline in all HFrEF patients (-1.3 vs -1.8 ml/min/1.73 m per year).In HFrEF patients who also had diabetes, the benefit of treatment with Entresto was doubled vs. those without diabetes (+0.6 (0.4, 0.8) vs. +0.3 (0.2, 0.5) ml/min/1.73m per year).
Entresto is a twice-a-day medicine that reduces the strain on the failing heart. It does this by enhancing the protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Other common heart failure medicines, called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto contains the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan.
Adocia begins phase 1 study of insulin in people with
type 1 diabetes
Adocia , a biopharma company, announced the initiation of a phase 1 study of BioChaperone Pramlintide Insulin (BC Pram Ins), its ready-to-use co-formulation of pramlintide and human insulin. The BioChaperone proprietary technology enables the solubilization and stabilization, in aqueous solution at neutral pH, of pramlintide, the only FDA-approved amylin analog for the treatment of diabetes, hence allowing its combination with insulin.
This study aims to investigate the pharmacokinetics, pharmacodynamics, and the safety and tolerability of BC Pram Ins in people with type 1 diabetes compared to separate injections of human insulin (Humulin, Eli Lilly) and pramlintide (Symlin, AstraZeneca), and also to an injection of insulin lispro (Humalog, Eli Lilly). In people without diabetes insulin and amylin are co-secreted by pancreatic beta cells and act in synergy to control blood glucose. While insulin controls glucose disposal, amylin modulates glucose appearance in the blood by suppressing liver glycogenolysis through glucagon inhibition and by controlling gastric emptying and decreases food intake by inducing a feeling of satiety. As diabetes progresses, neither insulin nor amylin are eventually secreted. While life-saving for people with type 1 diabetes and ultimately required for people with type 2 diabetes, insulin therapy alone is often not sufficient to achieve optimal prandial control, possibly because amylin is also needed. Many people using insulin therapy exhibit profound glycemic variability, especially after a meal, and they frequently fail to reach their treatment goals.
Pramlintide (Symlin, AstraZeneca), a short-acting amylin analog, is the only molecule in this class approved by FDA for the treatment of diabetes. Pramlintide is approved in the USA for both type 1 and type 2 diabetes as an adjunct therapy to insulin treatment. The Phase 3 trials leading to pramlintide approval showed that, when added to an existing insulin regimen, pramlintide strongly improves post-prandial glucose control by flattening postprandial glucose excursions. After 6 months of use, pramlintide as an adjunct to insulin therapy, resulted in improved HbA1c, reduced prandial insulin consumption and induced weight loss compared to the use of insulin alone in both people with type 1 and with type 2 diabetes. Like amylin, pramlintide delays the timing and reduces the amount of postprandial blood glucose. Some studies suggest that, because of the resulting delay in glucose appearance, human insulin’s slow action profile makes it the most suited agent to combine with pramlintide in order to enable an optimal reduction of postprandial glucose excursion.
However, as intensified insulin therapy requires multiple daily injections and frequent glucose monitoring, the addition of three injections of pramlintide a day has proved a challenge to patient adherence, compliance and persistency. Indeed, to achieve optimal long-term effects, new treatment options in diabetes should not only demonstrate superior efficacy, but also avoid increasing the everyday burden of disease management, while remaining affordable. This should be achieved with this novel combination product, BioChaperone Pramlintide Insulin.
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins and peptides.
Adocia , a biopharma company, announced the initiation of a phase 1 study of BioChaperone Pramlintide Insulin (BC Pram Ins), its ready-to-use co-formulation of pramlintide and human insulin. The BioChaperone proprietary technology enables the solubilization and stabilization, in aqueous solution at neutral pH, of pramlintide, the only FDA-approved amylin analog for the treatment of diabetes, hence allowing its combination with insulin.
This study aims to investigate the pharmacokinetics, pharmacodynamics, and the safety and tolerability of BC Pram Ins in people with type 1 diabetes compared to separate injections of human insulin (Humulin, Eli Lilly) and pramlintide (Symlin, AstraZeneca), and also to an injection of insulin lispro (Humalog, Eli Lilly). In people without diabetes insulin and amylin are co-secreted by pancreatic beta cells and act in synergy to control blood glucose. While insulin controls glucose disposal, amylin modulates glucose appearance in the blood by suppressing liver glycogenolysis through glucagon inhibition and by controlling gastric emptying and decreases food intake by inducing a feeling of satiety. As diabetes progresses, neither insulin nor amylin are eventually secreted. While life-saving for people with type 1 diabetes and ultimately required for people with type 2 diabetes, insulin therapy alone is often not sufficient to achieve optimal prandial control, possibly because amylin is also needed. Many people using insulin therapy exhibit profound glycemic variability, especially after a meal, and they frequently fail to reach their treatment goals.
Pramlintide (Symlin, AstraZeneca), a short-acting amylin analog, is the only molecule in this class approved by FDA for the treatment of diabetes. Pramlintide is approved in the USA for both type 1 and type 2 diabetes as an adjunct therapy to insulin treatment. The Phase 3 trials leading to pramlintide approval showed that, when added to an existing insulin regimen, pramlintide strongly improves post-prandial glucose control by flattening postprandial glucose excursions. After 6 months of use, pramlintide as an adjunct to insulin therapy, resulted in improved HbA1c, reduced prandial insulin consumption and induced weight loss compared to the use of insulin alone in both people with type 1 and with type 2 diabetes. Like amylin, pramlintide delays the timing and reduces the amount of postprandial blood glucose. Some studies suggest that, because of the resulting delay in glucose appearance, human insulin’s slow action profile makes it the most suited agent to combine with pramlintide in order to enable an optimal reduction of postprandial glucose excursion.
However, as intensified insulin therapy requires multiple daily injections and frequent glucose monitoring, the addition of three injections of pramlintide a day has proved a challenge to patient adherence, compliance and persistency. Indeed, to achieve optimal long-term effects, new treatment options in diabetes should not only demonstrate superior efficacy, but also avoid increasing the everyday burden of disease management, while remaining affordable. This should be achieved with this novel combination product, BioChaperone Pramlintide Insulin.
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins and peptides.
Glenmark initiates phase 2b trial to treat atopic
dermatitis
Glenmark Pharmaceuticals, a global pharmaceutical company, announced the initiation of a phase 2b clinical trial of GBR 830, a novel, investigational treatment for moderate-to-severe atopic dermatitis. The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018.
The phase 2b, double-blind, placebo-controlled multicenter trial will randomize approximately 392 patients across four dosing arms of GBR 830 and placebo. The trial’s primary endpoint will assess the effectiveness of GBR 830, compared to placebo, on reducing the severity of atopic dermatitis as measured by Investigator’s Global Assessment (IGA).
Secondary efficacy measures include patients with a greater than 75 percent improvement in disease severity, as measured by the Eczema Area and Severity Index (EASI), along with other measures including disease activity using validated assessment tools such as EASI response, and Scoring Atopic Dermatitis (SCORAD). The trial will also assess safety, and biomarkers relevant to the disease and unique mechanism of GBR 830.
In addition to moderate-to-severe atopic dermatitis, Glenmark is evaluating the potential for conducting studies with GBR 830 for the treatment of other inflammatory autoimmune conditions where dysregulation of OX40 overexpression is implicated in disease activity. Preparations for a clinical trial assessing GBR 830 for the treatment of systemic lupus erythematosus (SLE) are currently underway.
GBR 830 is designed to inhibit OX40, a costimulatory immune checkpoint receptor expressed on activated T cells and memory T cells. Costimulatory signals are essential for T cell activity, and binding between OX40 and OX40L is a biomarker for the severity of autoimmune diseases. The activation of this pathway leads to conversion of activated T cells into memory T cells, which promotes inflammation . In addition, regulatory T cells also contribute to inflammation, and OX40 signalling by these cells downregulates immune suppressing functions. It is believed that GBR 830 inhibits the dual activities of OX40 and OX40L binding in both activated T cells and regulatory T cells, thus potentially reducing inflammation associated with symptoms of atopic dermatitis.
Glenmark Pharmaceuticals, a global pharmaceutical company, announced the initiation of a phase 2b clinical trial of GBR 830, a novel, investigational treatment for moderate-to-severe atopic dermatitis. The trial’s primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018.
The phase 2b, double-blind, placebo-controlled multicenter trial will randomize approximately 392 patients across four dosing arms of GBR 830 and placebo. The trial’s primary endpoint will assess the effectiveness of GBR 830, compared to placebo, on reducing the severity of atopic dermatitis as measured by Investigator’s Global Assessment (IGA).
Secondary efficacy measures include patients with a greater than 75 percent improvement in disease severity, as measured by the Eczema Area and Severity Index (EASI), along with other measures including disease activity using validated assessment tools such as EASI response, and Scoring Atopic Dermatitis (SCORAD). The trial will also assess safety, and biomarkers relevant to the disease and unique mechanism of GBR 830.
In addition to moderate-to-severe atopic dermatitis, Glenmark is evaluating the potential for conducting studies with GBR 830 for the treatment of other inflammatory autoimmune conditions where dysregulation of OX40 overexpression is implicated in disease activity. Preparations for a clinical trial assessing GBR 830 for the treatment of systemic lupus erythematosus (SLE) are currently underway.
GBR 830 is designed to inhibit OX40, a costimulatory immune checkpoint receptor expressed on activated T cells and memory T cells. Costimulatory signals are essential for T cell activity, and binding between OX40 and OX40L is a biomarker for the severity of autoimmune diseases. The activation of this pathway leads to conversion of activated T cells into memory T cells, which promotes inflammation . In addition, regulatory T cells also contribute to inflammation, and OX40 signalling by these cells downregulates immune suppressing functions. It is believed that GBR 830 inhibits the dual activities of OX40 and OX40L binding in both activated T cells and regulatory T cells, thus potentially reducing inflammation associated with symptoms of atopic dermatitis.
CPhI & P-MEC China 2018: Build lucrative pharma
business partnerships in China
Are you looking for new business partners, extendingyour distributor network or sourcing specific products on the Chinese pharma market?
We can support you on this! The upcoming CPhI & P-MEC China, taking place on 20 - 22 June 2018 in Shanghai, China, will gather 3,000+ exhibitors, providing you with solutions covering the needs of the entire pharmaceutical supply chain, including pharmaceutical ingredients, the growing biopharmaceutical industry, laboratory equipment, pharma packaging, machinery, logistics, environmental protection and clean room solutions.
What’s new?
PharmaExcipients zone: Asia’s premium event dedicated to pharmaceutical
excipients!
Driven by the development of drugs and the different materials used in the market, the excipients industry is growing rapidly, and the growing generic drug market is increasing the demand of medicinal materials in China as well. This year at PharmaExcipients China, you can meet numerous Chinese pharma companies specialized in high-end excipients.Come onsite, meet them and expand your network!
Animal Health & Feed:a unique opportunity to source from over 100
suppliers.
Home to the world's largest livestock industry, China has been the object of much fascination among global animal health companies. This new launch in 2018 will gather more than 100 manufacturers of veterinary drugs and feed from China and overseas. This is your one-stop platform for the veterinary industry.
Join the 2nd edition of CPhI China Pharma week!
Similar to last year, China Pharma Weekwill take place alongside CPhI & P-MEC China on19 - 23 June 2018focusing on Leadership, Business, Networking, Innovation, Recognition and Knowledge. Activities includea Cocktail & Dinner Reception at the Bund, plant visits giving a deeper work floor insight and dedicatedindustry conferences on different sectors to name a few.
Take part in on-site conferences and forums targeting various pharma sub-sections!
Mark the dates in your agenda!
Join us at Shanghai's New International Expo Centre (SNIEC):
With the opportunity to receive your personal visitor badgeright after completing your registration.
Get your free access now!
For more information, visit our website at www.cphi-china.cn/en or contact Ms. Tina Zheng at Tina.Zheng@ubmsinoexpo.com
Are you looking for new business partners, extendingyour distributor network or sourcing specific products on the Chinese pharma market?
We can support you on this! The upcoming CPhI & P-MEC China, taking place on 20 - 22 June 2018 in Shanghai, China, will gather 3,000+ exhibitors, providing you with solutions covering the needs of the entire pharmaceutical supply chain, including pharmaceutical ingredients, the growing biopharmaceutical industry, laboratory equipment, pharma packaging, machinery, logistics, environmental protection and clean room solutions.
What’s new?
Driven by the development of drugs and the different materials used in the market, the excipients industry is growing rapidly, and the growing generic drug market is increasing the demand of medicinal materials in China as well. This year at PharmaExcipients China, you can meet numerous Chinese pharma companies specialized in high-end excipients.Come onsite, meet them and expand your network!
Home to the world's largest livestock industry, China has been the object of much fascination among global animal health companies. This new launch in 2018 will gather more than 100 manufacturers of veterinary drugs and feed from China and overseas. This is your one-stop platform for the veterinary industry.
Join the 2nd edition of CPhI China Pharma week!
Similar to last year, China Pharma Weekwill take place alongside CPhI & P-MEC China on19 - 23 June 2018focusing on Leadership, Business, Networking, Innovation, Recognition and Knowledge. Activities includea Cocktail & Dinner Reception at the Bund, plant visits giving a deeper work floor insight and dedicatedindustry conferences on different sectors to name a few.
Take part in on-site conferences and forums targeting various pharma sub-sections!
Mark the dates in your agenda!
Join us at Shanghai's New International Expo Centre (SNIEC):
- CPhI & P-MEC China: 20 – 22 June 2018
- China Pharma week: 19 – 23 June 2018
With the opportunity to receive your personal visitor badgeright after completing your registration.
Get your free access now!
For more information, visit our website at www.cphi-china.cn/en or contact Ms. Tina Zheng at Tina.Zheng@ubmsinoexpo.com
Eli Lilly Appoints Luca Visini MD for
its Operations in India
Multinational biopharmaceutical leader, Eli Lilly and Company, announced earlier this year the appointment of Luca Visini as Managing Director of its Indian subsidiary, Eli Lilly and Company (India) Pvt. Ltd, effective February 1, 2018. Visini replaces Edgard Olaizola, who headed Lilly India operations from September 2013 to January 2018 and will now be moving internally to a new role.
Visini joined Lilly in 2004 and held several strategic leadership roles in various functional departments out of Lilly headquarters in Indianapolis, the USA and Europe. From 2011 to 2014 he was the country manager for Lilly Romania. He is taking this executive role endowed with a diverse and solid management experience at Lilly.
Visini is a native of Italy, and an alumnus of SDA Bocconi School of Management and Università degli Studi di Bergamo in Italy.
Multinational biopharmaceutical leader, Eli Lilly and Company, announced earlier this year the appointment of Luca Visini as Managing Director of its Indian subsidiary, Eli Lilly and Company (India) Pvt. Ltd, effective February 1, 2018. Visini replaces Edgard Olaizola, who headed Lilly India operations from September 2013 to January 2018 and will now be moving internally to a new role.
Visini joined Lilly in 2004 and held several strategic leadership roles in various functional departments out of Lilly headquarters in Indianapolis, the USA and Europe. From 2011 to 2014 he was the country manager for Lilly Romania. He is taking this executive role endowed with a diverse and solid management experience at Lilly.
Visini is a native of Italy, and an alumnus of SDA Bocconi School of Management and Università degli Studi di Bergamo in Italy.
Premas Life Sciences, IncellDx Sign
Distribution Deal
Premas Life Sciences Pvt, Ltd and IncellDx, Inc have signed an exclusive distribution agreement. The commercial partnership brings the power of cell by cell multiplex diagnostics for solid tumors carcinomas that can now be analyzed for molecular and protein biomarkers by flow cytometry. Included in the deal are : IncellDx's patented single-cell assays for quantifying PDL1 on tumor cells and immune cell subtypes; patented singlecell assay for HPV E6/E7 mRNA detection in cervical samples; and, its incellPREP single-cell preparation kit for solid tissues including tumors.
Researchers at AIIMS, New Delhi have completed a successful study utilizing IncellDx's next generation (3Dx) investigational molecular assay which quantifies E6, E7 mRNA overexpression in single cells simultaneously with the measurement of cell cycle and cell proliferation, the hallmark of progressive disease.
IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company's focus is on critical life threatening diseases in the areas of cancer, specifically lung, cervical, head and neck, bladder, cancers.
Premas Life Sciences Pvt, Ltd and IncellDx, Inc have signed an exclusive distribution agreement. The commercial partnership brings the power of cell by cell multiplex diagnostics for solid tumors carcinomas that can now be analyzed for molecular and protein biomarkers by flow cytometry. Included in the deal are : IncellDx's patented single-cell assays for quantifying PDL1 on tumor cells and immune cell subtypes; patented singlecell assay for HPV E6/E7 mRNA detection in cervical samples; and, its incellPREP single-cell preparation kit for solid tissues including tumors.
Researchers at AIIMS, New Delhi have completed a successful study utilizing IncellDx's next generation (3Dx) investigational molecular assay which quantifies E6, E7 mRNA overexpression in single cells simultaneously with the measurement of cell cycle and cell proliferation, the hallmark of progressive disease.
IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company's focus is on critical life threatening diseases in the areas of cancer, specifically lung, cervical, head and neck, bladder, cancers.
IPA Conducts Training Sessions at IPC
The National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare, Government of India, Ghaziabad, Uttar Pradesh(U.P.) organized Skill Development Programme (SDP) on "Basics and Regulatory Aspects of Pharmacovigilance - Optimising Medicine Safety is our Goal†from January 15-24, 2018 at Conference Hall of IPC, Ghaziabad. The Pharmacovigilance (PV) programme is conducted every year to accomplish SDP in the country under the government's ambitious Pradhan Mantri Kaushal Vikas Yojana. The objective of the workshop was to enhance the knowledge and skill of qualified PV professionals to ensure better patient safety as per the requirement of Schedule Y of Drugs & Cosmetics Act, 1940 and to enhance career prospects & employment opportunities in PV in government as well as in private sector. The target group for the programme was young pharma/medical/paramedical professionals seeking career in PV and existing professionals in PV. Faculties drawn for the programme were renowned experts from government teaching & corporate hospitals, regulatory authority, WHO, pharmaceutical industry, academia and research institutions
The National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare, Government of India, Ghaziabad, Uttar Pradesh(U.P.) organized Skill Development Programme (SDP) on "Basics and Regulatory Aspects of Pharmacovigilance - Optimising Medicine Safety is our Goal†from January 15-24, 2018 at Conference Hall of IPC, Ghaziabad. The Pharmacovigilance (PV) programme is conducted every year to accomplish SDP in the country under the government's ambitious Pradhan Mantri Kaushal Vikas Yojana. The objective of the workshop was to enhance the knowledge and skill of qualified PV professionals to ensure better patient safety as per the requirement of Schedule Y of Drugs & Cosmetics Act, 1940 and to enhance career prospects & employment opportunities in PV in government as well as in private sector. The target group for the programme was young pharma/medical/paramedical professionals seeking career in PV and existing professionals in PV. Faculties drawn for the programme were renowned experts from government teaching & corporate hospitals, regulatory authority, WHO, pharmaceutical industry, academia and research institutions
LifeCell Initiates Development of Large
Scale Manufacturing of MSCs
LifeCell, India's first & largest stem cell bank in the country, a pioneer in stem cell research has embarked on a journey to develop large scale manufacturing of Mesenchymal Stem Cells (MSCs).
Mesenchymal Stem Cells are one type of master stem cells that have the potential to form bone, cartilage, muscle and adipose tissues, thereby making them capable of being used in the several therapeutic areas. Importantly these MSC's can be made available off-the-shelf for immediate treatment as they don't need donor -recipient matching.
The potential of these MSCs of medical conditions are being checked in 50+ clinical trials around the world, with several companies like TiGenix, Mesoblast , etc., are also receiving market approvals in many countries such as Europe, Canada, Japan, and Australia. Even in India recently, the DCGI provided a limited approval to Stempeutics to market their MSC product for treatment of Critical Limb Ischemia
LifeCell, India's first & largest stem cell bank in the country, a pioneer in stem cell research has embarked on a journey to develop large scale manufacturing of Mesenchymal Stem Cells (MSCs).
Mesenchymal Stem Cells are one type of master stem cells that have the potential to form bone, cartilage, muscle and adipose tissues, thereby making them capable of being used in the several therapeutic areas. Importantly these MSC's can be made available off-the-shelf for immediate treatment as they don't need donor -recipient matching.
The potential of these MSCs of medical conditions are being checked in 50+ clinical trials around the world, with several companies like TiGenix, Mesoblast , etc., are also receiving market approvals in many countries such as Europe, Canada, Japan, and Australia. Even in India recently, the DCGI provided a limited approval to Stempeutics to market their MSC product for treatment of Critical Limb Ischemia
Sanofi Launches New Insulin Toujeo in India
Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product - Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes.
Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience.
The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo). This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques , sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi’s Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date.
Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product - Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes.
Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience.
The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo). This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques , sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi’s Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date.
Lupin Forays into OTC Segment with Softovac
Pharma major Lupin Limited (Lupin) has made a foray into the over-the-counter (OTC) segment under the 'Lupin Life Consumer Healthcare' umbrella with the pan -India launch of Softovac. A 34-year old legacy brand, Softovac has been trusted by millions of consumers who suffer from constipation and irregular bowel habits .
Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report, the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores) mark by 2026. Softovac's shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan -India roll-out was initiated.
Softovac is a bowel regulator made with 100 percent natural actives like Isabgol , Sonamukhi, Harad, Mulethi, Gulab dal (ingredient), Amaltas, and Saunf, all of which are time-tested ingredients known to provide effective relief from constipation and irregular bowel habits.
Pharma major Lupin Limited (Lupin) has made a foray into the over-the-counter (OTC) segment under the 'Lupin Life Consumer Healthcare' umbrella with the pan -India launch of Softovac. A 34-year old legacy brand, Softovac has been trusted by millions of consumers who suffer from constipation and irregular bowel habits .
Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report, the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores) mark by 2026. Softovac's shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan -India roll-out was initiated.
Softovac is a bowel regulator made with 100 percent natural actives like Isabgol , Sonamukhi, Harad, Mulethi, Gulab dal (ingredient), Amaltas, and Saunf, all of which are time-tested ingredients known to provide effective relief from constipation and irregular bowel habits.
Historic Deal Signed Between Panacea Biotec & Serum
Institute of India
Panacea Biotec Ltd. (PBL) is delighted to announce the collaboration with signing of two long term agreements with Serum Institute of India Pvt. Ltd. (SII ) and SII's wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO). Under the collaboration SII is entitled to manufacture & sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed & commercialized by Panacea Biotec, a first of its kind in this category.
WHO prequalified IPV is essential to successfully eradicating Polio across the globe, an effort that has already cost USD 20 Billion worldwide. There is a Global Polio Eradication Initiative(GPEI) in place & Global Alliance for Vaccine Initiative (GAVI) has been supporting the program since 2013 having allocated USD 430 Million till 2018 with an additional donor pledge of USD 23 Million for 2019. At present GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good.
Global demand of IPV/ IPV containing vaccines is estimated to rise significantly from ~100 Million in the year 2020 till supply constraints remain, to 250-350 Million doses every year starting 2022 depending upon a two or three dose schedule as Strategic Advisory Group of Experts (SAGE) on Immunization in April 2017 has recommended at least 2 doses of IPV in the routine Immunization schedule of the countries post OPV Lupin Forays into OTC Segment with withdrawal .
Panacea Biotec Ltd. (PBL) is delighted to announce the collaboration with signing of two long term agreements with Serum Institute of India Pvt. Ltd. (SII ) and SII's wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO). Under the collaboration SII is entitled to manufacture & sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed & commercialized by Panacea Biotec, a first of its kind in this category.
WHO prequalified IPV is essential to successfully eradicating Polio across the globe, an effort that has already cost USD 20 Billion worldwide. There is a Global Polio Eradication Initiative(GPEI) in place & Global Alliance for Vaccine Initiative (GAVI) has been supporting the program since 2013 having allocated USD 430 Million till 2018 with an additional donor pledge of USD 23 Million for 2019. At present GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good.
Global demand of IPV/ IPV containing vaccines is estimated to rise significantly from ~100 Million in the year 2020 till supply constraints remain, to 250-350 Million doses every year starting 2022 depending upon a two or three dose schedule as Strategic Advisory Group of Experts (SAGE) on Immunization in April 2017 has recommended at least 2 doses of IPV in the routine Immunization schedule of the countries post OPV Lupin Forays into OTC Segment with withdrawal .
Dr. Reddy's Launches Tetrabenazine Tablets in the US
Market
Dr. Reddy's Laboratories Ltd has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine(tetrabenazine) in the United States market approved by the US Food and Drug Administration (USFDA).
The Xenazine brand and generic had US sales of approximately USD 322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health.
Dr. Reddy's Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112.
Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L .
Dr. Reddy's Laboratories Ltd has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine(tetrabenazine) in the United States market approved by the US Food and Drug Administration (USFDA).
The Xenazine brand and generic had US sales of approximately USD 322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health.
Dr. Reddy's Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112.
Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L .
Breakthrough Study Reveals a New Monogenic Form of
Diabetes in India
A breakthrough study on Maturity Onset Diabetes of the Young (MODY) was published in 'BMC Medical Genetics' journal by Dr. V. Mohan and Dr. RadhaVenkatesan from Madras Diabetes Research Foundation (MDRF), Chennai, in collaboration with Dr. Andrew S. Peterson, Dr. Somasekar Seshagiri and Dr. Thong T. Nguyen from Genentech, California, and Dr. Ramprasad and Sam Santhosh at MedGenome, India.
The usual forms of diabetes are type 2 Diabetes, (which comprises 90 - 95% of all forms of diabetes) and type 1 diabetes. Type 2 Diabetes normally affects adults, and does not require insulin for control of hyperglycemia except in the more advanced stages. Type 1 diabetes, usually affects children and in this type of diabetes there is complete insulin deficiency and hence they require lifelong insulin injections, several times a day. However, there are many other forms of diabetes which are increasingly being recognized nowadays.
There is a genetic form of diabetes due to a single gene defect and hence these are called as 'Monogenic Diabetes'. The commonest form of monogenic diabetes is "Maturity Onset Diabetes of the Young (MODY)" which like type 1 Diabetes also affects young people or children. Patients with MODY are usually lean and because of their young age, they are often wrongly labeled as having type 1 diabetes and advised to have lifelong insulin injections. MODY can only be diagnosed by doing 'genetic testing'. Further, it is now known that there are 14 different forms of MODY, each with its own unique clinical characteristics. While there have been a few scattered studies on different forms of MODY in India, this was the most comprehensive and largest study of all forms of MODY done in India.
GNH India Clears Oman Pharmacy and Poison Board Audit
GNH India, a global source for priority pharmaceuticals has cleared an audit conducted by the Muscat Pharmacy and Poisons board to export pharmaceuticals and priority medications into the Gulf state of Oman. This milestone is yet another in GNH - India's march towards becoming the premier global distributor for priority pharmaceuticals and medications. Earlier GNH India had cleared and audits to trade orphan drugs with the UK and had become the first Indian company to clear the Kenyan Pharmacy and Poisons Board audit as well. It has also become the first pharma distributor to clear the Muscat Pharmacy and Poisons Board audit, which functions under Oman health ministry.
In 2010, India ranked fifth largest source of imports into Oman after the UAE, Japan, United States and China. The audit will not only give preferential status to GNH India in the Oman trade market over other suppliers from countries including USA and EU but will also lead the company to become a key player in contributing towards the growth of Indian's pharma export share to Oman which in 2016 stands at 39.07%.
On January 25th, two delegates from Oman Health Ministry visited GNH India's warehouse in Prabhadevi, Mumbai to audit the company and to inspect its GDP standard. After receiving a positive response from the auditors, GNH India immediately lined up the export of scheduled drugs to Oman and is looking to establish long lasting business relations with the country. GNH India has been trading with Oman for past eight years, leading as largest pharma suppliers to the market for life-saving and orphan drugs.
Brinton Pharmaceuticals wins Three Accolades at Pharma Excellence Award 2018
Brinton Pharmaceuticals, India's fastest growing multinational pharmaceuticals company, won three accolades at Pharma Excellence Awards 2018, reinforcing its fast pacing growth in the Pharma Industry. Brinton Pharmaceuticals was awarded as the 'Most Admired Pharma Company' and was also adjudged as 'The Emerging Pharma company of the Year'. Also, Mr. Rahul Darda, Chairman & Managing Director was awarded as ‘Business Leader' of the Year'.
Brinton Pharmaceuticals Ltd started its India operations in September 2014 and within a year of its inception became the fastest growing pharmaceutical company in the domain of Dermatology in India. Brinton Paediatric division markets products ranging from paediatric nutrition, respiratory and other therapy areas and are already available in the market. Brinton is currently pursuing a strong R & D to bring more innovative products like paediatric nutrition, probiotics, Juvenile diabetes, paediatric cardiology and many more.
Indian Pharmacological Society Concludes Golden Jubilee Celebrations at Annual Conference IPSCON 2017
Golden Jubilee Concluding Celebrations of Indian Pharmacological Society and Annual Conference of Indian Pharmacological Society (IPSCON - 2017 ) was organised in collaboration with NMIMS ShobhabenPratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM), in Mumbai on 15-17 February, 2018. The theme of the conference was "Integrating Pharmacology with Modern Healthcare". The three-day conference was enriched with various scientific sessions that extensively covered vital current issues.
Chief Guest of the ceremony Padmashri Dr. Shashank Joshi, Endocrinologist stressed that modern research should be integrated with traditional system of medicine. While lauding the efforts of Japanese, Chinese and Korean researchers, Dr Joshi directed a question to the audience asking "why can't we (Indians) have largest research output?"
Dr. Joshi made a special mention of NMIMS while congratulating the University on winning two global patents. He also appreciated the organisers as the conference saw large number of participants in his keynote address.
Chairman of IPSCON 2017 Local Organizing Committee, Dr. R. S. Gaud , Director, NMIMS Mukesh Patel Technology Park, Shirpur& SVKM's Pharma Institutions, while welcoming the delegates and dignitaries, presented an overview of NMIMS as an educational institution. He stressed on the need for introduction of more paramedical courses and more jobs in pharmacovigilance.
Mylan Launches Saugella in India
Mylan Pharmaceuticals Private Limited announced the launch of SAUGELLA Dermoliquido, suitable for use for daily intimate hygiene use, and SAUGELLA Attiva, designed for expecting mothers, new mothers, women athletes, and for protection from infection during menstruation.
India's first 'natural' feminine intimate hygiene product, SAUGELLA intimate hygiene wash is pH-balanced, 100% free of preservatives used in cosmetic/pharmaceutical products[ii], and is tested by gynecologists[ii] .SAUGELLA is based on natural plants extracts with pharmacological properties. It is a mild, water-based solution that addresses the intimate personal care needs of women while ensuring safety and respecting the physiological vaginal environment for all ages.
SAUGELLA contains natural plant extracts, which have proven antifungal and antibacterial action that allow it to gently deodorize the area of application and provide a balanced solution that caters to every skin type. This gentle formula is designed to maintain hygiene, comfort and intimate balance, while preventing skin irritation and making women less susceptible to infections caused by natural changes in vaginal pH.
Roche Pharma India Partners with Cipla
Roche Pharma India and Cipla announced that the two companies have entered into an agreement under which Cipla will promote and distribute tocilizumab (Actemra) and Syndyma, the 2nd brand of Roche's cancer therapy, bevacizumab (Avastin) in India. This partnership is in line with Roche and Cipla's efforts to improve healthcare and increase access to innovative, life-changing medicines in India, particularly to patients who currently do not have access to them.
Lara Bezerra, Managing Director - Roche Pharma India said: "At Roche, improving access to the critical medicines that patients need is an integral part of what we do. We believe that everyone who needs our medicines should be able to access and benefit from them. This partnership will significantly advance our efforts to expand the reach of, and improve access to, our innovative medicines. This will also enable us at Roche to focus on bringing new, transformative medicines to patients in India. As Roche, we will continue to collaborate with various stakeholders to help transform healthcare in India."
WHO Approves Cholera Vaccine from ShanthaBiotechnics
Sanofi Pasteur, the vaccines division of Sanofi, is proud to announce that its affiliate ShanthaBiotechnics has received approval from the World Health Organisation (WHO) for Shanchol, its oral cholera vaccine, that the vaccine may be kept for single period of time of up to 14 days at temperature of up to 40°C immediately prior to administration, provided the vaccine has not reached its expiry date and vaccine vial monitor has not reached discard point. The approval is of great significance to regions where the vaccine is used, including India, as it eliminates the challenges of maintaining the vaccine cold chain (between +2°C and +8°C to maintain vaccine potency) during transport.
The WHO approval for use of Shanchol in controlled temperature chain (CTC) was granted after a review of its stability data. Used for prevention and control of cholera in outbreak, endemic settings during humanitarian crises, ShanthaBiotechnics’ Shanchol™ cholera vaccine is the second “mass campaign†vaccine and first cholera vaccine worldwide to receive such a stamp of approval for storage and distribution outside the traditional cold chain.
Since WHO pre-qualification in 2011, 12 million doses of Shanchol vaccine have been shipped to 25 countries across the world, including Democratic Republic of the Congo, Haiti, Mozambique and South Sudan. The largest ever shipment ofShanchol vaccine took place in September 2017 when ShanthaBiotechnics responded to an urgent call for humanitarian help from international agencies and sent 900,000 doses to Nigeria to respond to a cholera epidemic in the country.
A breakthrough study on Maturity Onset Diabetes of the Young (MODY) was published in 'BMC Medical Genetics' journal by Dr. V. Mohan and Dr. RadhaVenkatesan from Madras Diabetes Research Foundation (MDRF), Chennai, in collaboration with Dr. Andrew S. Peterson, Dr. Somasekar Seshagiri and Dr. Thong T. Nguyen from Genentech, California, and Dr. Ramprasad and Sam Santhosh at MedGenome, India.
The usual forms of diabetes are type 2 Diabetes, (which comprises 90 - 95% of all forms of diabetes) and type 1 diabetes. Type 2 Diabetes normally affects adults, and does not require insulin for control of hyperglycemia except in the more advanced stages. Type 1 diabetes, usually affects children and in this type of diabetes there is complete insulin deficiency and hence they require lifelong insulin injections, several times a day. However, there are many other forms of diabetes which are increasingly being recognized nowadays.
There is a genetic form of diabetes due to a single gene defect and hence these are called as 'Monogenic Diabetes'. The commonest form of monogenic diabetes is "Maturity Onset Diabetes of the Young (MODY)" which like type 1 Diabetes also affects young people or children. Patients with MODY are usually lean and because of their young age, they are often wrongly labeled as having type 1 diabetes and advised to have lifelong insulin injections. MODY can only be diagnosed by doing 'genetic testing'. Further, it is now known that there are 14 different forms of MODY, each with its own unique clinical characteristics. While there have been a few scattered studies on different forms of MODY in India, this was the most comprehensive and largest study of all forms of MODY done in India.
GNH India Clears Oman Pharmacy and Poison Board Audit
GNH India, a global source for priority pharmaceuticals has cleared an audit conducted by the Muscat Pharmacy and Poisons board to export pharmaceuticals and priority medications into the Gulf state of Oman. This milestone is yet another in GNH - India's march towards becoming the premier global distributor for priority pharmaceuticals and medications. Earlier GNH India had cleared and audits to trade orphan drugs with the UK and had become the first Indian company to clear the Kenyan Pharmacy and Poisons Board audit as well. It has also become the first pharma distributor to clear the Muscat Pharmacy and Poisons Board audit, which functions under Oman health ministry.
In 2010, India ranked fifth largest source of imports into Oman after the UAE, Japan, United States and China. The audit will not only give preferential status to GNH India in the Oman trade market over other suppliers from countries including USA and EU but will also lead the company to become a key player in contributing towards the growth of Indian's pharma export share to Oman which in 2016 stands at 39.07%.
On January 25th, two delegates from Oman Health Ministry visited GNH India's warehouse in Prabhadevi, Mumbai to audit the company and to inspect its GDP standard. After receiving a positive response from the auditors, GNH India immediately lined up the export of scheduled drugs to Oman and is looking to establish long lasting business relations with the country. GNH India has been trading with Oman for past eight years, leading as largest pharma suppliers to the market for life-saving and orphan drugs.
Brinton Pharmaceuticals wins Three Accolades at Pharma Excellence Award 2018
Brinton Pharmaceuticals, India's fastest growing multinational pharmaceuticals company, won three accolades at Pharma Excellence Awards 2018, reinforcing its fast pacing growth in the Pharma Industry. Brinton Pharmaceuticals was awarded as the 'Most Admired Pharma Company' and was also adjudged as 'The Emerging Pharma company of the Year'. Also, Mr. Rahul Darda, Chairman & Managing Director was awarded as ‘Business Leader' of the Year'.
Brinton Pharmaceuticals Ltd started its India operations in September 2014 and within a year of its inception became the fastest growing pharmaceutical company in the domain of Dermatology in India. Brinton Paediatric division markets products ranging from paediatric nutrition, respiratory and other therapy areas and are already available in the market. Brinton is currently pursuing a strong R & D to bring more innovative products like paediatric nutrition, probiotics, Juvenile diabetes, paediatric cardiology and many more.
Indian Pharmacological Society Concludes Golden Jubilee Celebrations at Annual Conference IPSCON 2017
Golden Jubilee Concluding Celebrations of Indian Pharmacological Society and Annual Conference of Indian Pharmacological Society (IPSCON - 2017 ) was organised in collaboration with NMIMS ShobhabenPratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM), in Mumbai on 15-17 February, 2018. The theme of the conference was "Integrating Pharmacology with Modern Healthcare". The three-day conference was enriched with various scientific sessions that extensively covered vital current issues.
Chief Guest of the ceremony Padmashri Dr. Shashank Joshi, Endocrinologist stressed that modern research should be integrated with traditional system of medicine. While lauding the efforts of Japanese, Chinese and Korean researchers, Dr Joshi directed a question to the audience asking "why can't we (Indians) have largest research output?"
Dr. Joshi made a special mention of NMIMS while congratulating the University on winning two global patents. He also appreciated the organisers as the conference saw large number of participants in his keynote address.
Chairman of IPSCON 2017 Local Organizing Committee, Dr. R. S. Gaud , Director, NMIMS Mukesh Patel Technology Park, Shirpur& SVKM's Pharma Institutions, while welcoming the delegates and dignitaries, presented an overview of NMIMS as an educational institution. He stressed on the need for introduction of more paramedical courses and more jobs in pharmacovigilance.
Mylan Launches Saugella in India
Mylan Pharmaceuticals Private Limited announced the launch of SAUGELLA Dermoliquido, suitable for use for daily intimate hygiene use, and SAUGELLA Attiva, designed for expecting mothers, new mothers, women athletes, and for protection from infection during menstruation.
India's first 'natural' feminine intimate hygiene product, SAUGELLA intimate hygiene wash is pH-balanced, 100% free of preservatives used in cosmetic/pharmaceutical products[ii], and is tested by gynecologists[ii] .SAUGELLA is based on natural plants extracts with pharmacological properties. It is a mild, water-based solution that addresses the intimate personal care needs of women while ensuring safety and respecting the physiological vaginal environment for all ages.
SAUGELLA contains natural plant extracts, which have proven antifungal and antibacterial action that allow it to gently deodorize the area of application and provide a balanced solution that caters to every skin type. This gentle formula is designed to maintain hygiene, comfort and intimate balance, while preventing skin irritation and making women less susceptible to infections caused by natural changes in vaginal pH.
Roche Pharma India Partners with Cipla
Roche Pharma India and Cipla announced that the two companies have entered into an agreement under which Cipla will promote and distribute tocilizumab (Actemra) and Syndyma, the 2nd brand of Roche's cancer therapy, bevacizumab (Avastin) in India. This partnership is in line with Roche and Cipla's efforts to improve healthcare and increase access to innovative, life-changing medicines in India, particularly to patients who currently do not have access to them.
Lara Bezerra, Managing Director - Roche Pharma India said: "At Roche, improving access to the critical medicines that patients need is an integral part of what we do. We believe that everyone who needs our medicines should be able to access and benefit from them. This partnership will significantly advance our efforts to expand the reach of, and improve access to, our innovative medicines. This will also enable us at Roche to focus on bringing new, transformative medicines to patients in India. As Roche, we will continue to collaborate with various stakeholders to help transform healthcare in India."
WHO Approves Cholera Vaccine from ShanthaBiotechnics
Sanofi Pasteur, the vaccines division of Sanofi, is proud to announce that its affiliate ShanthaBiotechnics has received approval from the World Health Organisation (WHO) for Shanchol, its oral cholera vaccine, that the vaccine may be kept for single period of time of up to 14 days at temperature of up to 40°C immediately prior to administration, provided the vaccine has not reached its expiry date and vaccine vial monitor has not reached discard point. The approval is of great significance to regions where the vaccine is used, including India, as it eliminates the challenges of maintaining the vaccine cold chain (between +2°C and +8°C to maintain vaccine potency) during transport.
The WHO approval for use of Shanchol in controlled temperature chain (CTC) was granted after a review of its stability data. Used for prevention and control of cholera in outbreak, endemic settings during humanitarian crises, ShanthaBiotechnics’ Shanchol™ cholera vaccine is the second “mass campaign†vaccine and first cholera vaccine worldwide to receive such a stamp of approval for storage and distribution outside the traditional cold chain.
Since WHO pre-qualification in 2011, 12 million doses of Shanchol vaccine have been shipped to 25 countries across the world, including Democratic Republic of the Congo, Haiti, Mozambique and South Sudan. The largest ever shipment ofShanchol vaccine took place in September 2017 when ShanthaBiotechnics responded to an urgent call for humanitarian help from international agencies and sent 900,000 doses to Nigeria to respond to a cholera epidemic in the country.
GNH India clears Oman Pharmacy and Poison board audit
GNH India, a global source for priority pharmaceuticals has cleared an audit conducted by the Muscat Pharmacy and Poisons board to export pharmaceuticals and priority medications into the Gulf state of Oman. This milestone is yet another in GNH - India’s march towards becoming the premier global distributor for priority pharmaceuticals and medications. Earlier GNH India had cleared and audits to trade orphan drugs with the UK and had become the first Indian company to clear the Kenyan Pharmacy and Poisons Board audit as well. It has also become the first pharma distributor to clear the Muscat Pharmacy and Poisons Board audit, which functions under Oman health ministry.
In 2010, India ranked fifth largest source of imports into Oman after the UAE, Japan, United States and China. The audit will not only give preferential status to GNH India in the Oman trade market over other suppliers from countries including USA and EU but will also lead the company to become a key player in contributing towards the growth of Indian’s pharma export share to Oman which in 2016 stands at 39.07%.
On January 25th, two delegates from Oman Health Ministry visited GNH India’s warehouse in Prabhadevi, Mumbai to audit the company and to inspect its GDP standard. After receiving a positive response from the auditors, GNH India immediately lined up the export of scheduled drugs to Oman and is looking to establish long lasting business relations with the country. GNH India has been trading with Oman for past eight years, leading as largest pharma suppliers to the market for life-saving and orphan drugs.
Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, “The visit from the official of the Pharmacy and poison board of Oman authenticates and further validates GNH India as a distributor of priority medicines. There is no stone left unturned to ensure that all the measures taken are compliant with international standards. Getting through this audit has opened a new vista for GNH India and has propelled trade relations with Oman in a great way.â€
GNH India exports to more than 180 countries and has 135,000 product lines to choose from which makes this company one of the leading businesses in the $12.5 billion Indian pharmaceutical export industry. It has recently exported a large non- profit shipment to Somalia to aid the people with basic medicines which are lacking in the country.
GNH India, a global source for priority pharmaceuticals has cleared an audit conducted by the Muscat Pharmacy and Poisons board to export pharmaceuticals and priority medications into the Gulf state of Oman. This milestone is yet another in GNH - India’s march towards becoming the premier global distributor for priority pharmaceuticals and medications. Earlier GNH India had cleared and audits to trade orphan drugs with the UK and had become the first Indian company to clear the Kenyan Pharmacy and Poisons Board audit as well. It has also become the first pharma distributor to clear the Muscat Pharmacy and Poisons Board audit, which functions under Oman health ministry.
In 2010, India ranked fifth largest source of imports into Oman after the UAE, Japan, United States and China. The audit will not only give preferential status to GNH India in the Oman trade market over other suppliers from countries including USA and EU but will also lead the company to become a key player in contributing towards the growth of Indian’s pharma export share to Oman which in 2016 stands at 39.07%.
On January 25th, two delegates from Oman Health Ministry visited GNH India’s warehouse in Prabhadevi, Mumbai to audit the company and to inspect its GDP standard. After receiving a positive response from the auditors, GNH India immediately lined up the export of scheduled drugs to Oman and is looking to establish long lasting business relations with the country. GNH India has been trading with Oman for past eight years, leading as largest pharma suppliers to the market for life-saving and orphan drugs.
Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, “The visit from the official of the Pharmacy and poison board of Oman authenticates and further validates GNH India as a distributor of priority medicines. There is no stone left unturned to ensure that all the measures taken are compliant with international standards. Getting through this audit has opened a new vista for GNH India and has propelled trade relations with Oman in a great way.â€
GNH India exports to more than 180 countries and has 135,000 product lines to choose from which makes this company one of the leading businesses in the $12.5 billion Indian pharmaceutical export industry. It has recently exported a large non- profit shipment to Somalia to aid the people with basic medicines which are lacking in the country.
2018 China International Pharma 4.0 summit will be held on May 17-18 in Shanghai, China
The deep integration of the new generation of information technology and manufacturing industry is triggering a far-reaching industrial change and shaping new production mode, industrial form, business model and economic growth point. Following German Industry 4.0, China has issued its Made in China 2025 strategy in an aim to accelerate the transformation of its manufacturing industry. Based on cyber physical system, intelligent manufacturing including intelligent equipment and plant is leading the change of manufacturing mode. Biomedicine and high performance medical instruments, as one of the key areas of Made in China 2025 initiative, is facing big challenges and opportunities for innovation and development.
Compared with the pharmaceutical industry in Europe and America, there is still a considerable gap to be filled in China. Many problems remain to be addressed including the frequent issuing of policies and regulations, stringent quality requirements, drug price control, optimization and standardization of production process, risk control and looming human resource problems.
Based on the actual situation of pharmaceutical industry in China, the 2018 China International Pharma 4.0 Summit will be held on May 17-18 in Shanghai China. It will bring together over 300 delegates from relevant governments, associations, institutions, pharmaceutical manufacturers, pharmaceutical equipment suppliers, intelligent solution providers of pharmaceutical, packaging, warehouse and logistics, among those the industry regulators, experts and opinion leaders will share the latest policies and regulations, global market trends, technical innovation in the whole chain of drug production, architecture and practice of intelligent pharmaceutical plants as well as advanced technologies such as robotics, AI, informatization, IoT, big data, cloud computing, comparing notes on the transformation and upgrading of pharmaceutical industry.
Sessions & Highlights
1. Policies, regulations and key trends of global pharma industry
The deep integration of the new generation of information technology and manufacturing industry is triggering a far-reaching industrial change and shaping new production mode, industrial form, business model and economic growth point. Following German Industry 4.0, China has issued its Made in China 2025 strategy in an aim to accelerate the transformation of its manufacturing industry. Based on cyber physical system, intelligent manufacturing including intelligent equipment and plant is leading the change of manufacturing mode. Biomedicine and high performance medical instruments, as one of the key areas of Made in China 2025 initiative, is facing big challenges and opportunities for innovation and development.
Compared with the pharmaceutical industry in Europe and America, there is still a considerable gap to be filled in China. Many problems remain to be addressed including the frequent issuing of policies and regulations, stringent quality requirements, drug price control, optimization and standardization of production process, risk control and looming human resource problems.
Based on the actual situation of pharmaceutical industry in China, the 2018 China International Pharma 4.0 Summit will be held on May 17-18 in Shanghai China. It will bring together over 300 delegates from relevant governments, associations, institutions, pharmaceutical manufacturers, pharmaceutical equipment suppliers, intelligent solution providers of pharmaceutical, packaging, warehouse and logistics, among those the industry regulators, experts and opinion leaders will share the latest policies and regulations, global market trends, technical innovation in the whole chain of drug production, architecture and practice of intelligent pharmaceutical plants as well as advanced technologies such as robotics, AI, informatization, IoT, big data, cloud computing, comparing notes on the transformation and upgrading of pharmaceutical industry.
Sessions & Highlights
1. Policies, regulations and key trends of global pharma industry
- The interpretation on the Guidelines for the Development Plan of the Pharmaceutical Industry
- Analysis of current status and pain points of the pharmaceutical industry
- Combining software and hardware organically to realize intelligent manufacturing
- Focus on talent training and achieve human-computer interaction to embrace Industry 5.0
- Added value of the industry brought by continuous manufacturing
- How should the API break up the monopoly and transform toward the preparation?
- Intelligent transformation and green upgrade of TCM industry
- How will AI and robotics reform the traditional pharmaceutical industry?
- The impact of MES on Pharma 4.0 and its application in the operation of pharmaceutical plants
- Key to the intelligent pharmaceutical plants: the seamless integration of ERP and MES
- Changes in the process management modes like drug test, life-cycle quality control and compliance based on IoT
- The practice of data integrity management in pharmaceutical plants
- How can big data and cloud computing help pharmaceutical companies to achieve precision marketing
- Data security and privacy: Pre-interpretation of EU’s General Data Protection Regulations
- The development and application of “smart tag†and RFID technology
- Build a complete supply chain system that features the combination of storage technology and logistics management
Eli Lilly Appoints Luca Visini MD for
its Operations in India
Multinational biopharmaceutical leader, Eli Lilly and Company, announced earlier this year the appointment of Luca Visini as Managing Director of its Indian subsidiary, Eli Lilly and Company (India) Pvt. Ltd, effective February 1, 2018. Visini replaces Edgard Olaizola, who headed Lilly India operations from September 2013 to January 2018 and will now be moving internally to a new role.
Visini joined Lilly in 2004 and held several strategic leadership roles in various functional departments out of Lilly headquarters in Indianapolis, the USA and Europe. From 2011 to 2014 he was the country manager for Lilly Romania. He is taking this executive role endowed with a diverse and solid management experience at Lilly. Visini is a native of Italy, and an alumnus of SDA Bocconi School of Management and Università degli Studi di Bergamo in Italy.
Multinational biopharmaceutical leader, Eli Lilly and Company, announced earlier this year the appointment of Luca Visini as Managing Director of its Indian subsidiary, Eli Lilly and Company (India) Pvt. Ltd, effective February 1, 2018. Visini replaces Edgard Olaizola, who headed Lilly India operations from September 2013 to January 2018 and will now be moving internally to a new role.
Visini joined Lilly in 2004 and held several strategic leadership roles in various functional departments out of Lilly headquarters in Indianapolis, the USA and Europe. From 2011 to 2014 he was the country manager for Lilly Romania. He is taking this executive role endowed with a diverse and solid management experience at Lilly. Visini is a native of Italy, and an alumnus of SDA Bocconi School of Management and Università degli Studi di Bergamo in Italy.
Sanofi Launches New Insulin Toujeo in India
Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product - Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes.
Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience.
The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo). This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques, sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi's Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date.
Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product - Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes.
Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience.
The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo). This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques, sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi's Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date.
IPA Conducts Training Sessions at IPC
The National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare, Government of India, Ghaziabad, Uttar Pradesh (U.P.) organized Skill Development Programme (SDP) on “Basics and Regulatory Aspects of Pharmacovigilance – Optimising Medicine Safety is our Goal†from January 15-24, 2018 at Conference Hall of IPC, Ghaziabad. The Pharmacovigilance (PV) programme is conducted every year to accomplish SDP in the country under the government’s ambitious Pradhan Mantri Kaushal Vikas Yojana. The objective of the workshop was to enhance the knowledge and skill of qualified PV professionals to ensure better patient safety as per the requirement of Schedule Y of Drugs & Cosmetics Act, 1940 and to enhance career prospects & employment opportunities in PV in government as well as in private sector. The target group for the programme was young pharma / medical / paramedical professionals seeking career in PV and existing professionals in PV. Faculties drawn for the programme were renowned experts from government teaching & corporate hospitals, regulatory authority, WHO, pharmaceutical industry, academia and research institutions.
The National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) under the Ministry of Health & Family Welfare, Government of India, Ghaziabad, Uttar Pradesh (U.P.) organized Skill Development Programme (SDP) on “Basics and Regulatory Aspects of Pharmacovigilance – Optimising Medicine Safety is our Goal†from January 15-24, 2018 at Conference Hall of IPC, Ghaziabad. The Pharmacovigilance (PV) programme is conducted every year to accomplish SDP in the country under the government’s ambitious Pradhan Mantri Kaushal Vikas Yojana. The objective of the workshop was to enhance the knowledge and skill of qualified PV professionals to ensure better patient safety as per the requirement of Schedule Y of Drugs & Cosmetics Act, 1940 and to enhance career prospects & employment opportunities in PV in government as well as in private sector. The target group for the programme was young pharma / medical / paramedical professionals seeking career in PV and existing professionals in PV. Faculties drawn for the programme were renowned experts from government teaching & corporate hospitals, regulatory authority, WHO, pharmaceutical industry, academia and research institutions.
Dr. Reddy's Launches Tetrabenazine
Tablets in the US Market
Dr. Reddy’s Laboratories Ltd has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine (tetrabenazine) in the United States market approved by the US Food and Drug Administration (USFDA). The Xenazine brand and generic had US sales of approximately USD 322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health.
Dr. Reddy's Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112. Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L.
Dr. Reddy’s Laboratories Ltd has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine (tetrabenazine) in the United States market approved by the US Food and Drug Administration (USFDA). The Xenazine brand and generic had US sales of approximately USD 322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health.
Dr. Reddy's Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112. Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L.
Premas Life Sciences, IncellDx Sign
Distribution Deal
Premas Life Sciences Pvt, Ltd and IncellDx, Inc have signed an exclusive distribution agreement. The commercial partnership brings the power of cell by cell multiplex diagnostics for solid tumors carcinomas that can now be analyzed for molecular and protein biomarkers by flow cytometry. Included in the deal are: IncellDx’s patented single-cell assays for quantifying PD-L1 on tumor cells and immune cell subtypes; patented single-cell assay for HPV E6/ E7 mRNA detection in cervical samples; and, its incellPREP singlecell preparation kit for solid tissues including tumors.
Researchers at AIIMS, New Delhi have completed a successful study utilizing IncellDx’s next generation (3Dx) investigational molecular assay which quantifies E6, E7 mRNA overexpression in single cells simultaneously with the measurement of cell cycle and cell proliferation, the hallmark of progressive disease.
IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company’s focus is on critical life threatening diseases in the areas of cancer, specifically lung, cervical, head and neck, bladder, cancers.
Premas Life Sciences Pvt, Ltd and IncellDx, Inc have signed an exclusive distribution agreement. The commercial partnership brings the power of cell by cell multiplex diagnostics for solid tumors carcinomas that can now be analyzed for molecular and protein biomarkers by flow cytometry. Included in the deal are: IncellDx’s patented single-cell assays for quantifying PD-L1 on tumor cells and immune cell subtypes; patented single-cell assay for HPV E6/ E7 mRNA detection in cervical samples; and, its incellPREP singlecell preparation kit for solid tissues including tumors.
Researchers at AIIMS, New Delhi have completed a successful study utilizing IncellDx’s next generation (3Dx) investigational molecular assay which quantifies E6, E7 mRNA overexpression in single cells simultaneously with the measurement of cell cycle and cell proliferation, the hallmark of progressive disease.
IncellDx is a molecular diagnostics company dedicated to revolutionizing healthcare one cell at a time. By combining molecular diagnostics with high throughput cellular analysis, the company’s focus is on critical life threatening diseases in the areas of cancer, specifically lung, cervical, head and neck, bladder, cancers.
LifeCell Initiates Development of
Large Scale Manufacturing of MSCs
LifeCell, India’s first & largest stem cell bank in the country, a pioneer in stem cell research has embarked on a journey to develop large scale manufacturing of Mesenchymal Stem Cells (MSCs).
Mesenchymal Stem Cells are one type of master stem cells that have the potential to form bone, cartilage, muscle and adipose tissues, thereby making them capable of being used in the several therapeutic areas. Importantly these MSC’s can be made available off-the-shelf for immediate treatment as they don’t need donor-recipient matching.
The potential of these MSCs of medical conditions are being checked in 50+ clinical trials around the world, with several companies like TiGenix, Mesoblast, etc., are also receiving market approvals in many countries such as Europe, Canada, Japan, and Australia. Even in India recently, the DCGI provided a limited approval to Stempeutics to market their MSC product for treatment of Critical Limb Ischemia.
LifeCell, India’s first & largest stem cell bank in the country, a pioneer in stem cell research has embarked on a journey to develop large scale manufacturing of Mesenchymal Stem Cells (MSCs).
Mesenchymal Stem Cells are one type of master stem cells that have the potential to form bone, cartilage, muscle and adipose tissues, thereby making them capable of being used in the several therapeutic areas. Importantly these MSC’s can be made available off-the-shelf for immediate treatment as they don’t need donor-recipient matching.
The potential of these MSCs of medical conditions are being checked in 50+ clinical trials around the world, with several companies like TiGenix, Mesoblast, etc., are also receiving market approvals in many countries such as Europe, Canada, Japan, and Australia. Even in India recently, the DCGI provided a limited approval to Stempeutics to market their MSC product for treatment of Critical Limb Ischemia.
Historic Deal Signed Between Panacea
Biotec & Serum Institute of India
Panacea Biotec Ltd. (PBL) is delighted to announce the collaboration with signing of two long term agreements with Serum Institute of India Pvt. Ltd. (SII) and SII’s wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO). Under the collaboration SII is entitled to manufacture & sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed & commercialized by Panacea Biotec, a first of its kind in this category.
WHO prequalified IPV is essential to successfully eradicating Polio across the globe, an effort that has already cost USD 20 Billion worldwide. There is a Global Polio Eradication Initiative (GPEI) in place & Global Alliance for Vaccine Initiative (GAVI) has been supporting the program since 2013 having allocated USD 430 Million till 2018 with an additional donor pledge of USD 23 Million for 2019. At present GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good.
Global demand of IPV/ IPV containing vaccines is estimated to rise significantly from ~100 Million in the year 2020 till supply constraints remain, to 250-350 Million doses every year starting 2022 depending upon a two or three dose schedule as Strategic Advisory Group of Experts (SAGE) on Immunization in April 2017 has recommended at least 2 doses of IPV in the routine Immunization schedule of the countries post OPV withdrawal
Panacea Biotec Ltd. (PBL) is delighted to announce the collaboration with signing of two long term agreements with Serum Institute of India Pvt. Ltd. (SII) and SII’s wholly owned subsidiary, Bilthovan Biologicals B.V. (BBIO). Under the collaboration SII is entitled to manufacture & sell fully liquid Whole cell Pertussis (wP) and Salk based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed & commercialized by Panacea Biotec, a first of its kind in this category.
WHO prequalified IPV is essential to successfully eradicating Polio across the globe, an effort that has already cost USD 20 Billion worldwide. There is a Global Polio Eradication Initiative (GPEI) in place & Global Alliance for Vaccine Initiative (GAVI) has been supporting the program since 2013 having allocated USD 430 Million till 2018 with an additional donor pledge of USD 23 Million for 2019. At present GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good.
Global demand of IPV/ IPV containing vaccines is estimated to rise significantly from ~100 Million in the year 2020 till supply constraints remain, to 250-350 Million doses every year starting 2022 depending upon a two or three dose schedule as Strategic Advisory Group of Experts (SAGE) on Immunization in April 2017 has recommended at least 2 doses of IPV in the routine Immunization schedule of the countries post OPV withdrawal
Lupin Forays into OTC Segment with Softovac
Pharma major Lupin Limited (Lupin) has made a foray into the over-the-counter (OTC) segment under the ‘Lupin Life Consumer Healthcare’ umbrella with the pan-India launch of Softovac. A 34- year old legacy brand, Softovac has been trusted by millions of consumers who suffer from constipation and irregular bowel habits.
Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report , the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores) mark by 2026. Softovac’s shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan-India roll-out was initiated.
Softovac is a bowel regulator made with 100 percent natural actives like Isabgol, Sonamukhi, Harad, Mulethi, Gulab dal (ingredient), Amaltas, and Saunf, all of which are time-tested ingredients known to provide effective relief from constipation and irregular bowel habits.
Pharma major Lupin Limited (Lupin) has made a foray into the over-the-counter (OTC) segment under the ‘Lupin Life Consumer Healthcare’ umbrella with the pan-India launch of Softovac. A 34- year old legacy brand, Softovac has been trusted by millions of consumers who suffer from constipation and irregular bowel habits.
Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report , the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores) mark by 2026. Softovac’s shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan-India roll-out was initiated.
Softovac is a bowel regulator made with 100 percent natural actives like Isabgol, Sonamukhi, Harad, Mulethi, Gulab dal (ingredient), Amaltas, and Saunf, all of which are time-tested ingredients known to provide effective relief from constipation and irregular bowel habits.
Evofem Biosciences Completes
Enrollment of Amphora Phase 3 Trial
Evofem Biosciences, a biotechnology company developing innovative products to fill women’s unmet healthcare needs, announced early completion of enrollment in its phase 3 clinical trial evaluating Amphora (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy. Clinical trial data is expected in the first quarter of 2019.
This single-arm, open-label, multicenter, phase 3 clinical trial enrolled over 1,350 women aged 18-35 at risk of pregnancy at over 100 centers in the United States. The primary endpoint of the study is the contraceptive efficacy of Amphora over seven cycles of use.
Amphora is concurrently being evaluated in a double-blinded placebo-controlled phase 2b/3 trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women. This sexually transmitted infection (STI) trial, which announced first patient enrollment on January 23, 2018, is designed to enroll approximately 850 women at up to 20 centers in the United States. Patients will be on-study for a four-month interventional period and subsequent one-month follow-up period
Evofem Biosciences, a biotechnology company developing innovative products to fill women’s unmet healthcare needs, announced early completion of enrollment in its phase 3 clinical trial evaluating Amphora (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy. Clinical trial data is expected in the first quarter of 2019.
This single-arm, open-label, multicenter, phase 3 clinical trial enrolled over 1,350 women aged 18-35 at risk of pregnancy at over 100 centers in the United States. The primary endpoint of the study is the contraceptive efficacy of Amphora over seven cycles of use.
Amphora is concurrently being evaluated in a double-blinded placebo-controlled phase 2b/3 trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women. This sexually transmitted infection (STI) trial, which announced first patient enrollment on January 23, 2018, is designed to enroll approximately 850 women at up to 20 centers in the United States. Patients will be on-study for a four-month interventional period and subsequent one-month follow-up period
15TH EDITION OF CLEAN INDIA SHOW TO KICK-START IN
MUMBAI ON JANUARY 18, 2018
The inaugural day will feature sessions on technologies for solid waste management and reuse and recycling of sewage and industrial waste water treatment, among other topics. Vinod Kumar Jindal, Joint Secretary and mission Director, SBM, Ministry of Housing and Urban Affairs will make a special address at this session.
“Waste to energy technology is an essential aspect of Solid Waste Management. It is all the more pertinent in a country like India where the metro cities produce nearly 2 lakh tons MSW per day. While we are using our energies to dispose of this waste, developed nations are converting waste into energy and profiting from it. We have brought together some of the best minds in the world who will share their knowledge on best practices in waste management,†says Mangala Chandran, Director, VIS Group.
The second day will host the first ever show on infection control and hospital hygiene in India. Inaugurated by Dr Deepak Ramchandra Sawant, Hon’ble Minister for Public Health & Family Welfare, Government of Maharashtra the programme will see the participation of several leaders from the fraternity. “It will also witness the launch of India’s first WhatsApp group formed by microbiologists and infection control officials from over 400 hospitals in India. A landmark development, the WhatsApp group will facilitate free flow of information and real time updates on hospital hygiene,†says Jayaraman Nair, Chairman, VIS Group.
The third and concluding day, Jan 20 will host dedicated conferences on Facility Management and Laundry, dry cleaning and textile care.
“With more than ten thousand trade visitors, buyers, technology seekers, start-ups and international companies converging at the exhibition, this will be one of the largest of its kind shows,†adds Mangala Chandran. More than twenty seven industrial segments, corporate houses, malls, multiplexes, educational institutions, railways, airports, State Transport Authorities, Municipal Corporations, and Defence and Naval Departments are expected to visit the show to source the latest solutions that will be on display from across the world.
For further details, please contact:
Harshala Nayak Kiran Rao
Media Manager Account Manager
Spin Communiqué Spin Communiqué
Tel: 09619700161 Tel: 09619700164
Email: harshalan@spincommunique.com kiran@spincommunique.com
Mumbai Mumbai
- ASIA'S LARGEST EVENT ON PROFESSIONAL CLEANING, CLEAN INDIA SHOW ALONG WITH
WASTE TECHNOLOGY EXPO, LAUNDREX INDIA EXPO AND CAR CARE EXPO, TO BE
INAUGURATED BY DR RANJIT PATIL, MINISTER OF STATE, HOME (URBAN), URBAN
DEVELOPMENT, GOVERNMENT OF MAHARASHTRA
- DR DEEPAK SAWANT, MINISTER FOR PUBLIC HEALTH & FAMILY WELFARE, GOVERNMENT OF MAHARASHTRA TO INAUGURATE CONFERENCE ON INFECTION CONTROL & HOSPITAL HYGIENE ON JANUARY 19
The inaugural day will feature sessions on technologies for solid waste management and reuse and recycling of sewage and industrial waste water treatment, among other topics. Vinod Kumar Jindal, Joint Secretary and mission Director, SBM, Ministry of Housing and Urban Affairs will make a special address at this session.
“Waste to energy technology is an essential aspect of Solid Waste Management. It is all the more pertinent in a country like India where the metro cities produce nearly 2 lakh tons MSW per day. While we are using our energies to dispose of this waste, developed nations are converting waste into energy and profiting from it. We have brought together some of the best minds in the world who will share their knowledge on best practices in waste management,†says Mangala Chandran, Director, VIS Group.
The second day will host the first ever show on infection control and hospital hygiene in India. Inaugurated by Dr Deepak Ramchandra Sawant, Hon’ble Minister for Public Health & Family Welfare, Government of Maharashtra the programme will see the participation of several leaders from the fraternity. “It will also witness the launch of India’s first WhatsApp group formed by microbiologists and infection control officials from over 400 hospitals in India. A landmark development, the WhatsApp group will facilitate free flow of information and real time updates on hospital hygiene,†says Jayaraman Nair, Chairman, VIS Group.
The third and concluding day, Jan 20 will host dedicated conferences on Facility Management and Laundry, dry cleaning and textile care.
“With more than ten thousand trade visitors, buyers, technology seekers, start-ups and international companies converging at the exhibition, this will be one of the largest of its kind shows,†adds Mangala Chandran. More than twenty seven industrial segments, corporate houses, malls, multiplexes, educational institutions, railways, airports, State Transport Authorities, Municipal Corporations, and Defence and Naval Departments are expected to visit the show to source the latest solutions that will be on display from across the world.
For further details, please contact:
Harshala Nayak Kiran Rao
Media Manager Account Manager
Spin Communiqué Spin Communiqué
Tel: 09619700161 Tel: 09619700164
Email: harshalan@spincommunique.com kiran@spincommunique.com
Mumbai Mumbai
MedGenome Receives Accreditation
from CAP
MedGenome, India’s market leader in genetic diagnostics announced today that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an on-site inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors and is designed to go well beyond regulatory compliance.
During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standards of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world.
With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, PGS/PGD, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and also the high resolution HLA typing.
MedGenome, India’s market leader in genetic diagnostics announced today that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an on-site inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors and is designed to go well beyond regulatory compliance.
During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standards of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world.
With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, PGS/PGD, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and also the high resolution HLA typing.
DocExa by GlobalSpace Technologies
Launched at DigiPharmaX Awards 2017
GlobalSpace Technologies launched DocExa, “an exclusive digital platform developed using AI technology to help Doctors efficiently manage their patients & other engagementsâ€, during DigiPharmaX (Digital Pharma Excellence) Awards 2017 at Mumbai. DocExa leverages artificial intelligence, cloud & mobility technology to empower Doctor, Patients & Pharma companies for meaningful & transparent engagement.
DocExa helps create a transparent engagement between the Doctor and Pharmaceutical communities, while adhering to the Government regulations and guidelines like UCPMP. Additionally, doctors can file ADR through DocExa which provides real-time access of adverse drug reactions reports to Pharmaceutical companies and helps them to improve the quality of drugs. Doctors can also avail medico-legal consulting from a team of trusted, verified and reputed Legal Advisors, with the help of just a click or a tap.
Today 60% of India’s population lies in tier two or three states. With greater penetration of mobility and growing number of internet users in rural India, pharmaceutical companies will be able to expand their reach to connect with increasing number of doctors through the DocExa platform. Leveraging technology, Doctors based in rural areas will be able to stay updated with the latest medical advancements and drug brands in the market, creating a win-win for the entire industry.
Speaking on the launch, Mr. Krishna Singh, Founder, Chairman & Managing Director, GlobalSpace Technologies said, “DocExa is the industry’s first AI driven Doctor-Pharmaceutical-Patient Connect Platform. In India, still the Doctor- Patient ratio is abysmally low at 1:1700. In its evolved form Docexa can enable Doctors to carry out differential diagnostics & help more number of patients, efficiently.
GlobalSpace Technologies launched DocExa, “an exclusive digital platform developed using AI technology to help Doctors efficiently manage their patients & other engagementsâ€, during DigiPharmaX (Digital Pharma Excellence) Awards 2017 at Mumbai. DocExa leverages artificial intelligence, cloud & mobility technology to empower Doctor, Patients & Pharma companies for meaningful & transparent engagement.
DocExa helps create a transparent engagement between the Doctor and Pharmaceutical communities, while adhering to the Government regulations and guidelines like UCPMP. Additionally, doctors can file ADR through DocExa which provides real-time access of adverse drug reactions reports to Pharmaceutical companies and helps them to improve the quality of drugs. Doctors can also avail medico-legal consulting from a team of trusted, verified and reputed Legal Advisors, with the help of just a click or a tap.
Today 60% of India’s population lies in tier two or three states. With greater penetration of mobility and growing number of internet users in rural India, pharmaceutical companies will be able to expand their reach to connect with increasing number of doctors through the DocExa platform. Leveraging technology, Doctors based in rural areas will be able to stay updated with the latest medical advancements and drug brands in the market, creating a win-win for the entire industry.
Speaking on the launch, Mr. Krishna Singh, Founder, Chairman & Managing Director, GlobalSpace Technologies said, “DocExa is the industry’s first AI driven Doctor-Pharmaceutical-Patient Connect Platform. In India, still the Doctor- Patient ratio is abysmally low at 1:1700. In its evolved form Docexa can enable Doctors to carry out differential diagnostics & help more number of patients, efficiently.
Purushottam Agrawal, Founder
Ajanta Pharma Ltd Receives Lifetime
Achievement Award
Purushottam Agrawal, Chairman – Gencrest & Founder – Ajanta Pharma Ltd receives Jeevan Gaurav Navratna Sammaan by Maharashtra Rajya Agrawal Sammelan for his unparalleled achievements in the field of business as well as philanthropy. A visionary businessman and compassionate human being, he embodies all that is best in the entrepreneurial spirit of the famed Marwari community that has been the backbone of the saga of India’s commerce, industry and philanthropy.
Coming from a very humble background in a small remote village in the state of Maharashtra, his entrepreneurial journey started with a borrowed capital of Rs. 10,000 in 1973. His efforts turned a small repacking unit in a garage in Aurangabad into a pharmaceutical empire. Ajanta Pharma operates in 45 countries, which includes US, Europe, Asia and most of the least developed countries in African continent. The company, today, has a market capitalization of over Rs 13,000 Cr and employee strength of around 8,000 across the globe. His astute business acumen has resulted in introducing several revolutionary 1st to the market products in India.
Purushottam Agrawal, Chairman – Gencrest & Founder – Ajanta Pharma Ltd receives Jeevan Gaurav Navratna Sammaan by Maharashtra Rajya Agrawal Sammelan for his unparalleled achievements in the field of business as well as philanthropy. A visionary businessman and compassionate human being, he embodies all that is best in the entrepreneurial spirit of the famed Marwari community that has been the backbone of the saga of India’s commerce, industry and philanthropy.
Coming from a very humble background in a small remote village in the state of Maharashtra, his entrepreneurial journey started with a borrowed capital of Rs. 10,000 in 1973. His efforts turned a small repacking unit in a garage in Aurangabad into a pharmaceutical empire. Ajanta Pharma operates in 45 countries, which includes US, Europe, Asia and most of the least developed countries in African continent. The company, today, has a market capitalization of over Rs 13,000 Cr and employee strength of around 8,000 across the globe. His astute business acumen has resulted in introducing several revolutionary 1st to the market products in India.
Dr. Reddy’s Launches Melphalan
Hydrochloride for Injection in US Market
Dr. Reddy’s Laboratories Ltd has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for Injection in the United States market approved by the US Food and Drug Administration (USFDA).
The Alkeran brand and generic had US sales of approximately USD 107 million MAT for the most recent twelve months ending in October 2017 according to IMS Health.
Dr. Reddy’s Melphalan Hydrochloride for Injection is available in a carton containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.
Dr. Reddy’s Laboratories Ltd has launched Melphalan Hydrochloride for Injection, a therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for Injection in the United States market approved by the US Food and Drug Administration (USFDA).
The Alkeran brand and generic had US sales of approximately USD 107 million MAT for the most recent twelve months ending in October 2017 according to IMS Health.
Dr. Reddy’s Melphalan Hydrochloride for Injection is available in a carton containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent.
Clinigen Extends Deal with Eisai to Supply
Medicines to Africa
Clinigen Group plc the global pharmaceutical and services company, has extended its exclusive agreement with Eisai Europe Ltd to obtain the marketing authorisation and subsequently launch Halaven (eribulin), Fycompa (perampanel) and Lenvima (lenvatinib) into 10 African countries.
The new agreement follows the successful launch of Halaven and Fycompa in South Africa in February and July 2017 respectively. All three medicines will be submitted for registration in Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval.
Eribulin is currently licensed in South Africa only for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their disease. These would usually include an anthracycline and taxane, unless not suitable. In 2012, breast cancer was the leading cancer among the female population in the majority of countries in Africa and is responsible for one in four diagnosed cancers and one in five cancer deaths in women worldwide.
Perampanel is currently licensed in South Africa only for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Across Africa, the prevalence of epilepsy varies between 2.2 to 58 cases per 1000 people, with an average prevalence of 15.8 per 1000. The World Health Organisation estimates that in Africa, epilepsy directly affects 10 million people.
Lenvatinib is not currently registered in any of the 10 countries. In Europe, lenvatinib is licensed for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine. DTC is the most common form of thyroid cancer. Overall annual incidence globally is about 1/10,000, and the incidence appears to be increasing.
Clinigen Group plc the global pharmaceutical and services company, has extended its exclusive agreement with Eisai Europe Ltd to obtain the marketing authorisation and subsequently launch Halaven (eribulin), Fycompa (perampanel) and Lenvima (lenvatinib) into 10 African countries.
The new agreement follows the successful launch of Halaven and Fycompa in South Africa in February and July 2017 respectively. All three medicines will be submitted for registration in Namibia, Botswana, Zimbabwe, Zambia, Ghana, Nigeria, Kenya, Uganda and Tanzania, subject to local regulatory approval.
Eribulin is currently licensed in South Africa only for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their disease. These would usually include an anthracycline and taxane, unless not suitable. In 2012, breast cancer was the leading cancer among the female population in the majority of countries in Africa and is responsible for one in four diagnosed cancers and one in five cancer deaths in women worldwide.
Perampanel is currently licensed in South Africa only for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older. Across Africa, the prevalence of epilepsy varies between 2.2 to 58 cases per 1000 people, with an average prevalence of 15.8 per 1000. The World Health Organisation estimates that in Africa, epilepsy directly affects 10 million people.
Lenvatinib is not currently registered in any of the 10 countries. In Europe, lenvatinib is licensed for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine. DTC is the most common form of thyroid cancer. Overall annual incidence globally is about 1/10,000, and the incidence appears to be increasing.
IIL Launches India’s 1st Intranasal
Vaccine for Parvo Virus in Dogs
Indian Immunologicals Limited (IIL) launches India’s first “nasal vaccine against dreaded Parvo virus†for Dogs- Branded as MEGAVAC-P NASAL the vaccine will protect pups as young as 4-6 weeks old. MEGAVAC-P NASAL is an intranasal vaccine containing live attenuated canine Parvovirus grown in cell culture. Hitherto only an injectable vaccine was available for vaccination against Parvo virus.
Canine parvovirus (CPV) infection in dogs has been associated with outbreaks of acute gastroenteritis characterized by bloody diarrhea, vomiting, depression, leukopenia, pyrexia, dehydration, with very high mortality rate. Puppies below 6 months of age are severely affected and adult dogs having inadequate immunity suffer from the disease. Interference of maternal antibodies, long survival rate of the virus in the environment, high infectious /contagious nature of the virus and susceptibility of the pups and weak animals are the factors that propagate the disease. Contaminated surroundings especially in kennels make it a difficult disease to control. Mortality rates are very high in affected dogs. Effective immunization is essential for the protection of the individual pet and the decrease of virus population. Live attenuated vaccines are currently used worldwide affording prolonged immunity that would confer protection against disease.
When MEGAVAC-P NASAL gets absorbed in the mucosal membrane in the nose it generates a mucosal immune response against the Canine Parvo Virus. Some of the important advantages are that Vaccine is administered at the source of natural infection (nasal cavity), provides fast immune response leading to superior protection against diseasecausing pathogens, safe, long-lasting and broad protection, less likely to cause allergic reactions and higher safety. It is extremely convenient to use the intra nasal vaccine than the injectable vaccine.
Indian Immunologicals Limited (IIL) launches India’s first “nasal vaccine against dreaded Parvo virus†for Dogs- Branded as MEGAVAC-P NASAL the vaccine will protect pups as young as 4-6 weeks old. MEGAVAC-P NASAL is an intranasal vaccine containing live attenuated canine Parvovirus grown in cell culture. Hitherto only an injectable vaccine was available for vaccination against Parvo virus.
Canine parvovirus (CPV) infection in dogs has been associated with outbreaks of acute gastroenteritis characterized by bloody diarrhea, vomiting, depression, leukopenia, pyrexia, dehydration, with very high mortality rate. Puppies below 6 months of age are severely affected and adult dogs having inadequate immunity suffer from the disease. Interference of maternal antibodies, long survival rate of the virus in the environment, high infectious /contagious nature of the virus and susceptibility of the pups and weak animals are the factors that propagate the disease. Contaminated surroundings especially in kennels make it a difficult disease to control. Mortality rates are very high in affected dogs. Effective immunization is essential for the protection of the individual pet and the decrease of virus population. Live attenuated vaccines are currently used worldwide affording prolonged immunity that would confer protection against disease.
When MEGAVAC-P NASAL gets absorbed in the mucosal membrane in the nose it generates a mucosal immune response against the Canine Parvo Virus. Some of the important advantages are that Vaccine is administered at the source of natural infection (nasal cavity), provides fast immune response leading to superior protection against diseasecausing pathogens, safe, long-lasting and broad protection, less likely to cause allergic reactions and higher safety. It is extremely convenient to use the intra nasal vaccine than the injectable vaccine.
Hilleman Laboratories Partners with
Innovative Future Vaccine Manufacturing Hub
Hilleman Laboratories, an equal joint-venture partnership between MSD and Wellcome Trust, is honored to be one of the key partners of the new Future Vaccine Manufacturing Hub led by Imperial College London. The hub has been established to increase immunisation coverage across the globe and improve the response to disease outbreaks through the rapid and cost-effective deployment of vaccines. £10 million of funding has been granted by the UK Department for Health, and will be managed by the Engineering and Physical Sciences Research Council (EPSRC).
The all-new Future Vaccine Manufacturing Hub aims to address two major challenges facing creation of future vaccine manufacturing systems: How to design vaccine production systems that can produce tens of thousands of new doses within weeks of a new threat being identified; and How to improve current manufacturing processes and change the way vaccines are manufactured, stabilized and stored so that existing and new diseases can be prevented effectively, at reduced costs.
The hub will collaborate with the Developing Countries Vaccine Manufacturing Network on manufacturing projects in India, Vietnam, Bangladesh, Uganda and China. Integrated approaches that will be explored by researchers at the Hub include the development of synthetic RNA vaccines which can be rapidly manufactured; the rapid production of yeast and bacterially-expressed particles that mimic components of pathogenic viruses and bacteria; and protein stabilisation to preserve vaccines at high temperatures, avoiding the need for refrigerated distribution and storage.
The Hub is led by Imperial College London, and also involves the Universities of Bristol, Cambridge and Nottingham, Cranfield University, the Clinical Biotechnology Centre (CBC) as part of NHS Blood and Transplant, UK National Biologics Manufacturing Centre, CPI and National Institute for Biological Standards and Control (NIBSC). The hub will also collaborate with the Developing Countries Vaccine Manufacturing Network (DCVMN) and African Vaccine Manufacturers Initiative (AVMI) to maximise dissemination of knowledge.
Hilleman Laboratories, an equal joint-venture partnership between MSD and Wellcome Trust, is honored to be one of the key partners of the new Future Vaccine Manufacturing Hub led by Imperial College London. The hub has been established to increase immunisation coverage across the globe and improve the response to disease outbreaks through the rapid and cost-effective deployment of vaccines. £10 million of funding has been granted by the UK Department for Health, and will be managed by the Engineering and Physical Sciences Research Council (EPSRC).
The all-new Future Vaccine Manufacturing Hub aims to address two major challenges facing creation of future vaccine manufacturing systems: How to design vaccine production systems that can produce tens of thousands of new doses within weeks of a new threat being identified; and How to improve current manufacturing processes and change the way vaccines are manufactured, stabilized and stored so that existing and new diseases can be prevented effectively, at reduced costs.
The hub will collaborate with the Developing Countries Vaccine Manufacturing Network on manufacturing projects in India, Vietnam, Bangladesh, Uganda and China. Integrated approaches that will be explored by researchers at the Hub include the development of synthetic RNA vaccines which can be rapidly manufactured; the rapid production of yeast and bacterially-expressed particles that mimic components of pathogenic viruses and bacteria; and protein stabilisation to preserve vaccines at high temperatures, avoiding the need for refrigerated distribution and storage.
The Hub is led by Imperial College London, and also involves the Universities of Bristol, Cambridge and Nottingham, Cranfield University, the Clinical Biotechnology Centre (CBC) as part of NHS Blood and Transplant, UK National Biologics Manufacturing Centre, CPI and National Institute for Biological Standards and Control (NIBSC). The hub will also collaborate with the Developing Countries Vaccine Manufacturing Network (DCVMN) and African Vaccine Manufacturers Initiative (AVMI) to maximise dissemination of knowledge.
Unichem Completes Sale and Transfer
of Domestic Formulations Business to Torrent Pharma
Unichem Laboratories Limited (Unichem) has completed the sale and transfer of its domestic formulations business in India and Nepal, on a going concern basis by way of slump sale, to Torrent Pharmaceuticals Limited (TPL).
Going ahead Unichem will focus attention on all aspects of the international business including finished formulations, API, contract manufacturing and contract research; increase its investments in R & D in the New Chemical and Biological Entities (NCE & NBE), Bio-similars and complex generics; and reward shareholders
Mr. Jayendra Shah, played a pivotal role in successful consummation of the transaction. He was the sole financial advisor to Unichem on negotiations, valuations and deal closure. N A Shah Associates LLP, Chartered Accountants were the advisors for tax and related matters and Trans Continental Capital Advisors Pvt. Ltd. were the strategic advisors
Unichem Laboratories Limited (Unichem) has completed the sale and transfer of its domestic formulations business in India and Nepal, on a going concern basis by way of slump sale, to Torrent Pharmaceuticals Limited (TPL).
Going ahead Unichem will focus attention on all aspects of the international business including finished formulations, API, contract manufacturing and contract research; increase its investments in R & D in the New Chemical and Biological Entities (NCE & NBE), Bio-similars and complex generics; and reward shareholders
Mr. Jayendra Shah, played a pivotal role in successful consummation of the transaction. He was the sole financial advisor to Unichem on negotiations, valuations and deal closure. N A Shah Associates LLP, Chartered Accountants were the advisors for tax and related matters and Trans Continental Capital Advisors Pvt. Ltd. were the strategic advisors
Hurun Names Biocon's Kiran Mazumdar
Shaw As the Most Respected Entrepreneur in 2017
The most coveted awards in individual excellence for India Inc., set up by Hurun Report was held with much fanfare at Four Seasons Hotel in Worli, Mumbai on 14th December 2017. Kiran Mazumdar-Shaw, chairman of Biocon and Rana Kapoor, CEO of Yes Bank were named as the 2017 Most Respected Entrepreneurs of the Year for their role in the growth of their individual business, job creation, philanthropy, and overall contribution to the development of the nation.
The other coveted awards were received by Jitendra Virwani, Chairman and MD, Embassy Group, who is named 2017 Impact Entrepreneur of the Year, and Arokiaswamy Velumani, MD of Thyrocare Technologies Ltd. as 2017 Self-Made Entrepreneur of the Year.
Five billionaires won 2017 Industry Achievement Awards for their contribution in their respective sectors. They are Anant Goenka, MD of CEAT Ltd., for manufacturing (tyres), Ajit Isaac, Chairman of the Board of Directors of Quess Corp, for Services, Arun Chittilappilly, MD of Wonderla Holidays Ltd for Amusement Parks and Dr. GSK Velu, Chairman & MD, Trivitron Healthcare Group of Companies, for Medical Technology.
Kiran Mazumdar-Shaw was the only self-made woman billionaire entrepreneur from India in the Hurun India Rich List 2017. She has grown her business by 200% in the last one year alone. Rana Kapoor on the other hand has been recognised for the innovation in the financial sector in India. The Impact Entrepreneur Award is given to Jitendra Virwani who has not only grown his business of innovative co-working spaces but has significant achievements in philanthropy by adopting 36 schools in Bangalore.
Hurun Awards are given to individuals who have made significant contributions to the economy. The awards are bestowed after careful data gathering and qualitative research of India’s richest individuals. The Hurun Most Respected Entrepreneur Award was first established in 1999. This annual award focusses on two growing economies China and India. The Award is set up to recognise the success stories of entrepreneurs and talk about their stories on a global platform. The London based Hurun Report has been recognising the contributions made by entrepreneurs towards nation building by creating more jobs, build big businesses and engaging in philanthropy.
Hurun Awards is one of the most objective awards for individual achievement in wealth creation and nation building. The jury for the Hurun Awards consists of members from Hurun India and China teams, top entrepreneurs from India and UK, members from the Hurun India Rich List, and also senior economists who track India and China.
The most coveted awards in individual excellence for India Inc., set up by Hurun Report was held with much fanfare at Four Seasons Hotel in Worli, Mumbai on 14th December 2017. Kiran Mazumdar-Shaw, chairman of Biocon and Rana Kapoor, CEO of Yes Bank were named as the 2017 Most Respected Entrepreneurs of the Year for their role in the growth of their individual business, job creation, philanthropy, and overall contribution to the development of the nation.
The other coveted awards were received by Jitendra Virwani, Chairman and MD, Embassy Group, who is named 2017 Impact Entrepreneur of the Year, and Arokiaswamy Velumani, MD of Thyrocare Technologies Ltd. as 2017 Self-Made Entrepreneur of the Year.
Five billionaires won 2017 Industry Achievement Awards for their contribution in their respective sectors. They are Anant Goenka, MD of CEAT Ltd., for manufacturing (tyres), Ajit Isaac, Chairman of the Board of Directors of Quess Corp, for Services, Arun Chittilappilly, MD of Wonderla Holidays Ltd for Amusement Parks and Dr. GSK Velu, Chairman & MD, Trivitron Healthcare Group of Companies, for Medical Technology.
Kiran Mazumdar-Shaw was the only self-made woman billionaire entrepreneur from India in the Hurun India Rich List 2017. She has grown her business by 200% in the last one year alone. Rana Kapoor on the other hand has been recognised for the innovation in the financial sector in India. The Impact Entrepreneur Award is given to Jitendra Virwani who has not only grown his business of innovative co-working spaces but has significant achievements in philanthropy by adopting 36 schools in Bangalore.
Hurun Awards are given to individuals who have made significant contributions to the economy. The awards are bestowed after careful data gathering and qualitative research of India’s richest individuals. The Hurun Most Respected Entrepreneur Award was first established in 1999. This annual award focusses on two growing economies China and India. The Award is set up to recognise the success stories of entrepreneurs and talk about their stories on a global platform. The London based Hurun Report has been recognising the contributions made by entrepreneurs towards nation building by creating more jobs, build big businesses and engaging in philanthropy.
Hurun Awards is one of the most objective awards for individual achievement in wealth creation and nation building. The jury for the Hurun Awards consists of members from Hurun India and China teams, top entrepreneurs from India and UK, members from the Hurun India Rich List, and also senior economists who track India and China.
Piramal Enterprises Acquires Digeplex
and Associated Brands
Piramal Enterprises’ Consumer Products Division announces the acquisition of Digeplex and associated brands from Shreya Lifesciences. This acquisition strengthens Piramal’s position in the Gastro-Intestinal (GI) segment and is complementary to its existing brands - Polycrol and Naturolax, in the GI segment. These brands hold rich legacy amongst consumers across India.
Nandini Piramal, Executive Director, Piramal Enterprises said, “Our aim is to be a significant player in every business under the Healthcare vertical of Piramal Enterprises Limited. Acquisition is one of the important routes to help us achieve our goal and in the last 2 years, we have completed three acquisitions in the Consumer Products business, itself. We believe Digeplex and its associated brands, are a strategic fit for our product portfolio that will help us move closer towards our stated objective. The combination of organically growing our existing core brands and strategically acquiring accretive brands, has helped us create a powerful portfolio of OTC brands in India.â€
Kedar Rajadnye, COO - Consumer Products Division, Piramal Enterprises said, “Today’s consumers lead a fast and hectic lifestyle, which coupled with stress and infrequent food habits, tends to take a toll on their digestive wellbeing. As per AIOCD October 2017 data, the Gastro Intestinal market in India, which addresses the constipation, diarrhoea and appetite stimulant categories, is a ~INR 13,000 Crore market and has grown at ~11% y-o-y. We already have a well-established antacid brand – Polycrol, and Naturolax, an isabgol husk based brand which helps in treating constipation. With these additions, our basket of offerings in the Gastro Intestinal market will become larger.
We expect these brands to leverage the strong sales and distribution capability that we have built over the years and help us improve our profit margins. This brand has a huge potential to become a power brand in its category.â€
Piramal Enterprises’ Consumer Products Division announces the acquisition of Digeplex and associated brands from Shreya Lifesciences. This acquisition strengthens Piramal’s position in the Gastro-Intestinal (GI) segment and is complementary to its existing brands - Polycrol and Naturolax, in the GI segment. These brands hold rich legacy amongst consumers across India.
Nandini Piramal, Executive Director, Piramal Enterprises said, “Our aim is to be a significant player in every business under the Healthcare vertical of Piramal Enterprises Limited. Acquisition is one of the important routes to help us achieve our goal and in the last 2 years, we have completed three acquisitions in the Consumer Products business, itself. We believe Digeplex and its associated brands, are a strategic fit for our product portfolio that will help us move closer towards our stated objective. The combination of organically growing our existing core brands and strategically acquiring accretive brands, has helped us create a powerful portfolio of OTC brands in India.â€
Kedar Rajadnye, COO - Consumer Products Division, Piramal Enterprises said, “Today’s consumers lead a fast and hectic lifestyle, which coupled with stress and infrequent food habits, tends to take a toll on their digestive wellbeing. As per AIOCD October 2017 data, the Gastro Intestinal market in India, which addresses the constipation, diarrhoea and appetite stimulant categories, is a ~INR 13,000 Crore market and has grown at ~11% y-o-y. We already have a well-established antacid brand – Polycrol, and Naturolax, an isabgol husk based brand which helps in treating constipation. With these additions, our basket of offerings in the Gastro Intestinal market will become larger.
We expect these brands to leverage the strong sales and distribution capability that we have built over the years and help us improve our profit margins. This brand has a huge potential to become a power brand in its category.â€
MedGenome Receives Accreditation
from CAP
MedGenome, India’s market leader in genetic diagnostics has announced that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an onsite inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. and is designed to go well beyond regulatory compliance.
During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standard of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world.
“Being awarded the accreditation by CAP is an extremely proud moment for us. It further validates our commitment to provide the highest standards in quality laboratory services†said Dr. V.L Ramprasad, COO MedGenome. “Having launched India’s first validated Liquid biopsy and the carrier screening tests, we are trying to find answers to some of the most complex diseases. We strive to provide the most accurate results based on thorough and rigorous processes to clinicians across India, so that they can produce the best outcomes for patientsâ€.
With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and high resolution HLA typing.
MedGenome, India’s market leader in genetic diagnostics has announced that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an onsite inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. and is designed to go well beyond regulatory compliance.
During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standard of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world.
“Being awarded the accreditation by CAP is an extremely proud moment for us. It further validates our commitment to provide the highest standards in quality laboratory services†said Dr. V.L Ramprasad, COO MedGenome. “Having launched India’s first validated Liquid biopsy and the carrier screening tests, we are trying to find answers to some of the most complex diseases. We strive to provide the most accurate results based on thorough and rigorous processes to clinicians across India, so that they can produce the best outcomes for patientsâ€.
With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and high resolution HLA typing.
A Turnkey Meeting to Add Fillip to India’s
Pre-eminent Position in Pharma Domain
The 2nd edition of the celebrated India Pharma Week, a UBM India initiative -- introduced last year to celebrate a decade of CPhI & P-MEC, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event -- witnessed one of its most significant events, the CEO Round Table.
The exclusive, closed-door Round Table was a congregation of India’s most influential CEOs, Presidents & Founders from leading pharmaceutical companies, and Policy Makers & Senior Representatives from Pharmaceutical Associations who engaged with one another on the vital issue of Make in India – Ensuring India’s Pharma Supremacy with a special focus on affordable healthcare in the urban and rural areas in India.
Speaking on the occasion of the CEO Round Table, Mr. Yogesh Mudras, Managing Director, UBM India said, “Renowned as the pharmacy hub of the world, the Indian pharma economy has been lauded for its rapid growth, with a CAGR of 17.6%. As we congregated for this elite knowledge sharing session, we confronted the Indian pharma industry at a very crucial juncture in its growth trajectory. While India ranks amongst the top four pharmaceutical markets in terms of volume of produced drugs, certain challenges continue to surround its pharma industry. India faces issues including a time-consuming approval process, dependence on China for cheaper API sources, sub-optimal infrastructure, lack of funding avenues, and a shortage of highly skilled talent, among others."
The best-in-class industry professionals who were a part of the exclusive meeting included D G Shah, Secretary General, Indian Pharmaceutical Alliance; Dinesh Dua, CEO & Director, Nector Lifesciences; S V Veeramani, Chairman & MD, Fourrts (India) Laboratories Pvt Ltd; Prashant Nagre, CEO, Fermenta Biotach; Ranga Iyer, Former MD, Wyeth; Rajiv Gulati, Former President, Ranbaxy; Suresh Subramanium, Senior VP & Head, Branded Formulations, South Asia; Ashok Bhattacharya, Executive Director/ Country Manager, Takeda Pharmaceuticals India Pvt Ltd; Prof. Pierre Pienaar, President, WPO; Dev Prakash Yadava, Managing Director , Shardachem; Dr. G.M. Warke, Founder & CMD HiMedia Laboratories; A. Vaidheesh, MD, GSK; Ziva Abraham, CEO, Microrite Inc; Srinivas Lanka, Vice Chairman Pharma and Bio Taskforce, Andhra Pradesh Economic Development Board; Kewal Handa, Director, Salus Lifesciences; B.G. Barve, Joint Managing Director, Bluecross Laboratories Pvt Ltd; S M Mudda, Director Global Strategy, Microlabs and Mr Yogesh Mudras, Managing Director, UBM India.
A representative body of the group comprising Kewal Handa, Dr. Dinesh Dua, Sriram Shrinivasan, S.M. Mudda and Yogesh Mudras later interacted with the media to discuss the key tenets of its proposals.
The 2nd edition of the celebrated India Pharma Week, a UBM India initiative -- introduced last year to celebrate a decade of CPhI & P-MEC, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event -- witnessed one of its most significant events, the CEO Round Table.
The exclusive, closed-door Round Table was a congregation of India’s most influential CEOs, Presidents & Founders from leading pharmaceutical companies, and Policy Makers & Senior Representatives from Pharmaceutical Associations who engaged with one another on the vital issue of Make in India – Ensuring India’s Pharma Supremacy with a special focus on affordable healthcare in the urban and rural areas in India.
Speaking on the occasion of the CEO Round Table, Mr. Yogesh Mudras, Managing Director, UBM India said, “Renowned as the pharmacy hub of the world, the Indian pharma economy has been lauded for its rapid growth, with a CAGR of 17.6%. As we congregated for this elite knowledge sharing session, we confronted the Indian pharma industry at a very crucial juncture in its growth trajectory. While India ranks amongst the top four pharmaceutical markets in terms of volume of produced drugs, certain challenges continue to surround its pharma industry. India faces issues including a time-consuming approval process, dependence on China for cheaper API sources, sub-optimal infrastructure, lack of funding avenues, and a shortage of highly skilled talent, among others."
The best-in-class industry professionals who were a part of the exclusive meeting included D G Shah, Secretary General, Indian Pharmaceutical Alliance; Dinesh Dua, CEO & Director, Nector Lifesciences; S V Veeramani, Chairman & MD, Fourrts (India) Laboratories Pvt Ltd; Prashant Nagre, CEO, Fermenta Biotach; Ranga Iyer, Former MD, Wyeth; Rajiv Gulati, Former President, Ranbaxy; Suresh Subramanium, Senior VP & Head, Branded Formulations, South Asia; Ashok Bhattacharya, Executive Director/ Country Manager, Takeda Pharmaceuticals India Pvt Ltd; Prof. Pierre Pienaar, President, WPO; Dev Prakash Yadava, Managing Director , Shardachem; Dr. G.M. Warke, Founder & CMD HiMedia Laboratories; A. Vaidheesh, MD, GSK; Ziva Abraham, CEO, Microrite Inc; Srinivas Lanka, Vice Chairman Pharma and Bio Taskforce, Andhra Pradesh Economic Development Board; Kewal Handa, Director, Salus Lifesciences; B.G. Barve, Joint Managing Director, Bluecross Laboratories Pvt Ltd; S M Mudda, Director Global Strategy, Microlabs and Mr Yogesh Mudras, Managing Director, UBM India.
A representative body of the group comprising Kewal Handa, Dr. Dinesh Dua, Sriram Shrinivasan, S.M. Mudda and Yogesh Mudras later interacted with the media to discuss the key tenets of its proposals.
Cadila Pharma Organised Walk-a-thon
to Raise Awareness on AIDS
On the occasion of World AIDS Day, the employees of Cadila Pharmaceuticals Ltd took a ‘Step to Stop AIDS’ by participating in an AIDS Walk-a-thon organised on Friday, December 1, 2017. The aim of the walk-a-thon was to raise awareness about AIDS and also to open a dialogue for discussion.
The walk-a-thon was flagged off at ISKCON and saw the enthusiastic participation of the company’s employees. Dressed in blue and white, over 150 employees marched to Prahladnagar raising slogans and banners to throw spotlight on AIDS prevention. Several key messages about this pandemic disease were highlighted as well as archaic, discriminatory myths were busted. Slogans such as “START TALKING, STOP HIVâ€, “SILENCE=DEATHâ€, “Kissing and Hugging doesn’t spread HIV†were carried by the participants.
Adding further fervour to this walkathon were the members of the Avengers Biker Club of Ahmedabad who had specially escorted the participants throughout their stride.
At the end of the walk the participants gathered together in a group and took an oath to remain committed to fight the battle against AIDS by continuing to spread awareness on the disease.
On the occasion of World AIDS Day, the employees of Cadila Pharmaceuticals Ltd took a ‘Step to Stop AIDS’ by participating in an AIDS Walk-a-thon organised on Friday, December 1, 2017. The aim of the walk-a-thon was to raise awareness about AIDS and also to open a dialogue for discussion.
The walk-a-thon was flagged off at ISKCON and saw the enthusiastic participation of the company’s employees. Dressed in blue and white, over 150 employees marched to Prahladnagar raising slogans and banners to throw spotlight on AIDS prevention. Several key messages about this pandemic disease were highlighted as well as archaic, discriminatory myths were busted. Slogans such as “START TALKING, STOP HIVâ€, “SILENCE=DEATHâ€, “Kissing and Hugging doesn’t spread HIV†were carried by the participants.
Adding further fervour to this walkathon were the members of the Avengers Biker Club of Ahmedabad who had specially escorted the participants throughout their stride.
At the end of the walk the participants gathered together in a group and took an oath to remain committed to fight the battle against AIDS by continuing to spread awareness on the disease.
First ‘South Asian and Indian Ancestry
Genetic Test’
Xcode, an innovative personal genomics company based out of Chennai was in the city, has announced the Worldwide launch of the first of its kind ‘South Asian Ancestry Genetic Test’ that will trace one’s ancestry in the global and South Asian sub-population level. The test will reveal information about oneself comparing the DNA samples of each individual with more than 35 ethnic groups in India, Pakistan, Nepal, Bangladesh and other regional countries to provide a detailed ancestry break-up.
Talking on this Occasion, Dr. Abdur Rub, Co-Founder and Chief Technology Officer, Xcode Life Sciences said - “Our unique heritage, our unique history, the history of our ancestors, is living within each of us! You may be 20, 30 or 50 years old, but your genes are 3 billion years old. For the first time in human history, genetic technology makes it possible to uncover this unique past that each of us carry in us. I am very excited that Xcode is launching world’s first ‘South Asian Ancestry Genetic Test’ through which your DNA is matched with more than 35 ethnic groups in India and other groups worldwide, and your most recent paternal ancestorâ€.
Present at the launch to to spread awareness on using genomics to deduce Indian ancestry was Dr. Analabha Basu, Associate Professor, National Institute of Biomedical Genomics. Sharing his views on the subject, he said, “Knowledge about the origin of the human species as a whole has the potential to reshape our society. The more we learn about our diversity, the more we learn how connected we are. It can lead to path-breaking medical discoveries and pave the way forward to research based on our DNA patterns.â€
Xcode will also help individuals to trace their paternal ancestry by evaluating your DNA which will decode ancient migratory patterns of their forefathers. Tracing our family tree is an activity that features in all our childhoods, but did any of us manage to reach beyond our grandparents or our great grandparents? All of us are products of generations of ancestry with a rich history and heritage, all embedded in our genes waiting to be uncovered. Every cell in our body contains DNA which can reveal everything from our family history to our ancestral migratory patterns and with Xcode’s innovative DNA ancestry test, you now have the chance to unravel this rich history written in your DNA.
Xcode, an innovative personal genomics company based out of Chennai was in the city, has announced the Worldwide launch of the first of its kind ‘South Asian Ancestry Genetic Test’ that will trace one’s ancestry in the global and South Asian sub-population level. The test will reveal information about oneself comparing the DNA samples of each individual with more than 35 ethnic groups in India, Pakistan, Nepal, Bangladesh and other regional countries to provide a detailed ancestry break-up.
Talking on this Occasion, Dr. Abdur Rub, Co-Founder and Chief Technology Officer, Xcode Life Sciences said - “Our unique heritage, our unique history, the history of our ancestors, is living within each of us! You may be 20, 30 or 50 years old, but your genes are 3 billion years old. For the first time in human history, genetic technology makes it possible to uncover this unique past that each of us carry in us. I am very excited that Xcode is launching world’s first ‘South Asian Ancestry Genetic Test’ through which your DNA is matched with more than 35 ethnic groups in India and other groups worldwide, and your most recent paternal ancestorâ€.
Present at the launch to to spread awareness on using genomics to deduce Indian ancestry was Dr. Analabha Basu, Associate Professor, National Institute of Biomedical Genomics. Sharing his views on the subject, he said, “Knowledge about the origin of the human species as a whole has the potential to reshape our society. The more we learn about our diversity, the more we learn how connected we are. It can lead to path-breaking medical discoveries and pave the way forward to research based on our DNA patterns.â€
Xcode will also help individuals to trace their paternal ancestry by evaluating your DNA which will decode ancient migratory patterns of their forefathers. Tracing our family tree is an activity that features in all our childhoods, but did any of us manage to reach beyond our grandparents or our great grandparents? All of us are products of generations of ancestry with a rich history and heritage, all embedded in our genes waiting to be uncovered. Every cell in our body contains DNA which can reveal everything from our family history to our ancestral migratory patterns and with Xcode’s innovative DNA ancestry test, you now have the chance to unravel this rich history written in your DNA.
SCHOTT KAISHA Introduces Path
Breaking Pharma Packaging Innovation
SCHOTT KAISHA has introduced state-of-the art technologies and pathbreaking innovations in the pharmaceutical primary packaging space. With its advanced operational capabilities, SCHOTT KAISHA was the first manufacturer of glass syringes and cartridges in India, and continues to be a prime supplier for drug producers. “With our commitment to establish India as a leading export hub, we are a perfect success story of India’s ‘Make in India’ and Germany’s ‘Industry 4.0’ for automation in manufacturing technologies. For us, meeting and exceling in international standards is just a matter of fact but not the end goal. We want to raise the bar higher and set standards which others will follow,†said Rishad Dadachanji, Director, SCHOTT KAISHA.
Going into its second decade of joint venture operations in India next year, SCHOTT KAISHA has announced the opening of a second production module at its manufacturing plant in Jambusar, Gujarat to keep up with the rising market demand. The expanded module will increase the existing production capacity by almost 50 % and will be running in full capacity by the end of 2018, enabling SCHOTT KAISHA to cross 3 billion containers produced per annum.
Besides expanding its industrial footprint, SCHOTT KAISHA has continuously invested in research and development. With the recently launched new opto-electronic inspection systems for vials, a 100% cosmetic inspection of the entire vial from 5 different cameras has been achieved for the first time. The company is not only offering a standard inspection protocol with this system, but also various customization avenues, based on the evolving customer requirements. “We take pride in not just running our manufacturing plants as per the international standards, but also in becoming pioneers in introducing best practices in the Indian pharmaceutical packaging space. Our new offering is a classic example, being one of the most advanced cosmetic inspection systems as it covers 100% of the entire vialâ€, Rishad shared.
SCHOTT KAISHA has also introduced SCHOTT’s iQ™ platform in India, providing a versatile portfolio of Ready To Use (RTU) pre-fillable syringes - syriQ®, vials - adaptiQ®, as well as cartridges - cartriQ™. With the iQ™ platform, these RTU containers are packed in a nest inside an industry-standard tub, permitting smooth integration into existing syringe filling lines or new flexible filling lines. This not only enables a considerable reduction in the overall Time to Market, but also helps reducing investments by up to 40%, clean room space by up to 60%, and running costs by up to 40%.
SCHOTT KAISHA has introduced state-of-the art technologies and pathbreaking innovations in the pharmaceutical primary packaging space. With its advanced operational capabilities, SCHOTT KAISHA was the first manufacturer of glass syringes and cartridges in India, and continues to be a prime supplier for drug producers. “With our commitment to establish India as a leading export hub, we are a perfect success story of India’s ‘Make in India’ and Germany’s ‘Industry 4.0’ for automation in manufacturing technologies. For us, meeting and exceling in international standards is just a matter of fact but not the end goal. We want to raise the bar higher and set standards which others will follow,†said Rishad Dadachanji, Director, SCHOTT KAISHA.
Going into its second decade of joint venture operations in India next year, SCHOTT KAISHA has announced the opening of a second production module at its manufacturing plant in Jambusar, Gujarat to keep up with the rising market demand. The expanded module will increase the existing production capacity by almost 50 % and will be running in full capacity by the end of 2018, enabling SCHOTT KAISHA to cross 3 billion containers produced per annum.
Besides expanding its industrial footprint, SCHOTT KAISHA has continuously invested in research and development. With the recently launched new opto-electronic inspection systems for vials, a 100% cosmetic inspection of the entire vial from 5 different cameras has been achieved for the first time. The company is not only offering a standard inspection protocol with this system, but also various customization avenues, based on the evolving customer requirements. “We take pride in not just running our manufacturing plants as per the international standards, but also in becoming pioneers in introducing best practices in the Indian pharmaceutical packaging space. Our new offering is a classic example, being one of the most advanced cosmetic inspection systems as it covers 100% of the entire vialâ€, Rishad shared.
SCHOTT KAISHA has also introduced SCHOTT’s iQ™ platform in India, providing a versatile portfolio of Ready To Use (RTU) pre-fillable syringes - syriQ®, vials - adaptiQ®, as well as cartridges - cartriQ™. With the iQ™ platform, these RTU containers are packed in a nest inside an industry-standard tub, permitting smooth integration into existing syringe filling lines or new flexible filling lines. This not only enables a considerable reduction in the overall Time to Market, but also helps reducing investments by up to 40%, clean room space by up to 60%, and running costs by up to 40%.
Mylan Launches Biosimilar Bevacizumab in India
Mylan Pharmaceuticals Private Limited has announced the launch of ABEVMY (Injection Bevacizumab 100 mg and 400 mg), an anti-angiogenic drug approved by the Drug Controller General of India (DCGI) for all indications of the Roche’s Avastin, including for the treatment of metastatic colorectal, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of specific regimens for Indian patients.
The approval of ABEVMY was supported by a comprehensive data package to prove biosimilarity including robust analytical, pharmacokinetic, and pharmacodynamic studies and an India-specific, randomized, doubleblind clinical trial in metastatic colorectal cancer patients.
ABEVMY is a recombinant “humanized†monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth. An important benefit for patients is its price for each therapy cycle, which is comparatively lower than the existing options.
According to data from the Indian Council of Medical Research, 1.45 million new cases of cancer in the country were reported in 2016. This figure is estimated to increase by approximately 1.73 million new cases annually by 2020. Mylan’s oncology portfolio in India includes cytotoxic and targeted oncology therapies for common types of cancer.
Mylan Pharmaceuticals Private Limited has announced the launch of ABEVMY (Injection Bevacizumab 100 mg and 400 mg), an anti-angiogenic drug approved by the Drug Controller General of India (DCGI) for all indications of the Roche’s Avastin, including for the treatment of metastatic colorectal, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of specific regimens for Indian patients.
The approval of ABEVMY was supported by a comprehensive data package to prove biosimilarity including robust analytical, pharmacokinetic, and pharmacodynamic studies and an India-specific, randomized, doubleblind clinical trial in metastatic colorectal cancer patients.
ABEVMY is a recombinant “humanized†monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth. An important benefit for patients is its price for each therapy cycle, which is comparatively lower than the existing options.
According to data from the Indian Council of Medical Research, 1.45 million new cases of cancer in the country were reported in 2016. This figure is estimated to increase by approximately 1.73 million new cases annually by 2020. Mylan’s oncology portfolio in India includes cytotoxic and targeted oncology therapies for common types of cancer.
XCODE LIFE Launches the World’s
Bill Gates Acknowledges Hester for Developing a Newcastle Disease Vaccine
It gives us immense pride to share with you that Mr. Bill Gates mentioned Hester’s name in his speech at AP AgTech Summit 2017 in Visakhapatnam on 17 November 2017. Mr. Gates referred to the Bill & Melinda Gates Foundation’s partnership with Hester in developing a Thermostable Newcastle disease vaccine for the smallholder backyard farmers.
Since 1997, Hester has been manufacturing the conventional Newcastle Disease vaccine, which is required to be stored and transported under a cold chain between 2 to 8 degrees Celsius. Facilitating mass access to the Newcastle Disease Vaccine in rural backyard poultry farms was therefore always a challenge due to the inability to maintain the cold chain up to the end user of the vaccine.
In 2014, Hester developed a Thermostable Newcastle disease vaccine that withstands a temperature up to 40 degrees Celsius for a few days. This vaccine was developed in collaboration with Galvmed, an international NGO having its head office in Edinburgh, Scotland, funded by the Gates Foundation.
This Thermostable Newcastle disease vaccine is being considered as an appropriate solution to the problem of last-mile-service delivery for backyard farms in rural area where cold-chain infrastructure is available in a compromised form.
It gives us immense pride to share with you that Mr. Bill Gates mentioned Hester’s name in his speech at AP AgTech Summit 2017 in Visakhapatnam on 17 November 2017. Mr. Gates referred to the Bill & Melinda Gates Foundation’s partnership with Hester in developing a Thermostable Newcastle disease vaccine for the smallholder backyard farmers.
Since 1997, Hester has been manufacturing the conventional Newcastle Disease vaccine, which is required to be stored and transported under a cold chain between 2 to 8 degrees Celsius. Facilitating mass access to the Newcastle Disease Vaccine in rural backyard poultry farms was therefore always a challenge due to the inability to maintain the cold chain up to the end user of the vaccine.
In 2014, Hester developed a Thermostable Newcastle disease vaccine that withstands a temperature up to 40 degrees Celsius for a few days. This vaccine was developed in collaboration with Galvmed, an international NGO having its head office in Edinburgh, Scotland, funded by the Gates Foundation.
This Thermostable Newcastle disease vaccine is being considered as an appropriate solution to the problem of last-mile-service delivery for backyard farms in rural area where cold-chain infrastructure is available in a compromised form.
Ion Exchange (India) Limited Launches
High Purity Water Generation Product for the Pharma Industry
Industry leaders in water treatment, liquid waste management and environment solutions, Ion Exchange (India) Limited has announces the launch of INDION SWIFT 5Gx – a high purity water generation product catering to the special needs of the pharmaceutical industry. The product has been designed in consultation with pharmaceutical engineers and end users for maximum performance. This launch marks the company’s expansion of its product line for the sector within its ‘INDION’ purified water systems range.
353_SWIFTINDION SWIFT 5Gx improves efficiency and purity by introducing a new and unique technology which uses ‘Uniform Particle Size’ resins instead of the conventional resins otherwise used in water treatment and purification. The new product uses a shortcycle regeneration method and takes up to 35 minutes only in order to regenerate as compared to other available conventional products which have an average time of 8 hours for a single regeneration cycle. The product is a first of its kind for the pharmaceutical sector and with validation package.
Launching the product, Mr. Ajay Popat, President, Ion Exchange (India) Limited said, “Water is a primary ingredient for pharmaceutical preparations and high purity is an essential factor. Being pioneers in water treatment, Ion Exchange (India) has always invested in R&D to introduce some of the most innovative and technically advanced products and services to meet the needs of the pharma industry’s stringent and critical requirements. While we have a complete range of high purity water generation and demineralisation products, INDION SWIFT 5Gx offers state-of-the-art technology for producing high purity water consistently for the pharmaceutical and biotechnology sectors. The performance driven product is cost effective, modular, energy efficient and has a very short regeneration time of only 35 minutes. This is sure to improve overall productivity for varied pharmaceutical processes.â€
INDION SWIFT 5Gx is fully automatic and has minimum bacteria buildup due to its short cycle. The product is also entirely compliant with latest USP & Eur. specifications and with GAMP & ISPE design standards. The INDION range by Ion Exchange is known for complete pure water generation package and is pre-validated to industry accepted standards.
Ion Exchange has been a preferred and trusted partner to the pharma sector for water treatment and purification across the world. In addition to high purity water solutions for the pharma and biotech sectors, Ion Exchange is also a specialist in ion exchange resins used for water applications and non-water applications i.e. excipients in pharmaceutical formulations, and polymeric adsorbents. It also offers a complete range of reverse osmosis membranes from its state-of-the-art integrated manufacturing facility in Goa. Other areas of specialization are Zero Liquid Discharge Systems, Raw Water Treatment Systems, Waste Water Treatment and Recycle Systems, and Sewage Treatment Plants. Additionally, it offers ASTOM, Japan’s wide range of Electro Deionisation Reversal/Diffusion Dialysis Membrane & Systems for Separation,
Industry leaders in water treatment, liquid waste management and environment solutions, Ion Exchange (India) Limited has announces the launch of INDION SWIFT 5Gx – a high purity water generation product catering to the special needs of the pharmaceutical industry. The product has been designed in consultation with pharmaceutical engineers and end users for maximum performance. This launch marks the company’s expansion of its product line for the sector within its ‘INDION’ purified water systems range.
353_SWIFTINDION SWIFT 5Gx improves efficiency and purity by introducing a new and unique technology which uses ‘Uniform Particle Size’ resins instead of the conventional resins otherwise used in water treatment and purification. The new product uses a shortcycle regeneration method and takes up to 35 minutes only in order to regenerate as compared to other available conventional products which have an average time of 8 hours for a single regeneration cycle. The product is a first of its kind for the pharmaceutical sector and with validation package.
Launching the product, Mr. Ajay Popat, President, Ion Exchange (India) Limited said, “Water is a primary ingredient for pharmaceutical preparations and high purity is an essential factor. Being pioneers in water treatment, Ion Exchange (India) has always invested in R&D to introduce some of the most innovative and technically advanced products and services to meet the needs of the pharma industry’s stringent and critical requirements. While we have a complete range of high purity water generation and demineralisation products, INDION SWIFT 5Gx offers state-of-the-art technology for producing high purity water consistently for the pharmaceutical and biotechnology sectors. The performance driven product is cost effective, modular, energy efficient and has a very short regeneration time of only 35 minutes. This is sure to improve overall productivity for varied pharmaceutical processes.â€
INDION SWIFT 5Gx is fully automatic and has minimum bacteria buildup due to its short cycle. The product is also entirely compliant with latest USP & Eur. specifications and with GAMP & ISPE design standards. The INDION range by Ion Exchange is known for complete pure water generation package and is pre-validated to industry accepted standards.
Ion Exchange has been a preferred and trusted partner to the pharma sector for water treatment and purification across the world. In addition to high purity water solutions for the pharma and biotech sectors, Ion Exchange is also a specialist in ion exchange resins used for water applications and non-water applications i.e. excipients in pharmaceutical formulations, and polymeric adsorbents. It also offers a complete range of reverse osmosis membranes from its state-of-the-art integrated manufacturing facility in Goa. Other areas of specialization are Zero Liquid Discharge Systems, Raw Water Treatment Systems, Waste Water Treatment and Recycle Systems, and Sewage Treatment Plants. Additionally, it offers ASTOM, Japan’s wide range of Electro Deionisation Reversal/Diffusion Dialysis Membrane & Systems for Separation,
Avvashya CCI Logistics Commences
Operations at Bhiwandi Warehouse
Avvashya CCI Logistics (ACCI), a subsidiary company of Allcargo Logistics Ltd, has started operations at its new warehouse in Bhiwandi. The state-of-the-art warehouse is located at the Renaissance Logistics Park, WB-09 Bhiwandi. A part of the warehouse, upto 2500 pallet position, is dedicated for Clariant, a multinational specialty chemicals company and rest for other customers.
Spread across 1.31 lakh sq ft, the warehouse meets global standards in safety and security compliances. The facility functions on a multi-client mode and has a clear height of 10 meters, with mid height being 11.5 meters and fully racked with a capacity of 10,776 pallet positions.
The Bhiwandi warehouse has a geographical advantage as it is located on the proposed junction of Delhi Mumbai industrial freight corridor and Nagpur – Mumbai Industrial corridor thus having the attention of both central and state government for all its projects. The complex is located on the state highway no. 40 which is a proposed 4 lane road in the years to come, and is well connected with close proximity from Kalyan and thane railway stations as well as Kalamboli CFS. This park also falls under the proposed SMART CITY project of the Government and hence gets maximum attention of the MIDC and other government authorities in areas of development.
Avvashya CCI Logistics (ACCI), a subsidiary company of Allcargo Logistics Ltd, has started operations at its new warehouse in Bhiwandi. The state-of-the-art warehouse is located at the Renaissance Logistics Park, WB-09 Bhiwandi. A part of the warehouse, upto 2500 pallet position, is dedicated for Clariant, a multinational specialty chemicals company and rest for other customers.
Spread across 1.31 lakh sq ft, the warehouse meets global standards in safety and security compliances. The facility functions on a multi-client mode and has a clear height of 10 meters, with mid height being 11.5 meters and fully racked with a capacity of 10,776 pallet positions.
The Bhiwandi warehouse has a geographical advantage as it is located on the proposed junction of Delhi Mumbai industrial freight corridor and Nagpur – Mumbai Industrial corridor thus having the attention of both central and state government for all its projects. The complex is located on the state highway no. 40 which is a proposed 4 lane road in the years to come, and is well connected with close proximity from Kalyan and thane railway stations as well as Kalamboli CFS. This park also falls under the proposed SMART CITY project of the Government and hence gets maximum attention of the MIDC and other government authorities in areas of development.
The 'India Pharma Week' returns with a week full of avant-garde events alongside CPhI and P-MEC India
The 'India Pharma Week' returns with a week full of avant-garde events alongside CPhI and P-MEC India
• South Asia's largest Pharma event
• CPhI and P-MEC India to be held at two different venues i.e., MMRDA Grounds (BKC), Mumbai – 27th to 29th Nov ; the Bombay Exhibition Centre (Goregaon) – 28th to 30th Nov
• 1500+ exhibitors ; 40+ countries
• More than 10 eclectic events across Mumbai throughout the India Pharma Week
Mumbai, 14 November 2017 - UBM India, India's leading B2B exhibition organizer, is all set to bring in the second edition of the widely appreciated India Pharma Week, a week-long celebration packed with avant-garde events from 25th to 30th November alongside its flagship expo CPhI and P-MEC India. In its 11th edition, the marquee expo will be held at two venues in Mumbai - MMRDA Grounds, Bandra Kurla Complex (27th to 29th November) and Bombay Exhibition Centre (28th to 30th November).
Celebrating 11 years of CPhI and P-MEC India, the India Pharma Week will organise more than 10 events and activities taking place across the city of Mumbai pertaining to the streams of business, knowledge, leadership, innovation, recognition and networking in the field of Pharma.
Speaking on the announcement of the IPW, Mr. Yogesh Mudras, Managing Director, UBM India said, "I am delighted to announce the second edition of the India Pharma Week, an unrivalled offering to the world of exhibitions along with CPhI & P-MEC India, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event. An epitome of India’s strength in the Pharma industry, the expo has consistently grown to serve as an exclusive congregation of key global players across the pharmaceutical sector. Further, the expo would deliberate upon Government of India's ‘Pharma Vision 2020' to make India a global leader in end-to-end drug manufacturing in boosting investments.
“The India Pharma Week stems from the proactive role it plays in driving key Governmental initiatives such as ‘Make in India’, ‘Start-Up India, Stand Up India’, and ‘Skill India’ connecting the global community to eke out solutions to challenges, and establishing superior standards within it. With the recent proposal by the Drug Controller General of India (DCGI) to make it mandatory for all employees in pharmaceutical manufacturing facilities to get skill certification, a notable congregation of industry experts and knowledge sharing, such as IPW provides becomes even more significant,†he further added.
The week will commence with a Plant visit followed by a series of engagements such as Pharma Leaders Golf, Pre-Connect Congress, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, the CPhI & P-MEC India Exhibition, a closed-door CEO Roundtable and many more activities. CPHI provides global platform for the Indian Pharma industry to know and have the exposure of the latest technology available. In the past, Indian Pharmaceutical decision makers had to travel to international exhibitions to get to know new innovations on the technology front, however CPHI & P-Mec has brought this information to Indian pharma’s doorstepsâ€, said Mr. Damanjit Singh, CEO, Food & Pharma Specialities.
Ms. Saloni Wagh, Marketing & Business Development – Asia Pacific, Supriya Lifescience also shared her past experiences of the CPhI conference and said, “CPhI is one of the leading Pharma events in the world where the entire Industry comes together to discuss and get updated on the current trends, information and issues. CPhI Worldwide exhibitions do play an important role in our marketing strategy as it is a platform for us to meet all our customers from across the globe under one roof. It is also a great platform to launch new products and to identify potential customers, she further added.â€
Incepted in 2006, the CPhI & P-MEC India exhibition has grown remarkably larger over the years with exhibitors and visitors engaging over significant levels of business. It has been approved and comprehensively assisted in its endeavours by governing bodies such as Pharmaceuticals Export Promotion Council (Pharmexcil). Spread across two locations, this year's edition will see more than 1500 exhibitors and participation from over 40 countries.
About the CPhi-PMEC expo:
Originating from CPhI Worldwide – CPhI India has become South Asia’s leading Pharma meeting place covering every step of the supply chain from drug discovery to finished dosage, encompassing CROs, CMOs and manufacturers of API, Generics, Excipients and Drug formulation, Fine chemicals, Biosimilars, Finished Formulations, Lab chemicals and Biotechnology.
P-MEC, on the other hand, includes manufacturers of Pharma Machinery and Equipment, Analytical Equipment, Automation & Robotics, Packaging Equipment & Supplies, Plant / Facility Equipment, Automation & Controls, Processing Equipment, RFID, Tableting / Capsule fillers, Clean room equipment, Filling equipment and Laboratory products.
About UBM India:
UBM India is India's leading exhibition organizer that provides the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences and seminars. UBM India hosts over 25 large scale exhibitions and 40 conferences across the country every year; thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices across Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia. For further details, please visit ubmindia.in.
The 'India Pharma Week' returns with a week full of avant-garde events alongside CPhI and P-MEC India
• South Asia's largest Pharma event
• CPhI and P-MEC India to be held at two different venues i.e., MMRDA Grounds (BKC), Mumbai – 27th to 29th Nov ; the Bombay Exhibition Centre (Goregaon) – 28th to 30th Nov
• 1500+ exhibitors ; 40+ countries
• More than 10 eclectic events across Mumbai throughout the India Pharma Week
Mumbai, 14 November 2017 - UBM India, India's leading B2B exhibition organizer, is all set to bring in the second edition of the widely appreciated India Pharma Week, a week-long celebration packed with avant-garde events from 25th to 30th November alongside its flagship expo CPhI and P-MEC India. In its 11th edition, the marquee expo will be held at two venues in Mumbai - MMRDA Grounds, Bandra Kurla Complex (27th to 29th November) and Bombay Exhibition Centre (28th to 30th November).
Celebrating 11 years of CPhI and P-MEC India, the India Pharma Week will organise more than 10 events and activities taking place across the city of Mumbai pertaining to the streams of business, knowledge, leadership, innovation, recognition and networking in the field of Pharma.
Speaking on the announcement of the IPW, Mr. Yogesh Mudras, Managing Director, UBM India said, "I am delighted to announce the second edition of the India Pharma Week, an unrivalled offering to the world of exhibitions along with CPhI & P-MEC India, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event. An epitome of India’s strength in the Pharma industry, the expo has consistently grown to serve as an exclusive congregation of key global players across the pharmaceutical sector. Further, the expo would deliberate upon Government of India's ‘Pharma Vision 2020' to make India a global leader in end-to-end drug manufacturing in boosting investments.
“The India Pharma Week stems from the proactive role it plays in driving key Governmental initiatives such as ‘Make in India’, ‘Start-Up India, Stand Up India’, and ‘Skill India’ connecting the global community to eke out solutions to challenges, and establishing superior standards within it. With the recent proposal by the Drug Controller General of India (DCGI) to make it mandatory for all employees in pharmaceutical manufacturing facilities to get skill certification, a notable congregation of industry experts and knowledge sharing, such as IPW provides becomes even more significant,†he further added.
The week will commence with a Plant visit followed by a series of engagements such as Pharma Leaders Golf, Pre-Connect Congress, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, the CPhI & P-MEC India Exhibition, a closed-door CEO Roundtable and many more activities. CPHI provides global platform for the Indian Pharma industry to know and have the exposure of the latest technology available. In the past, Indian Pharmaceutical decision makers had to travel to international exhibitions to get to know new innovations on the technology front, however CPHI & P-Mec has brought this information to Indian pharma’s doorstepsâ€, said Mr. Damanjit Singh, CEO, Food & Pharma Specialities.
Ms. Saloni Wagh, Marketing & Business Development – Asia Pacific, Supriya Lifescience also shared her past experiences of the CPhI conference and said, “CPhI is one of the leading Pharma events in the world where the entire Industry comes together to discuss and get updated on the current trends, information and issues. CPhI Worldwide exhibitions do play an important role in our marketing strategy as it is a platform for us to meet all our customers from across the globe under one roof. It is also a great platform to launch new products and to identify potential customers, she further added.â€
Incepted in 2006, the CPhI & P-MEC India exhibition has grown remarkably larger over the years with exhibitors and visitors engaging over significant levels of business. It has been approved and comprehensively assisted in its endeavours by governing bodies such as Pharmaceuticals Export Promotion Council (Pharmexcil). Spread across two locations, this year's edition will see more than 1500 exhibitors and participation from over 40 countries.
About the CPhi-PMEC expo:
Originating from CPhI Worldwide – CPhI India has become South Asia’s leading Pharma meeting place covering every step of the supply chain from drug discovery to finished dosage, encompassing CROs, CMOs and manufacturers of API, Generics, Excipients and Drug formulation, Fine chemicals, Biosimilars, Finished Formulations, Lab chemicals and Biotechnology.
P-MEC, on the other hand, includes manufacturers of Pharma Machinery and Equipment, Analytical Equipment, Automation & Robotics, Packaging Equipment & Supplies, Plant / Facility Equipment, Automation & Controls, Processing Equipment, RFID, Tableting / Capsule fillers, Clean room equipment, Filling equipment and Laboratory products.
About UBM India:
UBM India is India's leading exhibition organizer that provides the industry with platforms that bring together buyers and sellers from around the world, through a portfolio of exhibitions, content led conferences and seminars. UBM India hosts over 25 large scale exhibitions and 40 conferences across the country every year; thereby enabling trade across multiple industry verticals. A UBM Asia Company, UBM India has offices across Mumbai, New Delhi, Bangalore and Chennai. UBM Asia is owned by UBM plc which is listed on the London Stock Exchange. UBM Asia is the leading exhibition organizer in Asia and the biggest commercial organizer in mainland China, India and Malaysia. For further details, please visit ubmindia.in.
Bristol-Myers Squibb and Syngene
Expand Ongoing Research Collaboration
Syngene International, India’s largest contract research organization, has expanded its ongoing collaboration with Bristol- Myers Squibb. The next phase of the partnership will see the addition of a new facility to support future Bristol-Myers Squibb research and development operations, an expansion of the team and the extension of the existing agreement through 2026. The expansion will enable the two companies to undertake a greater range of scientific research and development for pharmaceuticals across a broader range of activities.
Syngene and Bristol-Myers Squibb have worked together since 1998. The research campus, known as Biocon BMS Research Center (BBRC), Syngene’s first dedicated R&D Center, was established in 2007, which was subsequently renewed through 2020 and now has been further extended through 2026. It is the largest research and development facility for Bristol-Myers Squibb outside of the United States and plays an integral part within their global research and development network.
Since its inception, BBRC has contributed to the discovery and pre-clinical development of numerous drug candidates for further study, as well as generated data that has led to multiple patent filings around the world. It has also played a key role in reducing the time and costs associated with advancing new compounds to first-in-human studies for Bristol-Myers Squibb.
As part of the expansion, Syngene will set up a new dedicated facility spread across 25,000 sq. ft. of laboratory and office space for Bristol-Myers Squibb. This facility will house an additional team of 75 Syngene scientists who will work exclusively in support of Bristol-Myers Squibb.
BBRC provides integrated services supporting Discovery, Translational Sciences and Product Development functions for Bristol-Myers Squibb.
Syngene International, India’s largest contract research organization, has expanded its ongoing collaboration with Bristol- Myers Squibb. The next phase of the partnership will see the addition of a new facility to support future Bristol-Myers Squibb research and development operations, an expansion of the team and the extension of the existing agreement through 2026. The expansion will enable the two companies to undertake a greater range of scientific research and development for pharmaceuticals across a broader range of activities.
Syngene and Bristol-Myers Squibb have worked together since 1998. The research campus, known as Biocon BMS Research Center (BBRC), Syngene’s first dedicated R&D Center, was established in 2007, which was subsequently renewed through 2020 and now has been further extended through 2026. It is the largest research and development facility for Bristol-Myers Squibb outside of the United States and plays an integral part within their global research and development network.
Since its inception, BBRC has contributed to the discovery and pre-clinical development of numerous drug candidates for further study, as well as generated data that has led to multiple patent filings around the world. It has also played a key role in reducing the time and costs associated with advancing new compounds to first-in-human studies for Bristol-Myers Squibb.
As part of the expansion, Syngene will set up a new dedicated facility spread across 25,000 sq. ft. of laboratory and office space for Bristol-Myers Squibb. This facility will house an additional team of 75 Syngene scientists who will work exclusively in support of Bristol-Myers Squibb.
BBRC provides integrated services supporting Discovery, Translational Sciences and Product Development functions for Bristol-Myers Squibb.
Piramal Wins ‘Industry Partner of
the Year’ at the Global Generics &
Biosimilars Awards 2017
Piramal Pharma Solutions (PPS) is pleased to announce that it was recognised as the ‘Industry Partner of the Year’ at the recently held Global Generics & Biosimilars Awards 2017, in Frankfurt, Germany. It competed with several global peers in this category and emerged as the winner.
The Global Generics & Biosimilars Awards 2017 rewards ‘best practice’ in two sectors, while at the same time encouraging improvements in every aspect of the way business is conducted.
Every award effectively underscores the efforts made by the global generics and biosimilars sectors to make affordable medicines available to more people across the globe. These are among the most coveted recognitions in the pharmaceutical industry.
Piramal Pharma Solutions is a global leader in pharmaceutical manufacturing, with a large portfolio of APIs, intermediates & formulations. Since its inception in 1995, Piramal’s Generic API business has been the preferred partner of customers for providing a wide range of quality APIs. The Generic API business has grown consistently over the years based on strong customer relationships, a stand out quality record, an emphasis on innovation, and a stellar reputation on time delivery and customer centricity. Piramal holds a successful performance record of over 20 years of supplying API to US and European markets from facilities located in India and the UK. All the facilities meet global regulatory requirements, cGMP compliance standards and are FDA inspected and approved.
Piramal Pharma Solutions (PPS) is pleased to announce that it was recognised as the ‘Industry Partner of the Year’ at the recently held Global Generics & Biosimilars Awards 2017, in Frankfurt, Germany. It competed with several global peers in this category and emerged as the winner.
The Global Generics & Biosimilars Awards 2017 rewards ‘best practice’ in two sectors, while at the same time encouraging improvements in every aspect of the way business is conducted.
Every award effectively underscores the efforts made by the global generics and biosimilars sectors to make affordable medicines available to more people across the globe. These are among the most coveted recognitions in the pharmaceutical industry.
Piramal Pharma Solutions is a global leader in pharmaceutical manufacturing, with a large portfolio of APIs, intermediates & formulations. Since its inception in 1995, Piramal’s Generic API business has been the preferred partner of customers for providing a wide range of quality APIs. The Generic API business has grown consistently over the years based on strong customer relationships, a stand out quality record, an emphasis on innovation, and a stellar reputation on time delivery and customer centricity. Piramal holds a successful performance record of over 20 years of supplying API to US and European markets from facilities located in India and the UK. All the facilities meet global regulatory requirements, cGMP compliance standards and are FDA inspected and approved.
Roche Appoints Lara Bezerra as MD,
Roche Pharma India
Roche has announced the appointment of Lara Bezerra as Managing Director for Roche Products (India) Pvt. Ltd. She succeeds Maturin Tchoumi who has now moved to Roche Finland in a new role.
Lara has held various positions of leadership across geographies, including Europe and Latin America. With over 24 years of experience in the pharmaceutical industry, Lara comes to India after a successful assignment as the General Manager of Roche Venezuela. Her tenure in Venezuela was among the most turbulent times in the country’s history, and her leadership was critical in navigating that period. In 2016, Roche was named among the Top 20 Places to Work in Venezuela.
“We are delighted to have Lara Bezerra join Roche India from Venezuela,†says Dr. Christiane Hamacher, Region head of Roche Pharmaceutical Asia Pacific. “With her strong business acumen and unique, people-centric leadership approach, Lara is ideally positioned to drive Roche’s efforts to bring our innovative treatments to patients in India.â€
“I am excited to join the India team that has already made significant strides in bringing innovative healthcare solutions here,†says Lara Bezerra. “I look forward to building on this foundation by bringing our transformational medicines to the country, being a strong healthcare partner and making a meaningful difference for patients in India.â€
Lara has a degree in Business Administration from the Fundacao Getulio Vargas (FGV) University, Sao Paulo, Brazil.
Roche has announced the appointment of Lara Bezerra as Managing Director for Roche Products (India) Pvt. Ltd. She succeeds Maturin Tchoumi who has now moved to Roche Finland in a new role.
Lara has held various positions of leadership across geographies, including Europe and Latin America. With over 24 years of experience in the pharmaceutical industry, Lara comes to India after a successful assignment as the General Manager of Roche Venezuela. Her tenure in Venezuela was among the most turbulent times in the country’s history, and her leadership was critical in navigating that period. In 2016, Roche was named among the Top 20 Places to Work in Venezuela.
“We are delighted to have Lara Bezerra join Roche India from Venezuela,†says Dr. Christiane Hamacher, Region head of Roche Pharmaceutical Asia Pacific. “With her strong business acumen and unique, people-centric leadership approach, Lara is ideally positioned to drive Roche’s efforts to bring our innovative treatments to patients in India.â€
“I am excited to join the India team that has already made significant strides in bringing innovative healthcare solutions here,†says Lara Bezerra. “I look forward to building on this foundation by bringing our transformational medicines to the country, being a strong healthcare partner and making a meaningful difference for patients in India.â€
Lara has a degree in Business Administration from the Fundacao Getulio Vargas (FGV) University, Sao Paulo, Brazil.
UE LifeSciences Inks Distribution Pact
with GE Healthcare
USA-India based med-tech startup UE LifeSciences Inc has announced a distribution partnership with GE Healthcare to commercialize its iBreastExam (iBE) in countries across South Asia and Africa.
The partnership brings together UE LifeSciences\’ skills to design and develop mobile health innovations, and GE Healthcare\’s sales, marketing and distribution expertise in these markets to enable early detection of breast cancer in the developing world, the company officials said.
UE LifeSciences, Founder and CEO, Mihir Shah had expressed that the iBreastExam can create access where none exists right now across its partnership geography. This partnership will provide a significant opportunity to commercially scale-up iBE across India, South Asia, Africa and South-East Asia and also work towards improving breast cancer related outcomes in these regions, said GE Healthcare Sustainable Healthcare Solutions President and CEO, Terri Bresenham.
BE is a Made in India device developed by a team of 20-plus scientists, engineers and clinicians with USD 1.3 million in grant funding from Pennsylvania Department of Health (CURE Grant), University City Science Center (QED & DHA), Drexel University (Coulter Programme) and Unitus Seed Fund (StartHealth grant). It is currently commercially available in India, Myanmar and Botswana The project has been mentored and invested by Dr Kiran Mazumdar-Shaw of Biocon, Dr Ranjan Pai of Manipal Education and Medical Group and Unitus Seed Fund, a social impact investor in affordable healthcare innovations.
USA-India based med-tech startup UE LifeSciences Inc has announced a distribution partnership with GE Healthcare to commercialize its iBreastExam (iBE) in countries across South Asia and Africa.
The partnership brings together UE LifeSciences\’ skills to design and develop mobile health innovations, and GE Healthcare\’s sales, marketing and distribution expertise in these markets to enable early detection of breast cancer in the developing world, the company officials said.
UE LifeSciences, Founder and CEO, Mihir Shah had expressed that the iBreastExam can create access where none exists right now across its partnership geography. This partnership will provide a significant opportunity to commercially scale-up iBE across India, South Asia, Africa and South-East Asia and also work towards improving breast cancer related outcomes in these regions, said GE Healthcare Sustainable Healthcare Solutions President and CEO, Terri Bresenham.
BE is a Made in India device developed by a team of 20-plus scientists, engineers and clinicians with USD 1.3 million in grant funding from Pennsylvania Department of Health (CURE Grant), University City Science Center (QED & DHA), Drexel University (Coulter Programme) and Unitus Seed Fund (StartHealth grant). It is currently commercially available in India, Myanmar and Botswana The project has been mentored and invested by Dr Kiran Mazumdar-Shaw of Biocon, Dr Ranjan Pai of Manipal Education and Medical Group and Unitus Seed Fund, a social impact investor in affordable healthcare innovations.
Glenmark Launches Apremilast
Glenmark Pharmaceuticals Limited, a research-led global integrated pharmaceutical company, announced the launch of Apremilast in India. Apremilast is the first advanced Oral Systemic treatment for Psoriasis in India. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor which is indicated for the treatment of moderate to severe Psoriasis. The launch of Apremilast will revolutionize the treatment of Psoriasis impacting close to 33 million Indians suffering from the condition.
Apremilast is an advanced oral treatment for Psoriasis which addresses the limitations of the current available therapies in India. It acts in a targeted manner at an early stage of the disease progression. Also, it is an immunomodulator whereas the other available drugs in the country are immunosuppressant including biologics and are mostly indicated for the treatment of oncological conditions. Immunosuppressants suppress the immune system thereby making the body susceptible to various infections. Apremilast being an immunomodulator does not suppress the immune system and treats the condition of psoriasis at an intracellular level which will benefit psoriasis patients across the country.
Apremilast is an oral therapy which can be self-administered unlike some of the currently available injectable therapy which have to be administered by paramedics. Further, Apremilast is a safer drug having no effects on other organs like the liver and kidney and does not require routine laboratory diagnostic tests like CBC, liver & Kidney test or TB screening as required in the case of other therapies used currently.
Glenmark has launched Apremilast under the brand name ‘Aprezo’ indicated for the treatment of Psoriasis. Glenmark received approval from DCGI for Apremilast after conducting clinical trials on the molecule as per the regulatory requirements.
Globally, about 3% of the world population has some form of Psoriasis. Another study reveals that the prevalence of psoriasis in countries ranges between 0.09% and 11.43%, making psoriasis as one of the serious issues.
India has now become one of the largest patient pool in the world and is estimated to have around 33 million psoriasis patients. As per a study on psoriasis in India, based on data collected across various medical colleges located in Lucknow, Dibrugarh, Calcutta, Patna, Darbhanga, New Delhi and Amritsar, it was found that the incidence of psoriasis among total skin patients ranged between 0.44 and 2.2%. It was also found that the ratio of male to female (2.46:1) was very high and the highest incidence was noted in the age group of 20-39 years.
Apremilast will revolutionize the treatment for 33 million psoriasis patients in the country. Apremilast is the first oral treatment in India specific for psoriasis treatment; it is convenient to administer, it is safer compared to existing therapies and will transform the psoriasis treatment regime in the country.
Glenmark Pharmaceuticals Limited, a research-led global integrated pharmaceutical company, announced the launch of Apremilast in India. Apremilast is the first advanced Oral Systemic treatment for Psoriasis in India. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor which is indicated for the treatment of moderate to severe Psoriasis. The launch of Apremilast will revolutionize the treatment of Psoriasis impacting close to 33 million Indians suffering from the condition.
Apremilast is an advanced oral treatment for Psoriasis which addresses the limitations of the current available therapies in India. It acts in a targeted manner at an early stage of the disease progression. Also, it is an immunomodulator whereas the other available drugs in the country are immunosuppressant including biologics and are mostly indicated for the treatment of oncological conditions. Immunosuppressants suppress the immune system thereby making the body susceptible to various infections. Apremilast being an immunomodulator does not suppress the immune system and treats the condition of psoriasis at an intracellular level which will benefit psoriasis patients across the country.
Apremilast is an oral therapy which can be self-administered unlike some of the currently available injectable therapy which have to be administered by paramedics. Further, Apremilast is a safer drug having no effects on other organs like the liver and kidney and does not require routine laboratory diagnostic tests like CBC, liver & Kidney test or TB screening as required in the case of other therapies used currently.
Glenmark has launched Apremilast under the brand name ‘Aprezo’ indicated for the treatment of Psoriasis. Glenmark received approval from DCGI for Apremilast after conducting clinical trials on the molecule as per the regulatory requirements.
Globally, about 3% of the world population has some form of Psoriasis. Another study reveals that the prevalence of psoriasis in countries ranges between 0.09% and 11.43%, making psoriasis as one of the serious issues.
India has now become one of the largest patient pool in the world and is estimated to have around 33 million psoriasis patients. As per a study on psoriasis in India, based on data collected across various medical colleges located in Lucknow, Dibrugarh, Calcutta, Patna, Darbhanga, New Delhi and Amritsar, it was found that the incidence of psoriasis among total skin patients ranged between 0.44 and 2.2%. It was also found that the ratio of male to female (2.46:1) was very high and the highest incidence was noted in the age group of 20-39 years.
Apremilast will revolutionize the treatment for 33 million psoriasis patients in the country. Apremilast is the first oral treatment in India specific for psoriasis treatment; it is convenient to administer, it is safer compared to existing therapies and will transform the psoriasis treatment regime in the country.
Mylan Introduces DURART R 450
Mylan Pharmaceuticals Private Limited, a leading global pharmaceutical company, has launched DURART R 450, a Fixed- Dose Combination (FDC) drug comprising of Darunavir/Ritonavir 400/50mg for treatment experienced adults and adolescents weighing more than 40kg with HIV-1 in India. This is the first FDC drug available to patients in India. Alternative treatments require patients to take two drugs separately from two different bottles.
Darunavir and Ritonavir are HIV protease inhibitors and can be used in combination for patients failing first and second-line regimens during the management of HIV-1 infection. Darunavir is currently available in India in 600 mg and 800 mg dose forms and Ritonavir is available in the 100 mg and 50 mg dose forms.
Globally, Mylan supplies life-saving antiretroviral (ARV) medicines to nearly 50% of the men, women and children living with HIV in more than 100 developing countries. The company’s comprehensive ARV portfolio includes 14 APIs and 50 finished dosage forms in first-line, second-line and pediatric formulations.
Mylan Pharmaceuticals Private Limited, a leading global pharmaceutical company, has launched DURART R 450, a Fixed- Dose Combination (FDC) drug comprising of Darunavir/Ritonavir 400/50mg for treatment experienced adults and adolescents weighing more than 40kg with HIV-1 in India. This is the first FDC drug available to patients in India. Alternative treatments require patients to take two drugs separately from two different bottles.
Darunavir and Ritonavir are HIV protease inhibitors and can be used in combination for patients failing first and second-line regimens during the management of HIV-1 infection. Darunavir is currently available in India in 600 mg and 800 mg dose forms and Ritonavir is available in the 100 mg and 50 mg dose forms.
Globally, Mylan supplies life-saving antiretroviral (ARV) medicines to nearly 50% of the men, women and children living with HIV in more than 100 developing countries. The company’s comprehensive ARV portfolio includes 14 APIs and 50 finished dosage forms in first-line, second-line and pediatric formulations.
Agilent Thought Leader Award
Presented to Professor Jiandong Jiang
Agilent Technologies Inc has announced that Professor Jiandong Jiang has received an Agilent Thought Leader Award in support of his studies on cancer stem cells differentiation induced by natural products.
“Cancer is a chronic disease generated by multiple factors. Our research is focused on the treatment of cancers with new concepts or principles, using cutting-edge techniques,†said Professor Jiang.
Professor Jiang is director of the Institute of Materia Medica (IMM), Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) in Beijing, China. He is also the vice chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA). Professor Jiang’s research focuses on antimicrobial drugs, including viruses and bacteria, anticancer drugs, and the development of treatments for metabolic syndrome.
The Agilent Thought Leader Award will enable Professor Jiang’s team to implement metabolite flux analyses, metabolism analyses, and integrated biology approaches to characterize the anti-tumor activity of natural products. In addition to Agilent mass spectrometry solutions, Professor Jiang’s lab will also make extensive use of Agilent Seahorse XF technology, and Agilent MassHunter and VistaFlux software. The project will also include a collaboration with Professor Wenbin Li from the Beijing Shijitan Hospital, Capital Medical University to perform clinical related research.
The IMM supports research and discovery of innovative drugs useful in treating or preventing human diseases. This work is done via creative multidisciplinary research based on Chinese herbal medicine and natural product research, along with the adoption of modern medical, and pharmaceutical theories and technologies.
Agilent Technologies Inc has announced that Professor Jiandong Jiang has received an Agilent Thought Leader Award in support of his studies on cancer stem cells differentiation induced by natural products.
“Cancer is a chronic disease generated by multiple factors. Our research is focused on the treatment of cancers with new concepts or principles, using cutting-edge techniques,†said Professor Jiang.
Professor Jiang is director of the Institute of Materia Medica (IMM), Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) in Beijing, China. He is also the vice chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA). Professor Jiang’s research focuses on antimicrobial drugs, including viruses and bacteria, anticancer drugs, and the development of treatments for metabolic syndrome.
The Agilent Thought Leader Award will enable Professor Jiang’s team to implement metabolite flux analyses, metabolism analyses, and integrated biology approaches to characterize the anti-tumor activity of natural products. In addition to Agilent mass spectrometry solutions, Professor Jiang’s lab will also make extensive use of Agilent Seahorse XF technology, and Agilent MassHunter and VistaFlux software. The project will also include a collaboration with Professor Wenbin Li from the Beijing Shijitan Hospital, Capital Medical University to perform clinical related research.
The IMM supports research and discovery of innovative drugs useful in treating or preventing human diseases. This work is done via creative multidisciplinary research based on Chinese herbal medicine and natural product research, along with the adoption of modern medical, and pharmaceutical theories and technologies.
Clariant Healthcare Packaging Site in
Cuddalore, India Now Operational
Clariant, a world leader in specialty chemicals, announces that its new Clariant Healthcare Packaging production facility in Cuddalore, Tamil Nadu, India is now operational. The new site is capable of producing Clariant’s line of Sorb-it, Tri-Sorb, 2-in-1 Can, and Getter Can sorbent canisters for the growing Indian and Asia-Pacific pharmaceutical packaging markets.
“The new site has been validated as scheduled, and we look forward to serving customers with Clariant desiccants directly from Cuddalore,†says Matthias Brommer, Head – Clariant Healthcare Packaging business line. “By manufacturing regionally, we will be able to provide improved supply and service to our significant customer base in India while further addressing important and emerging markets in Greater China, the rest of Asia and Australia.â€
The Cuddalore site is already certified ISO 9001, with ISO 14001, 18001, and 15378 certifications intended to be obtained by the end of the year, the latter of which will add Cuddalore to Clariant Healthcare Packaging’s network of GMP-certified production facilities. Cuddalore is equipped with an ISO Class 8 clean room, and products produced at the site meet the relevant US FDA, USP and EU standards for use in pharmaceutical applications.
“Clariant canisters are among the most widely used pharmaceutical desiccants by generic manufacturers in India,†says Ketan Premani, Head – Healthcare Packaging India. “Thanks to the latest manufacturing equipment and product design, customers can expect the highest level of quality, and now with improved customer service.â€
Not only does the new Cuddalore site augment Clariant’s production capacity for desiccant canisters, it also adds to Clariant’s ability to meet BCP (Business Continuity Planning) requirements of global customers by producing identical products at multiple sites worldwide. Furthermore, Clariant continues to offer the Indian market a full range of controlled atmosphere packaging solutions from its global production sites, and it can help customers determine the ideal packaging configuration via its Stablus™ program.
Clariant, a world leader in specialty chemicals, announces that its new Clariant Healthcare Packaging production facility in Cuddalore, Tamil Nadu, India is now operational. The new site is capable of producing Clariant’s line of Sorb-it, Tri-Sorb, 2-in-1 Can, and Getter Can sorbent canisters for the growing Indian and Asia-Pacific pharmaceutical packaging markets.
“The new site has been validated as scheduled, and we look forward to serving customers with Clariant desiccants directly from Cuddalore,†says Matthias Brommer, Head – Clariant Healthcare Packaging business line. “By manufacturing regionally, we will be able to provide improved supply and service to our significant customer base in India while further addressing important and emerging markets in Greater China, the rest of Asia and Australia.â€
The Cuddalore site is already certified ISO 9001, with ISO 14001, 18001, and 15378 certifications intended to be obtained by the end of the year, the latter of which will add Cuddalore to Clariant Healthcare Packaging’s network of GMP-certified production facilities. Cuddalore is equipped with an ISO Class 8 clean room, and products produced at the site meet the relevant US FDA, USP and EU standards for use in pharmaceutical applications.
“Clariant canisters are among the most widely used pharmaceutical desiccants by generic manufacturers in India,†says Ketan Premani, Head – Healthcare Packaging India. “Thanks to the latest manufacturing equipment and product design, customers can expect the highest level of quality, and now with improved customer service.â€
Not only does the new Cuddalore site augment Clariant’s production capacity for desiccant canisters, it also adds to Clariant’s ability to meet BCP (Business Continuity Planning) requirements of global customers by producing identical products at multiple sites worldwide. Furthermore, Clariant continues to offer the Indian market a full range of controlled atmosphere packaging solutions from its global production sites, and it can help customers determine the ideal packaging configuration via its Stablus™ program.
Wellthy Therapeutics Conducts First
Made-in-India ‘Digital Pill’ Clinical Trial
Wellthy Therapeutics a digital therapeutics company that uses artificial intelligence (AI) and patient centric design to improve patient outcomes is now conducting the first made-in-India ‘digital pill’ clinical trial for diabetes.
The #WeDiDiT (Wellthy Digital Diabetes Therapy) trial is all set to prove the efficacy of its 16-week structured diabetes management programme delivered through a mobile app.
The trial was launched by, Dr. Sarita Bajaj, past president, Research Society for the Study of Diabetes in India (RSSDI), at the RSSDI Annual Conference in Bhubaneswar in the first week of November. The outcome of this multi-center randomized control trial will be measured by the HbA1C levels of patients before and after the trial.
As part of the programme, personalized diabetes self-management education and real time coaching will be offered through dedicated health coaches and an artificial intelligence powered chat bot, to engage and improve the health of patients with type 2 diabetes by facilitating behavior change.
According to Dr. Rajeev Chawla, Current President Elect, RSSDI, the need for digital interventions in diabetes care is more now than ever, especially in India. The Wellthy Diabetes intervention is an innovation born out of India, for Indians and South Asians.
Wellthy Therapeutics a digital therapeutics company that uses artificial intelligence (AI) and patient centric design to improve patient outcomes is now conducting the first made-in-India ‘digital pill’ clinical trial for diabetes.
The #WeDiDiT (Wellthy Digital Diabetes Therapy) trial is all set to prove the efficacy of its 16-week structured diabetes management programme delivered through a mobile app.
The trial was launched by, Dr. Sarita Bajaj, past president, Research Society for the Study of Diabetes in India (RSSDI), at the RSSDI Annual Conference in Bhubaneswar in the first week of November. The outcome of this multi-center randomized control trial will be measured by the HbA1C levels of patients before and after the trial.
As part of the programme, personalized diabetes self-management education and real time coaching will be offered through dedicated health coaches and an artificial intelligence powered chat bot, to engage and improve the health of patients with type 2 diabetes by facilitating behavior change.
According to Dr. Rajeev Chawla, Current President Elect, RSSDI, the need for digital interventions in diabetes care is more now than ever, especially in India. The Wellthy Diabetes intervention is an innovation born out of India, for Indians and South Asians.
Torrent Pharma’s Project Gets
Centre Nod
The Centre gave green nod to Torrent Pharmaceuticals’ proposal to establish a bulk drug manufacturing unit in Gujarat with an investment of Rs 300 crore, as per an official document.
The Union Environment Ministry issued the environment clearance certificate for the proposed project saying that the approval has been given with certain riders. The Ahmedabad-based firm’s unit will cover 57,737 sq mt area in Kalol taluk. It would have a production capacity of 21,415 tonnes per annum.
The project is estimated to cost about Rs 300 crore and is expected to provide employment to 100 persons, as per the document. The ministry has asked the company to take necessary permissions from the state pollution control board, ensure zero liquid discharge and take waste minimisation measures. The company has been asked to plant 25,000 trees per year for next five years.
It has also been told to ensure storage of raw materials does not exceed three days at any point of time, it added. Torrent Pharma has strong presence in cardiovascular, dialectology, pain management, gastro-intestinal segments, dermatology, among other healthcare products.
The Centre gave green nod to Torrent Pharmaceuticals’ proposal to establish a bulk drug manufacturing unit in Gujarat with an investment of Rs 300 crore, as per an official document.
The Union Environment Ministry issued the environment clearance certificate for the proposed project saying that the approval has been given with certain riders. The Ahmedabad-based firm’s unit will cover 57,737 sq mt area in Kalol taluk. It would have a production capacity of 21,415 tonnes per annum.
The project is estimated to cost about Rs 300 crore and is expected to provide employment to 100 persons, as per the document. The ministry has asked the company to take necessary permissions from the state pollution control board, ensure zero liquid discharge and take waste minimisation measures. The company has been asked to plant 25,000 trees per year for next five years.
It has also been told to ensure storage of raw materials does not exceed three days at any point of time, it added. Torrent Pharma has strong presence in cardiovascular, dialectology, pain management, gastro-intestinal segments, dermatology, among other healthcare products.
Sciformix Corporation Collaborates
with Oracle Health Sciences
Sciformix Corporation, a leading scientific knowledge-based organization, is proud to announce its adoption of Oracle Argus Enterprise Edition platform to offer superior value to their customers in the Life Science industry. Through its collaboration with Oracle Health Sciences, Sciformix is able to offer its customers a fully automated and integrated safety database solution, allowing easy reporting and analytics for improving the quality and efficiency of drug safety operations. With headquarters in the United States and operations in the United Kingdom, Romania, India and the Philippines, Sciformix partners with Life Sciences clients to provide a full range of services including safety and risk management, clinical development, real world evidence and market research, scientific writing, regulatory affairs and technology services.
The Life Science industry is facing ongoing change with mergers, acquisitions, and increasingly complex regulations, along with the pressure of doing more with less. As a result, organizations have to develop strategies to manage divergent priorities in order to implement cost-saving measures while keeping a keen eye on innovative technology solutions that address growing compliance and data analytics needs. Rapidly growing organizations, with complex safety needs for clinical trials, often lack the necessary technology and scientific knowledge and look to partner with specialized solutions providers to manage their safety data. In addition, well-established companies are looking to increase efficiencies and compliance in the area of post-marketing surveillance. Many of these companies address this by turning to service providers who offer end-to-end solutions so they can focus on their core competencies of developing medicinal products.
In Pharmacovigilance (PV), Sciformix provides adverse event processing services such as safety case intake, medical review of adverse events, regulatory reporting and proactive risk management. Sciformix offers these services leveraging the Argus platform for both customers who utilize its PV services, and companies engaging their own PV delivery model. This offering includes technology infrastructure, user services, application services, regulatory reporting and data analytics. The Argus suite of software solutions enable compliance with E2B exchange standards for expedited reporting, allowing users to conduct global case processing that can scale up to many thousands of annual cases, while also improving reporting capabilities. This comprehensive services offering improves operational efficiencies through individual and bulk case processing, built in audit trails validation, instant scalability, and business agility to meet changing needs, while embracing innovation and reducing IT costs.
The Oracle Argus Platform offered through Sciformix enables companies to increase their visibility into their entire risk and safety continuum, including signal management, adverse drug event (ADE) trends, and performance analytics.
Sciformix Corporation, a leading scientific knowledge-based organization, is proud to announce its adoption of Oracle Argus Enterprise Edition platform to offer superior value to their customers in the Life Science industry. Through its collaboration with Oracle Health Sciences, Sciformix is able to offer its customers a fully automated and integrated safety database solution, allowing easy reporting and analytics for improving the quality and efficiency of drug safety operations. With headquarters in the United States and operations in the United Kingdom, Romania, India and the Philippines, Sciformix partners with Life Sciences clients to provide a full range of services including safety and risk management, clinical development, real world evidence and market research, scientific writing, regulatory affairs and technology services.
The Life Science industry is facing ongoing change with mergers, acquisitions, and increasingly complex regulations, along with the pressure of doing more with less. As a result, organizations have to develop strategies to manage divergent priorities in order to implement cost-saving measures while keeping a keen eye on innovative technology solutions that address growing compliance and data analytics needs. Rapidly growing organizations, with complex safety needs for clinical trials, often lack the necessary technology and scientific knowledge and look to partner with specialized solutions providers to manage their safety data. In addition, well-established companies are looking to increase efficiencies and compliance in the area of post-marketing surveillance. Many of these companies address this by turning to service providers who offer end-to-end solutions so they can focus on their core competencies of developing medicinal products.
In Pharmacovigilance (PV), Sciformix provides adverse event processing services such as safety case intake, medical review of adverse events, regulatory reporting and proactive risk management. Sciformix offers these services leveraging the Argus platform for both customers who utilize its PV services, and companies engaging their own PV delivery model. This offering includes technology infrastructure, user services, application services, regulatory reporting and data analytics. The Argus suite of software solutions enable compliance with E2B exchange standards for expedited reporting, allowing users to conduct global case processing that can scale up to many thousands of annual cases, while also improving reporting capabilities. This comprehensive services offering improves operational efficiencies through individual and bulk case processing, built in audit trails validation, instant scalability, and business agility to meet changing needs, while embracing innovation and reducing IT costs.
The Oracle Argus Platform offered through Sciformix enables companies to increase their visibility into their entire risk and safety continuum, including signal management, adverse drug event (ADE) trends, and performance analytics.
Dr. Reddy’s Launches Generic Azacitidine
Dr. Reddy’s Laboratories Ltd is pleased to announce that generic Azacitidine for injection 100 mg/vial, a bioequivalent generic version of VIDAZA (azacitidine for injection), is approved by Health Canada.
“Bringing Azacitidine for Injection to the Canadian market at this time is very important for us, as well as for our customers and their patients,†says Alok Sonig, Executive Vice President and Head of the North America Generics business at Dr. Reddy’s. “This launch represents Dr. Reddy’s commitment to make affordable injectable drugs available in Canada.†Dr. Reddy’s is first to market with this Azacitidine for injection in Canada.
Vinod Ramachandran, Ph.D., Country Manager, Dr. Reddy’s Canada says that “The approval and launch of Azacitidine for injection is an important milestone for Dr. Reddy’s in Canada. The launch of first generic Azacitidine for injection is another step in our long-term commitment to bring more cost-effective options to Canadian patients.â€
Dr. Reddy’s Laboratories Ltd is pleased to announce that generic Azacitidine for injection 100 mg/vial, a bioequivalent generic version of VIDAZA (azacitidine for injection), is approved by Health Canada.
“Bringing Azacitidine for Injection to the Canadian market at this time is very important for us, as well as for our customers and their patients,†says Alok Sonig, Executive Vice President and Head of the North America Generics business at Dr. Reddy’s. “This launch represents Dr. Reddy’s commitment to make affordable injectable drugs available in Canada.†Dr. Reddy’s is first to market with this Azacitidine for injection in Canada.
Vinod Ramachandran, Ph.D., Country Manager, Dr. Reddy’s Canada says that “The approval and launch of Azacitidine for injection is an important milestone for Dr. Reddy’s in Canada. The launch of first generic Azacitidine for injection is another step in our long-term commitment to bring more cost-effective options to Canadian patients.â€
A Vaidheesh Elected President of OPPI
The Organisation of Pharmaceutical Producers of India (OPPI), which represents research-based pharmaceutical companies in India, has unanimously elected Mr. A. Vaidheesh, Vice President, South Asia & Managing Director, GlaxoSmithKline Pharmaceuticals Ltd as President for the year 2017-18. He takes over from Dr. Shailesh Ayyangar, Managing Director, India & Head - South Asia, Sanofi who held this position since 2013. The four elected Vice Presidents are Sharad Tyagi, Managing Director, Boehringer Ingelheim; Sanjiv Navangul, Managing Director, Janssen India (Pharmaceutical Companies of Johnson & Johnson Ltd); S. Sridhar, Managing Director, Pfizer Ltd and Anand Nambiar, Managing Director, Managing Director, Merck India Ltd.
Speaking on his appointment, A. Vaidheesh, President- OPPI said, “I am honoured to be taking over the responsibility as President OPPI. Today, we are at the intersection of technology and medicine and the future of healthcare seems to be progressing towards ‘personalised’ medicines and ‘personalised’ patient-care. The pharmaceutical industry has an important role to play in delivering responsible healthcare and we look forward to partnering with the Government and other stakeholders in realizing the collective dream of a Healthy India. This dream can become a reality only when science and research deliver new cures for the unmet medical needs; thereby fostering an environment of innovation. On the policy front, I am sure that the National Health Policy and the National IPR Policy will lead the way for better health outcomes. Along with an inclusive ecosystem, in the coming years, healthcare financing will also play its role in improving access to healthcare. I believe we at the OPPI have clear priorities and along with the OPPI Secretariat led by Kanchana TK, Director General, OPPI, we will together work towards serving more patients in India â€
The Organisation of Pharmaceutical Producers of India (OPPI), which represents research-based pharmaceutical companies in India, has unanimously elected Mr. A. Vaidheesh, Vice President, South Asia & Managing Director, GlaxoSmithKline Pharmaceuticals Ltd as President for the year 2017-18. He takes over from Dr. Shailesh Ayyangar, Managing Director, India & Head - South Asia, Sanofi who held this position since 2013. The four elected Vice Presidents are Sharad Tyagi, Managing Director, Boehringer Ingelheim; Sanjiv Navangul, Managing Director, Janssen India (Pharmaceutical Companies of Johnson & Johnson Ltd); S. Sridhar, Managing Director, Pfizer Ltd and Anand Nambiar, Managing Director, Managing Director, Merck India Ltd.
Speaking on his appointment, A. Vaidheesh, President- OPPI said, “I am honoured to be taking over the responsibility as President OPPI. Today, we are at the intersection of technology and medicine and the future of healthcare seems to be progressing towards ‘personalised’ medicines and ‘personalised’ patient-care. The pharmaceutical industry has an important role to play in delivering responsible healthcare and we look forward to partnering with the Government and other stakeholders in realizing the collective dream of a Healthy India. This dream can become a reality only when science and research deliver new cures for the unmet medical needs; thereby fostering an environment of innovation. On the policy front, I am sure that the National Health Policy and the National IPR Policy will lead the way for better health outcomes. Along with an inclusive ecosystem, in the coming years, healthcare financing will also play its role in improving access to healthcare. I believe we at the OPPI have clear priorities and along with the OPPI Secretariat led by Kanchana TK, Director General, OPPI, we will together work towards serving more patients in India â€
Clariant Launches MEVOPUR PEAM 176045
Clariant, a world leader in specialty chemicals, announces a new amide/amine-free anti-static masterbatch concentrate for polyethylene films used in pharmaceutical production. The new anti-stat, known under grade name MEVOPUR PEAM 176045, will be introduced at CPhI Worldwide, being held 24 - 26 October 2017 at Messe Frankfurt. Clariant is exhibiting on Stand 42L20.
The introduction is timely due to the changes in industry standards which, by 2020, will limit the acceptability of many of the currently used films that contain amide- and amine-based anti-stats, says Stephen Duckworth, Clariant’s Head of Global Segment Medical and Pharmaceutical. For the first time, plastics used in pharma manufacturing, including anti-static films, will need to comply with the same standards as plastics packaging used for finished pharmaceuticals.
“Anti-static additives are routinely incorporated in the polyethylene ‘clean-room films’ that line containers and dispensers for active pharmaceutical ingredients (APIs), and in the tubes used to transfer powdered and liquid API during drug production. They are important because the anti-static properties help to reduce the risk of dangerous conditions like explosions,†he explained.
The new additive masterbatch concentrate is part of MEVOPUR, the brand of ‘Controlled, Consistent and Compliant’ products for plastics applications in the medical and pharmaceutical industries.
When incorporated into PE films Clariant’s new anti-static provides very good static-dissipating performance and a competitive cost profile relative to alternatives. In addition, it has already been tested to the stricter new United States Pharmacopeia (USP) pharmaceutical standard for pharmaceutical-contacting plastics, which are scheduled to come into force in 2020. The new standard -- USP<665> ‘Plastic Components and Systems Used in the Manufacturing of Drug Products’ -- will, for the first time, apply the same risk-based assessment of materials. Plastic components and single-use containers are increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their advantages, these plastic assemblies elicit concerns about chemical compounds that may leach or migrate into finished products and impact product quality or safety.
Clariant, a world leader in specialty chemicals, announces a new amide/amine-free anti-static masterbatch concentrate for polyethylene films used in pharmaceutical production. The new anti-stat, known under grade name MEVOPUR PEAM 176045, will be introduced at CPhI Worldwide, being held 24 - 26 October 2017 at Messe Frankfurt. Clariant is exhibiting on Stand 42L20.
The introduction is timely due to the changes in industry standards which, by 2020, will limit the acceptability of many of the currently used films that contain amide- and amine-based anti-stats, says Stephen Duckworth, Clariant’s Head of Global Segment Medical and Pharmaceutical. For the first time, plastics used in pharma manufacturing, including anti-static films, will need to comply with the same standards as plastics packaging used for finished pharmaceuticals.
“Anti-static additives are routinely incorporated in the polyethylene ‘clean-room films’ that line containers and dispensers for active pharmaceutical ingredients (APIs), and in the tubes used to transfer powdered and liquid API during drug production. They are important because the anti-static properties help to reduce the risk of dangerous conditions like explosions,†he explained.
The new additive masterbatch concentrate is part of MEVOPUR, the brand of ‘Controlled, Consistent and Compliant’ products for plastics applications in the medical and pharmaceutical industries.
When incorporated into PE films Clariant’s new anti-static provides very good static-dissipating performance and a competitive cost profile relative to alternatives. In addition, it has already been tested to the stricter new United States Pharmacopeia (USP) pharmaceutical standard for pharmaceutical-contacting plastics, which are scheduled to come into force in 2020. The new standard -- USP<665> ‘Plastic Components and Systems Used in the Manufacturing of Drug Products’ -- will, for the first time, apply the same risk-based assessment of materials. Plastic components and single-use containers are increasingly used in manufacturing processes, particularly biological manufacturing processes. Despite their advantages, these plastic assemblies elicit concerns about chemical compounds that may leach or migrate into finished products and impact product quality or safety.
Hilleman Receives Indo-Swedish
Grant for Developing OCV
Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, received a 6 million krona Indo – Swedish grant for the project ‘Improved, affordable single strain whole cell-B subunit oral cholera vaccine’.
The proposed project, carried out by Hilleman Laboratories, is being jointly funded by the Department of Biotechnology (DBT), Government of India and Vinnova, the Swedish Governmental Agency for Innovation Systems.
The project will fuel further Research & Development of the Oral Cholera Vaccine (OCV) with knowledge exchange and transfer of scientists across India and Sweden.
Speaking on the partnership, Dr Davinder Gill, CEO Hilleman Laboratories said, “Cholera remains a threat to global public health and is a barometer of health inequity and lack of social development. Considering the urgent need for effective and affordable Cholera vaccines, both for use in Cholera outbreaks and in mass vaccination campaigns, we would like to accelerate development of our simplified Oral Cholera Vaccine, HILLCHOLTM.â€
Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, received a 6 million krona Indo – Swedish grant for the project ‘Improved, affordable single strain whole cell-B subunit oral cholera vaccine’.
The proposed project, carried out by Hilleman Laboratories, is being jointly funded by the Department of Biotechnology (DBT), Government of India and Vinnova, the Swedish Governmental Agency for Innovation Systems.
The project will fuel further Research & Development of the Oral Cholera Vaccine (OCV) with knowledge exchange and transfer of scientists across India and Sweden.
Speaking on the partnership, Dr Davinder Gill, CEO Hilleman Laboratories said, “Cholera remains a threat to global public health and is a barometer of health inequity and lack of social development. Considering the urgent need for effective and affordable Cholera vaccines, both for use in Cholera outbreaks and in mass vaccination campaigns, we would like to accelerate development of our simplified Oral Cholera Vaccine, HILLCHOLTM.â€
Price Caps Helps Indian Medical
Device Makers Grow Positively: AiMeD
Association of Indian Medical Device Industry (AiMeD) has announced that the price cap on medical devices such as knee implants and heart stents is helping the domestic medical device market grow manifold.
Hailing the price control measures, Mr Rajiv Nath, Forum Coordinator, AiMeD said “In the last six months, we have seen a positive trend towards increased sales for domestic manufacturers. This is more so in Tier 2 & Tier 3 towns due to higher affordable access post reduction of prices. We estimate that this trend shall continue and boost the idea for manufacturing and the Indian manufacturers will grab 60% of the market share by next year.â€
Mr Rajiv Nath said “Heavy lobbying is going on and pressure has increased on India to revise its stance on price caps for medical devices and not to extend it to other devices, but India should do what’s good for India and give advantage mainly to the common citizens who now have access to the best products at the most affordable prices and to domestic manufacturers.â€
The lobbying against Price Capping is being done by MNC importers with overseas factories claiming to be Indian Industry when none of these makes stents in India. We await the announcements of price cap on other devices notified as Drugs e.g. heart valves, Intra Ocular Lens and Syringes and Infusion Products.
NPPA had exercised their powers to stop total withdrawal to avoid market shortages of dominant players. From AiMeD’s viewpoint it need not do so and after 6 months moratorium any importer can leave the market if he does not want to play it - but here it’s not about an importer abandoning the market, it’s actually more about market rationalisation while wanting to make the Indian Government look bad. Seemingly DoP has now relented and permitted withdrawal to one brand of Abbot, over riding the NPPA order which wanted supplies to be available and maintained for a year.
Association of Indian Medical Device Industry (AiMeD) has announced that the price cap on medical devices such as knee implants and heart stents is helping the domestic medical device market grow manifold.
Hailing the price control measures, Mr Rajiv Nath, Forum Coordinator, AiMeD said “In the last six months, we have seen a positive trend towards increased sales for domestic manufacturers. This is more so in Tier 2 & Tier 3 towns due to higher affordable access post reduction of prices. We estimate that this trend shall continue and boost the idea for manufacturing and the Indian manufacturers will grab 60% of the market share by next year.â€
Mr Rajiv Nath said “Heavy lobbying is going on and pressure has increased on India to revise its stance on price caps for medical devices and not to extend it to other devices, but India should do what’s good for India and give advantage mainly to the common citizens who now have access to the best products at the most affordable prices and to domestic manufacturers.â€
The lobbying against Price Capping is being done by MNC importers with overseas factories claiming to be Indian Industry when none of these makes stents in India. We await the announcements of price cap on other devices notified as Drugs e.g. heart valves, Intra Ocular Lens and Syringes and Infusion Products.
NPPA had exercised their powers to stop total withdrawal to avoid market shortages of dominant players. From AiMeD’s viewpoint it need not do so and after 6 months moratorium any importer can leave the market if he does not want to play it - but here it’s not about an importer abandoning the market, it’s actually more about market rationalisation while wanting to make the Indian Government look bad. Seemingly DoP has now relented and permitted withdrawal to one brand of Abbot, over riding the NPPA order which wanted supplies to be available and maintained for a year.
Claris Completes Sale of its Stake in
JV to Otsuka
Claris Lifesciences Limited has announced that it has completed the sale of its remaining 20 per cent stake in Otsuka Pharmaceutical India Private Limited; the joint venture with Otsuka Pharmaceutical Factory, Inc. and Mitsui & Co. Ltd; to Otsuka Pharmaceutical Factory, Inc. (Japan) for a consideration of USD 20 million.
The agreement to sell was announced on May 8, 2017 “Claris sells its stake in JV to Otsukaâ€
Claris Lifesciences Limited has announced that it has completed the sale of its remaining 20 per cent stake in Otsuka Pharmaceutical India Private Limited; the joint venture with Otsuka Pharmaceutical Factory, Inc. and Mitsui & Co. Ltd; to Otsuka Pharmaceutical Factory, Inc. (Japan) for a consideration of USD 20 million.
The agreement to sell was announced on May 8, 2017 “Claris sells its stake in JV to Otsukaâ€
Danone India Launches Protinex Bytes
Danone India, part of a leading global food company Danone, which has a mission ‘to bring health through food to as many people as possible’, today announced the launch of Protinex Bytes, a specially formulated protein rich, on-the-go nutrition snack for everyone with busy lifestyles. Consumers today are looking for convenient food supplements that provide adequate nutrition anywhere, anytime.
Protinex Bytes has been launched nationally. It is available in Vanilla Flavour in two SKUs of 100 gms and 200 gms for Rs. 145 and Rs. 280 respectively. Protein is an essential nutrient at every life-stage. Inadequate intake of protein can lead to tiredness. fatigue and loss of muscle mass associated with aging. Indian diets are inadequate in protein and majority of the proteins are obtained from cereals which are not a source of good quality proteins. It is important to consume good quality protein throughout the day to meet the protein requirements and activate body protein synthesis. The current formats are available in powder form and are required to be mixed in milk. Protinex Bytes is a more convenient format of a food supplement which not only helps meet nutritional requirements but is also a tasty and healthy on-the-go snack option. Five Protinex bytes provide more proteins (8g) than 1 glass of milk or 1 egg (6g).
Danone India, part of a leading global food company Danone, which has a mission ‘to bring health through food to as many people as possible’, today announced the launch of Protinex Bytes, a specially formulated protein rich, on-the-go nutrition snack for everyone with busy lifestyles. Consumers today are looking for convenient food supplements that provide adequate nutrition anywhere, anytime.
Protinex Bytes has been launched nationally. It is available in Vanilla Flavour in two SKUs of 100 gms and 200 gms for Rs. 145 and Rs. 280 respectively. Protein is an essential nutrient at every life-stage. Inadequate intake of protein can lead to tiredness. fatigue and loss of muscle mass associated with aging. Indian diets are inadequate in protein and majority of the proteins are obtained from cereals which are not a source of good quality proteins. It is important to consume good quality protein throughout the day to meet the protein requirements and activate body protein synthesis. The current formats are available in powder form and are required to be mixed in milk. Protinex Bytes is a more convenient format of a food supplement which not only helps meet nutritional requirements but is also a tasty and healthy on-the-go snack option. Five Protinex bytes provide more proteins (8g) than 1 glass of milk or 1 egg (6g).
Agilent Launches Triple Quadrupole
Mass Spectrometer in India
Agilent Technologies Inc has introduced the newest member of its family of triple quadrupole liquid chromatography mass spectrometers (triple quad LC/MS) at the Analytica Anacon India, being held on 21st September through 23rd September in Hyderabad, India. The Ultivo triple quad is a transformative approach to LC/MS that integrates several hardware and software innovations designed to deliver even more improved business results for customers.
Ultivo is optimized to address the food and environmental routine testing segments employing triple quad LC/MS systems for quantitative analyses. Ultivo delivers robust performance, superior uptime, and easier serviceability, in a footprint that is 70% smaller than previous instruments. Customers can now significantly increase their analytical throughput without having to increase the size of their existing laboratories.
In addition to its trendsetting size, Ultivo provides reproducible, reliable assays that result in exceptional performance in complex matrices. Greater ion transmission efficiency leads to optimized sensitivity; and improved, intelligent diagnostics use intuitive readbacks that can quickly identify issues, ensuring optimum uptime. Furthermore, Ultivo’s new VacShield vacuum provides vent-less ion injector exchange capabilities that reduce wear and tear and facilitate rapid front-end maintenance.
Agilent Technologies Inc has introduced the newest member of its family of triple quadrupole liquid chromatography mass spectrometers (triple quad LC/MS) at the Analytica Anacon India, being held on 21st September through 23rd September in Hyderabad, India. The Ultivo triple quad is a transformative approach to LC/MS that integrates several hardware and software innovations designed to deliver even more improved business results for customers.
Ultivo is optimized to address the food and environmental routine testing segments employing triple quad LC/MS systems for quantitative analyses. Ultivo delivers robust performance, superior uptime, and easier serviceability, in a footprint that is 70% smaller than previous instruments. Customers can now significantly increase their analytical throughput without having to increase the size of their existing laboratories.
In addition to its trendsetting size, Ultivo provides reproducible, reliable assays that result in exceptional performance in complex matrices. Greater ion transmission efficiency leads to optimized sensitivity; and improved, intelligent diagnostics use intuitive readbacks that can quickly identify issues, ensuring optimum uptime. Furthermore, Ultivo’s new VacShield vacuum provides vent-less ion injector exchange capabilities that reduce wear and tear and facilitate rapid front-end maintenance.
LifeCell Respectfully Challenges
ICMR’s Recommendations
The Indian Council of Medical Research (ICMR) had made recommendations in its National guidelines to stem cell research, 2017, to suspend commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood. In its recommendation ICMR which functions under the health ministry had stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells. Accordingly, the ICMR has issued guidelines stating that commercial banking of all other biological materials, other than UCB, is not permitted until further notification.
Mr Mayur Abhaya, CEO & Managing Director of LifeCell - India’s largest umbilical cord stem cell bank today questioned the hurried decision of ICMR in this guideline recommendations for preserving vital stem cells from cord tissue, menstrual blood and other biological material without considering many aspects. He commented that the decision does not carry a rationale for many reasons which he elaborated.
Mr Mayur Abhaya, CEO & Managing Director, LifeCell said “The decision to recommend a ban on banking of stem cells from cord tissue, menstrual blood and other biological sources is very unfortunate and totally overlooks the potential contribution of stem cells in research and development. Though today, applications of these are restricted, research and advanced clinical trials across the globe on these products have been demonstrating a significant progress. It is only a matter of time when these stem cells could become treatment solutions for many disorders that have very few other options for treatment.â€
Now, if the contention is that these cord tissue and other MSC stem cells are going to be used for treatments today, if that is the concern of ICMR then the answer is a clear “No†since they have not been approved for therapies.
The Indian Council of Medical Research (ICMR) had made recommendations in its National guidelines to stem cell research, 2017, to suspend commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood. In its recommendation ICMR which functions under the health ministry had stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells. Accordingly, the ICMR has issued guidelines stating that commercial banking of all other biological materials, other than UCB, is not permitted until further notification.
Mr Mayur Abhaya, CEO & Managing Director of LifeCell - India’s largest umbilical cord stem cell bank today questioned the hurried decision of ICMR in this guideline recommendations for preserving vital stem cells from cord tissue, menstrual blood and other biological material without considering many aspects. He commented that the decision does not carry a rationale for many reasons which he elaborated.
Mr Mayur Abhaya, CEO & Managing Director, LifeCell said “The decision to recommend a ban on banking of stem cells from cord tissue, menstrual blood and other biological sources is very unfortunate and totally overlooks the potential contribution of stem cells in research and development. Though today, applications of these are restricted, research and advanced clinical trials across the globe on these products have been demonstrating a significant progress. It is only a matter of time when these stem cells could become treatment solutions for many disorders that have very few other options for treatment.â€
Now, if the contention is that these cord tissue and other MSC stem cells are going to be used for treatments today, if that is the concern of ICMR then the answer is a clear “No†since they have not been approved for therapies.
Regenerative Medicine Set to Shake
up the Therapy Market
In what could be a radical shake-up of the healthcare sector, regenerative medical procedures such as stem-cell or gene therapy hold the promise of completely curing diseases rather than simply treating them. With the pharmaceutical industry’s business model currently based on treating incurable diseases with drugs, regenerative therapies are mostly being developed in specialist clinics and trial situations. Despite the rapid expansion of the market for new therapies – anticipated to grow 33 percent per year from 2020 through 2025 – Big Pharma show a striking lack of involvement and therefore risk missing out on a slice of this significant market.
Regenerative medicine could produce new therapeutic interventions for cancers, genetic disorders or autoimmune diseases. Stemcell therapy, for example, can restore damaged tissue or even regenerate entire organs. In a revolution for patients, many of whom have had to rely on medication for years, the focus is shifting from treatment to cure. And the market for regenerative medicine is set to grow rapidly, from a value of EUR 20 billion today to somewhere in the region of EUR 130 billion by 2025. These are among the findings of the latest study by Roland Berger, “Regenerative medicine – The next generation of therapeutic products is set to shake up the pharmaceutical worldâ€.
“Regenerative medicine has the potential to turn the healthcare sector upside down for all involved: health insurers, hospitals and pharmaceutical players alike,†says Roland Berger Partner Thilo Kaltenbach. “As regenerative medicine becomes established over the coming years, it is going to transform the drug market in particular.â€
In what could be a radical shake-up of the healthcare sector, regenerative medical procedures such as stem-cell or gene therapy hold the promise of completely curing diseases rather than simply treating them. With the pharmaceutical industry’s business model currently based on treating incurable diseases with drugs, regenerative therapies are mostly being developed in specialist clinics and trial situations. Despite the rapid expansion of the market for new therapies – anticipated to grow 33 percent per year from 2020 through 2025 – Big Pharma show a striking lack of involvement and therefore risk missing out on a slice of this significant market.
Regenerative medicine could produce new therapeutic interventions for cancers, genetic disorders or autoimmune diseases. Stemcell therapy, for example, can restore damaged tissue or even regenerate entire organs. In a revolution for patients, many of whom have had to rely on medication for years, the focus is shifting from treatment to cure. And the market for regenerative medicine is set to grow rapidly, from a value of EUR 20 billion today to somewhere in the region of EUR 130 billion by 2025. These are among the findings of the latest study by Roland Berger, “Regenerative medicine – The next generation of therapeutic products is set to shake up the pharmaceutical worldâ€.
“Regenerative medicine has the potential to turn the healthcare sector upside down for all involved: health insurers, hospitals and pharmaceutical players alike,†says Roland Berger Partner Thilo Kaltenbach. “As regenerative medicine becomes established over the coming years, it is going to transform the drug market in particular.â€
GNC Strengthens its Presence in India
GNC (General Nutrition Centre), headquartered in Pittsburgh, US, and a leading global specialty health, wellness, and nutraceuticals retailer, is strengthening its presence in India through its association with Guardian Healthcare, the official importer and seller of GNC products in India. Globally, GNC is a multi-billion brand and has around 9,000 locations and franchise operations in approximately 50 countries.
In India, Guardian Healthcare Services Pvt Ltd. has tied up with GNC as a sole franchisee with exclusive distribution and marketing rights. Founded by Mr Ashutosh Taparia, who has over two decades of expertise in healthcare, Guardian has a vision of establishing thought leadership position in Indian nutraceuticals market. GNC products are now available online on the e-commerce portals as well as at the retail outlets of Guardian Healthcare and other pharmacy chains. Guardian aims to make GNC range available at 4000 stores across all Metros & Tier 1 towns by 2020. Built on 80 years of superior product quality and innovation, GNC is committed to help Indian consumers in better managing lifestyle issues such as fatigue, stress, vitamin deficiencies, and cholesterol amongst others through the principles of ‘Scientific Nutrition’. With the objective of laying foundation for “Live Well†amongst the Indian consumers, GNC has identified four building blocks of nutrition - Multivitamins, Omega-3’s, Proteins, and Probiotics.
As many as 91 percent vegetarians and 85 percent non-vegetarians among Indians were deficient in proteins according to the survey titled ‘Protein Consumption in the Diet of adult Indians Survey’ (PRODIGY). GNC India is endeavouring to build the cause of #BuildingBlocksofNutrition to raise awareness about missing blocks in nutrition amongst Indians. It refers to need for bridging the gap between insufficient nutrition intakes in our day to day diet with the assistance of health and nourishment products.
GNC (General Nutrition Centre), headquartered in Pittsburgh, US, and a leading global specialty health, wellness, and nutraceuticals retailer, is strengthening its presence in India through its association with Guardian Healthcare, the official importer and seller of GNC products in India. Globally, GNC is a multi-billion brand and has around 9,000 locations and franchise operations in approximately 50 countries.
In India, Guardian Healthcare Services Pvt Ltd. has tied up with GNC as a sole franchisee with exclusive distribution and marketing rights. Founded by Mr Ashutosh Taparia, who has over two decades of expertise in healthcare, Guardian has a vision of establishing thought leadership position in Indian nutraceuticals market. GNC products are now available online on the e-commerce portals as well as at the retail outlets of Guardian Healthcare and other pharmacy chains. Guardian aims to make GNC range available at 4000 stores across all Metros & Tier 1 towns by 2020. Built on 80 years of superior product quality and innovation, GNC is committed to help Indian consumers in better managing lifestyle issues such as fatigue, stress, vitamin deficiencies, and cholesterol amongst others through the principles of ‘Scientific Nutrition’. With the objective of laying foundation for “Live Well†amongst the Indian consumers, GNC has identified four building blocks of nutrition - Multivitamins, Omega-3’s, Proteins, and Probiotics.
As many as 91 percent vegetarians and 85 percent non-vegetarians among Indians were deficient in proteins according to the survey titled ‘Protein Consumption in the Diet of adult Indians Survey’ (PRODIGY). GNC India is endeavouring to build the cause of #BuildingBlocksofNutrition to raise awareness about missing blocks in nutrition amongst Indians. It refers to need for bridging the gap between insufficient nutrition intakes in our day to day diet with the assistance of health and nourishment products.
Piramal Pharma Solutions Names John
Fowler as its Chief Operating Officer
Piramal Pharma Solutions (PPS), part of Piramal Enterprises Limited, announce the appointment of John Fowler as its Chief Operating Officer. PPS is a leader in Integrated Contract Development and Manufacturing, with a global network of 12 development and manufacturing facilities across North America, Europe and Asia. PPS offers a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies and Commercial supply of APIs and Finished dosage forms. As Chief Operating Officer, John will be responsible for Global Operations and Research & Development (R & D), and will play a lead role in ensuring that our customers consistently experience differentiated and excellent levels of service.
Most recently, John served as the Divisional CEO of the Global Fine Chemicals business at Johnson Matthey (JM), with responsibility for JM’s Services (Custom API Development, Manufacturing, Catalyst & Chiral Technologies), and Products (Generics Development and Manufacturing) portfolio. Before leading JM’s Fine Chemical Division, John held senior leadership roles in several business verticals at JM, including Pharmaceutical Materials and Services, Environmental Catalysts and Technologies, among others. John has a Chemical Engineering degree from Bucknell University and an MBA from St. Joseph University.
Piramal Pharma Solutions (PPS), part of Piramal Enterprises Limited, announce the appointment of John Fowler as its Chief Operating Officer. PPS is a leader in Integrated Contract Development and Manufacturing, with a global network of 12 development and manufacturing facilities across North America, Europe and Asia. PPS offers a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies and Commercial supply of APIs and Finished dosage forms. As Chief Operating Officer, John will be responsible for Global Operations and Research & Development (R & D), and will play a lead role in ensuring that our customers consistently experience differentiated and excellent levels of service.
Most recently, John served as the Divisional CEO of the Global Fine Chemicals business at Johnson Matthey (JM), with responsibility for JM’s Services (Custom API Development, Manufacturing, Catalyst & Chiral Technologies), and Products (Generics Development and Manufacturing) portfolio. Before leading JM’s Fine Chemical Division, John held senior leadership roles in several business verticals at JM, including Pharmaceutical Materials and Services, Environmental Catalysts and Technologies, among others. John has a Chemical Engineering degree from Bucknell University and an MBA from St. Joseph University.
Aurigene and Curis Announce CA-170
Program Update
Aurigene Discovery Technologies Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, announced plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India. This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc, a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial.
CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses. Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.
Aurigene Discovery Technologies Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, announced plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India. This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc, a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial.
CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses. Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.
SCHOTT Integrates Big Data Solution
into Pharma Tubing Production
SCHOTT has recently integrated a specially developed big data solution into its pharmaceutical tubing production in India, replacing statistical sample-based quality assurance with 100 percent on-line measurement.
With the new IT-based process called perfeXion, process- and product- quality data of each individual glass tube is collected online and in real-time – an innovation that sets new standards in the pharmaceutical glass industry.
During the multi-layered process of pharmaceutical tubing production, statistical quality control is not 100% thorough. However, thanks to a unique big data approach, SCHOTT Glass India is now able to measure 100% of every single glass tube in production. Instead of selecting a few glass tubes from each batch for statistical quality control, the new perfeXion system measures the entire glass tube many times over as it is drawn from the melt. Lasers recognize deviations in diameter and wall thickness, for example, and camera and IR inspection systems can even detect the smallest inclusions in the glass. Around 100,000 data tags are generated every minute.
An integrated IT system, evaluating the continuous glass tube with real-time data measurements, calculates incidents of imperfection with such precision that it can later differentiate corresponding individual tubes which can then be sorted out. Each tube is checked again at its completion.
The system’s development took several years. Analyzing a curved tube surface zooming down a production line was a particularly difficult challenge. The effort, however, has paid off – not least because the data analysis is a source of insight into how production can be further optimized.
SCHOTT has recently integrated a specially developed big data solution into its pharmaceutical tubing production in India, replacing statistical sample-based quality assurance with 100 percent on-line measurement.
With the new IT-based process called perfeXion, process- and product- quality data of each individual glass tube is collected online and in real-time – an innovation that sets new standards in the pharmaceutical glass industry.
During the multi-layered process of pharmaceutical tubing production, statistical quality control is not 100% thorough. However, thanks to a unique big data approach, SCHOTT Glass India is now able to measure 100% of every single glass tube in production. Instead of selecting a few glass tubes from each batch for statistical quality control, the new perfeXion system measures the entire glass tube many times over as it is drawn from the melt. Lasers recognize deviations in diameter and wall thickness, for example, and camera and IR inspection systems can even detect the smallest inclusions in the glass. Around 100,000 data tags are generated every minute.
An integrated IT system, evaluating the continuous glass tube with real-time data measurements, calculates incidents of imperfection with such precision that it can later differentiate corresponding individual tubes which can then be sorted out. Each tube is checked again at its completion.
The system’s development took several years. Analyzing a curved tube surface zooming down a production line was a particularly difficult challenge. The effort, however, has paid off – not least because the data analysis is a source of insight into how production can be further optimized.
Align National TB Strategies with
Commitment to End TB by 2030: WHO
World Health Organization has called on countries in South-East Asia Region to build on recent momentum aimed at ending TB by 2030, commending their resolve to take action and urging all countries to review and align national plans with the Delhi Call to Action.
“The Region-wide momentum established to ‘bend the curve’ and end TB by 2030 is laudable. The Delhi Call for Action, issued by health ministers in March, demonstrates high-level awareness that business as usual is not enough, and that intensified efforts are needed. We have reached a critical consensus; the pressing need now is to translate commitment into action,†Dr Khetrapal Singh, Regional Director, WHO South-East Asia, said.
Across the Region, TB remains the largest cause of death and suffering due to any communicable disease among the most productive age groups. Although the Region accounts for approximately one quarter of the world’s population, it has nearly half the number of new TB cases and close to 40% of TB deaths globally. In recognition of TB’s outsized burden, accelerating progress towards the 2030 target – which requires a 90% reduction in TB deaths and 80% decrease in TB incidence – is now one of WHO South-East Asia Region’s Flagship Priority Areas of work.
As a critical first step in implementing recent commitments, Dr Khetrapal Singh emphasized the need for countries to align national plans with the 2030 target. “By reviewing and amending national TB plans countries will enhance their ability to mobilize and utilize resources efficiently. Good planning is key to establishing the foundations for success,†she said.
World Health Organization has called on countries in South-East Asia Region to build on recent momentum aimed at ending TB by 2030, commending their resolve to take action and urging all countries to review and align national plans with the Delhi Call to Action.
“The Region-wide momentum established to ‘bend the curve’ and end TB by 2030 is laudable. The Delhi Call for Action, issued by health ministers in March, demonstrates high-level awareness that business as usual is not enough, and that intensified efforts are needed. We have reached a critical consensus; the pressing need now is to translate commitment into action,†Dr Khetrapal Singh, Regional Director, WHO South-East Asia, said.
Across the Region, TB remains the largest cause of death and suffering due to any communicable disease among the most productive age groups. Although the Region accounts for approximately one quarter of the world’s population, it has nearly half the number of new TB cases and close to 40% of TB deaths globally. In recognition of TB’s outsized burden, accelerating progress towards the 2030 target – which requires a 90% reduction in TB deaths and 80% decrease in TB incidence – is now one of WHO South-East Asia Region’s Flagship Priority Areas of work.
As a critical first step in implementing recent commitments, Dr Khetrapal Singh emphasized the need for countries to align national plans with the 2030 target. “By reviewing and amending national TB plans countries will enhance their ability to mobilize and utilize resources efficiently. Good planning is key to establishing the foundations for success,†she said.
Merck to Join Forces with Project
Data Sphere
Merck, a leading science and technology company has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck’s Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.
The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.
Merck, a leading science and technology company has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck’s Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.
The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.
IIL Forays into Herbal Market with 'Zuspray'
Hyderabad-based Indian Immunological Limited (IIL), a leading player in human and animal health has launched its first herbal product 'Zuspray' for animals. The launch of this herbal topical spray marks IIL's entry into the Rs 480 crores valued domestic animal health herbal market. The herbal ingredients in ‘Zuspray’ will help in the treatment of all types of open wounds including surgical wounds.
IIL has forayed into the herbal market with Zuspray. This will expand IIL’s target market by a diversification strategy of entering into the herbal market. In the coming years IIL will plan to enrich their portfolio with few more products related to animal health care particularly the productivity of the animal. Zuspray is a reliable wound healer for all animals. The product will be available in 100 ml spray bottles across all retail shops in India which caters to animal health products.
Hyderabad-based Indian Immunological Limited (IIL), a leading player in human and animal health has launched its first herbal product 'Zuspray' for animals. The launch of this herbal topical spray marks IIL's entry into the Rs 480 crores valued domestic animal health herbal market. The herbal ingredients in ‘Zuspray’ will help in the treatment of all types of open wounds including surgical wounds.
IIL has forayed into the herbal market with Zuspray. This will expand IIL’s target market by a diversification strategy of entering into the herbal market. In the coming years IIL will plan to enrich their portfolio with few more products related to animal health care particularly the productivity of the animal. Zuspray is a reliable wound healer for all animals. The product will be available in 100 ml spray bottles across all retail shops in India which caters to animal health products.
Dr. Reddy's Launches USP (XL) in the
US Market
Dr. Reddy’s Laboratories Ltd. announced that it has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, a therapeutic equivalent generic version of Wellbutrin XL (Bupropion Hydrochloride Extended-Release) Tablets, approved by the US Food & Drug Administration (USFDA).
The Wellbutrin XL brand and generic had US sales of approximately USD 754 million MAT for the most recent twelve months ending in July 2017 according to IMS Health.
Dr. Reddy’s Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, are each available in bottle count sizes of 30, 90 and 500.
Wellbutrin XL is a trademark of GlaxoSmithKline LLC.
Dr. Reddy’s Laboratories Ltd. announced that it has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, a therapeutic equivalent generic version of Wellbutrin XL (Bupropion Hydrochloride Extended-Release) Tablets, approved by the US Food & Drug Administration (USFDA).
The Wellbutrin XL brand and generic had US sales of approximately USD 754 million MAT for the most recent twelve months ending in July 2017 according to IMS Health.
Dr. Reddy’s Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, are each available in bottle count sizes of 30, 90 and 500.
Wellbutrin XL is a trademark of GlaxoSmithKline LLC.
Dr. Reddy's & CHD Bioscience Ink
Commercialization Deal
Dr Reddy's Laboratories Ltdand CHD Bioscience Inc., a privately-held biopharmaceutical company, announced a global licensing agreement for the clinical development and commercialization of Dr. Reddy’s phase III clinical trial candidate, DFA-02. It is intended to be used for the prevention of surgical site infections, following non-emergency, elective colorectal surgery. Phase II studies for DFA-02 have been successfully completed, and the product will be transitioning to pivotal Phase III registration studies.
Under the terms of the agreement, Dr. Reddy's would receive equity in CHD valued at $30 million upon an IPO of CHD or a minimum of $30 million in cash within 18 months of execution of the agreement. Dr. Reddy’s will also receive additional milestone payments of $40 million upon USFDA approval. In addition, CHD will pay Dr. Reddy's double-digit royalties on sales and commercial milestones.
Commenting on the signing of the agreement, Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma, a wholly owned subsidiary of Dr. Reddy’s, said, "We are pleased to announce our partnership with CHD Bioscience. We feel that the needs of patients undergoing surgery will be well served by CHD, given their strong focus on offering targeted solutions for surgical site infections. DFA-02 has demonstrated promising results in clinical studies, and we are excited about the prospect of CHD undertaking further development and commercialization of the asset."
"This transaction advances our strategy to become a world leader in the targeted prevention and treatment of drug-resistant infections. Building on our development work with VERIOXâ„¢ in orthopedics and wound care, DFA-02 potentially extends our ability to help patients in the surgical setting who may be at high risk of infections without exposing the patient to large amounts of systemic antibiotics," said Michael Handley, director and chief executive officer of CHD Bioscience. "DFA-02 fits our strategy of targeting the site of the infection rather than the whole patient, and we are pleased to be continuing the great work that Dr. Reddy's has started."
Dr Reddy's Laboratories Ltdand CHD Bioscience Inc., a privately-held biopharmaceutical company, announced a global licensing agreement for the clinical development and commercialization of Dr. Reddy’s phase III clinical trial candidate, DFA-02. It is intended to be used for the prevention of surgical site infections, following non-emergency, elective colorectal surgery. Phase II studies for DFA-02 have been successfully completed, and the product will be transitioning to pivotal Phase III registration studies.
Under the terms of the agreement, Dr. Reddy's would receive equity in CHD valued at $30 million upon an IPO of CHD or a minimum of $30 million in cash within 18 months of execution of the agreement. Dr. Reddy’s will also receive additional milestone payments of $40 million upon USFDA approval. In addition, CHD will pay Dr. Reddy's double-digit royalties on sales and commercial milestones.
Commenting on the signing of the agreement, Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma, a wholly owned subsidiary of Dr. Reddy’s, said, "We are pleased to announce our partnership with CHD Bioscience. We feel that the needs of patients undergoing surgery will be well served by CHD, given their strong focus on offering targeted solutions for surgical site infections. DFA-02 has demonstrated promising results in clinical studies, and we are excited about the prospect of CHD undertaking further development and commercialization of the asset."
"This transaction advances our strategy to become a world leader in the targeted prevention and treatment of drug-resistant infections. Building on our development work with VERIOXâ„¢ in orthopedics and wound care, DFA-02 potentially extends our ability to help patients in the surgical setting who may be at high risk of infections without exposing the patient to large amounts of systemic antibiotics," said Michael Handley, director and chief executive officer of CHD Bioscience. "DFA-02 fits our strategy of targeting the site of the infection rather than the whole patient, and we are pleased to be continuing the great work that Dr. Reddy's has started."
PolyPid Completes Enrollment in Phase
Ib/II Study of D-PLEX
PolyPidLtd.,acbiopharmacompanywithaninitialfocus ontheprevention and treatment of post-surgical site infections, has announced the completion of enrollment in its Phase Ib /II study of D-PLEX (Doxycycline / Polymer-Lipid Encapsulation Matrix), the lead product candidate, for the prevention of post- cardiac surgery sternal infection. D-PLEX is a secured antibiotic drug reservoir that provides a safe and effective local anti bacterial prevention and treatment measure during surgical procedures.
Sternal infection following cardiac surgery is an unmet medical need and one of the most significant complications following open cardiac surgery, which, according to known literature, has a mortality rate of up to 40 percent.
The Phase Ib /II study of D-PLEX is a prospective, multi-center, two-part trial evaluating the safety and efficacy of D-PLEX in the prevention of sternal infection post-cardiac surgery. The study is being conducted in Israel on a total of 80 patients. PolyPid expects first line data on all patients in this trial to be available by the end of 2017. The Company intends to seek regulatory approvals in the U.S. and Europe in 2018 to conduct a Phase III trial of D-PLEX in prevention of post-cardiac surgery sternal infection.
To date PolyPid has treated more than 100 patients with its PLEX based anti-infective products. Preliminary data from studies in orthopedic indications showed no infections in the treated organ. Moreover, D-PLEX was safe with no adverse events related to the product.
PolyPidLtd.,acbiopharmacompanywithaninitialfocus ontheprevention and treatment of post-surgical site infections, has announced the completion of enrollment in its Phase Ib /II study of D-PLEX (Doxycycline / Polymer-Lipid Encapsulation Matrix), the lead product candidate, for the prevention of post- cardiac surgery sternal infection. D-PLEX is a secured antibiotic drug reservoir that provides a safe and effective local anti bacterial prevention and treatment measure during surgical procedures.
Sternal infection following cardiac surgery is an unmet medical need and one of the most significant complications following open cardiac surgery, which, according to known literature, has a mortality rate of up to 40 percent.
The Phase Ib /II study of D-PLEX is a prospective, multi-center, two-part trial evaluating the safety and efficacy of D-PLEX in the prevention of sternal infection post-cardiac surgery. The study is being conducted in Israel on a total of 80 patients. PolyPid expects first line data on all patients in this trial to be available by the end of 2017. The Company intends to seek regulatory approvals in the U.S. and Europe in 2018 to conduct a Phase III trial of D-PLEX in prevention of post-cardiac surgery sternal infection.
To date PolyPid has treated more than 100 patients with its PLEX based anti-infective products. Preliminary data from studies in orthopedic indications showed no infections in the treated organ. Moreover, D-PLEX was safe with no adverse events related to the product.
PharmaLytica 2017
UBM India, organisers of CPhI and P-MEC India, the leading global pharma trade show and conference, hosted the 4th Edition of PharmaLytica 2017 on 11th – 12th August. The two day event was inaugurated by Chief Guest Shri Jayesh Ranjan, Principal Secretary to Government of Telangana, Industries & Commerce (I&C) Department & Information Technology, Electronics and Communications (ITE&C) Department, in the presence of Guests of Honour, Dr. Rao Vadlamudi, President, Indian Pharmaceutical Association (IPA), Shri Madan Mohan Reddy, Chairman, Pharmexcil and Director, Aurobindo Pharma, Dr Ravi Uday Bhaskar, Director General, Pharmexcil, Mr. Avinash Talwar, Director & Head – Global Sourcing, Dr Reddy's Laboratories, Mr. Chakravarthi AVPS, Managing Director at Ecobliss India Pvt Limited, Mr. Yogesh Mudras, Managing Director, UBM India and Mr Rahul Deshpande, Group Director, UBM India, at the HITEX Exhibition Center.
PharmaLytica 2017 is considered to be an ideal platform for pharma professionals from the Analytical & Bio Tech, Lab equipments & Lab Chemicals, Pharma Machinery and Packaging sub-sectors, to keep abreast with innovations in the growing businesses of India’s pharma industry. Over 100 exhibiting companies have participated for the first time at the show, reiterating its acknowledged pole position in the South.
The 4th edition of the expo has witnessed participation from over 150 exhibitors from across the country including notable industry players such as Standard Group of Companies, Sanitt Equipment & Machines, Gandhi Automations, Mack Pharmatech, S.K. Pharma Machinery, Sterimax Engineering, Utopia Optovision, Rahul Enterprises, Chemipack India, Shree Naina Glass, Komal Industries, Allpharm Technologies, Subodh Engineering, Kirloskar Pneumatic, Integrated Cleanroom Technology, Accura Pharmaquip Inos Technologies among others.
On the day one of the PharmaLytica, a series of insightful sessions were organized to discuss the growth phase of the Indian pharma industry, the challenges it faces and how it can again truly distinguish itself in the global pharma industry in the years to come. Having made a mark in the bulk drug sector, Indian pharma companies have also started focusing on R&D, drug inventions and investing in new age technology and machinery for an all round, faster and efficient growth.
UBM India, organisers of CPhI and P-MEC India, the leading global pharma trade show and conference, hosted the 4th Edition of PharmaLytica 2017 on 11th – 12th August. The two day event was inaugurated by Chief Guest Shri Jayesh Ranjan, Principal Secretary to Government of Telangana, Industries & Commerce (I&C) Department & Information Technology, Electronics and Communications (ITE&C) Department, in the presence of Guests of Honour, Dr. Rao Vadlamudi, President, Indian Pharmaceutical Association (IPA), Shri Madan Mohan Reddy, Chairman, Pharmexcil and Director, Aurobindo Pharma, Dr Ravi Uday Bhaskar, Director General, Pharmexcil, Mr. Avinash Talwar, Director & Head – Global Sourcing, Dr Reddy's Laboratories, Mr. Chakravarthi AVPS, Managing Director at Ecobliss India Pvt Limited, Mr. Yogesh Mudras, Managing Director, UBM India and Mr Rahul Deshpande, Group Director, UBM India, at the HITEX Exhibition Center.
PharmaLytica 2017 is considered to be an ideal platform for pharma professionals from the Analytical & Bio Tech, Lab equipments & Lab Chemicals, Pharma Machinery and Packaging sub-sectors, to keep abreast with innovations in the growing businesses of India’s pharma industry. Over 100 exhibiting companies have participated for the first time at the show, reiterating its acknowledged pole position in the South.
The 4th edition of the expo has witnessed participation from over 150 exhibitors from across the country including notable industry players such as Standard Group of Companies, Sanitt Equipment & Machines, Gandhi Automations, Mack Pharmatech, S.K. Pharma Machinery, Sterimax Engineering, Utopia Optovision, Rahul Enterprises, Chemipack India, Shree Naina Glass, Komal Industries, Allpharm Technologies, Subodh Engineering, Kirloskar Pneumatic, Integrated Cleanroom Technology, Accura Pharmaquip Inos Technologies among others.
On the day one of the PharmaLytica, a series of insightful sessions were organized to discuss the growth phase of the Indian pharma industry, the challenges it faces and how it can again truly distinguish itself in the global pharma industry in the years to come. Having made a mark in the bulk drug sector, Indian pharma companies have also started focusing on R&D, drug inventions and investing in new age technology and machinery for an all round, faster and efficient growth.
Praj Recognised by IIMM for its Supply Chain Management Practices
Praj Industries, a global process solutions company, has been recognised for its supply chain management (SCM) practices by Indian Institute of Materials Management (IIMM). Praj has been awarded the “Best Supply Chain Management Practices†in the large manufacturing sector category at the 4th Annual Awards held at Sheraton Grand Pune.
IIMM is a national apex body representing a wide spectrum of professionals engaged in various facets of Material Management such as planning, sourcing, logistics & supply chain management. It has a network of 51 branches and 19 chapters and IIMM Pune is the oldest branch established way back in 1966. IIMM Pune started First Logistics and Supply Chain Management Awards in 2014 and these awards have gained widespread acceptability in India Inc.
The 4th Annual Award recognizes an organisation that has demonstrated superior commitment, innovative strategic leadership and significant supply chain management/logistics contributions within the industry. It had esteemed jury comprising industry stalwarts and they unanimously selected Praj for implementing effective supply chain management using powerful SCM solutions.
Praj has been focussing on real time monitoring of savings by implementing various techniques such as partnering with the suppliers, pivoting alternate suppliers and smart logistics initiatives. The company also applies various innovative strategies for international sourcing such as Best Cost Countries for various commodities, leveraging embassies and trade bodies, sourcing through trade bodies and establishing Tri-party agreement ‘We win together (Three handshake)’ for leveraging geographic advantage. Under the green partner program, Praj has retained BSI to do audit training and certification of partners for green SCM initiative.
Praj Industries, a global process solutions company, has been recognised for its supply chain management (SCM) practices by Indian Institute of Materials Management (IIMM). Praj has been awarded the “Best Supply Chain Management Practices†in the large manufacturing sector category at the 4th Annual Awards held at Sheraton Grand Pune.
IIMM is a national apex body representing a wide spectrum of professionals engaged in various facets of Material Management such as planning, sourcing, logistics & supply chain management. It has a network of 51 branches and 19 chapters and IIMM Pune is the oldest branch established way back in 1966. IIMM Pune started First Logistics and Supply Chain Management Awards in 2014 and these awards have gained widespread acceptability in India Inc.
The 4th Annual Award recognizes an organisation that has demonstrated superior commitment, innovative strategic leadership and significant supply chain management/logistics contributions within the industry. It had esteemed jury comprising industry stalwarts and they unanimously selected Praj for implementing effective supply chain management using powerful SCM solutions.
Praj has been focussing on real time monitoring of savings by implementing various techniques such as partnering with the suppliers, pivoting alternate suppliers and smart logistics initiatives. The company also applies various innovative strategies for international sourcing such as Best Cost Countries for various commodities, leveraging embassies and trade bodies, sourcing through trade bodies and establishing Tri-party agreement ‘We win together (Three handshake)’ for leveraging geographic advantage. Under the green partner program, Praj has retained BSI to do audit training and certification of partners for green SCM initiative.
BASF Expands Pharmaceutical Technical Lab
BASF India Limited, subsidiary of BASF SE has inaugurated its pharma technical lab at its Innovation Campus Asia Pacific, located in Navi Mumbai, India. Named "BASF Pharma Solutions Lab", the facility will cater to the fast-growing pharmaceutical market in South Asia, especially generic drug manufacturing, which accounts for more than 70 percent of the sector in India.
This pharma technical lab is the fifth application lab in BASF's global innovation network for pharmaceutical solutions, which also includes labs in Germany, North America, South America, and Shanghai, China.
The 200-square-meter application lab boasts technical capabilities in creating and delivering BASF's functional solutions for drug formulation, especially in solubilization and instant & modified release. This will enable pharmaceutical manufacturers to solve drug formulation challenges such as developing fixed dose combinations, taste masking and temperature- or moisture-sensitive drugs.
BASF has been providing technical services to customers in drug formulation and manufacturing in South Asia since 2008. The upgraded pharmaceutical application facility is located within Innovation Campus Asia Pacific (Mumbai), BASF's biggest research and development (R&D) investment in South Asia. Inaugurated in March of this year, the Innovation Campus Asia Pacific also houses the company’s other existing scientific disciplines. This creates the opportunity for innovation synergies to be able to meet the unique technological needs of diverse customers across South Asia.
BASF India Limited, subsidiary of BASF SE has inaugurated its pharma technical lab at its Innovation Campus Asia Pacific, located in Navi Mumbai, India. Named "BASF Pharma Solutions Lab", the facility will cater to the fast-growing pharmaceutical market in South Asia, especially generic drug manufacturing, which accounts for more than 70 percent of the sector in India.
This pharma technical lab is the fifth application lab in BASF's global innovation network for pharmaceutical solutions, which also includes labs in Germany, North America, South America, and Shanghai, China.
The 200-square-meter application lab boasts technical capabilities in creating and delivering BASF's functional solutions for drug formulation, especially in solubilization and instant & modified release. This will enable pharmaceutical manufacturers to solve drug formulation challenges such as developing fixed dose combinations, taste masking and temperature- or moisture-sensitive drugs.
BASF has been providing technical services to customers in drug formulation and manufacturing in South Asia since 2008. The upgraded pharmaceutical application facility is located within Innovation Campus Asia Pacific (Mumbai), BASF's biggest research and development (R&D) investment in South Asia. Inaugurated in March of this year, the Innovation Campus Asia Pacific also houses the company’s other existing scientific disciplines. This creates the opportunity for innovation synergies to be able to meet the unique technological needs of diverse customers across South Asia.
Dr Rao V S V Vadlamudi Elected President of Commonwealth Pharmacists Association
Dr. Rao Vadlamudi, President of Indian Pharmaceutical Association (IPA), has been elected as President of Commonwealth Pharmacists Association (CPA) for the year 2017 – 19 at CPA Conference held at Hyatt Regency, Sydney, Australia from 28 – 30, July 2017. Dr. Rao Vadlamudi is the second Indian professional to be elected as CPA President after a gap of 30 years. The first CPA President from India was late Dr. J.N. Banerjee during the period 1982 – 1987. The CPA is an organization of Commonwealth professional pharmaceutical bodies and individual members with an objective to empowering Pharmacists to improve health and well-being throughout the Commonwealth there by adding quality to the range of services offered by the pharmacists with head quarter based at United Kingdom.
Dr. Rao Vadlamudi has been President of IPA, the national body of pharmaceutical professionals in India for the period 2014 – 18. During this period, he ably led the Association in organizing hugely successful international and national events including the 61st International Pharmaceutical Students’ Federation (IPSF) World Congress in 2015. During this period, he also initiated advocacy exercises with the Indian government, pushing forth policy inputs and documents, furthering the cause of pharmacists and pharmacy profession in the country. Under his tutelage, in December 2016, IPA went on to organize another hugely successful mega event – the Indian Pharmaceutical Congress (IPC) that witnessed participation of over 10,000 national and international delegates from various facets of the profession. His active partnering with leaders of international organizations like FIP, FAPA and WHPA has helped him espouse some of the raging health care issues including tackling Antimicrobial Resistance and Campaign against Drug Counterfeiting globally. An academician par excellence and an eminent scientist with impeccable knowledge base, Dr. Rao Vadlamudi has also had an illustrious stint with the industry where he has led senior scientists in cutting – edge drug discovery programs in companies like Hoechst India Ltd (Sanofi) and Nektar Therapeutics India Limited.
Dr. Rao Vadlamudi, President of Indian Pharmaceutical Association (IPA), has been elected as President of Commonwealth Pharmacists Association (CPA) for the year 2017 – 19 at CPA Conference held at Hyatt Regency, Sydney, Australia from 28 – 30, July 2017. Dr. Rao Vadlamudi is the second Indian professional to be elected as CPA President after a gap of 30 years. The first CPA President from India was late Dr. J.N. Banerjee during the period 1982 – 1987. The CPA is an organization of Commonwealth professional pharmaceutical bodies and individual members with an objective to empowering Pharmacists to improve health and well-being throughout the Commonwealth there by adding quality to the range of services offered by the pharmacists with head quarter based at United Kingdom.
Dr. Rao Vadlamudi has been President of IPA, the national body of pharmaceutical professionals in India for the period 2014 – 18. During this period, he ably led the Association in organizing hugely successful international and national events including the 61st International Pharmaceutical Students’ Federation (IPSF) World Congress in 2015. During this period, he also initiated advocacy exercises with the Indian government, pushing forth policy inputs and documents, furthering the cause of pharmacists and pharmacy profession in the country. Under his tutelage, in December 2016, IPA went on to organize another hugely successful mega event – the Indian Pharmaceutical Congress (IPC) that witnessed participation of over 10,000 national and international delegates from various facets of the profession. His active partnering with leaders of international organizations like FIP, FAPA and WHPA has helped him espouse some of the raging health care issues including tackling Antimicrobial Resistance and Campaign against Drug Counterfeiting globally. An academician par excellence and an eminent scientist with impeccable knowledge base, Dr. Rao Vadlamudi has also had an illustrious stint with the industry where he has led senior scientists in cutting – edge drug discovery programs in companies like Hoechst India Ltd (Sanofi) and Nektar Therapeutics India Limited.
Dr. Reddy's Announces Commercialization
of Vozet in India
Dr.Reddy's Laboratories Ltd announced today the commercilazation of Vozet Tablets in India, indicated for the treatment of allergic Rhinitis and chronic Urticaria.
The Vozet Tablets contain Levocetirizine 5 mg, and are available in a strip size of 10.
The anti-histamine market in India had sales of INR 1038cr MAT for the most recent twelve months ended in March 2017, according to IMS ORG. Dr. Reddy's will further strengthen its anti-allergy portfolio with the addition of Vozet.
Dr.Reddy's Laboratories Ltd announced today the commercilazation of Vozet Tablets in India, indicated for the treatment of allergic Rhinitis and chronic Urticaria.
The Vozet Tablets contain Levocetirizine 5 mg, and are available in a strip size of 10.
The anti-histamine market in India had sales of INR 1038cr MAT for the most recent twelve months ended in March 2017, according to IMS ORG. Dr. Reddy's will further strengthen its anti-allergy portfolio with the addition of Vozet.
Unprecedented QC Standards for
Indian Pharma Tubing Industry
In an unprecedented development, SCHOTT India has presented new technical specifications to achieve unparalleled quality control standards for its FIOLAX pharmaceutical glass tubing manufactured in India. By harnessing big data through the implementation of its perfeXion system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 percent of the tubing. As a result, SCHOTT now offers an improved product with superior auditability and traceability for the pharmaceutical industry. These improvements are anchored in the company's new specifications and thus made visible for customers globally.
The new process has been introduced in all SCHOTT plants worldwide and will be applied to all FIOLAX tubes manufactured in its Jambusar plant from July 1, 2017. These technical standards are the culmination of years of in-house research into the development of tubing geometry measurement, suitable for SCHOTT's fast-paced production environment. The tubing, used for vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning, even for parameters such as the inside diameter, which previously were difficult to measure. By improving the measurement of visual quality characteristics as well, SCHOTT can offer individual specifications tailored even closer to customers' requirements.
Indian pharmaceuticals market is in the midst of major developments and dynamic changes. According to industry reports, it is currently growing at double-digit rates per year. Pharmaceutical packaging industry gets directly impacted by the growing needs of the pharmaceutical industry.
In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, we have now added specifications for the precise measurement of circularity, siding, and straightness in these new standards. Furthermore, the minimum length restrictions for outside diameter and wall thickness tolerance deviations have been completely eliminated, the maximum permissible airline width has been reduced from 0.1 mm to 0.08 mm, and an extractables profile for the glass composition has been added for the first time .
In an unprecedented development, SCHOTT India has presented new technical specifications to achieve unparalleled quality control standards for its FIOLAX pharmaceutical glass tubing manufactured in India. By harnessing big data through the implementation of its perfeXion system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 percent of the tubing. As a result, SCHOTT now offers an improved product with superior auditability and traceability for the pharmaceutical industry. These improvements are anchored in the company's new specifications and thus made visible for customers globally.
The new process has been introduced in all SCHOTT plants worldwide and will be applied to all FIOLAX tubes manufactured in its Jambusar plant from July 1, 2017. These technical standards are the culmination of years of in-house research into the development of tubing geometry measurement, suitable for SCHOTT's fast-paced production environment. The tubing, used for vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning, even for parameters such as the inside diameter, which previously were difficult to measure. By improving the measurement of visual quality characteristics as well, SCHOTT can offer individual specifications tailored even closer to customers' requirements.
Indian pharmaceuticals market is in the midst of major developments and dynamic changes. According to industry reports, it is currently growing at double-digit rates per year. Pharmaceutical packaging industry gets directly impacted by the growing needs of the pharmaceutical industry.
In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, we have now added specifications for the precise measurement of circularity, siding, and straightness in these new standards. Furthermore, the minimum length restrictions for outside diameter and wall thickness tolerance deviations have been completely eliminated, the maximum permissible airline width has been reduced from 0.1 mm to 0.08 mm, and an extractables profile for the glass composition has been added for the first time .
BASF Receives Recommendation
from WHO for Interceptor G2
BASF has received a recommendation from the World Health Organization (WHO) for Interceptor G2, along-lasting insecticide-treated mosquito net (LN) based on chlorfenapyr. Chlorfenapyr is a completely new insecticide class for combating mosquitoes for public health. This is the first WHO recommendation for a product based on a new insecticide class in more than 30 years.
Working with the Innovative Vector Control Consortium (IVCC) and the London School of Hygiene & Tropical Medicine in a collaboration lasting over a decade, BASF's scientists successfully repurposed chlorfenapyr to be effective on mosquito nets and meet stringent WHO performance thresholds for public health.
A second chlorfenapyr product, an indoor residual spray named Sylando 240SC, is also in the final phases of WHO evaluation. Around the world, every two minutes a child dies from malaria and there are more than 200 million new cases every year. Malaria is also a major cause of global poverty and its burden is greatest among the most vulnerable.
Long-lasting insecticide-treated mosquito nets (LN) and indoor residual sprays (IRS) are the cornerstones of malaria prevention, particularly in sub-Saharan Africa. But 60 countries have already reported resistance to at least one class of insecticide used in them. Part of the problem is that there were previously only four WHO-recommended insecticide classes for adult mosquito control: Only one of them, the pyrethroid class, was recommended for LNs. Continual use of the same insecticides enabled the highly-adaptable mosquito to develop significant levels of resistance.
BASF has received a recommendation from the World Health Organization (WHO) for Interceptor G2, along-lasting insecticide-treated mosquito net (LN) based on chlorfenapyr. Chlorfenapyr is a completely new insecticide class for combating mosquitoes for public health. This is the first WHO recommendation for a product based on a new insecticide class in more than 30 years.
Working with the Innovative Vector Control Consortium (IVCC) and the London School of Hygiene & Tropical Medicine in a collaboration lasting over a decade, BASF's scientists successfully repurposed chlorfenapyr to be effective on mosquito nets and meet stringent WHO performance thresholds for public health.
A second chlorfenapyr product, an indoor residual spray named Sylando 240SC, is also in the final phases of WHO evaluation. Around the world, every two minutes a child dies from malaria and there are more than 200 million new cases every year. Malaria is also a major cause of global poverty and its burden is greatest among the most vulnerable.
Long-lasting insecticide-treated mosquito nets (LN) and indoor residual sprays (IRS) are the cornerstones of malaria prevention, particularly in sub-Saharan Africa. But 60 countries have already reported resistance to at least one class of insecticide used in them. Part of the problem is that there were previously only four WHO-recommended insecticide classes for adult mosquito control: Only one of them, the pyrethroid class, was recommended for LNs. Continual use of the same insecticides enabled the highly-adaptable mosquito to develop significant levels of resistance.
American Academy of Ophthalmology
Collaborate with Lupin
The American Academy of Ophthalmology and Pharma major Lupin Limited (Lupin) has announced an agreement that would seek to expand and enhance continuing ophthalmic education in India. The effort is expected to reach 3,000 ophthalmologists in the country.
The collaboration will provide ophthalmologists access to several clinical education tools including the Academy's flagship clinical education resource, the Ophthalmic News and Education Network. The World's largest online compendium of ophthalmic knowledge, the ONE Network is accessed by approximately 130,000 users every month.
The Academy typically offers access to the ONE Network and its other educational resources as a benefit of Academy membership as well as to ophthalmologists in other countries through a special application. The collaboration provides a new channel for distributing this content in India. The Academy also distributes its content in India to 16,000 members of the All India Ophthalmological Society. Through this partnership, over 3,000 ophthalmologists across the country will be provided online access to knowledge repository, which includes journals and videos to help practitioners stay abreast of the latest developments in the space.
The American Academy of Ophthalmology and Pharma major Lupin Limited (Lupin) has announced an agreement that would seek to expand and enhance continuing ophthalmic education in India. The effort is expected to reach 3,000 ophthalmologists in the country.
The collaboration will provide ophthalmologists access to several clinical education tools including the Academy's flagship clinical education resource, the Ophthalmic News and Education Network. The World's largest online compendium of ophthalmic knowledge, the ONE Network is accessed by approximately 130,000 users every month.
The Academy typically offers access to the ONE Network and its other educational resources as a benefit of Academy membership as well as to ophthalmologists in other countries through a special application. The collaboration provides a new channel for distributing this content in India. The Academy also distributes its content in India to 16,000 members of the All India Ophthalmological Society. Through this partnership, over 3,000 ophthalmologists across the country will be provided online access to knowledge repository, which includes journals and videos to help practitioners stay abreast of the latest developments in the space.
GNH India Clears Audit to Trade
Orphan Drugs with UK
GNH India, a global source for priority pharmaceuticals, is amongst the handful of Indian companies to clear an audit from one of the largest UK pharmaceutical distribution companies. Armed with a WHO-GDP (Good Distribution Practice) certification, GNH India has entered a two-way partnership with the UK based company for the trade in life-saving drugs into their respective countries.
Through this new development, accessibility to medicines for the treatment of an array of diseases is now not just plausible; but extremely possible. Orphan drugs such as Ferripox (used in the treatment of iron overload in Thalassaemia major patients), Raxone (used in the treatment of visually impaired adolescents and adults), Trientine (used to treat a rare but growing rate of Wilson's disease) and Mitocin (a drug used to treat a range of cancers) are now available to the Indian population.
Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, "With a change in lifestyle and increased travel abroad, India's population has become a crucible for various diseases. Even though we have seen a marked increase in incidences of rare diseases, our pharmaceutical industry is yet to catch up in response to this growth trajectory. At GNH India, we had ensured to follow due protocol by applying and receiving the WHO-GDP certification well before hand. This has led to a high success rate in terms of clearing audits from various countries- the UK is the latest." The WHO-GDP certification ensures that procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record-keeping practices are met with stringent protocols.
GNH India exports to more than 180 countries and has 135,000 product lines to choose from. With this new development, GNH India has forayed into the UK market as a legal distributor of rare and life-saving drugs.
GNH India, a global source for priority pharmaceuticals, is amongst the handful of Indian companies to clear an audit from one of the largest UK pharmaceutical distribution companies. Armed with a WHO-GDP (Good Distribution Practice) certification, GNH India has entered a two-way partnership with the UK based company for the trade in life-saving drugs into their respective countries.
Through this new development, accessibility to medicines for the treatment of an array of diseases is now not just plausible; but extremely possible. Orphan drugs such as Ferripox (used in the treatment of iron overload in Thalassaemia major patients), Raxone (used in the treatment of visually impaired adolescents and adults), Trientine (used to treat a rare but growing rate of Wilson's disease) and Mitocin (a drug used to treat a range of cancers) are now available to the Indian population.
Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, "With a change in lifestyle and increased travel abroad, India's population has become a crucible for various diseases. Even though we have seen a marked increase in incidences of rare diseases, our pharmaceutical industry is yet to catch up in response to this growth trajectory. At GNH India, we had ensured to follow due protocol by applying and receiving the WHO-GDP certification well before hand. This has led to a high success rate in terms of clearing audits from various countries- the UK is the latest." The WHO-GDP certification ensures that procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record-keeping practices are met with stringent protocols.
GNH India exports to more than 180 countries and has 135,000 product lines to choose from. With this new development, GNH India has forayed into the UK market as a legal distributor of rare and life-saving drugs.
Sayre Signs Exclusive License and
Distribution Deal with Navidea
Sayre Therapeutics with a portfolio of oncology and immunology focused commercial products, has entered into an exclusive license agreement with Navidea Biopharmaceuticals, Inc, a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutic, for the development and commercialization of Tc 99m tilmanocept in India.
The receptor-targeted, radiopharmaceutical imaging agent was approved by the U.S. Food and Drug Administration in 2013 and by the European Medicines Agency in November 2014 under the brand name LYMPHOSEEK. Tc 99m Tilmanocept is already commercialized in three major European Countries along with the US and represents Next-Generation Standard of Diagnosis for Sentinel Lymph Node Detection. Tc 99m Tilmanocept is approved for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, squamous cell carcinoma of the oral cavity, or melanoma.
Sayre Therapeutics with a portfolio of oncology and immunology focused commercial products, has entered into an exclusive license agreement with Navidea Biopharmaceuticals, Inc, a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutic, for the development and commercialization of Tc 99m tilmanocept in India.
The receptor-targeted, radiopharmaceutical imaging agent was approved by the U.S. Food and Drug Administration in 2013 and by the European Medicines Agency in November 2014 under the brand name LYMPHOSEEK. Tc 99m Tilmanocept is already commercialized in three major European Countries along with the US and represents Next-Generation Standard of Diagnosis for Sentinel Lymph Node Detection. Tc 99m Tilmanocept is approved for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, squamous cell carcinoma of the oral cavity, or melanoma.
Cytecare Appoints Dr Mythri Shankar as
Senior Consultant – Nuclear Medicine
Cytecare, committed to revolutionise Cancer care in India, announces the appointment of a Dr Mythri Shankar, Senior Consultant, Nuclear Medicine Department.
Dr Mythri Shankar has trained extensively in Nuclear Medicine from various globally renowned institutions such as UCLA, Cedars Sinai, Children's Hospital of Los Angeles, and Harvard Medical School. With over 15 years of clinical expertise, Dr. Shankar's experience has enabled the integration of most appropriate protocol selection while performing sophisticated radioactive injection procedures. She is a member of several international organizations such as the American Society of Nuclear Cardiology and the Society of Nuclear Medicine (USA & India), and is also actively involved in academics and several research projects.
Cytecare, committed to revolutionise Cancer care in India, announces the appointment of a Dr Mythri Shankar, Senior Consultant, Nuclear Medicine Department.
Dr Mythri Shankar has trained extensively in Nuclear Medicine from various globally renowned institutions such as UCLA, Cedars Sinai, Children's Hospital of Los Angeles, and Harvard Medical School. With over 15 years of clinical expertise, Dr. Shankar's experience has enabled the integration of most appropriate protocol selection while performing sophisticated radioactive injection procedures. She is a member of several international organizations such as the American Society of Nuclear Cardiology and the Society of Nuclear Medicine (USA & India), and is also actively involved in academics and several research projects.
Sayre Signs Exclusive License and Distribution Deal
with Navidea
Sayre Therapeutics with a portfolio of oncology and immunology focused commercial products, has entered into an exclusive license agreement with Navidea Biopharmaceuticals, Inc, a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutic, for the development and commercialization of Tc 99m tilmanocept in India.
The receptor-targeted, radiopharmaceutical imaging agent was approved by the U.S . Food and Drug Administration in 2013 and by the European Medicines Agency in November 2014 under the brand name LYMPHOSEEK. Tc 99m Tilmanocept is already commercialized in three major European Countries along with the US and represents Next-Generation Standard of Diagnosis for Sentinel Lymph Node Detection. Tc 99m Tilmanocept is approved for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, squamous cell carcinoma of the oral cavity, or melanoma.
Sayre Therapeutics with a portfolio of oncology and immunology focused commercial products, has entered into an exclusive license agreement with Navidea Biopharmaceuticals, Inc, a company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutic, for the development and commercialization of Tc 99m tilmanocept in India.
The receptor-targeted, radiopharmaceutical imaging agent was approved by the U.S . Food and Drug Administration in 2013 and by the European Medicines Agency in November 2014 under the brand name LYMPHOSEEK. Tc 99m Tilmanocept is already commercialized in three major European Countries along with the US and represents Next-Generation Standard of Diagnosis for Sentinel Lymph Node Detection. Tc 99m Tilmanocept is approved for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, squamous cell carcinoma of the oral cavity, or melanoma.
GNH India Clears Audit to Trade Orphan Drugs with UK
GNH India, a global source for priority pharmaceuticals, is amongst the handful of Indian companies to clear an audit from one of the largest UK pharmaceutical distribution companies. Armed with a WHO-GDP (Good Distribution Practice) certification, GNH India has entered a two-way partnership with the UK based company for the trade in life-saving drugs into their respective countries.
Through this new development, accessibility to medicines for the treatment of an array of diseases is now not just plausible; but extremely possible. Orphan drugs such as Ferripox (used in the treatment of iron overload in Thalassaemia major patients), Raxone (used in the treatment of visually impaired adolescents and adults), Trientine (used to treat a rare but growing rate of Wilson's disease) and Mitocin (a drug used to treat a range of cancers) are now available to the Indian population.
Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, “With a change in lifestyle and increased travel abroad, India's population has become a crucible for various diseases. Even though we have seen a marked increase in incidences of rare diseases, our pharmaceutical industry is yet to catch up in response to this growth trajectory. At GNH India, we had ensured to follow due protocol by applying and receiving the WHO-GDP certification well before hand. This has led to a high success rate in terms of clearing audits from various countries- the UK is the latest."
The WHO-GDP certification ensures that procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record -keeping practices are met with stringent protocols.
GNH India exports to more than 180 countries and has 135,000 product lines to choose from. With this new development, GNH India has forayed into the UK market as a legal distributor of rare and life-saving drugs.
GNH India, a global source for priority pharmaceuticals, is amongst the handful of Indian companies to clear an audit from one of the largest UK pharmaceutical distribution companies. Armed with a WHO-GDP (Good Distribution Practice) certification, GNH India has entered a two-way partnership with the UK based company for the trade in life-saving drugs into their respective countries.
Through this new development, accessibility to medicines for the treatment of an array of diseases is now not just plausible; but extremely possible. Orphan drugs such as Ferripox (used in the treatment of iron overload in Thalassaemia major patients), Raxone (used in the treatment of visually impaired adolescents and adults), Trientine (used to treat a rare but growing rate of Wilson's disease) and Mitocin (a drug used to treat a range of cancers) are now available to the Indian population.
Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, “With a change in lifestyle and increased travel abroad, India's population has become a crucible for various diseases. Even though we have seen a marked increase in incidences of rare diseases, our pharmaceutical industry is yet to catch up in response to this growth trajectory. At GNH India, we had ensured to follow due protocol by applying and receiving the WHO-GDP certification well before hand. This has led to a high success rate in terms of clearing audits from various countries- the UK is the latest."
The WHO-GDP certification ensures that procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record -keeping practices are met with stringent protocols.
GNH India exports to more than 180 countries and has 135,000 product lines to choose from. With this new development, GNH India has forayed into the UK market as a legal distributor of rare and life-saving drugs.
SCHOTT Sets Unprecedented Quality Control Standards
for Indian Pharma Tubing Industry
In an unprecedented development, SCHOTT India has presented new technical specifications to achieve unparalleled quality control standards for its FIOLAX pharmaceutical glass tubing manufactured in India. By harnessing big data through the implementation of its perfeXion system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 percent of the tubing. As a result, SCHOTT now offers an improved product with superior auditability and traceability for the pharmaceutical industry. These improvements are anchored in the company’s new specifications and thus made visible for customers globally.
The new process has been introduced in all SCHOTT plants worldwide and will be applied to all FIOLAX tubes manufactured in its Jambusar plant from July 1, 2017 . These technical standards are the culmination of years of in-house research into the development of tubing geometry measurement, suitable for SCHOTT's fast-paced production environment. The tubing, used for vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning, even for parameters such as the inside diameter, which previously were difficult to measure. By improving the measurement of visual quality characteristics as well, SCHOTT can offer individual specifications tailored even closer to customers' requirements.
Indian pharmaceuticals market is in the midst of major developments and dynamic changes. According to industry reports, it is currently growing at double-digit rates per year. Pharmaceutical packaging industry gets directly impacted by the growing needs of the pharmaceutical industry.
In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, we have now added specifications for the precise measurement of circularity, siding, and straightness in these new standards. Furthermore, the minimum length restrictions for outside diameter and wall thickness tolerance deviations have been completely eliminated, the maximum permissible airline width has been reduced from 0.1 mm to 0.08 mm, and an extractables profile for the glass composition has been added for the first time.
In an unprecedented development, SCHOTT India has presented new technical specifications to achieve unparalleled quality control standards for its FIOLAX pharmaceutical glass tubing manufactured in India. By harnessing big data through the implementation of its perfeXion system, SCHOTT has moved from a statistical sample-based quality-control process to one that inspects 100 percent of the tubing. As a result, SCHOTT now offers an improved product with superior auditability and traceability for the pharmaceutical industry. These improvements are anchored in the company’s new specifications and thus made visible for customers globally.
The new process has been introduced in all SCHOTT plants worldwide and will be applied to all FIOLAX tubes manufactured in its Jambusar plant from July 1, 2017 . These technical standards are the culmination of years of in-house research into the development of tubing geometry measurement, suitable for SCHOTT's fast-paced production environment. The tubing, used for vials, syringes, cartridges, and ampoules, can now be produced at an even higher quality from the beginning, even for parameters such as the inside diameter, which previously were difficult to measure. By improving the measurement of visual quality characteristics as well, SCHOTT can offer individual specifications tailored even closer to customers' requirements.
Indian pharmaceuticals market is in the midst of major developments and dynamic changes. According to industry reports, it is currently growing at double-digit rates per year. Pharmaceutical packaging industry gets directly impacted by the growing needs of the pharmaceutical industry.
In addition to tightening the tolerances for outside diameter, inside diameter, and wall thickness, we have now added specifications for the precise measurement of circularity, siding, and straightness in these new standards. Furthermore, the minimum length restrictions for outside diameter and wall thickness tolerance deviations have been completely eliminated, the maximum permissible airline width has been reduced from 0.1 mm to 0.08 mm, and an extractables profile for the glass composition has been added for the first time.
American Academy of Ophthalmology Collaborate with
Lupin
The American Academy of Ophthalmology and Pharma major Lupin Limited (Lupin) has announced an agreement that would seek to expand and enhance continuing ophthalmic education in India. The effort is expected to reach 3,000 ophthalmologists in the country.
The collaboration will provide ophthalmologists access to several clinical education tools including the Academy’s flagship clinical education resource, the Ophthalmic News and Education Network. The World’s largest online compendium of ophthalmic knowledge, the ONE Network is accessed by approximately 130,000 users every month.
The Academy typically offers access to the ONE Network and its other educational resources as a benefit of Academy membership as well as to ophthalmologists in other countries through a special application. The collaboration provides a new channel for distributing this content in India. The Academy also distributes its content in India to 16,000 members of the All India Ophthalmological Society. Through this partnership, over 3,000 ophthalmologists across the country will be provided online access to knowledge repository, which includes journals and videos to help practitioners stay abreast of the latest developments in the space
The American Academy of Ophthalmology and Pharma major Lupin Limited (Lupin) has announced an agreement that would seek to expand and enhance continuing ophthalmic education in India. The effort is expected to reach 3,000 ophthalmologists in the country.
The collaboration will provide ophthalmologists access to several clinical education tools including the Academy’s flagship clinical education resource, the Ophthalmic News and Education Network. The World’s largest online compendium of ophthalmic knowledge, the ONE Network is accessed by approximately 130,000 users every month.
The Academy typically offers access to the ONE Network and its other educational resources as a benefit of Academy membership as well as to ophthalmologists in other countries through a special application. The collaboration provides a new channel for distributing this content in India. The Academy also distributes its content in India to 16,000 members of the All India Ophthalmological Society. Through this partnership, over 3,000 ophthalmologists across the country will be provided online access to knowledge repository, which includes journals and videos to help practitioners stay abreast of the latest developments in the space
Cytecare Appoints Dr Mythri Shankar as Senior Consultant – Nuclear Medicine
Cytecare, committed to revolutionise Cancer care in India, announces the appointment of a Dr. Mythri Shankar, Senior Consultant, Nuclear Medicine Department.
Dr. Mythri Shankar has trained extensively in Nuclear Medicine from various globally renowned institutions such as UCLA, Cedars Sinai, Children's Hospital of Los Angeles, and Harvard Medical School. With over 15 years of clinical expertise, Dr. Shankar’s experience has enabled the integration of most appropriate protocol selection while performing sophisticated radioactive injection procedures. She is a member of several international organizations such as the American Society of Nuclear Cardiology and the Society of Nuclear Medicine (USA & India), and is also actively involved in academics and several research projects.
Cytecare, committed to revolutionise Cancer care in India, announces the appointment of a Dr. Mythri Shankar, Senior Consultant, Nuclear Medicine Department.
Dr. Mythri Shankar has trained extensively in Nuclear Medicine from various globally renowned institutions such as UCLA, Cedars Sinai, Children's Hospital of Los Angeles, and Harvard Medical School. With over 15 years of clinical expertise, Dr. Shankar’s experience has enabled the integration of most appropriate protocol selection while performing sophisticated radioactive injection procedures. She is a member of several international organizations such as the American Society of Nuclear Cardiology and the Society of Nuclear Medicine (USA & India), and is also actively involved in academics and several research projects.
BASF Introduces First New Class of Public Health Insecticide for Malaria Prevention in More Than 30 Years
BASF has received a recommendation from the World Health Organization (WHO) for Interceptor G2, a long-lasting insecticide-treated mosquito net (LN) based on chlorfenapyr. Chlorfenapyr is a completely new insecticide class for combating mosquitoes for public health. This is the first WHO recommendation for a product based on a new insecticide class in more than 30 years.
Working with the Innovative Vector Control Consortium (IVCC) and the London School of Hygiene & Tropical Medicine in a collaboration lasting over a decade, BASF's scientists successfully repurposed chlorfenapyr to be effective on mosquito nets and meet stringent WHO performance thresholds for public health.
A second chlorfenapyr product, an indoor residual spray named Sylando 240SC, is also in the final phases of WHO evaluation.
Around the world, every two minutes a child dies from malaria and there are more than 200 million new cases every year. Malaria is also a major cause of global poverty and its burden is greatest among the most vulnerable.
Long-lasting insecticide-treated mosquito nets (LN) and indoor residual sprays (IRS) are the cornerstones of malaria prevention, particularly in sub-Saharan Africa. But 60 countries have already reported resistance to at least one class of insecticide used in them. Part of the problem is that there were previously only four WHO-recommended insecticide classes for adult mosquito control: Only one of them, the pyrethroid class, was recommended for LNs. Continual use of the same insecticides enabled the highly-adaptable mosquito to develop significant levels of resistance.
BASF has received a recommendation from the World Health Organization (WHO) for Interceptor G2, a long-lasting insecticide-treated mosquito net (LN) based on chlorfenapyr. Chlorfenapyr is a completely new insecticide class for combating mosquitoes for public health. This is the first WHO recommendation for a product based on a new insecticide class in more than 30 years.
Working with the Innovative Vector Control Consortium (IVCC) and the London School of Hygiene & Tropical Medicine in a collaboration lasting over a decade, BASF's scientists successfully repurposed chlorfenapyr to be effective on mosquito nets and meet stringent WHO performance thresholds for public health.
A second chlorfenapyr product, an indoor residual spray named Sylando 240SC, is also in the final phases of WHO evaluation.
Around the world, every two minutes a child dies from malaria and there are more than 200 million new cases every year. Malaria is also a major cause of global poverty and its burden is greatest among the most vulnerable.
Long-lasting insecticide-treated mosquito nets (LN) and indoor residual sprays (IRS) are the cornerstones of malaria prevention, particularly in sub-Saharan Africa. But 60 countries have already reported resistance to at least one class of insecticide used in them. Part of the problem is that there were previously only four WHO-recommended insecticide classes for adult mosquito control: Only one of them, the pyrethroid class, was recommended for LNs. Continual use of the same insecticides enabled the highly-adaptable mosquito to develop significant levels of resistance.
Dr. Reddy's Announces Commercialization of Vozet in India
Dr. Reddy's Laboratories Ltd announced today the commercilazation of Vozet Tablets in India, indicated for the treatment of allergic Rhinitis and chronic Urticaria.
The Vozet Tablets contain Levocetirizine 5 mg, and are available in a strip size of 10.
The anti-histamine market in India had sales of INR 1038cr MAT for the most recent twelve months ended in March 2017, according to IMS ORG. Dr. Reddy’s will further strengthen its anti-allergy portfolio with the addition of Vozet.
Dr. Reddy's Laboratories Ltd announced today the commercilazation of Vozet Tablets in India, indicated for the treatment of allergic Rhinitis and chronic Urticaria.
The Vozet Tablets contain Levocetirizine 5 mg, and are available in a strip size of 10.
The anti-histamine market in India had sales of INR 1038cr MAT for the most recent twelve months ended in March 2017, according to IMS ORG. Dr. Reddy’s will further strengthen its anti-allergy portfolio with the addition of Vozet.
Agilent Technologies and Agendia Ink Deal on Molecular Cancer Diagnostics
Agilent Technologies Inc and Agendia, Inc jointly announced an agreement to expand their relationship to include the development of an RNASeq kit version of Agendia’s currently marketed MammaPrint and BluePrint tests.
Agendia's MammaPrint test provides High-Risk or Low-Risk test results to assess the risk of distant metastasis within five years, in breast cancer patients with Stage I or Stage II disease. Agendia’s BluePrint test builds on the foundational prognostic precision of MammaPrint, to classify the breast cancer into one of four molecular subtypes. These results help to predict clinical outcomes in women with early-stage breast cancer.
Using Agilent's SureSelect target enrichment system, the new RNAseq kit will enable Agendia to develop and perform the MammaPrint and BluePrint tests, as next-generation sequencing assays. This capability will allow the tests to be run in decentralized settings that can utilize a larger footprint of next-generation sequencing instruments, thus affording patients global access to these revolutionary tests. The ability to perform these tests at locations closer to the patients, provides greater accessibility and the potential for more cancer patients to get better individualized treatment management. The initial phase of kit development is expected to be completed in 2017, providing early access to limited markets in Europe.
Agilent Technologies is a leading provider of target enrichment for next-generation DNA and RNA sequencing solutions. Target enrichment saves researchers time and resources by enabling them to focus on regions of interest rather than looking at the entire genome. Agendia is a leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products. Agendia's MammaPrint microarray-based diagnostic test is currently the only FDA-cleared breast cancer recurrence test intended for use in breast cancer patients of all ages.
"We have had a long-term collaboration with Agilent and are excited to further our relationship,†said Mark Straley, chief executive officer of Agendia. “The addition of Agilent’s RNA next-generation sequencing technologies to our current microarray platform will allow us to penetrate international markets where decentralized kit offerings are preferred, and help us to achieve our core mission of providing all women access to advanced cancer diagnostics."
"We are excited to partner once again with Agendia" said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. “Both companies share a common goal of fighting cancer and this agreement leverages Agendia’s expertise in molecular cancer diagnostics and Agilent’s leading NGS target enrichment technologies to ultimately enable the best treatment decision to be made for each individual."
Agilent Technologies Inc and Agendia, Inc jointly announced an agreement to expand their relationship to include the development of an RNASeq kit version of Agendia’s currently marketed MammaPrint and BluePrint tests.
Agendia's MammaPrint test provides High-Risk or Low-Risk test results to assess the risk of distant metastasis within five years, in breast cancer patients with Stage I or Stage II disease. Agendia’s BluePrint test builds on the foundational prognostic precision of MammaPrint, to classify the breast cancer into one of four molecular subtypes. These results help to predict clinical outcomes in women with early-stage breast cancer.
Using Agilent's SureSelect target enrichment system, the new RNAseq kit will enable Agendia to develop and perform the MammaPrint and BluePrint tests, as next-generation sequencing assays. This capability will allow the tests to be run in decentralized settings that can utilize a larger footprint of next-generation sequencing instruments, thus affording patients global access to these revolutionary tests. The ability to perform these tests at locations closer to the patients, provides greater accessibility and the potential for more cancer patients to get better individualized treatment management. The initial phase of kit development is expected to be completed in 2017, providing early access to limited markets in Europe.
Agilent Technologies is a leading provider of target enrichment for next-generation DNA and RNA sequencing solutions. Target enrichment saves researchers time and resources by enabling them to focus on regions of interest rather than looking at the entire genome. Agendia is a leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products. Agendia's MammaPrint microarray-based diagnostic test is currently the only FDA-cleared breast cancer recurrence test intended for use in breast cancer patients of all ages.
"We have had a long-term collaboration with Agilent and are excited to further our relationship,†said Mark Straley, chief executive officer of Agendia. “The addition of Agilent’s RNA next-generation sequencing technologies to our current microarray platform will allow us to penetrate international markets where decentralized kit offerings are preferred, and help us to achieve our core mission of providing all women access to advanced cancer diagnostics."
"We are excited to partner once again with Agendia" said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. “Both companies share a common goal of fighting cancer and this agreement leverages Agendia’s expertise in molecular cancer diagnostics and Agilent’s leading NGS target enrichment technologies to ultimately enable the best treatment decision to be made for each individual."
Ozone Pharma Introduces DFO 4X Gel
Ozone Pharmaceuticals Ltd, one of India's premium Pharmaceutical companies brings its latest topical pain reliever product - DFO 4X Gel that aligns with the brand’s motto of ‘Pain Eradication’ [Pain Elimination]. In sync with offering this new and innovative product, the brand launched a campaign in May, 2017; named, 'Dard Baanton Nahi, Mitao', addressing the consumers' common pain points such as injuries, muscle pain, sprains etc. The aim was to create an emotional connect with consumers’ agony and the brand. With an objective of ‘eradicating’ the word pain from consumers’ life, the brand received an overwhelming response in the market, through this compelling campaign. Since the launch of this campaign, 70000 units of Ozone D.F.O. 4X Gel have been sold pan India - an incredible feat. It is noteworthy that, currently, DFO 4X Gel contributes about 12.5 per cent to the company's overall business.
With an efficacy rate of 31 per cent faster than normal gels, DFO 4X Gel is an effective and efficient advanced topical pain relief product containing ‘high dose’ - Diclofenac Diethylamine 4.64 per cent for ‘Direct Acting’ deep penetration of the epidermis (outer most layer of the skin), which translates into ‘site-specific effect’\' and instant pain and inflammation relief.
D.F.O. 4X Gel has superior efficacy without compromising safety in management of: osteoarthritis (oa) pain, acute musculoskeletal pain and inflammation, sprains and strains, sciatica pain, neck pain, back pain, epicondylitis (tennis elbow), carpal tunnel syndrome, knee pain and repetitive sports injury; this efficacy and safety profile makes D.F.O. 4X Gel the most preferred product
Ozone Pharmaceuticals Ltd, one of India's premium Pharmaceutical companies brings its latest topical pain reliever product - DFO 4X Gel that aligns with the brand’s motto of ‘Pain Eradication’ [Pain Elimination]. In sync with offering this new and innovative product, the brand launched a campaign in May, 2017; named, 'Dard Baanton Nahi, Mitao', addressing the consumers' common pain points such as injuries, muscle pain, sprains etc. The aim was to create an emotional connect with consumers’ agony and the brand. With an objective of ‘eradicating’ the word pain from consumers’ life, the brand received an overwhelming response in the market, through this compelling campaign. Since the launch of this campaign, 70000 units of Ozone D.F.O. 4X Gel have been sold pan India - an incredible feat. It is noteworthy that, currently, DFO 4X Gel contributes about 12.5 per cent to the company's overall business.
With an efficacy rate of 31 per cent faster than normal gels, DFO 4X Gel is an effective and efficient advanced topical pain relief product containing ‘high dose’ - Diclofenac Diethylamine 4.64 per cent for ‘Direct Acting’ deep penetration of the epidermis (outer most layer of the skin), which translates into ‘site-specific effect’\' and instant pain and inflammation relief.
D.F.O. 4X Gel has superior efficacy without compromising safety in management of: osteoarthritis (oa) pain, acute musculoskeletal pain and inflammation, sprains and strains, sciatica pain, neck pain, back pain, epicondylitis (tennis elbow), carpal tunnel syndrome, knee pain and repetitive sports injury; this efficacy and safety profile makes D.F.O. 4X Gel the most preferred product
Boston Scientific Brings the Next Generation Asthma Therapy to India
Boston Scientific India announced the availability of Bronchial Thermoplasty (BT) Therapy indicated for the treatment of severe, persistent, drug-resistant asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. The first BT procedure was performed in Royal Care Hospital, Coimbatore.
The Bronchial Thermoplasty therapy helps clear the bronchial airways by delivering thermal energy to the smooth muscle. This process decreases constriction in the patient’s airways and enables easier breathing, reducing the frequency and severity of asthma attacks for patients with severe, persistent, drug-resistant asthma Bronchial Thermoplasty is performed under moderate sedation on an outpatient basis. The first BT patient is a middle aged woman, who is suffering from severe, persistent, drug-resistant asthma for the past 30 years. She had recurrent asthma attacks and frequent emergency room visits despite her medication regimes.
"There are over 18 million estimated asthmatics in the country, for some of whom currently available medication has failed to provide any relief. Our Bronchial Thermoplasty Therapy holds great promise to help address this need gap. We have sufficient evidence that shows Bronchial Thermoplasty is an effective therapeutic option for patients with severe persistent, drug-resistant asthma,†said Prabal Chakraborty, vice president and managing director, Boston Scientific in India.
Dr. Pattabi Raman, Head- Pulmonology Associates, Royal Care Super Specialty Hospital, who performed the first BT procedure said, “This is a ground-breaking solution which may provide a complementary treatment to severe, persistent, drug-resistant asthma patients in the country." This therapy is recognized globally and has been well received in around 20 markets.
Boston Scientific India announced the availability of Bronchial Thermoplasty (BT) Therapy indicated for the treatment of severe, persistent, drug-resistant asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. The first BT procedure was performed in Royal Care Hospital, Coimbatore.
The Bronchial Thermoplasty therapy helps clear the bronchial airways by delivering thermal energy to the smooth muscle. This process decreases constriction in the patient’s airways and enables easier breathing, reducing the frequency and severity of asthma attacks for patients with severe, persistent, drug-resistant asthma Bronchial Thermoplasty is performed under moderate sedation on an outpatient basis. The first BT patient is a middle aged woman, who is suffering from severe, persistent, drug-resistant asthma for the past 30 years. She had recurrent asthma attacks and frequent emergency room visits despite her medication regimes.
"There are over 18 million estimated asthmatics in the country, for some of whom currently available medication has failed to provide any relief. Our Bronchial Thermoplasty Therapy holds great promise to help address this need gap. We have sufficient evidence that shows Bronchial Thermoplasty is an effective therapeutic option for patients with severe persistent, drug-resistant asthma,†said Prabal Chakraborty, vice president and managing director, Boston Scientific in India.
Dr. Pattabi Raman, Head- Pulmonology Associates, Royal Care Super Specialty Hospital, who performed the first BT procedure said, “This is a ground-breaking solution which may provide a complementary treatment to severe, persistent, drug-resistant asthma patients in the country." This therapy is recognized globally and has been well received in around 20 markets.
GNH Brings Malaria Relief to Yemen's Conflict Zone
India's global source for priority medicines, GNH India has successfully exported one of the largest orders for anti-malarial pharmaceuticals for a conflict zone in Yemen. The consignment contained 1, 20,000 Mefloquine tablets and Primaquine 45mg which were delivered in a record time of 3 weeks from receipt of order. The consignment was sent to a local aid agency operating in Oman; from there it was delivered to Yemen by road. Most established pharma companies fear to work in these zones due to the implication of US Sanctions, but GNH India has set an example by giving importance to humanity rather than business.
Dr Piyush Gupta, Associate Director, GNH India commented, "It is an accomplishment for GNH India to export such a big order to Yemen in a time span of 3 weeks. Such consignments are a testimony to our belief that everyone in all parts of the world deserves access to proper medicines irrespective of their geographical boundaries or political affiliations. We ensured that despite the obstacles placed in our way, the conflict ridden citizens of Yemen would receive medicines that are in dire need in of these drugs."
Mefloquine is commonly used to fight Malaria and used by travellers around the world to prevent malaria when visiting places where malaria is common. On the other hand, Primaquine is used with other medications to prevent and treat malaria. It is used when the primary medicine (such as Mefloquine) have killed the malaria parasites living in red blood cells.
India's global source for priority medicines, GNH India has successfully exported one of the largest orders for anti-malarial pharmaceuticals for a conflict zone in Yemen. The consignment contained 1, 20,000 Mefloquine tablets and Primaquine 45mg which were delivered in a record time of 3 weeks from receipt of order. The consignment was sent to a local aid agency operating in Oman; from there it was delivered to Yemen by road. Most established pharma companies fear to work in these zones due to the implication of US Sanctions, but GNH India has set an example by giving importance to humanity rather than business.
Dr Piyush Gupta, Associate Director, GNH India commented, "It is an accomplishment for GNH India to export such a big order to Yemen in a time span of 3 weeks. Such consignments are a testimony to our belief that everyone in all parts of the world deserves access to proper medicines irrespective of their geographical boundaries or political affiliations. We ensured that despite the obstacles placed in our way, the conflict ridden citizens of Yemen would receive medicines that are in dire need in of these drugs."
Mefloquine is commonly used to fight Malaria and used by travellers around the world to prevent malaria when visiting places where malaria is common. On the other hand, Primaquine is used with other medications to prevent and treat malaria. It is used when the primary medicine (such as Mefloquine) have killed the malaria parasites living in red blood cells.
Apollo Partners with RMS REGROW for Innovative Cell Therapy Treatment for Orthopedic Patients
Apollo Hospitals, Asia's largest and most trusted healthcare group, has partnered with RMS REGROW, the first 'Make in India' Company in Cell Therapy Technology, to offer two new Regenerative Medicine Cell Therapy products- Ossron and Chondron for bone and cartilage problems, respectively. The two products will address unmet clinical needs in the orthopaedic market with respect to sports injuries, accidents and alternate to hip replacements and knee replacements for a young arthritic knee. In an exclusive tie up between Apollo Hospitals and RMS Regrow, the treatment therapy will be made available across all Apollo Hospitals, Apollo Spectra Hospitals and Apollo clinics in India.
Ossron and Chondron are the results of a dedicated research team at REGROW. The two products are innovative proprietary and patented technology which has been developed for both the products following the regulatory guidelines. Through several clinical trials and evaluation studies over 8 years, the company has achieved the market authorization for the two cell therapy products.
As an exclusive offering, Apollo Hospitals will create a platform for orthopaedic doctors to practice Regenerative Medicine efficiently by conducting live surgical workshops, CME’s for doctors and conferences (national and international).
Apollo Hospitals, Asia's largest and most trusted healthcare group, has partnered with RMS REGROW, the first 'Make in India' Company in Cell Therapy Technology, to offer two new Regenerative Medicine Cell Therapy products- Ossron and Chondron for bone and cartilage problems, respectively. The two products will address unmet clinical needs in the orthopaedic market with respect to sports injuries, accidents and alternate to hip replacements and knee replacements for a young arthritic knee. In an exclusive tie up between Apollo Hospitals and RMS Regrow, the treatment therapy will be made available across all Apollo Hospitals, Apollo Spectra Hospitals and Apollo clinics in India.
Ossron and Chondron are the results of a dedicated research team at REGROW. The two products are innovative proprietary and patented technology which has been developed for both the products following the regulatory guidelines. Through several clinical trials and evaluation studies over 8 years, the company has achieved the market authorization for the two cell therapy products.
As an exclusive offering, Apollo Hospitals will create a platform for orthopaedic doctors to practice Regenerative Medicine efficiently by conducting live surgical workshops, CME’s for doctors and conferences (national and international).
Everest Group Names TCS as Leader and Star Performer in Life Sciences IT Application Services
Tata Consultancy Services (TCS), a leading global IT services, consulting and business solutions organization, has been recognized as a Leader and Star Performer for Life Sciences IT Application Services by leading advisory and research firm, Everest Group, in its report, "Life Sciences – IT Application Services Providers PEAK Matrix Assessment 2017."
Everest Group acknowledged TCS’ strong foothold in the pharmaceutical and medical devices sector, and a growing business presence with biotechnology firms. The report highlights TCS' strong focus on development of next-generation solutions, incorporating Artificial Intelligence, IoT and platform-driven approaches for areas such as drug development and patient engagement.
Everest Group analyzed the capabilities of 22 service providers on the Everest Group PEAK Matrix in the Global Life Sciences sector. The PEAK Matrix is a composite framework that provides an objective, data driven and comparative assessment of Life Science IT Apps Service Providers, which are then divided into three categories based on market success and delivery capability.
"Life Sciences firms are grappling with the reinvention of their business models, along with the need to unlock efficiency out of globally diversified operations. Technology is a key enabler to ensure this transition, and TCS continues to be a partner of choice for leading Life Sciences firms, based on its delivery excellence and ongoing market success," said Jimit Arora, Partner, Everest Group. "By taking a platform-driven approach to strategic value chain tenets, TCS is seeking to future-proof its portfolio and driving differentiation in a highly competitive market."
"Life Sciences customers are embracing newer technologies and next gen platforms to meet the challenges of higher R&D costs, declining revenue and increasingly complex regulations," added Debashis Ghosh, President, Life Sciences, Manufacturing and Energy Business Group, TCS. "Our deep industry expertise, global scale, investments in digital solutions, and focus on platforms enables us to offer true value to our customers across the Life Sciences value chain."
Tata Consultancy Services (TCS), a leading global IT services, consulting and business solutions organization, has been recognized as a Leader and Star Performer for Life Sciences IT Application Services by leading advisory and research firm, Everest Group, in its report, "Life Sciences – IT Application Services Providers PEAK Matrix Assessment 2017."
Everest Group acknowledged TCS’ strong foothold in the pharmaceutical and medical devices sector, and a growing business presence with biotechnology firms. The report highlights TCS' strong focus on development of next-generation solutions, incorporating Artificial Intelligence, IoT and platform-driven approaches for areas such as drug development and patient engagement.
Everest Group analyzed the capabilities of 22 service providers on the Everest Group PEAK Matrix in the Global Life Sciences sector. The PEAK Matrix is a composite framework that provides an objective, data driven and comparative assessment of Life Science IT Apps Service Providers, which are then divided into three categories based on market success and delivery capability.
"Life Sciences firms are grappling with the reinvention of their business models, along with the need to unlock efficiency out of globally diversified operations. Technology is a key enabler to ensure this transition, and TCS continues to be a partner of choice for leading Life Sciences firms, based on its delivery excellence and ongoing market success," said Jimit Arora, Partner, Everest Group. "By taking a platform-driven approach to strategic value chain tenets, TCS is seeking to future-proof its portfolio and driving differentiation in a highly competitive market."
"Life Sciences customers are embracing newer technologies and next gen platforms to meet the challenges of higher R&D costs, declining revenue and increasingly complex regulations," added Debashis Ghosh, President, Life Sciences, Manufacturing and Energy Business Group, TCS. "Our deep industry expertise, global scale, investments in digital solutions, and focus on platforms enables us to offer true value to our customers across the Life Sciences value chain."
LifeCell and LifeCodexx to Launch Rapid and Affordable NIPT in India
LifeCodexx AG, a pioneer in non-invasive prenatal DNA testing in Europe has announced its partnership with LifeCell – India's leading mother & baby preventive health care provider, to bring PrenaTesT qNIPT testing for the first time to India.
The qNIPT technology that detects the presence of fetal trisomy 21 (Down Syndrome) from maternal blood, received CE marking (European Conformity) in December 2016 last year. This certification was obtained after a successful blinded clinical validation of around 1000 samples, demonstrating a 100% credibility of test results obtained from PrenaTest. The novel qNIPT technology clearly demonstrates a significant cost-efficiency and rapid turnaround time compared to other NIPT techniques as it doesn't rely on costly and lengthy sequencing methodology.
Down Syndrome (DS), also called Trisomy 21, is a condition where extra genetic material causes delays in a child development both mentally & physically and is one of the most common genetic birth disorders. Down Syndrome (DS) is associated with mild to moderate learning disabilities, growth milestone delays, typical facial features and low muscle tone in early infancy. Though Down syndrome can't be prevented, it can be detected before a child is born.
India has the highest incidence of Down syndrome and it occurs in approximately 1 of 830 live births, as per Down Syndrome Federation of India. Through a series of screenings and tests, Down syndrome can be detected before the baby is born.
Routinely recommended prenatal screening tests are non-DNA based which unfortunately have lower detection rates (<95%) and higher false positives (5%). To confirm the diagnosis, further investigations are undertaken through invasive procedures causing a threat to the baby in the womb and added discomfort for the mother. Wider adoption of NIPT in global markets has substantially reduced the reporting of false positive diagnosis, which has reduced the need for any invasive tests by 60-70 per cent.
With this exclusive technology partnership with LifeCodexx AG, LifeCell will be able to perform the licensed qNIPT PrenaTest at LifeCell’s laboratories in Chennai (India) and will be the first in the country to offer qNIPT technology that is more advanced than sequencing methodology being used by others.
LifeCodexx AG, a pioneer in non-invasive prenatal DNA testing in Europe has announced its partnership with LifeCell – India's leading mother & baby preventive health care provider, to bring PrenaTesT qNIPT testing for the first time to India.
The qNIPT technology that detects the presence of fetal trisomy 21 (Down Syndrome) from maternal blood, received CE marking (European Conformity) in December 2016 last year. This certification was obtained after a successful blinded clinical validation of around 1000 samples, demonstrating a 100% credibility of test results obtained from PrenaTest. The novel qNIPT technology clearly demonstrates a significant cost-efficiency and rapid turnaround time compared to other NIPT techniques as it doesn't rely on costly and lengthy sequencing methodology.
Down Syndrome (DS), also called Trisomy 21, is a condition where extra genetic material causes delays in a child development both mentally & physically and is one of the most common genetic birth disorders. Down Syndrome (DS) is associated with mild to moderate learning disabilities, growth milestone delays, typical facial features and low muscle tone in early infancy. Though Down syndrome can't be prevented, it can be detected before a child is born.
India has the highest incidence of Down syndrome and it occurs in approximately 1 of 830 live births, as per Down Syndrome Federation of India. Through a series of screenings and tests, Down syndrome can be detected before the baby is born.
Routinely recommended prenatal screening tests are non-DNA based which unfortunately have lower detection rates (<95%) and higher false positives (5%). To confirm the diagnosis, further investigations are undertaken through invasive procedures causing a threat to the baby in the womb and added discomfort for the mother. Wider adoption of NIPT in global markets has substantially reduced the reporting of false positive diagnosis, which has reduced the need for any invasive tests by 60-70 per cent.
With this exclusive technology partnership with LifeCodexx AG, LifeCell will be able to perform the licensed qNIPT PrenaTest at LifeCell’s laboratories in Chennai (India) and will be the first in the country to offer qNIPT technology that is more advanced than sequencing methodology being used by others.
Hester Biosciences to Invest USD 3 Million in its Wholly Owned Subsidiary in Africa
Hester Biosciences Ltd one of India’s leading animal health care companies is planning to invest USD 3 million in its wholly owned subsidiary in Africa. Company’s board has approved the investment by way of equity in its wholly owned subsidiary company - Hester Biosciences Africa Limited, Tanzania, with an objective to manufacture animal vaccines and health products in Tanzania, to cater to the whole African continent.
The USD 3 million would be raised through internal accruals of Hester India.
While the project size has yet to be finalized, the balance amount for the project would be raised through debt.
More than 80 per cent of the required vaccines are imported in to Africa. Hester sees a very big potential in Africa for animal vaccines. Besides the common diseases, there are Africa-specific diseases, which currently remain unaddressed, thereby causing economical losses to poultry and livestock farmers.
Hester has already started the exports of animal vaccines & health products to Africa.
Hester’s distribution network in Africa not only aims at servicing the organized poultry & livestock farmers, but also the backyard farmers which constitute a big percentage of the animal population in Africa
Hester Biosciences Ltd one of India’s leading animal health care companies is planning to invest USD 3 million in its wholly owned subsidiary in Africa. Company’s board has approved the investment by way of equity in its wholly owned subsidiary company - Hester Biosciences Africa Limited, Tanzania, with an objective to manufacture animal vaccines and health products in Tanzania, to cater to the whole African continent.
The USD 3 million would be raised through internal accruals of Hester India.
While the project size has yet to be finalized, the balance amount for the project would be raised through debt.
More than 80 per cent of the required vaccines are imported in to Africa. Hester sees a very big potential in Africa for animal vaccines. Besides the common diseases, there are Africa-specific diseases, which currently remain unaddressed, thereby causing economical losses to poultry and livestock farmers.
Hester has already started the exports of animal vaccines & health products to Africa.
Hester’s distribution network in Africa not only aims at servicing the organized poultry & livestock farmers, but also the backyard farmers which constitute a big percentage of the animal population in Africa
IIL to Expand its Protozoan Vaccine Portfolio
Indian Immunologicals Limited (IIL) has signed MOU with INTA and Littoral Biologics of Argentina for transfer of technology for Bovine Parasitic vaccines in India. Introduction of vaccines against haemoprotozoan infections transmitted by ticks such as Babesiosis and Anaplasmosis will prevent loss in productivity in cattle and immensely benefit dairy farmers.
Instituto Nacional de Tecnologia Agropecuaria (INTA), Argentina is Argentinian federal agency in charge of the generation, adaptation and diffusion of technologies.
"Economic losses due to Babesisosis alone in India are estimated to be about USD 57.2 million", said Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited. He added that "IIL is only vaccine manufacturer in India which is capable of producing effective parasitic vaccines for animals with vast experience in producing vaccine against haemoprotozoan Theileria annulata, since three decades. IIL recently introduced vaccine against Porcine Cysticercosis, a parasitic vaccine for Pigs. This agreement with the Argentinean collaborators will go a long way in uplifting productivity among dairy farmers in India".
Dr Manual G Garcia, Director General of Littoral, Dr Nicora Amadeo, President INTA, Dr Cerioni Adolfo Luis, National Coordinator, INTA, Argentina signed the agreement with Indian Immunologicals to transfer technology to produce vaccine against Babesiosis and Anaplasmosis. IIL’s Rakshavac-T (Vaccine against Theileria annulata) is the only vaccine against haemoprotozoan infections in India.
IIL is set to address this unmet need to control haemoprotozoan diseases transmitted by ticks in India and prevent loss of productivity in cattle.
Indian Immunologicals Limited (IIL) has signed MOU with INTA and Littoral Biologics of Argentina for transfer of technology for Bovine Parasitic vaccines in India. Introduction of vaccines against haemoprotozoan infections transmitted by ticks such as Babesiosis and Anaplasmosis will prevent loss in productivity in cattle and immensely benefit dairy farmers.
Instituto Nacional de Tecnologia Agropecuaria (INTA), Argentina is Argentinian federal agency in charge of the generation, adaptation and diffusion of technologies.
"Economic losses due to Babesisosis alone in India are estimated to be about USD 57.2 million", said Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited. He added that "IIL is only vaccine manufacturer in India which is capable of producing effective parasitic vaccines for animals with vast experience in producing vaccine against haemoprotozoan Theileria annulata, since three decades. IIL recently introduced vaccine against Porcine Cysticercosis, a parasitic vaccine for Pigs. This agreement with the Argentinean collaborators will go a long way in uplifting productivity among dairy farmers in India".
Dr Manual G Garcia, Director General of Littoral, Dr Nicora Amadeo, President INTA, Dr Cerioni Adolfo Luis, National Coordinator, INTA, Argentina signed the agreement with Indian Immunologicals to transfer technology to produce vaccine against Babesiosis and Anaplasmosis. IIL’s Rakshavac-T (Vaccine against Theileria annulata) is the only vaccine against haemoprotozoan infections in India.
IIL is set to address this unmet need to control haemoprotozoan diseases transmitted by ticks in India and prevent loss of productivity in cattle.
'Patients First' ISCR's theme for International Clinical Trials Day 2017
The Indian Society for Clinical Research (ISCR), an association of clinical research professionals, has this year retained its theme of Patients First for International Clinical Trials Day 2017. Each year, May 20th is celebrated as International Clinical Trials Day to mark the day the world’s first controlled clinical trial was conducted in 1747.
Commenting on retaining the focus on patients for this year's International Clinical trials Day activities, Dr. Chirag Trivedi, President of ISCR said, "Every medicine or treatment we take has been made possible because of a patient who participated in a clinical trial. Our theme Patients First acknowledges the selfless contribution and our appreciation of clinical trial patients in bringing new drugs and new treatment to market. It is also dedicated to patients who are still waiting in hope of a better quality of life made possible through new treatment and to whom we commit the work we do as clinical research professionals."
India has 17 per cent of the world's population and 20 per cent of the global disease burden and yet, less than 1.4 per cent of global trials take place in India. “We call upon all clinical research professionals and patients in the country to join us in commemorating International Clinical Trials Day. We need greater awareness created about clinical research so that patient are aware of their rights and responsibilities. We need to encourage more innovation and research and development in India to make Make in India a reality for clinical research. We also need to ensure that global stakeholders are aware about the balanced regulatory environment we have in the country today. More clinical trials in India will mean that more patients can access the benefits of more effective and newer treatment,†added Dr. Trivedi.
The Indian Society for Clinical Research (ISCR), an association of clinical research professionals, has this year retained its theme of Patients First for International Clinical Trials Day 2017. Each year, May 20th is celebrated as International Clinical Trials Day to mark the day the world’s first controlled clinical trial was conducted in 1747.
Commenting on retaining the focus on patients for this year's International Clinical trials Day activities, Dr. Chirag Trivedi, President of ISCR said, "Every medicine or treatment we take has been made possible because of a patient who participated in a clinical trial. Our theme Patients First acknowledges the selfless contribution and our appreciation of clinical trial patients in bringing new drugs and new treatment to market. It is also dedicated to patients who are still waiting in hope of a better quality of life made possible through new treatment and to whom we commit the work we do as clinical research professionals."
India has 17 per cent of the world's population and 20 per cent of the global disease burden and yet, less than 1.4 per cent of global trials take place in India. “We call upon all clinical research professionals and patients in the country to join us in commemorating International Clinical Trials Day. We need greater awareness created about clinical research so that patient are aware of their rights and responsibilities. We need to encourage more innovation and research and development in India to make Make in India a reality for clinical research. We also need to ensure that global stakeholders are aware about the balanced regulatory environment we have in the country today. More clinical trials in India will mean that more patients can access the benefits of more effective and newer treatment,†added Dr. Trivedi.
India to Help Protect Children from the Life-threatening Pneumococcal Disease
Pfizer announced that its 13-valent Pneumococcal Conjugate Vaccine has been selected for inclusion in India’s immunization program in select states. In the first phase, the program will cover approximately 5.15 million babies – 20 per cent of around 26 million children of India’s birth cohort. Globally, pneumococcal disease is one of the leading causes of deaths in children younger than 5 years of age. In India, according to the Farooqui article published in 2015, approximately 105,000 children had died of pneumococcal pneumonia in 2010.
The 13-valent Pneumococcal Conjugate Vaccine (PCV 13) is the most widely used pneumococcal conjugate vaccine in the world, with deployment in over 100 countries’ immunization program. PCV 13 vaccine provides the broadest serotype coverage including those serotypes most prevalent in India. Epidemiological studies conducted in India confirm that the PCV 13 vaccine provides higher coverage than any other PCV vaccine. The additional strains that PCV 13 covers are 3, 6A and 19A.
PCV 13 will be introduced in a multi dose vial format in India. This presentation has been specially developed by Pfizer to enhance efficiencies of public immunization programs.
"The Government of India has made reaching every child with vaccines as a key priority. With the introduction of PCV 13, we will able to help protect India's birth cohort of 26 million children from the leading cause of child deaths in the country. Pfizer remains committed to supporting the Government and its partners in expanding the introduction of PCV 13 in the country such that every child in India gets access to protection from pneumococcal diseases", said S. Sridhar, Country Manager, Pfizer India.
For the first phase of expansion, the vaccine will be supplied directly by Pfizer Inc. through UNICEF, under the auspices of Gavi, the Vaccine Alliance’s Advance Market Commitment – an innovative funding mechanism that provides Gavi eligible and Gavi graduated countries with access to advanced life-saving
Pfizer announced that its 13-valent Pneumococcal Conjugate Vaccine has been selected for inclusion in India’s immunization program in select states. In the first phase, the program will cover approximately 5.15 million babies – 20 per cent of around 26 million children of India’s birth cohort. Globally, pneumococcal disease is one of the leading causes of deaths in children younger than 5 years of age. In India, according to the Farooqui article published in 2015, approximately 105,000 children had died of pneumococcal pneumonia in 2010.
The 13-valent Pneumococcal Conjugate Vaccine (PCV 13) is the most widely used pneumococcal conjugate vaccine in the world, with deployment in over 100 countries’ immunization program. PCV 13 vaccine provides the broadest serotype coverage including those serotypes most prevalent in India. Epidemiological studies conducted in India confirm that the PCV 13 vaccine provides higher coverage than any other PCV vaccine. The additional strains that PCV 13 covers are 3, 6A and 19A.
PCV 13 will be introduced in a multi dose vial format in India. This presentation has been specially developed by Pfizer to enhance efficiencies of public immunization programs.
"The Government of India has made reaching every child with vaccines as a key priority. With the introduction of PCV 13, we will able to help protect India's birth cohort of 26 million children from the leading cause of child deaths in the country. Pfizer remains committed to supporting the Government and its partners in expanding the introduction of PCV 13 in the country such that every child in India gets access to protection from pneumococcal diseases", said S. Sridhar, Country Manager, Pfizer India.
For the first phase of expansion, the vaccine will be supplied directly by Pfizer Inc. through UNICEF, under the auspices of Gavi, the Vaccine Alliance’s Advance Market Commitment – an innovative funding mechanism that provides Gavi eligible and Gavi graduated countries with access to advanced life-saving
US FDA Approves Dr. Reddy's Doxorubicin Hydrochloride Liposome Injection
Dr. Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration (USFDA) to launch Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market. USFDA approval is an outcome of extensive collaboration with the company's partner, Natco Pharma Ltd, on R&D and manufacturing capabilities.
"This approval represents the first of its kind for Dr. Reddy's in the complex depot injectables arena," explains Alok Sonig, Executive Vice President and Head of the North America Generics business at Dr. Reddy's Laboratories. "It is a testament to our commitment to bring affordable generic medicines to market for patients. The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon."
"We are pleased with our partnership with Dr.Reddy's Laboratories. This approval would not have been possible without their guidance and support," says Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer, Natco Pharma.
The Doxil brand and generic had U.S. sales of approximately USD 196 million MAT for the most recent twelve months ending in March 2017 according to IMS Health*.
Dr. Reddy's Doxorubicin Hydrochloride Liposome Injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each 10-mL vial contains 20 mg doxorubicin hydrochloride at a concentration of 2 mg/mL. Each 30-mL vial contains 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL.
Dr. Reddy's Laboratories Ltd has received approval from the U.S. Food and Drug Administration (USFDA) to launch Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market. USFDA approval is an outcome of extensive collaboration with the company's partner, Natco Pharma Ltd, on R&D and manufacturing capabilities.
"This approval represents the first of its kind for Dr. Reddy's in the complex depot injectables arena," explains Alok Sonig, Executive Vice President and Head of the North America Generics business at Dr. Reddy's Laboratories. "It is a testament to our commitment to bring affordable generic medicines to market for patients. The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon."
"We are pleased with our partnership with Dr.Reddy's Laboratories. This approval would not have been possible without their guidance and support," says Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer, Natco Pharma.
The Doxil brand and generic had U.S. sales of approximately USD 196 million MAT for the most recent twelve months ending in March 2017 according to IMS Health*.
Dr. Reddy's Doxorubicin Hydrochloride Liposome Injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each 10-mL vial contains 20 mg doxorubicin hydrochloride at a concentration of 2 mg/mL. Each 30-mL vial contains 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL.
Agilent Technologies Announces Expanded Use for PD-L1 IHC 28-8 pharmDx Diagnostic in Europe
Agilent Technologies Inc announced the expanded use of Agilent´s Dako PD-L1 IHC 28-8 pharmDx test for squamous cell carcinoma of the head and neck (SCCHN), the most prevalent type of head and neck cancer.
Europe is the first region to launch a PD-L1 CE-IVD test for SCCHN globally. The CE marking demonstrates that the product meets all relevant European Medical Device Directives. The PD-L1 IHC 28-8 pharmDx test has broad utility, as it has already been previously CE marked for tumor cell PD-L1 expression for non-squamous, non-small-cell lung cancer (ns-NSCLC) and melanoma.
With this latest indication, pathologists in Europe now have access to a clinically validated test to determine tumor PD-L1 status PD-L1, in patients with SCCHN. There are currently few treatment options for SCCHN, but this new test can identify which patients could most likely benefit from treatment with Opdivo (nivolumab), an immunotherapy developed by Bristol-Myers Squibb. Opdivo as monotherapy is indicated for the treatment of squamous cell cancer of the head and neck in adults progressing on, or after platinum-based therapy.
Data from a pre-specified exploratory analysis of the Checkmate 141 clinical trial showed that tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 pharmDx in SCCHN, may be associated with an enhanced survival benefit for the patient from the use of Opdivo.
Immunotherapies are designed to help an individual´s immune system detect and kill cancer cells. Because individual patients often respond differently to the same treatment, scientists have been focusing emphasis on personalized medicine, which is where Agilent´s Dako brand of diagnostics comes into play, providing important information about the status of key biomarkers in individual cancer patients.
Agilent Technologies Inc announced the expanded use of Agilent´s Dako PD-L1 IHC 28-8 pharmDx test for squamous cell carcinoma of the head and neck (SCCHN), the most prevalent type of head and neck cancer.
Europe is the first region to launch a PD-L1 CE-IVD test for SCCHN globally. The CE marking demonstrates that the product meets all relevant European Medical Device Directives. The PD-L1 IHC 28-8 pharmDx test has broad utility, as it has already been previously CE marked for tumor cell PD-L1 expression for non-squamous, non-small-cell lung cancer (ns-NSCLC) and melanoma.
With this latest indication, pathologists in Europe now have access to a clinically validated test to determine tumor PD-L1 status PD-L1, in patients with SCCHN. There are currently few treatment options for SCCHN, but this new test can identify which patients could most likely benefit from treatment with Opdivo (nivolumab), an immunotherapy developed by Bristol-Myers Squibb. Opdivo as monotherapy is indicated for the treatment of squamous cell cancer of the head and neck in adults progressing on, or after platinum-based therapy.
Data from a pre-specified exploratory analysis of the Checkmate 141 clinical trial showed that tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 pharmDx in SCCHN, may be associated with an enhanced survival benefit for the patient from the use of Opdivo.
Immunotherapies are designed to help an individual´s immune system detect and kill cancer cells. Because individual patients often respond differently to the same treatment, scientists have been focusing emphasis on personalized medicine, which is where Agilent´s Dako brand of diagnostics comes into play, providing important information about the status of key biomarkers in individual cancer patients.
Glenmark Pharmaceuticals to Initiate Clinical Study for GBR 1342
Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the US Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to initiate a Phase 1 study of GBR 1342, a humanized, bispecific monoclonal antibody (bsAb) being studied for the treatment of multiple myeloma in patients who have received prior therapies. GBR 1342 is designed to activate the patient's immune system by redirecting immune cells towards tumor tissue, which may lead to targeted destruction of tumors. It is based on Glenmark’s proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform.
,br /> "This is an exciting time for Glenmark as our flagship biotechnology platform and antibody science are beginning to become a reality for patients, now that we have a second oncology candidate entering clinical trials," said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals. "While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing." The first-in-human Phase 1 study of GBR 1342 will enroll subjects with multiple myeloma who have exhausted available therapies. The study is being conducted in two parts: the first part is a dose escalation to determine the safety profile and maximum tolerable dose; the second is an expansion cohort treated at maximum tolerable dose to further investigate the safety profile and preliminary efficacy of GBR 1342.
GBR 1342 simultaneously engages CD38, a proven target in multiple myeloma, and the CD3 molecule on T cells. GBR 1342 is also being considered for the treatment of other malignancies.
Glenmark Pharmaceuticals, a global pharmaceutical company, announced that the US Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to initiate a Phase 1 study of GBR 1342, a humanized, bispecific monoclonal antibody (bsAb) being studied for the treatment of multiple myeloma in patients who have received prior therapies. GBR 1342 is designed to activate the patient's immune system by redirecting immune cells towards tumor tissue, which may lead to targeted destruction of tumors. It is based on Glenmark’s proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform.
,br /> "This is an exciting time for Glenmark as our flagship biotechnology platform and antibody science are beginning to become a reality for patients, now that we have a second oncology candidate entering clinical trials," said Kurt Stoeckli, President and Chief Scientific Officer at Glenmark Pharmaceuticals. "While there is still significant development ahead, these steps signify that Glenmark's investment in discovery and development of biologics is rapidly progressing." The first-in-human Phase 1 study of GBR 1342 will enroll subjects with multiple myeloma who have exhausted available therapies. The study is being conducted in two parts: the first part is a dose escalation to determine the safety profile and maximum tolerable dose; the second is an expansion cohort treated at maximum tolerable dose to further investigate the safety profile and preliminary efficacy of GBR 1342.
GBR 1342 simultaneously engages CD38, a proven target in multiple myeloma, and the CD3 molecule on T cells. GBR 1342 is also being considered for the treatment of other malignancies.
Merck to Build Hypertension Experts Platform Across the Globe
Merck, a leading science and technology company in healthcare, life science and performance materials, marks World Hypertension Day with the announcement of the 2016 'Merck Hypertension Award' winners and the call for applications for the 2017 Hypertension Award. The award as part of the Merck Capacity Advancement Program was launched in April 2016 in partnership with African and Asian universities with the aim of building a platform of hypertension experts across the globe.
In Kampala, Uganda, Rasha Kelej, Senior Vice President and Chief Social Officer, Merck Healthcare emphasized: "Merck plays an important role in building diabetes and hypertension care capacity and improving access to quality and sustainable healthcare solutions in developing countries. Today marks an important day in the fight against hypertension as we mark the World Hypertension Day. In this context, we have announced ten Merck Hypertension Award 2016 winners."
Merck invited medical students to apply for the "Merck Hypertension Award 2016" with the theme of "What the Healthy Heart needs." Students across African and Asian medical universities were asked to submit a concept paper on how to improve hypertension awareness, early detection and prevention in their countries and how to encourage their society, scientific community, local authorities, media and relevant stakeholders to ‘think and act' on hypertension every day.
The scientific committee received over 500 concept submission applications from universities in Africa and Asia and 10 winners were selected for the award. Winners from each university have been granted a one year postgraduate Preventive Cardiovascular Medicine diploma with the University of South Wales, United Kingdom.
"Merck Hypertension Award is another step in our long term commitment to support hypertension care strategy through working with local governments, academia and relevant stakeholders in building healthcare capacity with a focus on diabetes, hypertension and other non-communicable diseases in various countries in Asia-Pacific, Middle East, Africa and Latin America," added Rasha Kelej when making the announcement of the winners during an event in Nairobi, Kenya.
Merck, a leading science and technology company in healthcare, life science and performance materials, marks World Hypertension Day with the announcement of the 2016 'Merck Hypertension Award' winners and the call for applications for the 2017 Hypertension Award. The award as part of the Merck Capacity Advancement Program was launched in April 2016 in partnership with African and Asian universities with the aim of building a platform of hypertension experts across the globe.
In Kampala, Uganda, Rasha Kelej, Senior Vice President and Chief Social Officer, Merck Healthcare emphasized: "Merck plays an important role in building diabetes and hypertension care capacity and improving access to quality and sustainable healthcare solutions in developing countries. Today marks an important day in the fight against hypertension as we mark the World Hypertension Day. In this context, we have announced ten Merck Hypertension Award 2016 winners."
Merck invited medical students to apply for the "Merck Hypertension Award 2016" with the theme of "What the Healthy Heart needs." Students across African and Asian medical universities were asked to submit a concept paper on how to improve hypertension awareness, early detection and prevention in their countries and how to encourage their society, scientific community, local authorities, media and relevant stakeholders to ‘think and act' on hypertension every day.
The scientific committee received over 500 concept submission applications from universities in Africa and Asia and 10 winners were selected for the award. Winners from each university have been granted a one year postgraduate Preventive Cardiovascular Medicine diploma with the University of South Wales, United Kingdom.
"Merck Hypertension Award is another step in our long term commitment to support hypertension care strategy through working with local governments, academia and relevant stakeholders in building healthcare capacity with a focus on diabetes, hypertension and other non-communicable diseases in various countries in Asia-Pacific, Middle East, Africa and Latin America," added Rasha Kelej when making the announcement of the winners during an event in Nairobi, Kenya.
Shire Launches "Rare Count" Campaign
Shire plc has announced the launch of "Rare Count" in honor of Rare Disease Day and the 350 million people worldwide living with rare diseases, which equates to nearly one in 20 global citizens. It is estimated that 50 per cent of rare diseases begin in childhood. The campaign, open for all to participate at www. shire.com/RareCount, highlights the under-recognized prevalence of rare diseases.
Speaking on the launch of the campaign on World Rare Disease Day, Vineet Singhal, Country Head, Baxalta Bioscience India Pvt. Ltd (now part of Shire) said, "Awareness about Rare Diseases in India is very minimal and there is a dire need to create awareness on the importance of timely and appropriate diagnosis that can help make difference in the lives of patients suffering from rare diseases. The Rare Count campaign in India and Globally will aim to reach out to such patients through social media platforms. As 66 per cent of the 180 million Internet users in urban India regularly access social media platforms, we strongly feel this campaign will help in reaching out to rare disease patients. At Shire we are committed to these patients and put their wellness first."
The Rare Count campaign applies the "one in 20" rare disease statistic to calculate the potential number of contacts in a user's social network who could be living with a rare disease. The shareable result represents the user's "Rare Count"and underscores the potential personal impact of rare diseases.
Anyone can go to www.shire.com/RareCount to calculate and share their individualized Rare Count through Facebook, Twitter or LinkedIn. For every person who participates, Shire will contribute USD 1, up to USD 10,000 to each of the following umbrella patient advocacy groups focused on rare diseases: National Organization for Rare Disorders, Global Genes and EURORDIS (Rare Diseases Europe).
Shire plc has announced the launch of "Rare Count" in honor of Rare Disease Day and the 350 million people worldwide living with rare diseases, which equates to nearly one in 20 global citizens. It is estimated that 50 per cent of rare diseases begin in childhood. The campaign, open for all to participate at www. shire.com/RareCount, highlights the under-recognized prevalence of rare diseases.
Speaking on the launch of the campaign on World Rare Disease Day, Vineet Singhal, Country Head, Baxalta Bioscience India Pvt. Ltd (now part of Shire) said, "Awareness about Rare Diseases in India is very minimal and there is a dire need to create awareness on the importance of timely and appropriate diagnosis that can help make difference in the lives of patients suffering from rare diseases. The Rare Count campaign in India and Globally will aim to reach out to such patients through social media platforms. As 66 per cent of the 180 million Internet users in urban India regularly access social media platforms, we strongly feel this campaign will help in reaching out to rare disease patients. At Shire we are committed to these patients and put their wellness first."
The Rare Count campaign applies the "one in 20" rare disease statistic to calculate the potential number of contacts in a user's social network who could be living with a rare disease. The shareable result represents the user's "Rare Count"and underscores the potential personal impact of rare diseases.
Anyone can go to www.shire.com/RareCount to calculate and share their individualized Rare Count through Facebook, Twitter or LinkedIn. For every person who participates, Shire will contribute USD 1, up to USD 10,000 to each of the following umbrella patient advocacy groups focused on rare diseases: National Organization for Rare Disorders, Global Genes and EURORDIS (Rare Diseases Europe).
CelluGen Counters LifeCell's Claims
of being Pioneer in UCB Pool Banking
Leading stem cell research organization CelluGen Biotech has challenged LifeCell's recent claim of being the pioneer of Pool/Shared Private Umbilcal Cord Blood banking Banking in India, contending that it was Cellugen that initiated the first UCB pool banking in the world with its revolutionary initiative Mycord.
In 2016, CelluGen Biotech redefined umbilical cord blood banking in India by introducing the Mycord Precious Pool Plan, to create a private pool of umbilical cord blood units. This was the first such private effort in the country that desperately needed shared UCB bankin g. While Lifecell's foray into the field is welcome, it is incorrect for the organization to present itself as the pioneer in the shared banking space. In a recent interview, the Managing Director and CEO of LifeCell International Pvt Ltd, Mayur Abhaya has made claims to this effect.
Lalit Jaiswal, Founder-Director, CelluGen Biotech Pvt Ltd has responded to this claim by saying, "We welcome LifeCell into this arena of pool/shared cord blood banking and appreciate their efforts to restructure the concept of umbilical cord banking after a decade of storing cord blood for self-use. It is very important in the interest of parents and the newborn that all private banks transform into shared/ pooled cord blood banks. In fact, we would advice other companies to follow suit."
Leading stem cell research organization CelluGen Biotech has challenged LifeCell's recent claim of being the pioneer of Pool/Shared Private Umbilcal Cord Blood banking Banking in India, contending that it was Cellugen that initiated the first UCB pool banking in the world with its revolutionary initiative Mycord.
In 2016, CelluGen Biotech redefined umbilical cord blood banking in India by introducing the Mycord Precious Pool Plan, to create a private pool of umbilical cord blood units. This was the first such private effort in the country that desperately needed shared UCB bankin g. While Lifecell's foray into the field is welcome, it is incorrect for the organization to present itself as the pioneer in the shared banking space. In a recent interview, the Managing Director and CEO of LifeCell International Pvt Ltd, Mayur Abhaya has made claims to this effect.
Lalit Jaiswal, Founder-Director, CelluGen Biotech Pvt Ltd has responded to this claim by saying, "We welcome LifeCell into this arena of pool/shared cord blood banking and appreciate their efforts to restructure the concept of umbilical cord banking after a decade of storing cord blood for self-use. It is very important in the interest of parents and the newborn that all private banks transform into shared/ pooled cord blood banks. In fact, we would advice other companies to follow suit."
Sanofi and Regeneron Announce FDA
Approval of Dupixent
Sanofi and Regeneron Pharmaceuticals, Inc has announced that the US FDA approved Dupixent (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
"People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," said Julie Block, President and Chief Executive Officer, National Eczema Association. "To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That's why today's approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease."
Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.
AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating. Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.
Sanofi and Regeneron Pharmaceuticals, Inc has announced that the US FDA approved Dupixent (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
"People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," said Julie Block, President and Chief Executive Officer, National Eczema Association. "To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That's why today's approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease."
Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.
AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating. Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.
Agilent to Showcase Breakthrough
Analytical Solutions
Agilent Technologies has announced that it will host the 'Total Agilent Experience' (TAE) symposium for the first time in Mumbai, on June 6-7, 2017. More than 500 scientists and researchers from commercial, scientific and research communities are expected to attend this symposium that has been held in a different region throughout Southeast Asia since 2011.
At the event, Agilent will showcase new platforms that will include: the Intuvo 9000 GC, the 4210 MP-AES, the 5110 ICP-OES and its liquid chromatography and mass-spectroscopy solutions. These analytical instruments can be used by scientists, chemists and laboratory professionals working in key industries such as pharmaceuticals, food, research, agriculture, chemicals, petrochemical and mining.
Using the sophisticated, user-friendly technologies offered by these platforms, scientists are now able to work on a wider range of challenging applications with improved performance and ease of use, whilst also increasing laboratory productivity and economic value.
Bhardwaj , country manager of Agilent Technologies India said, "Agilent takes all customer feedback seriously when it comes to developing new products. Concerns such as increasing laboratory productivity, and ease of use of both software and hardware consistently rate highly. As well as with the exhibition of our groundbreaking technology, we will also be hosting a Pharma Regulatory Summit, and a Food Safety Summit, where industry experts will share their insights on the emerging trends that are driving adoption of these technologies in these areas. The Total Agilent Experience aims to build a platform for the scientific community to share their concerns and suggest strategies to overcome these hurdles. We are committed to providing our customers with the best tools to meet their application needs."
Agilent Technologies has announced that it will host the 'Total Agilent Experience' (TAE) symposium for the first time in Mumbai, on June 6-7, 2017. More than 500 scientists and researchers from commercial, scientific and research communities are expected to attend this symposium that has been held in a different region throughout Southeast Asia since 2011.
At the event, Agilent will showcase new platforms that will include: the Intuvo 9000 GC, the 4210 MP-AES, the 5110 ICP-OES and its liquid chromatography and mass-spectroscopy solutions. These analytical instruments can be used by scientists, chemists and laboratory professionals working in key industries such as pharmaceuticals, food, research, agriculture, chemicals, petrochemical and mining.
Using the sophisticated, user-friendly technologies offered by these platforms, scientists are now able to work on a wider range of challenging applications with improved performance and ease of use, whilst also increasing laboratory productivity and economic value.
Bhardwaj , country manager of Agilent Technologies India said, "Agilent takes all customer feedback seriously when it comes to developing new products. Concerns such as increasing laboratory productivity, and ease of use of both software and hardware consistently rate highly. As well as with the exhibition of our groundbreaking technology, we will also be hosting a Pharma Regulatory Summit, and a Food Safety Summit, where industry experts will share their insights on the emerging trends that are driving adoption of these technologies in these areas. The Total Agilent Experience aims to build a platform for the scientific community to share their concerns and suggest strategies to overcome these hurdles. We are committed to providing our customers with the best tools to meet their application needs."
Dr. Reddy's and Integra LifeSciences
Ink Exclusive Distribution Deal
Dr. Reddy's Laboratories Limited and Integra LifeSciences Holdings Corporation, a leading global medical technology company, have entered into an exclusive distribution agreement. Under the agreement, Dr. Reddy's will market and distribute DuraGen Plus and Suturable DuraGen Dural Regeneration Matrices for use in patients in India.
The DuraGen product line offers Duraplasty Solutions meant for the repair of the dura mater. Dura mater is a thick membrane that surrounds the brain and spinal cord, and contains the cerebrospinal fluid (CSF). DuraGen Plus Dural Regeneration Matrix is indicated as a dural substitute for the repair of dura mater. It offers a simple technique for precise placement of the matrix as an onlay graft in cranial and spinal procedures, and easily conforms to the complex surfaces of exposed neural tissue. It provides effective protection against CSF leakage with sutureless closure and is fully resorbed and replaced by native tissue with complete dural closure.
Suturable DuraGen matrix is a versatile graft that can be sutured and is designed for repairing dural defects where mechanical anchoring of the graft is preferred. This offers excellent suture retention with all the benefits of DuraGen Plus Matrix.
Integra's DuraGen products have been implanted in more than 1.8 million patients worldwide to effect dural closure following neurosurgical procedures. Integra manufactures the DuraGen family of products based on its proprietary Ultra Pure Collagen technology platfor m.
Dr. Reddy's Laboratories Limited and Integra LifeSciences Holdings Corporation, a leading global medical technology company, have entered into an exclusive distribution agreement. Under the agreement, Dr. Reddy's will market and distribute DuraGen Plus and Suturable DuraGen Dural Regeneration Matrices for use in patients in India.
The DuraGen product line offers Duraplasty Solutions meant for the repair of the dura mater. Dura mater is a thick membrane that surrounds the brain and spinal cord, and contains the cerebrospinal fluid (CSF). DuraGen Plus Dural Regeneration Matrix is indicated as a dural substitute for the repair of dura mater. It offers a simple technique for precise placement of the matrix as an onlay graft in cranial and spinal procedures, and easily conforms to the complex surfaces of exposed neural tissue. It provides effective protection against CSF leakage with sutureless closure and is fully resorbed and replaced by native tissue with complete dural closure.
Suturable DuraGen matrix is a versatile graft that can be sutured and is designed for repairing dural defects where mechanical anchoring of the graft is preferred. This offers excellent suture retention with all the benefits of DuraGen Plus Matrix.
Integra's DuraGen products have been implanted in more than 1.8 million patients worldwide to effect dural closure following neurosurgical procedures. Integra manufactures the DuraGen family of products based on its proprietary Ultra Pure Collagen technology platfor m.
Biogaran Takes Over Swipha's
Activities in Nigeria
Biogaran, a French pharmaceutical company specialized in generic and biosimilar medicines, and a subsidiary of Servier has announced the takeover of all the activities of Swipha, a Nigerian company that manufactures and distributes pharmaceutical products known for their quality. This is an important step forward in the internationalization of the French company Biogaran.
In order to develop new markets to meet its commitment to provide all patients with quality medication, Biogaran, a pioneer in generics and biosimilars, and a subsidiary of Servier, has just taken over Swipha, a Nigerian pharmaceutical company that produces medicines to meet local health needs. Its portfolio is mainly focused on three families of products: anti-anxiety and tranquillizers, antimalarial drugs and antibiotics, which treat Nigeria's most widespread infections and health issues.
Swipha was the first Nigerian pharmaceutical company to obtain ISO 9001 certification in 2007. Approved by the World Health Organization (WHO) in 2014, Swipha employs 300 people locally and generated record sales of NGN 4bn (approximately € 20 million) in 2012. Beyond its production unit, the company also has a wide distribution network covering most parts of Nigeria, Africa's most dynamic country, with more than 184 million inhabitants in 2016 according to the IMF.
Health issues are particularly important in Africa. Beyond significant needs for good quality, affordable and efficient medicines, the problem of counterfeits is also becoming of concern. The WHO estimates that 100,000 deaths are due to fake medicines in Africa every year. In this context, supplying Nigeria's population with reliable medicines that are produced locally is a strong commitment made by Biogaran.
Biogaran, a French pharmaceutical company specialized in generic and biosimilar medicines, and a subsidiary of Servier has announced the takeover of all the activities of Swipha, a Nigerian company that manufactures and distributes pharmaceutical products known for their quality. This is an important step forward in the internationalization of the French company Biogaran.
In order to develop new markets to meet its commitment to provide all patients with quality medication, Biogaran, a pioneer in generics and biosimilars, and a subsidiary of Servier, has just taken over Swipha, a Nigerian pharmaceutical company that produces medicines to meet local health needs. Its portfolio is mainly focused on three families of products: anti-anxiety and tranquillizers, antimalarial drugs and antibiotics, which treat Nigeria's most widespread infections and health issues.
Swipha was the first Nigerian pharmaceutical company to obtain ISO 9001 certification in 2007. Approved by the World Health Organization (WHO) in 2014, Swipha employs 300 people locally and generated record sales of NGN 4bn (approximately € 20 million) in 2012. Beyond its production unit, the company also has a wide distribution network covering most parts of Nigeria, Africa's most dynamic country, with more than 184 million inhabitants in 2016 according to the IMF.
Health issues are particularly important in Africa. Beyond significant needs for good quality, affordable and efficient medicines, the problem of counterfeits is also becoming of concern. The WHO estimates that 100,000 deaths are due to fake medicines in Africa every year. In this context, supplying Nigeria's population with reliable medicines that are produced locally is a strong commitment made by Biogaran.
Shire Launches "Rare Count" Campaign
Shire plc has announced the launch of "Rare Count" in honor of Rare Disease Day and the 350 million people worldwide living with rare diseases, which equates to nearly one in 20 global citizens. It is estimated that 50 per cent of rare diseases begin in childhood. The campaign highlights the under-recognized prevalence of rare diseases.
Speaking on the launch of the campaign on World Rare Disease Day, Mr, Vineet Singhal, Country Head, Baxalta Bioscience India Pvt. Ltd (now part of Shire) said, "Awareness about Rare Diseases in India is very minimal and there is a dire need to create awareness on the importance of timely and appropriate diagnosis that can help make difference in the lives of patients suffering from rare diseases. The Rare Count campaign in India and Globally will aim to reach out to such patients through social media platforms. As 66 per cent of the 180 million Internet users in urban India regularly access social media platforms, we strongly feel this campaign will help in reaching out to rare disease patients. At Shire we are committed to these patients and put their wellness first."
Today, there are about 7,000 known rare diseases. While rare disease communities are small, the overall prevalence of rare diseases may be higher than the public recognizes. Since low awareness can contribute to the ongoing challenges facing people living with rare diseases, public education is critical. Shire is timing The Rare Count campaign to coincide with Rare Disease Day, an annual awareness day focused on educating the public about rare diseases and their associated challenges goal of providing new treatment options that meet significant unmet medical needs.
Shire plc has announced the launch of "Rare Count" in honor of Rare Disease Day and the 350 million people worldwide living with rare diseases, which equates to nearly one in 20 global citizens. It is estimated that 50 per cent of rare diseases begin in childhood. The campaign highlights the under-recognized prevalence of rare diseases.
Speaking on the launch of the campaign on World Rare Disease Day, Mr, Vineet Singhal, Country Head, Baxalta Bioscience India Pvt. Ltd (now part of Shire) said, "Awareness about Rare Diseases in India is very minimal and there is a dire need to create awareness on the importance of timely and appropriate diagnosis that can help make difference in the lives of patients suffering from rare diseases. The Rare Count campaign in India and Globally will aim to reach out to such patients through social media platforms. As 66 per cent of the 180 million Internet users in urban India regularly access social media platforms, we strongly feel this campaign will help in reaching out to rare disease patients. At Shire we are committed to these patients and put their wellness first."
Today, there are about 7,000 known rare diseases. While rare disease communities are small, the overall prevalence of rare diseases may be higher than the public recognizes. Since low awareness can contribute to the ongoing challenges facing people living with rare diseases, public education is critical. Shire is timing The Rare Count campaign to coincide with Rare Disease Day, an annual awareness day focused on educating the public about rare diseases and their associated challenges goal of providing new treatment options that meet significant unmet medical needs.
Ingersoll Rand Joins Paradigm for
Parity Coalition
Ingersoll Rand, a world leader in creating comfortable, sustainable and efficient environments, joined the Paradigm for Parity coalition and pledged to bring gender parity to its corporate leadership structure by 2030. The first in its industry to pledge, Ingersoll Rand has united with nearly 40 other companies in the coalition to address the corporate leadership gender gap. The company currently offers resources designed to engage and support women, including women's leadership and mentorship programs. In 2014, Ingersoll Rand established its 2020 Sustainability Goals, including clear targets to attract and retain an increase in the number of women in leadership and professional roles. The company's Sustainability Goals in this area also align with the United Nations Sustainable Development Goals for gender equality.
Ingersoll Rand, a world leader in creating comfortable, sustainable and efficient environments, joined the Paradigm for Parity coalition and pledged to bring gender parity to its corporate leadership structure by 2030. The first in its industry to pledge, Ingersoll Rand has united with nearly 40 other companies in the coalition to address the corporate leadership gender gap. The company currently offers resources designed to engage and support women, including women's leadership and mentorship programs. In 2014, Ingersoll Rand established its 2020 Sustainability Goals, including clear targets to attract and retain an increase in the number of women in leadership and professional roles. The company's Sustainability Goals in this area also align with the United Nations Sustainable Development Goals for gender equality.
Glenmark Pharmaceuticals Receives
FDA Clearance of IND for GSP 304
Glenmark Pharmaceuticals, a global pharmaceutical company, has announced that the US Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to begin a Phase 2 study of GSP 304 (tiotropium bromide) for administration by nebulization for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Glenmark plans to initiate clinical development with a Phase 2 study of GSP 304, a new orally administered formulation, in subjects with mild to moderate COPD, as determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The efficacy, pharmacokinetics, and safety profiles of currently available formulations of tiotropium bromide are well established. "Respiratory is a core area of focus for Glenmark as we continue to harness our heritage in generics and evolve into a specialty, innovation-focused company," said Fred Grossman D.O., President and Chief Medical Officer at Glenmark Pharmaceuticals Inc. "Moving GSP 304 into Phase 2 is a great example of that focus and, if approved, will be the first nebulized form of tiotropium bromide. This milestone further affirms our
Glenmark Pharmaceuticals, a global pharmaceutical company, has announced that the US Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to begin a Phase 2 study of GSP 304 (tiotropium bromide) for administration by nebulization for the long term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Glenmark plans to initiate clinical development with a Phase 2 study of GSP 304, a new orally administered formulation, in subjects with mild to moderate COPD, as determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The efficacy, pharmacokinetics, and safety profiles of currently available formulations of tiotropium bromide are well established. "Respiratory is a core area of focus for Glenmark as we continue to harness our heritage in generics and evolve into a specialty, innovation-focused company," said Fred Grossman D.O., President and Chief Medical Officer at Glenmark Pharmaceuticals Inc. "Moving GSP 304 into Phase 2 is a great example of that focus and, if approved, will be the first nebulized form of tiotropium bromide. This milestone further affirms our
USFDA to Lift Import Alert on Sun
Pharma's Mohali Facility
Sun Pharmaceutical Industries Ltd was informed by the US FDA, that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.
The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories Ltd. in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy's Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility. This development illustrates Sun Pharma's commitment to work closely with the US FDA and strive for 100 per cent cGMP compliance at its manufacturing facilities.
Sun Pharmaceutical Industries Ltd was informed by the US FDA, that it will lift the Import Alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal US FDA regulatory requirements.
The Mohali facility was inherited by Sun Pharma as part of its acquisition of Ranbaxy Laboratories Ltd. in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy's Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility. This development illustrates Sun Pharma's commitment to work closely with the US FDA and strive for 100 per cent cGMP compliance at its manufacturing facilities.
The Fragile X Society Creates Awareness
for Fragile X Syndrome Care
The first ever 4 city Indo - USA endeavor to create awareness for better Fragile X care in India by The Fragile X Society, India in association with UC DAVIS MIND Institute, USA; along with AIIMS, New Delhi; Institute of Genetics and Genomics, Sir Ganga Ram Hospital, New Delhi; Delhi Chapter, Indian Academy of Pediatrics; NIMHANS Bangalore; Indira Gandhi Institute of Child Health,Bangalore; Centre for Human Genetics, Bangalore; Indian Academy of Pediatrics Chapter of Neuro-developmental Pediatrics, Mumbai and New Horizons Health and Research Foundation,Mumbai; was successfully held in Delhi, Bangalore, Kolkata and Mumbai.
The Indo- USA symposium provided a never before platform to expand and develop relationships between Indian and American researchers and clinicians. It was an avenue to exchange knowledge between Indian and American professionals about the latest evidence-based treatments for Fragile X-associated Disorders. Further it also engaged the patient community to expand the reach of the Fragile X Society India.
The Fragile X Syndrome is a rare condition, which is caused by a change in a gene that is inherited at the time of conception. It causes a wide range of cognitive impairment, from mild learning disabilities to severe intellectual disabilities (ID) that can impact individuals and families in various ways. Fragile X Syndrome is the most common known cause of autism or "autistic-like" behaviors. Approximately 1 in 3,600 to 4000 among males and 1 in 4000 to 6000 among females are affected by FXS. Usually, males are more severely affected by this disorder than females. Therefore it is vital to spread awareness among the medical fraternity especially pediatricians and gynecologists' as well as parents and the couples planning to have a child, so that children with Fragile X Syndrome are detected early in life.
The first ever 4 city Indo - USA endeavor to create awareness for better Fragile X care in India by The Fragile X Society, India in association with UC DAVIS MIND Institute, USA; along with AIIMS, New Delhi; Institute of Genetics and Genomics, Sir Ganga Ram Hospital, New Delhi; Delhi Chapter, Indian Academy of Pediatrics; NIMHANS Bangalore; Indira Gandhi Institute of Child Health,Bangalore; Centre for Human Genetics, Bangalore; Indian Academy of Pediatrics Chapter of Neuro-developmental Pediatrics, Mumbai and New Horizons Health and Research Foundation,Mumbai; was successfully held in Delhi, Bangalore, Kolkata and Mumbai.
The Indo- USA symposium provided a never before platform to expand and develop relationships between Indian and American researchers and clinicians. It was an avenue to exchange knowledge between Indian and American professionals about the latest evidence-based treatments for Fragile X-associated Disorders. Further it also engaged the patient community to expand the reach of the Fragile X Society India.
The Fragile X Syndrome is a rare condition, which is caused by a change in a gene that is inherited at the time of conception. It causes a wide range of cognitive impairment, from mild learning disabilities to severe intellectual disabilities (ID) that can impact individuals and families in various ways. Fragile X Syndrome is the most common known cause of autism or "autistic-like" behaviors. Approximately 1 in 3,600 to 4000 among males and 1 in 4000 to 6000 among females are affected by FXS. Usually, males are more severely affected by this disorder than females. Therefore it is vital to spread awareness among the medical fraternity especially pediatricians and gynecologists' as well as parents and the couples planning to have a child, so that children with Fragile X Syndrome are detected early in life.
Arindam Haldar Appointed as CEO of
SRL Diagnostics
The Board of Directors of SRL Diagnostics Limited (SRL) has announced the appointment of Arindam Haldar as its new Chief Executive Officer with immediate effect. Arindam had joined SRL in October 2016 as its Chief Operating Officer.
Bringing in over two decades of experience to his role, Arindam has significant industry exposure in Sales, Marketing, M&A and business operations. Earlier he has worked with renowned global brands that includes Colgate, Pillsbury; Häagen-Dazs and Sterlite.
Commenting on the appointment, Malvinder M. Singh, Executive Chairman, SRL Diagnostics, said "The past few years have been a period of significant growth for SRL and it is critical for us to capitalize from this position of strength, to achieve our ambitious goals. I see a very promising future for the diagnostics industry in general and SRL in particular, and am confident, that Arindam with his valuable experience, drive and commitment, will take the organization to its next phase of growth".
On his elevation, Arindam Haldar said, "I thank the Board for reposing faith in me and am delighted to assume this exciting role in SRL Diagnostics. I am looking forward to working with Team SRL to deliver on our strategy for the medium and long term growth of the company"
The Board of Directors of SRL Diagnostics Limited (SRL) has announced the appointment of Arindam Haldar as its new Chief Executive Officer with immediate effect. Arindam had joined SRL in October 2016 as its Chief Operating Officer.
Bringing in over two decades of experience to his role, Arindam has significant industry exposure in Sales, Marketing, M&A and business operations. Earlier he has worked with renowned global brands that includes Colgate, Pillsbury; Häagen-Dazs and Sterlite.
Commenting on the appointment, Malvinder M. Singh, Executive Chairman, SRL Diagnostics, said "The past few years have been a period of significant growth for SRL and it is critical for us to capitalize from this position of strength, to achieve our ambitious goals. I see a very promising future for the diagnostics industry in general and SRL in particular, and am confident, that Arindam with his valuable experience, drive and commitment, will take the organization to its next phase of growth".
On his elevation, Arindam Haldar said, "I thank the Board for reposing faith in me and am delighted to assume this exciting role in SRL Diagnostics. I am looking forward to working with Team SRL to deliver on our strategy for the medium and long term growth of the company"
Innoplexus Enters Academic
Collaboration with RCC, Gwalior
Innoplexus, the technology and product development company focused on AI and advanced analytics, has announced a collaboration with Regional Cancer Centre (RCC), Gwalior. Innoplexus will provide an academic license to doctors and researchers at RCC, Gwalior, under the association, allowing them free access to its cloud-based decision support platform, iPlexusTM. With over 100+ terabytes of indexed scientific data available to them at their fingertips, researchers at RCC will be able to gain insights into the latest advancements in research and trials related to cancer and make swift, agile decisions pertinent to their R&D endeavours.
An end-to-end platform for Life Sciences which leverages artificial intelligence, iPlexusTM generates continuous intelligence and insights across discovery, clinical development, regulatory, and commercial stages of drug development spanning all major therapeutic areas and indications. This big data analytics-led approach facilitates a better way of discovering, exploring, and analyzing biomedical research, thereby enabling significant savings of time, effort, and costs for the R&D endeavours at RCC, Gwalior. Speaking on the collaboration, Dr. Gunjan Bhardwaj, Founder and Chairman, Innoplexus, said, "We are extremely delighted to announce our academic partnership with Regional Cancer Centre, Gwalior, which is in line with our vision to make access to insights real-time, comprehensive, and cost-effective. The need of the hour for medical research is to leverage machine learning, AI, and big data to generate continuous intelligence. This is what our recently launched iPlexus platform enables."
Innoplexus, the technology and product development company focused on AI and advanced analytics, has announced a collaboration with Regional Cancer Centre (RCC), Gwalior. Innoplexus will provide an academic license to doctors and researchers at RCC, Gwalior, under the association, allowing them free access to its cloud-based decision support platform, iPlexusTM. With over 100+ terabytes of indexed scientific data available to them at their fingertips, researchers at RCC will be able to gain insights into the latest advancements in research and trials related to cancer and make swift, agile decisions pertinent to their R&D endeavours.
An end-to-end platform for Life Sciences which leverages artificial intelligence, iPlexusTM generates continuous intelligence and insights across discovery, clinical development, regulatory, and commercial stages of drug development spanning all major therapeutic areas and indications. This big data analytics-led approach facilitates a better way of discovering, exploring, and analyzing biomedical research, thereby enabling significant savings of time, effort, and costs for the R&D endeavours at RCC, Gwalior. Speaking on the collaboration, Dr. Gunjan Bhardwaj, Founder and Chairman, Innoplexus, said, "We are extremely delighted to announce our academic partnership with Regional Cancer Centre, Gwalior, which is in line with our vision to make access to insights real-time, comprehensive, and cost-effective. The need of the hour for medical research is to leverage machine learning, AI, and big data to generate continuous intelligence. This is what our recently launched iPlexus platform enables."
LifeCell Launches Community Stem
Cell Banking
India's first & the largest stem cell provider, a pioneer in stem cell research, announced the launch of Baby Cord Share, Community Stem Cell banking to address the need for creating a large inventory of stem cells in the country. BabyCord Share brings together the unique benefits of private and public banks, while effectively addressing the challenges of sourcing matching stem cells in India. Community Stem Cell Banking is a first of its kind global initiative of LifeCell, which allows sharing of preserved umbilical cord stem cells amongst the community of parents. This provides larger access to donor stem cells within the community and higher probability for finding a matching donor stem cell for treatments. Community banking also helps parents and siblings in accessing stem cells from the community pool, thus providing a comprehensive family benefit for treatments.
According to statistics, individual risks of acquiring a blood or immune related conditions that are eventually treatable by stem cells is 1 in 20. 80 per cent of these conditions would require stem cells from a donor, with the remaining would require their own stem cells. Despite the large need, the transplants that are done are relatively very few, due to lack of availability of matching stem cells for treatment and prohibitive costs in sourcing matching stem cell units.
India's first & the largest stem cell provider, a pioneer in stem cell research, announced the launch of Baby Cord Share, Community Stem Cell banking to address the need for creating a large inventory of stem cells in the country. BabyCord Share brings together the unique benefits of private and public banks, while effectively addressing the challenges of sourcing matching stem cells in India. Community Stem Cell Banking is a first of its kind global initiative of LifeCell, which allows sharing of preserved umbilical cord stem cells amongst the community of parents. This provides larger access to donor stem cells within the community and higher probability for finding a matching donor stem cell for treatments. Community banking also helps parents and siblings in accessing stem cells from the community pool, thus providing a comprehensive family benefit for treatments.
According to statistics, individual risks of acquiring a blood or immune related conditions that are eventually treatable by stem cells is 1 in 20. 80 per cent of these conditions would require stem cells from a donor, with the remaining would require their own stem cells. Despite the large need, the transplants that are done are relatively very few, due to lack of availability of matching stem cells for treatment and prohibitive costs in sourcing matching stem cell units.
Xcode Partners with Medall
Xcode Life Sciences, a global genomics company, has announced its partnership with Medall, a leading provider of diagnostic testing services where the company will offer non-invasive general and targeted genetic testing packages. These include: General Tests: Predisposition to Diabetes, Obesity and Hypertension which will be complimentary to Medall's Master Health Check Targeted Tests: Nutritional genetics to screen for important mutations in genes such as FADS1 (Omega levels), MTHFR (Vitamin B12), Apolipoprotein E (Heart disease), TCF7L2 (Diabetes Type 2), MCM6 (Lactose intolerance) and HLA-DQ (Gluten Intolerance) among others.
Full gene sequencing services for specific genes are also available at affordable prices upon physician's prescription. Xcode and Medall have worked towards developing a customized genetic panel which would be a part of the Master Health package that would help in identifying genetic risk factors linked to manifestation of Diabetes, Obesity & Hypertension. Moreover, the service which generally costs more than Rs. 10,000/- in the market would be priced at less than Rs.5,000/-.
A leader in the field of diagnostic testing, Medall has built a premium brand both in rural and urban areas across 8 states; this therefore enables their technology to be easily accessible in a wide geography. Moreover, the company is known to offer high quality services that has touched the lives of over 20 million people so far; this would add further value to the partn ership.
Xcode Life Sciences, a global genomics company, has announced its partnership with Medall, a leading provider of diagnostic testing services where the company will offer non-invasive general and targeted genetic testing packages. These include: General Tests: Predisposition to Diabetes, Obesity and Hypertension which will be complimentary to Medall's Master Health Check Targeted Tests: Nutritional genetics to screen for important mutations in genes such as FADS1 (Omega levels), MTHFR (Vitamin B12), Apolipoprotein E (Heart disease), TCF7L2 (Diabetes Type 2), MCM6 (Lactose intolerance) and HLA-DQ (Gluten Intolerance) among others.
Full gene sequencing services for specific genes are also available at affordable prices upon physician's prescription. Xcode and Medall have worked towards developing a customized genetic panel which would be a part of the Master Health package that would help in identifying genetic risk factors linked to manifestation of Diabetes, Obesity & Hypertension. Moreover, the service which generally costs more than Rs. 10,000/- in the market would be priced at less than Rs.5,000/-.
A leader in the field of diagnostic testing, Medall has built a premium brand both in rural and urban areas across 8 states; this therefore enables their technology to be easily accessible in a wide geography. Moreover, the company is known to offer high quality services that has touched the lives of over 20 million people so far; this would add further value to the partn ership.
AstraZeneca Announces Results of 1st
Large Real-world Evidence Study of SGLT-2i
AstraZeneca has announced results of the first large real-world evidence study of its kind evaluating the risk of hospitalisation for heart failure and death from any cause in patients with type-2 diabetes (T2D) receiving treatment with a newer class of diabetes medicines, SGLT-2 inhibitors (SGLT-2i).
The CVD-REAL study assessed data from more than 300,000 patients across six countries, 87% of whom did not have a history of cardiovascular disease. The data showed that across this broad population of patients with T2D, treatment with SGLT-2i medicines - Farxiga (dapagliflozin), canagliflozin, empagliflozin - reduced the rate of hospitalisation for heart failure by 39% (p<0.001) and death from any cause by 51% (p<0.001), compared to other T2D medicines. For the composite endpoint of hospitalisation for heart failure and death from any cause, the reduction was 46% (p<0.001).
Dr. Anilda D'souza, Head of Medical Affairs, AstraZeneca India commented, "The newer SGLT2i class of medicines represents a significant advancement in treatment of type 2 diabetes. This real world study showed significant reduction in the rate of hospitalization and deaths associated with Cardiovascular diseases with the SGLT2i compared to other anti-diabetic agents. This data generated from a broad population of patients with type 2 diabetes exemplifies the clinical study results providing confidence to the broader physician community on the role of SGLT-2i class in diabetes care."
Worldwide, diabetes affects around 415 million adults, a number estimated to rise to 642 million by 2040 (1 in 10 adults). People with T2D have a 2-3 times greater risk of heart failure and are at an increased risk of having a heart attack or stroke, and some 50 per cent of deaths in people with T2D are caused by cardiovascular disease.
AstraZeneca has announced results of the first large real-world evidence study of its kind evaluating the risk of hospitalisation for heart failure and death from any cause in patients with type-2 diabetes (T2D) receiving treatment with a newer class of diabetes medicines, SGLT-2 inhibitors (SGLT-2i).
The CVD-REAL study assessed data from more than 300,000 patients across six countries, 87% of whom did not have a history of cardiovascular disease. The data showed that across this broad population of patients with T2D, treatment with SGLT-2i medicines - Farxiga (dapagliflozin), canagliflozin, empagliflozin - reduced the rate of hospitalisation for heart failure by 39% (p<0.001) and death from any cause by 51% (p<0.001), compared to other T2D medicines. For the composite endpoint of hospitalisation for heart failure and death from any cause, the reduction was 46% (p<0.001).
Dr. Anilda D'souza, Head of Medical Affairs, AstraZeneca India commented, "The newer SGLT2i class of medicines represents a significant advancement in treatment of type 2 diabetes. This real world study showed significant reduction in the rate of hospitalization and deaths associated with Cardiovascular diseases with the SGLT2i compared to other anti-diabetic agents. This data generated from a broad population of patients with type 2 diabetes exemplifies the clinical study results providing confidence to the broader physician community on the role of SGLT-2i class in diabetes care."
Worldwide, diabetes affects around 415 million adults, a number estimated to rise to 642 million by 2040 (1 in 10 adults). People with T2D have a 2-3 times greater risk of heart failure and are at an increased risk of having a heart attack or stroke, and some 50 per cent of deaths in people with T2D are caused by cardiovascular disease.
Dr Ajaz Hussain Appointed as Senior
Advisor, Risk Consulting, KPMG in India
KPMG in India announces the appointment of Dr. Ajaz Hussain as Senior Advisor to the firm from 1 January 2017. Changing regulations, adoption of new technologies and increasing demands across geographies around compliance have compelled KPMG in India to bring forth a proactive and continuous quality compliance programme which aims to deliver effective results. In this endeavour, Dr. Ajaz Hussain will serve as a Senior Advisor to KPMG in India.
Dr. Ajaz Hussain brings a wealth of international pharmaceutical regulatory and business experience to KPMG in India, including his decade-long tenure with the United States Food and Drug Administration (US FDA), Center for Drug Evaluation and Research (CDER). He has led some of the US Food and Drug Administration's major initiatives to develop regulatory policies that already have and are likely to continue to have a significant impact on product development and approval in many geographies. He has been honoured by US FDA on multiple occasions for his contribution and insights.
Dr. Ajaz Hussain is currently serving as the President of The National Institute for Pharmaceutical Technology and Education, a not-for-profit educational organisation which is a collaboration of 17 major universities in the U.S. Grants from US FDA primarily fund the research programmes at the institute. He also serves as an advisory to multiple pharmaceutical companies around the globe and also supports several regulatory agencies by conducting training programmes.
KPMG in India announces the appointment of Dr. Ajaz Hussain as Senior Advisor to the firm from 1 January 2017. Changing regulations, adoption of new technologies and increasing demands across geographies around compliance have compelled KPMG in India to bring forth a proactive and continuous quality compliance programme which aims to deliver effective results. In this endeavour, Dr. Ajaz Hussain will serve as a Senior Advisor to KPMG in India.
Dr. Ajaz Hussain brings a wealth of international pharmaceutical regulatory and business experience to KPMG in India, including his decade-long tenure with the United States Food and Drug Administration (US FDA), Center for Drug Evaluation and Research (CDER). He has led some of the US Food and Drug Administration's major initiatives to develop regulatory policies that already have and are likely to continue to have a significant impact on product development and approval in many geographies. He has been honoured by US FDA on multiple occasions for his contribution and insights.
Dr. Ajaz Hussain is currently serving as the President of The National Institute for Pharmaceutical Technology and Education, a not-for-profit educational organisation which is a collaboration of 17 major universities in the U.S. Grants from US FDA primarily fund the research programmes at the institute. He also serves as an advisory to multiple pharmaceutical companies around the globe and also supports several regulatory agencies by conducting training programmes.
MedGenome Launches ONCOTRACK
India is likely to have over 1.73 Million new cases of cancer and over 880,000 deaths due to the disease by 2020. Around 70 per cent of all cancer patients approach the doctor when the disease has advanced, and the chances of cure are very low
To address and better manage the disease, MedGenome - India's premier genomics based research and diagnostics company has announced the launch of "ONCOTRACK". The liquid biopsy based Oncotrack is a non-invasive screening test that is set to transform the way physicians in India can identify genetic alterations, interpret, assess and treat various forms of cancer.
"Management of cancer will undergo a massive transformation in India with NGS based liquid biopsies. We are constantly striving to get the most advanced genetic testing technology/technique at affordable prices to the patients and ONCOTRACK is one such offering.", said Sam Santhosh, Chairman, MedGenome.
The test developed entirely by MedGenome, is the only one to be validated in India and verified from samples of cancer patients from across the country. The test screens the samples by analyzing cell-free DNA that is isolated from the patients' blood. Using high end sequencing technology, the screening process identifies specific gene mutations that are linked with Melanoma, Lung and Colon cancers. The test facilitates detection of mutation where there is difficulty of obtaining biopsy or in the event of a damaged biopsy material and non-availability of tissue biopsy. This offers Oncologists the power to look for actionable alterations in a patient's treatment, management, without having to do an invasive biopsy or where biopsy is not an option.
India is likely to have over 1.73 Million new cases of cancer and over 880,000 deaths due to the disease by 2020. Around 70 per cent of all cancer patients approach the doctor when the disease has advanced, and the chances of cure are very low
To address and better manage the disease, MedGenome - India's premier genomics based research and diagnostics company has announced the launch of "ONCOTRACK". The liquid biopsy based Oncotrack is a non-invasive screening test that is set to transform the way physicians in India can identify genetic alterations, interpret, assess and treat various forms of cancer.
"Management of cancer will undergo a massive transformation in India with NGS based liquid biopsies. We are constantly striving to get the most advanced genetic testing technology/technique at affordable prices to the patients and ONCOTRACK is one such offering.", said Sam Santhosh, Chairman, MedGenome.
The test developed entirely by MedGenome, is the only one to be validated in India and verified from samples of cancer patients from across the country. The test screens the samples by analyzing cell-free DNA that is isolated from the patients' blood. Using high end sequencing technology, the screening process identifies specific gene mutations that are linked with Melanoma, Lung and Colon cancers. The test facilitates detection of mutation where there is difficulty of obtaining biopsy or in the event of a damaged biopsy material and non-availability of tissue biopsy. This offers Oncologists the power to look for actionable alterations in a patient's treatment, management, without having to do an invasive biopsy or where biopsy is not an option.
DSP and Sandoz Sign Licensing
Agreement
DSM Sinochem Pharmaceuticals (DSP) and Sandoz (a Novartis Division) have executed a definitive agreement licensing certain DSP intellectual property assets for the manufacture of beta lactam antibiotics.
The license agreement provides Sandoz a non-exclusive, worldwide license to certain patents including, inter alia, U.S. 8,541,199 B2 and EP 1,610,766 B1, granting freedom to operate to develop and commercialize its various beta lactam products and allows for the production of new enzymes for the sustainable manufacture of amoxicillin.
Karl Rotthier, CEO of DSP stated: "DSP is pleased to have Sandoz as a licensee of our innovative, sustainable and environmentally friendly amoxicillin manufacturing technology. As part of our commitment to fight antimicrobial resistance through minimizing the environmental impact from antibiotics manufacturing, DSP is actively seeking to promote green, enzymatic routes for production of amoxicillin and other antibiotics, utilizing our patented technology. This license agreement further validates the strength of DSP's intellectual property portfolio regarding enzymatically produced antimicrobials."
The commitment to reduce environmental impact from the production of antibioticsis also laid out in the Industry Roadmap for Progress on Combating Antimicrobial Resistance, signed by DSP, Novartis and 11 other leading pharmaceutical companies at the United Nations General Assembly in New York in September 2016.
DSM Sinochem Pharmaceuticals (DSP) and Sandoz (a Novartis Division) have executed a definitive agreement licensing certain DSP intellectual property assets for the manufacture of beta lactam antibiotics.
The license agreement provides Sandoz a non-exclusive, worldwide license to certain patents including, inter alia, U.S. 8,541,199 B2 and EP 1,610,766 B1, granting freedom to operate to develop and commercialize its various beta lactam products and allows for the production of new enzymes for the sustainable manufacture of amoxicillin.
Karl Rotthier, CEO of DSP stated: "DSP is pleased to have Sandoz as a licensee of our innovative, sustainable and environmentally friendly amoxicillin manufacturing technology. As part of our commitment to fight antimicrobial resistance through minimizing the environmental impact from antibiotics manufacturing, DSP is actively seeking to promote green, enzymatic routes for production of amoxicillin and other antibiotics, utilizing our patented technology. This license agreement further validates the strength of DSP's intellectual property portfolio regarding enzymatically produced antimicrobials."
The commitment to reduce environmental impact from the production of antibioticsis also laid out in the Industry Roadmap for Progress on Combating Antimicrobial Resistance, signed by DSP, Novartis and 11 other leading pharmaceutical companies at the United Nations General Assembly in New York in September 2016.
Jubilant Gets Responsible Care
14001:2013 Certification
Jubilant Life Sciences, an integrated global pharmaceuticals and life sciences company, receives 'Responsible Care 14001:2013 certification' under the American Chemistry Council's (ACC) Responsible Care program® for its Corporate Office in Noida and for its manufacturing Unit in Gajraula. Awarded to the Life Science Ingredients business, the certification is a demonstration of Jubilant's continued commitment towards sustainable business operations.
Jubilant Life Sciences was presented with the certification for its robust management system that ensures highest standards of health, safety, security and environmental performance for both its products and operations. Jubilant Life Sciences is one of the very few companies in India to achieve the certification, the distinction is an evidence of company's exemplary business practices and good corporate governance.
Jubilant Life Sciences, an integrated global pharmaceuticals and life sciences company, receives 'Responsible Care 14001:2013 certification' under the American Chemistry Council's (ACC) Responsible Care program® for its Corporate Office in Noida and for its manufacturing Unit in Gajraula. Awarded to the Life Science Ingredients business, the certification is a demonstration of Jubilant's continued commitment towards sustainable business operations.
Jubilant Life Sciences was presented with the certification for its robust management system that ensures highest standards of health, safety, security and environmental performance for both its products and operations. Jubilant Life Sciences is one of the very few companies in India to achieve the certification, the distinction is an evidence of company's exemplary business practices and good corporate governance.
GNH India Accredited with SGS
Certification
GNH India is rewarded with a certification by SGS for WHO (World health Organisation) GSDP (Good storage and distribution practise) in India. Currently shipping to over 180 countries globally, GNH India will now be able to expand its reach to institutional customers such as WHO, UN agencies globally and International tenders of Ministry of health of foreign countries.
SGS is a globally recognized leader in certifications in the pharmaceutical sector. GSDP is an internationally accepted quality system for warehouse and distribution centers in the pharmaceutical industry. The GSDP certification ensures that consistent quality management systems are in place throughout the entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. Companies are eligible for this certification post a thorough analysis of their processes and policies, conducted by highlyqualified auditors.Sharing his happiness, Dr. Piyush Gupta, Associate Director - GNH India, said "We have always maintained the quality standards in the services offered to our clients. The certification by SGS further justifies our commitment to service our clients with the required quality, safety and efficacy of the products. We are glad to receive this certification in our first attempt and we assure to continue to enrich the service experience of our customers."
GNH India has various others compliances such as Voluntary compliance of US FCPA and UK Anti Bribery laws, US GAAP accounting standards, Indian FEMA (Foreign Exchange Management Act) and many such others. The company has over 135,000 product lines to offer Hospitals, Ministries, Importers, Wholesalers, Pharmacists, Doctors, and others in the field of pharma.
GNH India is rewarded with a certification by SGS for WHO (World health Organisation) GSDP (Good storage and distribution practise) in India. Currently shipping to over 180 countries globally, GNH India will now be able to expand its reach to institutional customers such as WHO, UN agencies globally and International tenders of Ministry of health of foreign countries.
SGS is a globally recognized leader in certifications in the pharmaceutical sector. GSDP is an internationally accepted quality system for warehouse and distribution centers in the pharmaceutical industry. The GSDP certification ensures that consistent quality management systems are in place throughout the entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. Companies are eligible for this certification post a thorough analysis of their processes and policies, conducted by highlyqualified auditors.Sharing his happiness, Dr. Piyush Gupta, Associate Director - GNH India, said "We have always maintained the quality standards in the services offered to our clients. The certification by SGS further justifies our commitment to service our clients with the required quality, safety and efficacy of the products. We are glad to receive this certification in our first attempt and we assure to continue to enrich the service experience of our customers."
GNH India has various others compliances such as Voluntary compliance of US FCPA and UK Anti Bribery laws, US GAAP accounting standards, Indian FEMA (Foreign Exchange Management Act) and many such others. The company has over 135,000 product lines to offer Hospitals, Ministries, Importers, Wholesalers, Pharmacists, Doctors, and others in the field of pharma.
Piramal Acquires Spasticity and Pain
Management Drugs from Mallinckrodt
Piramal Enterprises Limited's wholly owned Critical Care subsidiary in the UK has entered into an agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC in an all cash deal for a consideration of USD 171 million and up to an additional USD 32 million payable depending on financial performance of the acquired assets over the next 3 years.
The portfolio acquired includes Gablofen (baclofen), a severe spasticity management product, which is currently marketed in the United States, and two pain management products, which are currently under development. Gablofen has also been approved for launch in 8 European markets. Gablofen is the only intrathecal baclofen drug available in vials and pre-filled syringes, which are preferred by users over the competing products available in ampoules. The pain management drugs under development are also for intrathecal administration. In the twelve months ending September 30, 2016, the acquired portfolio generated revenues of USD 44.6 million.
Piramal Enterprises Limited's wholly owned Critical Care subsidiary in the UK has entered into an agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC in an all cash deal for a consideration of USD 171 million and up to an additional USD 32 million payable depending on financial performance of the acquired assets over the next 3 years.
The portfolio acquired includes Gablofen (baclofen), a severe spasticity management product, which is currently marketed in the United States, and two pain management products, which are currently under development. Gablofen has also been approved for launch in 8 European markets. Gablofen is the only intrathecal baclofen drug available in vials and pre-filled syringes, which are preferred by users over the competing products available in ampoules. The pain management drugs under development are also for intrathecal administration. In the twelve months ending September 30, 2016, the acquired portfolio generated revenues of USD 44.6 million.
VAV Life Sciences Launches India's
First Phospholipid Manufacturing Plant
One of the top phospholipid manufacturers, VAV Life Sciences inaugurated its cGMP compliant Phospholipid manufacturing plant in Mirjole, Ratnagiri, Maharashtra. The plant is set up in India considering the emerging healthcare applications of lecithins & phospholipids in functional foods, nutritional supplements, novel pharmaceuticals and cosmetics. With the plant, the company will mark products manufactured at the factory with a 'Made in India' label and will export 80 per cent of them to North America, Europe, Asia and ROW region.
The existing brands manufactured include LECIVA, LIPOVA, OLEOVA. The first phase of the plant is spread across 30,000 sq.ft. with EU cGMP standard facilities. The facility utilises state-of-the-art technology, which allows the production of its all-natural higher grade of phospholipids ingredient in accordance with the global industry standards. Most phospholipids are derived from nature, hence classified as GRAS (Generally Recognised as Safe) by US FDA. Through the plant, VAV will be building distinct production lines for refined soya, egg and synthetic Phospholipids. Ratnagiri location was the first choice to set up this plant due to its excellent infrastructure facilities, conducive business environment, suitable weather conditions and quality trained manpower
One of the top phospholipid manufacturers, VAV Life Sciences inaugurated its cGMP compliant Phospholipid manufacturing plant in Mirjole, Ratnagiri, Maharashtra. The plant is set up in India considering the emerging healthcare applications of lecithins & phospholipids in functional foods, nutritional supplements, novel pharmaceuticals and cosmetics. With the plant, the company will mark products manufactured at the factory with a 'Made in India' label and will export 80 per cent of them to North America, Europe, Asia and ROW region.
The existing brands manufactured include LECIVA, LIPOVA, OLEOVA. The first phase of the plant is spread across 30,000 sq.ft. with EU cGMP standard facilities. The facility utilises state-of-the-art technology, which allows the production of its all-natural higher grade of phospholipids ingredient in accordance with the global industry standards. Most phospholipids are derived from nature, hence classified as GRAS (Generally Recognised as Safe) by US FDA. Through the plant, VAV will be building distinct production lines for refined soya, egg and synthetic Phospholipids. Ratnagiri location was the first choice to set up this plant due to its excellent infrastructure facilities, conducive business environment, suitable weather conditions and quality trained manpower
Protagen AG Join Forces with the US
National Cancer Institute
Protagen AG has executed a Material Transfer Agreement with the National Cancer Institute (NCI) under which the parties will utilize Protagens SeroTag immune system profiling technology to identify biomarkers that predict therapy responsiveness, to monitor patients receiving immunotherapies, and for early detection of immune-related adverse events (irAEs). This collaboration with NCI will be led by Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the NCI's Center for Cancer Research. Protagen AG is a provider of pharma development services and novel companion diagnostic tests in the fields of immuno-oncology and autoimmune disease. NCI is part of the National Institutes of Health.
While targeted immunotherapies such as therapeutic vaccination and checkpoint inhibition hold great promise for treating cancer, they currently work effectively on a small subset of patients. In addition, as these therapies stimulate the immune system to target the body's own cells, they can also trigger immune-related Adverse Events (irAEs) and even the onset of autoimmune diseases. Through this collaboration, Protagen and NCI intend to provide valuable insight into utilizing immune system profiling to predict response, monitor patients and for detection of immune-related adverse events.
Protagen AG has executed a Material Transfer Agreement with the National Cancer Institute (NCI) under which the parties will utilize Protagens SeroTag immune system profiling technology to identify biomarkers that predict therapy responsiveness, to monitor patients receiving immunotherapies, and for early detection of immune-related adverse events (irAEs). This collaboration with NCI will be led by Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the NCI's Center for Cancer Research. Protagen AG is a provider of pharma development services and novel companion diagnostic tests in the fields of immuno-oncology and autoimmune disease. NCI is part of the National Institutes of Health.
While targeted immunotherapies such as therapeutic vaccination and checkpoint inhibition hold great promise for treating cancer, they currently work effectively on a small subset of patients. In addition, as these therapies stimulate the immune system to target the body's own cells, they can also trigger immune-related Adverse Events (irAEs) and even the onset of autoimmune diseases. Through this collaboration, Protagen and NCI intend to provide valuable insight into utilizing immune system profiling to predict response, monitor patients and for detection of immune-related adverse events.
Need to Build Global Confidence & Trust
in Clinical Research in India
Given all the recent changes in the regulatory environment in the recent past and the regulators' commitment to a creating a favourable clinical research environment in India, there is now a strong need to rebuild global confidence and trust in doing clinical research in India. This was the unanimous opinion of industry panelists in the concluding session on Does India Feature in Discussions on Global Clinical Study Placements at the 10th Annual ISCR (Indian Society for Clinical Research) Conference. While on one hand, data of global inspections validates the high quality of clinical research being done in India, the clinical research environment is weighed down by negative perceptions of quality and therefore stakeholders need to take a more proactive approach to quality management, they said.
Speaking on the occasion, Suneela Thatte, President, ISCR said, "It is a key responsibility of each one of us to renew our pledge to quality, patient safety and data integrity and set an example to the rest of the world as to how quality and ethics are not mere tokenism but truly reflect the spirit of the clinical research community in India. When this happens only then will we be able to bridge the gap between India's potential in the field of clinical research and the actual clinical research being conducted in India at the moment and the gap between perception and reality. We at ISCR would like to reiterate our commitment to continue to engage with all our stakeholder and work towards the creation of a clinical research ecosystem that balances the interests of all stakeholders - particularly the patients."
Among the highlights of the concluding day was a panel on Research in Rare Diseases which had not for profit organisations, patients, medical and legal professionals talk about the needs of rare disease patients in India and what needs to be done to ensure access to research and early intervention for rare diseases. "Rare diseases are not so rare. If we were to put together the entire population of rare disease patients in the world, it would be the third most populous country," said Prasanna Shirol, Founder Member, Organisation for Rare Diseases India.
Given all the recent changes in the regulatory environment in the recent past and the regulators' commitment to a creating a favourable clinical research environment in India, there is now a strong need to rebuild global confidence and trust in doing clinical research in India. This was the unanimous opinion of industry panelists in the concluding session on Does India Feature in Discussions on Global Clinical Study Placements at the 10th Annual ISCR (Indian Society for Clinical Research) Conference. While on one hand, data of global inspections validates the high quality of clinical research being done in India, the clinical research environment is weighed down by negative perceptions of quality and therefore stakeholders need to take a more proactive approach to quality management, they said.
Speaking on the occasion, Suneela Thatte, President, ISCR said, "It is a key responsibility of each one of us to renew our pledge to quality, patient safety and data integrity and set an example to the rest of the world as to how quality and ethics are not mere tokenism but truly reflect the spirit of the clinical research community in India. When this happens only then will we be able to bridge the gap between India's potential in the field of clinical research and the actual clinical research being conducted in India at the moment and the gap between perception and reality. We at ISCR would like to reiterate our commitment to continue to engage with all our stakeholder and work towards the creation of a clinical research ecosystem that balances the interests of all stakeholders - particularly the patients."
Among the highlights of the concluding day was a panel on Research in Rare Diseases which had not for profit organisations, patients, medical and legal professionals talk about the needs of rare disease patients in India and what needs to be done to ensure access to research and early intervention for rare diseases. "Rare diseases are not so rare. If we were to put together the entire population of rare disease patients in the world, it would be the third most populous country," said Prasanna Shirol, Founder Member, Organisation for Rare Diseases India.
Chemtura Shareholders Approve
Acquisition by LANXESS
Specialty Chemicals Company LANXESS has taken a significant step forward in the planned acquisition of U.S. chemical company Chemtura. Chemtura's shareholders approved the merger at a special meeting in Philadelphia, United States. 99.88 per cent of the votes cast were in favor of the merger, representing 81.77 percent of Chemtura's outstanding common stock. Under the terms of the merger agreement, Chemtura shareholders will receive USD 33.50 for each outstanding share in cash at closing of the transaction.
Matthias Zachert, Chairman of the Board of Management of LANXESS AG, welcomed the vote approving the merger taken at the shareholders' meeting. "We are pleased that Chemtura's shareholders are so supportive of the planned acquisition. Their approval is an important milestone on LANXESS's route to becoming one of the major players in the field of additives chemistry."
Clearance for the acquisition from the U.S. antitrust authorities was already received at the end of December 2016. LANXESS expects to close the transaction in mid-2017 after all remaining regulatory approvals have been received.
Flame retardant and lubricant additives are the main pillars of Chemtura's business and would complement the current LANXESS portfolio. After closing of the transaction, these two business activities are to be integrated with LANXESS's Rhein Chemie Additives business unit to form a new segment. Today, Rhein Chemie Additives already supplies a broad range of special additives and service products for the manufacture of plastics, rubber, lubricants and coatings. It employs some 1,600 people at more than 20 sites around the world.
Specialty Chemicals Company LANXESS has taken a significant step forward in the planned acquisition of U.S. chemical company Chemtura. Chemtura's shareholders approved the merger at a special meeting in Philadelphia, United States. 99.88 per cent of the votes cast were in favor of the merger, representing 81.77 percent of Chemtura's outstanding common stock. Under the terms of the merger agreement, Chemtura shareholders will receive USD 33.50 for each outstanding share in cash at closing of the transaction.
Matthias Zachert, Chairman of the Board of Management of LANXESS AG, welcomed the vote approving the merger taken at the shareholders' meeting. "We are pleased that Chemtura's shareholders are so supportive of the planned acquisition. Their approval is an important milestone on LANXESS's route to becoming one of the major players in the field of additives chemistry."
Clearance for the acquisition from the U.S. antitrust authorities was already received at the end of December 2016. LANXESS expects to close the transaction in mid-2017 after all remaining regulatory approvals have been received.
Flame retardant and lubricant additives are the main pillars of Chemtura's business and would complement the current LANXESS portfolio. After closing of the transaction, these two business activities are to be integrated with LANXESS's Rhein Chemie Additives business unit to form a new segment. Today, Rhein Chemie Additives already supplies a broad range of special additives and service products for the manufacture of plastics, rubber, lubricants and coatings. It employs some 1,600 people at more than 20 sites around the world.
NSF & IDMA Offer Pharmaceutical
Quality Management Education
NSF International, a global public health and safety organization, is partnering with the Indian Drug Manufacturers' Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education program in Bangalore, India. Pharmaceutical industry professionals who complete the graduate-level, advanced education program will earn an internationally recognised certification in GMP compliance from NSF International and IDMA.
The Advanced Program in Pharmaceutical Quality Management consists of five modules, each lasting four days. With the modules taught every other month, the program can be completed in 10 months. Classes will be offered at Acharya College in Bangalore with a planned start in September 2017.
Pre-registration information sessions will be held in Bangalore, Hyderabad and Mumbai during the week of 12 February, 2017. The information sessions will be led by S.V. Veerramani, National President of IDMA, S.M Mudda, Chairman of the IDMA Regulatory Affairs Committee & Program Coordinator, and program tutor Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. The event in Hyderabad is sponsored by the Pharmaceutical Export Promotion Council and organized by the Ministry of Commerce and Industry, Government of India.
India has the highest number of GMP-approved manufacturing plants outside the United States and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. According to a report by Deloitte, 64 per cent of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth.
NSF International, a global public health and safety organization, is partnering with the Indian Drug Manufacturers' Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education program in Bangalore, India. Pharmaceutical industry professionals who complete the graduate-level, advanced education program will earn an internationally recognised certification in GMP compliance from NSF International and IDMA.
The Advanced Program in Pharmaceutical Quality Management consists of five modules, each lasting four days. With the modules taught every other month, the program can be completed in 10 months. Classes will be offered at Acharya College in Bangalore with a planned start in September 2017.
Pre-registration information sessions will be held in Bangalore, Hyderabad and Mumbai during the week of 12 February, 2017. The information sessions will be led by S.V. Veerramani, National President of IDMA, S.M Mudda, Chairman of the IDMA Regulatory Affairs Committee & Program Coordinator, and program tutor Martin Lush, Global Vice President of Pharma Biotech and Medical Devices for NSF International. The event in Hyderabad is sponsored by the Pharmaceutical Export Promotion Council and organized by the Ministry of Commerce and Industry, Government of India.
India has the highest number of GMP-approved manufacturing plants outside the United States and Europe. As global regulatory requirements become more rigorous, GMP compliance education is becoming a prime focus for the pharmaceutical industry. According to a report by Deloitte, 64 per cent of pharmaceutical companies in India say a shortage of skilled staff is curtailing their compliance ability and growth.
T-Hub Collaborates with NHPL
T-Hub, India's fastest growing start-up engine, catalyzing innovation, scale and deal flow has signed a Memorandum of Understanding (MoU) with pharmaceutical major Novartis Healthcare Private Ltd (NHPL) to create and execute joint programs that would benefit Health Tech startups from across segments.
Being leaders in healthcare, Novartis will be working together with T-Hub to develop plans and programs that will help health tech, healthcare and pharmaceutical startups to scale and grow. As a part of the initiatives health, research and development experts from Novartis will mentor and guide startups, in compliance with T-Hub's mentorship framework and evaluation process, in their respective ventures. The MoU will help foster a close relationship in these areas while contributing towards the building of a thriving ecosystem in Hyderabad. Headquartered in Basel, Switzerland, Novartis has a significant footprint in India with a strong base in Hyderabad through its Global Drug Development and Business Services Center.
Speaking about the partnership, Jay Krishnan, CEO, T-Hub said, "We are very excited to collaborate with Novartis, a world class leader in healthcare. Novartis will bring great value to the ecosystem and HealthTech startups will be greatly benefited. With HealthTech being one of our prime sectors, we are working towards ensuring that startups associated with T-Hub are well mentored and guided through various programs of ours, which will help them scale their business faster."
Subodh Deshmukh, Global Drug Development India Head, Novartis said, "As a global leader in biomedical innovation, we are excited about this potential partnership with T-Hub and its allied startups driving innovation in the healthcare space."
T-Hub, India's fastest growing start-up engine, catalyzing innovation, scale and deal flow has signed a Memorandum of Understanding (MoU) with pharmaceutical major Novartis Healthcare Private Ltd (NHPL) to create and execute joint programs that would benefit Health Tech startups from across segments.
Being leaders in healthcare, Novartis will be working together with T-Hub to develop plans and programs that will help health tech, healthcare and pharmaceutical startups to scale and grow. As a part of the initiatives health, research and development experts from Novartis will mentor and guide startups, in compliance with T-Hub's mentorship framework and evaluation process, in their respective ventures. The MoU will help foster a close relationship in these areas while contributing towards the building of a thriving ecosystem in Hyderabad. Headquartered in Basel, Switzerland, Novartis has a significant footprint in India with a strong base in Hyderabad through its Global Drug Development and Business Services Center.
Speaking about the partnership, Jay Krishnan, CEO, T-Hub said, "We are very excited to collaborate with Novartis, a world class leader in healthcare. Novartis will bring great value to the ecosystem and HealthTech startups will be greatly benefited. With HealthTech being one of our prime sectors, we are working towards ensuring that startups associated with T-Hub are well mentored and guided through various programs of ours, which will help them scale their business faster."
Subodh Deshmukh, Global Drug Development India Head, Novartis said, "As a global leader in biomedical innovation, we are excited about this potential partnership with T-Hub and its allied startups driving innovation in the healthcare space."
Vyome Announces Top-line Results
from Phase 1 Study of VB-1953
Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, has announced top-line data from its phase 1 clinical trial evaluating VB-1953, a topically administered gel designed to treat patients with moderate to severe acne. VB- 1953 exhibited a promising dermal safety signal, was generally well tolerated and showed the potential to treat moderate to severe acne.
According to a preliminary analysis of the data from 12 patients, VB- 1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability. Also, in addition to demonstrating safety in this 12-patient study, treatment with VB-1953 resulted in a reduction of inflammatory and non-inflammatory lesions and in IGA scores, compared to baseline, suggested a potential efficacy signal in these moderate to severe acne patients.
"VB-1953 was generally well tolerated with a good dermal safety signal and the early parameters of efficacy were encouraging after only a short duration of treatment," said study investigator Neal Bhatia, MD, of Therapeutics Clinical Research in San Diego, CA. "Based on these results, VB-1953 appears to demonstrate the potential to be a promising new treatment as further development continues."
"These data are encouraging for patients with moderate to severe acne, especially the one-third of whom do not respond to available treatment options due to microbial resistance. With a promising dermal safety signal, and potential anti-acne and anti-inflammatory activity, VB-1953 has the potential to fill this gap in acne treatment," said Venkateswarlu Nelabhotla (N. Venkat), co-founder and chief executive officer of Vyome Biosciences.
Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, has announced top-line data from its phase 1 clinical trial evaluating VB-1953, a topically administered gel designed to treat patients with moderate to severe acne. VB- 1953 exhibited a promising dermal safety signal, was generally well tolerated and showed the potential to treat moderate to severe acne.
According to a preliminary analysis of the data from 12 patients, VB- 1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability. Also, in addition to demonstrating safety in this 12-patient study, treatment with VB-1953 resulted in a reduction of inflammatory and non-inflammatory lesions and in IGA scores, compared to baseline, suggested a potential efficacy signal in these moderate to severe acne patients.
"VB-1953 was generally well tolerated with a good dermal safety signal and the early parameters of efficacy were encouraging after only a short duration of treatment," said study investigator Neal Bhatia, MD, of Therapeutics Clinical Research in San Diego, CA. "Based on these results, VB-1953 appears to demonstrate the potential to be a promising new treatment as further development continues."
"These data are encouraging for patients with moderate to severe acne, especially the one-third of whom do not respond to available treatment options due to microbial resistance. With a promising dermal safety signal, and potential anti-acne and anti-inflammatory activity, VB-1953 has the potential to fill this gap in acne treatment," said Venkateswarlu Nelabhotla (N. Venkat), co-founder and chief executive officer of Vyome Biosciences.
Agilent Technologies Extends
Collaboration on Reproductive Genetics
Agilent Technologies is extending its collaboration with the Centre for Human Genetics of the University of Leuven and the University Hospital of Leuven in Belgium. Joris Vermeesch, chair of the Centre for Human Genetics and a leading expert in human genetics, will coordinate the collaboration.
The earlier collaboration preceded the commercial launch of Agilent's OneSight software platform, which helps researchers visualize and explore chromosomal and sub-chromosomal aneuploidies in cell-free DNA sequencing data. Over the past few years, interest in cell-free DNA analysis has strongly increased, not only because it can be used to perform non-invasive prenatal testing, but also because cfDNA can be found in liquid biopsies from cancer patients. In addition, recent evidence suggests that cfDNA can be found in an embryo's blastocoel fluid and culture medium and used for preimplantation genetic screening.
The two teams are also investigating comprehensive solutions for preimplantation genetic testing, which could enable labs to use a single sequencing workflow to perform preimplantation genetic diagnoses for single gene disorders and translocation carriers as well as PGS for chromosomal abnormalities on the same embryo biopsy. The PGT development efforts are also supported by a grant from the Flemish government.
The collaborators estimate that a commercial solution for PGT analysis could be ready as early as this year, followed by a more extensive evaluation of the clinical utility of the PGT solution to discriminate between mitotic and meiotic aneuploidies and detect triploidy and uniparental isodisomy in embryo biopsies. These chromosomal abnormalities cannot be accurately detected by the currently available commercial solutions for PGS. It is the ultimate goal to enable the IVF community to reduce the number of IVF cycles and time that are needed to achieve a healthy live birth. If confirmed, the reduction in cost and time might then be the main drivers to obtain reimbursement with the corresponding authorities.
Agilent Technologies is extending its collaboration with the Centre for Human Genetics of the University of Leuven and the University Hospital of Leuven in Belgium. Joris Vermeesch, chair of the Centre for Human Genetics and a leading expert in human genetics, will coordinate the collaboration.
The earlier collaboration preceded the commercial launch of Agilent's OneSight software platform, which helps researchers visualize and explore chromosomal and sub-chromosomal aneuploidies in cell-free DNA sequencing data. Over the past few years, interest in cell-free DNA analysis has strongly increased, not only because it can be used to perform non-invasive prenatal testing, but also because cfDNA can be found in liquid biopsies from cancer patients. In addition, recent evidence suggests that cfDNA can be found in an embryo's blastocoel fluid and culture medium and used for preimplantation genetic screening.
The two teams are also investigating comprehensive solutions for preimplantation genetic testing, which could enable labs to use a single sequencing workflow to perform preimplantation genetic diagnoses for single gene disorders and translocation carriers as well as PGS for chromosomal abnormalities on the same embryo biopsy. The PGT development efforts are also supported by a grant from the Flemish government.
The collaborators estimate that a commercial solution for PGT analysis could be ready as early as this year, followed by a more extensive evaluation of the clinical utility of the PGT solution to discriminate between mitotic and meiotic aneuploidies and detect triploidy and uniparental isodisomy in embryo biopsies. These chromosomal abnormalities cannot be accurately detected by the currently available commercial solutions for PGS. It is the ultimate goal to enable the IVF community to reduce the number of IVF cycles and time that are needed to achieve a healthy live birth. If confirmed, the reduction in cost and time might then be the main drivers to obtain reimbursement with the corresponding authorities.
Jubilant Increases Price for Beta Picoline,
3-Cyanopyridine and Vitamin B3
Jubilant Life Sciences, a global leader in the pyridine, picolines and nutrition industry, announces a price increase of up to 15 per cent for its Beta Picoline, 3-Cyanopyridine and Vitamin B3 (Niacin & Niacinamide) with immediate effect, for non-contract customers and wherever existing contracts permit.
Jubilant Life Sciences, a global leader in the pyridine, picolines and nutrition industry, announces a price increase of up to 15 per cent for its Beta Picoline, 3-Cyanopyridine and Vitamin B3 (Niacin & Niacinamide) with immediate effect, for non-contract customers and wherever existing contracts permit.
BioAsia 2017 to Bring Together Global
Pharma Powerhouses
BioAsia, the annual flagship event of the Government of Telangana has over the years emerged as a preeminent technology and bio-business convention in Asia for Life sciences, pharmaceuticals and healthcare. Organized by the Department of Industries and Commerce, Government of Telangana today announced that the 14th Edition of BioAsia will bring together eminent industry leaders from across the globe. Demonstrating its dominant position, the event scheduled for February 6 - 8, 2017 is all set to bring together some of the most influential global corporate leaders to Hyderabad - the life sciences hub of India. BioAsia 2017 is expected to have participation of 1,500 delegates from 50 countries with 100 High profile speakers and 800 Corporates.
The 14th edition of the event, which is all set to be the biggest gathering, will have the likes Dr. Paul Stoffels, Worldwide Chairman of Pharmaceuticals and Chief Scientific Officer - Johnson & Johnson, Mr Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis, Dr. Patrick Vallance, President Worldwide Pharmaceuticals, R&D - GSK, among many others.
With combined revenues, of the three companies, of about USD 170 Billion, Johnson and Johnson and Novartis are listed as top two pharmaceutical companies in the world. While Dr Paul Stoffels is recognized globally as the champion of innovation and drug development as he led the development of a number of leading products for the treatment of HIV, Vasant Narasimhan has been listed in the prestigious Fortune's '40 Under 40' 2015. Dr Patrick Vallance is the person driving GSK's efforts to combat antibiotic resistance.
BioAsia, the annual flagship event of the Government of Telangana has over the years emerged as a preeminent technology and bio-business convention in Asia for Life sciences, pharmaceuticals and healthcare. Organized by the Department of Industries and Commerce, Government of Telangana today announced that the 14th Edition of BioAsia will bring together eminent industry leaders from across the globe. Demonstrating its dominant position, the event scheduled for February 6 - 8, 2017 is all set to bring together some of the most influential global corporate leaders to Hyderabad - the life sciences hub of India. BioAsia 2017 is expected to have participation of 1,500 delegates from 50 countries with 100 High profile speakers and 800 Corporates.
The 14th edition of the event, which is all set to be the biggest gathering, will have the likes Dr. Paul Stoffels, Worldwide Chairman of Pharmaceuticals and Chief Scientific Officer - Johnson & Johnson, Mr Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis, Dr. Patrick Vallance, President Worldwide Pharmaceuticals, R&D - GSK, among many others.
With combined revenues, of the three companies, of about USD 170 Billion, Johnson and Johnson and Novartis are listed as top two pharmaceutical companies in the world. While Dr Paul Stoffels is recognized globally as the champion of innovation and drug development as he led the development of a number of leading products for the treatment of HIV, Vasant Narasimhan has been listed in the prestigious Fortune's '40 Under 40' 2015. Dr Patrick Vallance is the person driving GSK's efforts to combat antibiotic resistance.
Protagen AG, Novartis Join Forces
PROTAGEN AG, a leading provider of pharma development services, novel diagnostic tests and companion diagnostics in the fields of immuno-oncology and autoimmune disease, today announced the successful completion a collaboration agreement with Novartis Pharma AG. During the collaboration, Protagen utilized its proprietary SeroTag technology to discover prediction as well as patient stratification markers for a novel drug being developed by Novartis.
Protagen CBO Georg Lautscham commented: "Our innovative SeroTag technology has proven on numerous occasions that it can monitor the immune-health status of patients, thereby allowing for the first time the systematic determination of response prediction and disease as well as patient stratification markers to select the most appropriate drug and therapy in autoimmune indications. This was evaluated in our collaboration with Novartis and we would like to thank Novartis' R&D team for the excellent, productive and collaborative relationship."
PROTAGEN AG, a leading provider of pharma development services, novel diagnostic tests and companion diagnostics in the fields of immuno-oncology and autoimmune disease, today announced the successful completion a collaboration agreement with Novartis Pharma AG. During the collaboration, Protagen utilized its proprietary SeroTag technology to discover prediction as well as patient stratification markers for a novel drug being developed by Novartis.
Protagen CBO Georg Lautscham commented: "Our innovative SeroTag technology has proven on numerous occasions that it can monitor the immune-health status of patients, thereby allowing for the first time the systematic determination of response prediction and disease as well as patient stratification markers to select the most appropriate drug and therapy in autoimmune indications. This was evaluated in our collaboration with Novartis and we would like to thank Novartis' R&D team for the excellent, productive and collaborative relationship."
Honeywell and Aereon to Leverage IIoT
for Oil and Gas
Honeywell and Aereon has announced they will collaborate on solutions to help industrial customers boost the safety, efficiency and reliability of their operations by leveraging Honeywell's Industrial Internet of Things (IIoT) ecosystem.
"For years, manufacturers and producers have looked for ways to solve operational problems that were believed to be unsolvable - such as unplanned downtime, underperforming assets and inefficient supply chains," said Andrew Hird, vice president and general manager of Honeywell Process Solutions' Digital Transformation business. "With the capabilities of the IIoT, we can find new ways to solve those problems. A key part is the creation of an industrial ecosystem that leverages the depth of knowledge and experience of a range of equipment and service providers such as Aereon."
The Inspire ecosystem is a key part of Honeywell's Connected Plant initiative that helps manufacturers leverage the IIoT to improve the safety, efficiency and reliability of operations across a single plant or several plants across an enterprise.
Aereon is widely recognized for its innovative air emissions solutions for the complete oil and gas sector, from the wellhead to the gas station. It offers products for flare systems, enclosed combustion systems, high efficiency thermal oxidizers and vapor/gas recovery units. Honeywell and its ecosystem partners are building a simple-to-use infrastructure that gives customers secure methods to capture and aggregate data, and apply advanced analytics. This infrastructure leverages domain knowledge from a vast and unique ecosystem of leading equipment vendors and process licensors, and allows customers to use this information to determine methods to reduce or even eliminate manufacturing upsets and inefficiencies.
With a larger, consolidated data set, manufacturers and producers can apply higher analytics for more detailed insight, scale the data as needed to meet the varied needs of single-site or enterprise-wide operations, and leverage a wider pool of data experts for monitoring and analysis.
Honeywell and Aereon has announced they will collaborate on solutions to help industrial customers boost the safety, efficiency and reliability of their operations by leveraging Honeywell's Industrial Internet of Things (IIoT) ecosystem.
"For years, manufacturers and producers have looked for ways to solve operational problems that were believed to be unsolvable - such as unplanned downtime, underperforming assets and inefficient supply chains," said Andrew Hird, vice president and general manager of Honeywell Process Solutions' Digital Transformation business. "With the capabilities of the IIoT, we can find new ways to solve those problems. A key part is the creation of an industrial ecosystem that leverages the depth of knowledge and experience of a range of equipment and service providers such as Aereon."
The Inspire ecosystem is a key part of Honeywell's Connected Plant initiative that helps manufacturers leverage the IIoT to improve the safety, efficiency and reliability of operations across a single plant or several plants across an enterprise.
Aereon is widely recognized for its innovative air emissions solutions for the complete oil and gas sector, from the wellhead to the gas station. It offers products for flare systems, enclosed combustion systems, high efficiency thermal oxidizers and vapor/gas recovery units. Honeywell and its ecosystem partners are building a simple-to-use infrastructure that gives customers secure methods to capture and aggregate data, and apply advanced analytics. This infrastructure leverages domain knowledge from a vast and unique ecosystem of leading equipment vendors and process licensors, and allows customers to use this information to determine methods to reduce or even eliminate manufacturing upsets and inefficiencies.
With a larger, consolidated data set, manufacturers and producers can apply higher analytics for more detailed insight, scale the data as needed to meet the varied needs of single-site or enterprise-wide operations, and leverage a wider pool of data experts for monitoring and analysis.
MSD in India Announces Leadership Change
MSD in India today announced leadership change. KG Ananthakrishnan (KG) current Managing Director of MSD in India will retire in the beginning of 2017 and Vivek Vasudev Kamath will assume role of Managing Director Designate from December 16, 2016. MSD in India operates its business in India through three legal entities, MSD Pharmaceuticals Private Limited, Organon (India) Private Limited, and Fulford (India) Limited.
Vivek joined MSD in India in July 2012 and is currently the Business Unit Director for Cardiovascular Metabolics and Market Access. KG and Vivek will work together to ensure smooth transition of business responsibilities.
Announcing the leadership change, Jan Van Acker, President Asia Pacific Region, MSD said, "I thank KG for his leadership and his contributions to MSD over the past ten years and congratulate Vivek on assuming the role of Managing Director of MSD in India. MSD has a robust succession planning process through which Vivek was identified to lead MSD in India and to deliver on our commitment to patients and communities in the Country. He has successfully led our Cardiovascular Metabolics and Market Access businesses and has fostered collaborative relationships with our customers and business partners, while delivering strong growth"
MSD in India today announced leadership change. KG Ananthakrishnan (KG) current Managing Director of MSD in India will retire in the beginning of 2017 and Vivek Vasudev Kamath will assume role of Managing Director Designate from December 16, 2016. MSD in India operates its business in India through three legal entities, MSD Pharmaceuticals Private Limited, Organon (India) Private Limited, and Fulford (India) Limited.
Vivek joined MSD in India in July 2012 and is currently the Business Unit Director for Cardiovascular Metabolics and Market Access. KG and Vivek will work together to ensure smooth transition of business responsibilities.
Announcing the leadership change, Jan Van Acker, President Asia Pacific Region, MSD said, "I thank KG for his leadership and his contributions to MSD over the past ten years and congratulate Vivek on assuming the role of Managing Director of MSD in India. MSD has a robust succession planning process through which Vivek was identified to lead MSD in India and to deliver on our commitment to patients and communities in the Country. He has successfully led our Cardiovascular Metabolics and Market Access businesses and has fostered collaborative relationships with our customers and business partners, while delivering strong growth"
Slayback Pharma Announces USD 60
Million in New Financing by KKR
Slayback Pharma, LLC, a privately held pharmaceutical research and development company, announced today the closing of a USD 60 million commitment by KKR, a leading global investment firm. The financing will help Slayback enhance and accelerate the development of its portfolio of complex generic and specialty pharmaceutical products.
Slayback is focused on expanding access to affordable health care. Since early 2011, Slayback has filed, through its out-licensing partners, numerous Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications with the Food and Drug Administration (FDA) for complex sterile and non-sterile dosage forms such as Propofol Injectable Emulsion USP 1 per cent and Generic Zovirax (Acyclovir) Ointment) 5 per cent, which the company announced last month. Additionally, Slayback is focused on bringing first generics to the market. Over the last five years, Slayback has developed two complex sterile products, which became rare sole First-to-File ANDAs with a Paragraph IV certification.
As part of the transaction, Ali Satvat and Neel Varshney of KKR will join Slayback's Board of Managers.
For KKR, the investment is part of the firm's health care growth equity strategy, which is focused on high-growth companies for which KKR can be a unique partner in helping reach scale. The investment in Slayback builds upon KKR's experience in the pharmaceutical value chain, including investments in Jazz Pharmaceuticals, Arbor Pharmaceuticals, Gland Pharmaceuticals, Coherus BioSciences, BridgeBio Pharma, PRA Health Sciences, Capsugel and Walgreens Boots Alliance.
Leerink Partners LLC served as financial advisor to Slayback on the transaction.
Slayback Pharma, LLC, a privately held pharmaceutical research and development company, announced today the closing of a USD 60 million commitment by KKR, a leading global investment firm. The financing will help Slayback enhance and accelerate the development of its portfolio of complex generic and specialty pharmaceutical products.
Slayback is focused on expanding access to affordable health care. Since early 2011, Slayback has filed, through its out-licensing partners, numerous Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications with the Food and Drug Administration (FDA) for complex sterile and non-sterile dosage forms such as Propofol Injectable Emulsion USP 1 per cent and Generic Zovirax (Acyclovir) Ointment) 5 per cent, which the company announced last month. Additionally, Slayback is focused on bringing first generics to the market. Over the last five years, Slayback has developed two complex sterile products, which became rare sole First-to-File ANDAs with a Paragraph IV certification.
As part of the transaction, Ali Satvat and Neel Varshney of KKR will join Slayback's Board of Managers.
For KKR, the investment is part of the firm's health care growth equity strategy, which is focused on high-growth companies for which KKR can be a unique partner in helping reach scale. The investment in Slayback builds upon KKR's experience in the pharmaceutical value chain, including investments in Jazz Pharmaceuticals, Arbor Pharmaceuticals, Gland Pharmaceuticals, Coherus BioSciences, BridgeBio Pharma, PRA Health Sciences, Capsugel and Walgreens Boots Alliance.
Leerink Partners LLC served as financial advisor to Slayback on the transaction.
Positive Bioscience Launches Positive– Academy for Training in Genomics and Clinical Applications
Positive Bioscience has launched Positive - Academy for Training in Genomics and Clinical applications (ATGC), an initiative to help oncologists gain competency at using genomics in their practice. The initiative will be rolled out across the country in association with ICON and MOS (Molecular Oncology Society).
Positive ATGC will conduct regular workshops in Delhi, Hyderabad, Bangalore, and Mumbai. Participants of the workshop will be awarded a certificate, which will be accepted as CME. The workshops will also be available online.
Positive ATGC workshops have been designed to enhance the education of clinical oncology professionals on the topics of cancer genomics, cancer risk assessment, and application of precision medicine in clinical practice. The workshops will include topics on technology and equipment, understanding and applying genomic report to clinical practice, as well as concept of pathways and its utility in clinical practice. Positive ATGC will also conduct six-month training programs on genomics for doctors. The training will be certified by a leading Medical University. Positive Academy for ATGC aims to reach out to over 200+ doctors by 2017.
The Academy will publish periodic newsletters for updating Oncologists with the latest developments in genomic technology.
Says Dr. Purvish M. Parikh, President of Molecular Oncology Society and Director of Precision Oncology at Asian Cancer Institute “The only way to optimize cure and treatment in cancer is by selecting the right drug at the very first instance. This requires proper understanding of the tumor as well as normal metabolism of the patient. These key aspects are identified only by in-depth genetic testing. Hence they have become the norm today's age of personalized medicine and precision oncology. In fact, we are quickly moving away from classifying cancer tumors based on organ of origin (e.g. breast or lung cancer) and now relooking at them based on driver mutations (changes in genetics that are causing the cell to become cancerous). For instance tumors that are caused by mutations in the "alk" gene will be called alkomas.â€
Says Samarth Jain, Founder & CEO, Positive Biosciences “With the vast increase in knowledge stemming from genetics research and the development of new technologies in genomics, Genetics education and training of oncologists is critical for building capacities to understand, interpret, and appropriately apply such information. As the advancement of genetic technologies accelerates, so must the education and training efforts. This initiative is our contribution to enabling the integration of genomics into clinical practice, so that patients in India can benefit.
Positive Bioscience has launched Positive - Academy for Training in Genomics and Clinical applications (ATGC), an initiative to help oncologists gain competency at using genomics in their practice. The initiative will be rolled out across the country in association with ICON and MOS (Molecular Oncology Society).
Positive ATGC will conduct regular workshops in Delhi, Hyderabad, Bangalore, and Mumbai. Participants of the workshop will be awarded a certificate, which will be accepted as CME. The workshops will also be available online.
Positive ATGC workshops have been designed to enhance the education of clinical oncology professionals on the topics of cancer genomics, cancer risk assessment, and application of precision medicine in clinical practice. The workshops will include topics on technology and equipment, understanding and applying genomic report to clinical practice, as well as concept of pathways and its utility in clinical practice. Positive ATGC will also conduct six-month training programs on genomics for doctors. The training will be certified by a leading Medical University. Positive Academy for ATGC aims to reach out to over 200+ doctors by 2017.
The Academy will publish periodic newsletters for updating Oncologists with the latest developments in genomic technology.
Says Dr. Purvish M. Parikh, President of Molecular Oncology Society and Director of Precision Oncology at Asian Cancer Institute “The only way to optimize cure and treatment in cancer is by selecting the right drug at the very first instance. This requires proper understanding of the tumor as well as normal metabolism of the patient. These key aspects are identified only by in-depth genetic testing. Hence they have become the norm today's age of personalized medicine and precision oncology. In fact, we are quickly moving away from classifying cancer tumors based on organ of origin (e.g. breast or lung cancer) and now relooking at them based on driver mutations (changes in genetics that are causing the cell to become cancerous). For instance tumors that are caused by mutations in the "alk" gene will be called alkomas.â€
Says Samarth Jain, Founder & CEO, Positive Biosciences “With the vast increase in knowledge stemming from genetics research and the development of new technologies in genomics, Genetics education and training of oncologists is critical for building capacities to understand, interpret, and appropriately apply such information. As the advancement of genetic technologies accelerates, so must the education and training efforts. This initiative is our contribution to enabling the integration of genomics into clinical practice, so that patients in India can benefit.
Rockwell Automation Organises Life Science Symposium in Mumbai
Rockwell Automation organised daylong session with the theme ‘Leveraging Technology to Ensure Quality and Compliance’ on 27 May 2016 in Mumbai to discuss how technology can be used to meet the needs of increased regulation and quality while reducing manufacturing costs and reducing risk in the Life Sciences industry. The symposium was attended by distinguished leaders from top Industry Associations, Pharma Manufacturers, Pharma Equipment Suppliers, Industry Consultants and Industry & Automation Specialist among others.
The event was designed for insightful discussions on:
- India Pharma Manufacturing: Global Expectations & Way forward
- Regulatory Environment & Infrastructure Necessities
- Role of Machinery Manufacturer in Creating a Growth Story
- Connecting Enterprise for Sustainable Manufacturing
- Leveraging Global Packaging Trends to Gain Competitive Advantage
Click here to view “Pharma Manufacturing Executive Presentation – The Connected Enterprises
Click here to view “The Connected Enterprise - Overview
Click here to view “The Connected Enterprise - Execution Model
Rockwell Automation organised daylong session with the theme ‘Leveraging Technology to Ensure Quality and Compliance’ on 27 May 2016 in Mumbai to discuss how technology can be used to meet the needs of increased regulation and quality while reducing manufacturing costs and reducing risk in the Life Sciences industry. The symposium was attended by distinguished leaders from top Industry Associations, Pharma Manufacturers, Pharma Equipment Suppliers, Industry Consultants and Industry & Automation Specialist among others.
The event was designed for insightful discussions on:
- India Pharma Manufacturing: Global Expectations & Way forward
- Regulatory Environment & Infrastructure Necessities
- Role of Machinery Manufacturer in Creating a Growth Story
- Connecting Enterprise for Sustainable Manufacturing
- Leveraging Global Packaging Trends to Gain Competitive Advantage
Click here to view “Pharma Manufacturing Executive Presentation – The Connected Enterprises
Click here to view “The Connected Enterprise - Overview
Click here to view “The Connected Enterprise - Execution Model
Apply Innovative Risk Strategies to Protect Consumers and Enhance Drug Safety
Marcus evans brings together heads of drug safety and regulatory affairs to establish effective pharmacovigilance strategies to comply with the global regulatory standards
Philadelphia, PA– June 11, 2015 – marcus evans, for the fifth year in a row, will host the Pharmacovigilance, Risk Management & AER Conference, September 16-17, 2015 in Philadelphia. As one of the marquee annual meetings in the marcus evans life science conference series, our expert speaker panel will cover how to manage changes in global regulatory standards and the impact on risk management and postmarket safety surveillance. Additionally, emerging challenges such as social media and signal detection and its role in pharmacovigilance across the product lifecycle will be discussed.
Featuring Case Studies from Leading Risk Management Experts, Including:
Syed S. Islam, M.D., MSPH, Dr. PH, Sr. Director, Global Surveillance and Pharmacoepidemiology, AbbVie Robert Livingston, M.D., MPH, Vice President, Drug Safety and Pharmacovigilance, Incyte Corporation Pedro L. Oyuela, M.D., MPH, Medical Director, Head of Medical Safety Review, Amgen Arshadul Haque, Senior Medical Director, Global Pharmacovigilance, Alexion Pharmaceuticals Arpad Simon, Vice President, Drug Safety and Pharmacovigilance, Relypsa, Inc.
For the last 4 years, pharmaceutical and biopharmaceutical professionals have left this meeting with the ability to effectively monitor adverse event reports and comply with regulatory standards. This conference provides attendees with solutions to the ongoing pressures from government entities and public concern.
"Up to date, stimulating and interactive meeting. Enthusiastic audience & high quality speakers." Shire Pharmaceuticals
"Every marcus evans conference we attend has been exciting, informative. I recommend the conference to all of my colleagues. Always a job well done." Amarin Pharma Inc.
"The content of the event was very up to date and well explained. Q & A very interactive." Teva Pharmaceuticals
Marcus evans brings together heads of drug safety and regulatory affairs to establish effective pharmacovigilance strategies to comply with the global regulatory standards
Philadelphia, PA– June 11, 2015 – marcus evans, for the fifth year in a row, will host the Pharmacovigilance, Risk Management & AER Conference, September 16-17, 2015 in Philadelphia. As one of the marquee annual meetings in the marcus evans life science conference series, our expert speaker panel will cover how to manage changes in global regulatory standards and the impact on risk management and postmarket safety surveillance. Additionally, emerging challenges such as social media and signal detection and its role in pharmacovigilance across the product lifecycle will be discussed.
Featuring Case Studies from Leading Risk Management Experts, Including:
Syed S. Islam, M.D., MSPH, Dr. PH, Sr. Director, Global Surveillance and Pharmacoepidemiology, AbbVie Robert Livingston, M.D., MPH, Vice President, Drug Safety and Pharmacovigilance, Incyte Corporation Pedro L. Oyuela, M.D., MPH, Medical Director, Head of Medical Safety Review, Amgen Arshadul Haque, Senior Medical Director, Global Pharmacovigilance, Alexion Pharmaceuticals Arpad Simon, Vice President, Drug Safety and Pharmacovigilance, Relypsa, Inc.
For the last 4 years, pharmaceutical and biopharmaceutical professionals have left this meeting with the ability to effectively monitor adverse event reports and comply with regulatory standards. This conference provides attendees with solutions to the ongoing pressures from government entities and public concern.
"Up to date, stimulating and interactive meeting. Enthusiastic audience & high quality speakers." Shire Pharmaceuticals
"Every marcus evans conference we attend has been exciting, informative. I recommend the conference to all of my colleagues. Always a job well done." Amarin Pharma Inc.
"The content of the event was very up to date and well explained. Q & A very interactive." Teva Pharmaceuticals
Superba(TM) Krill Oil Receives Regulatory Approval in India
Aker BioMarine Antarctic AS, a customer-driven supplier of krill-derived phospholipid omega-3 products, has received product approval for Superba(TM) Krill oil from Food Safety Standards Authorities of India (FSSAI). According to publically available information, Superba(TM) Krill oil is, as of today, the first and only krill oil that has obtained product approval by the FSSAI.
"We are delighted to introduce Superba(TM) Krill oil - an omega-3 product evaluated in several clinical studies - to the Indian market," said Atul Barman, Aker BioMarine Antarctic AS's India representative in Mumbai. "This new ingredient approval will enable Indian consumers to benefit from omega-3 fatty acids in phospholipid form. Omega-3 phospholipids are more efficiently incorporated into cell membranes and are therefore an excellent source of omega-3 fatty acids to support heart, brain and joint health."
"This approval represents a key milestone for our entry into India," said Tim de Haas, Vice President of Business Development, Aker BioMarine Antarctic AS, Oslo, Norway. "We feel confident that with our local presence we can successfully support our customers in India. Backed by our success, especially in the US and Australian markets, expanding into the Indian dietary supplement market presents great opportunities for Superba(TM) Krill oil."
Aker BioMarine Antarctic AS, a customer-driven supplier of krill-derived phospholipid omega-3 products, has received product approval for Superba(TM) Krill oil from Food Safety Standards Authorities of India (FSSAI). According to publically available information, Superba(TM) Krill oil is, as of today, the first and only krill oil that has obtained product approval by the FSSAI.
"We are delighted to introduce Superba(TM) Krill oil - an omega-3 product evaluated in several clinical studies - to the Indian market," said Atul Barman, Aker BioMarine Antarctic AS's India representative in Mumbai. "This new ingredient approval will enable Indian consumers to benefit from omega-3 fatty acids in phospholipid form. Omega-3 phospholipids are more efficiently incorporated into cell membranes and are therefore an excellent source of omega-3 fatty acids to support heart, brain and joint health."
"This approval represents a key milestone for our entry into India," said Tim de Haas, Vice President of Business Development, Aker BioMarine Antarctic AS, Oslo, Norway. "We feel confident that with our local presence we can successfully support our customers in India. Backed by our success, especially in the US and Australian markets, expanding into the Indian dietary supplement market presents great opportunities for Superba(TM) Krill oil."
Free Webinar & Demo of Pharmacovigilance Software PV247
Coimbatore-based global pharmacovigilance consulting & drug safety services company Oviya MedSafe and St Neots-based software development company Assured Information Systems joined hands in April 2014, to provide phenomenally cost-effective pharmacovigilance support to pharmaceutical companies. This strategic alliance aspires to promote the adoption of drug safety systems, especially among small & mid-sized innovators and generic drug marketers of any size throughout the world, by delivering comprehensive pharmacovigilance solutions in an economical and user-friendly manner.
PV247, a product of Assured, is a human pharmacovigilance hosted software database that offers intuitive end-to-end pharmacovigilance support to the global pharmaceutical industry. PV247 is E2B and 21 CFR Part 11 compliant. It is capable of electronic reporting to all regulatory authorities across the globe, including EMA and USFDA. Oviya MedSafe represents Assured in India & the Asia Pacific region.
Oviya MedSafe and Assured have jointly announced a free webinar & demo session on PV247 to share the advantages of this hosted application with its prospective users. This session has been exclusively designed to showcase the user-friendliness of PV247 and to educate the end-user of its capabilities. This free webinar & demo has been scheduled on Wednesday 10th September 2014 between 3 pm and 4 pm IST.
Pharmacovigilance professionals working in pharmaceutical companies are invited to register to attend the webinar & demo. For registration, the professionals are requested to write to register@oviyamedsafe.com with their name, designation, organization name, official e-mail address and mobile numbers. The deadline for the registration will be 6 pm IST on 08-September-2014. Early registration is preferred, as the number of places is limited. For queries, please call Karthik @ +918220763222.
Coimbatore-based global pharmacovigilance consulting & drug safety services company Oviya MedSafe and St Neots-based software development company Assured Information Systems joined hands in April 2014, to provide phenomenally cost-effective pharmacovigilance support to pharmaceutical companies. This strategic alliance aspires to promote the adoption of drug safety systems, especially among small & mid-sized innovators and generic drug marketers of any size throughout the world, by delivering comprehensive pharmacovigilance solutions in an economical and user-friendly manner.
PV247, a product of Assured, is a human pharmacovigilance hosted software database that offers intuitive end-to-end pharmacovigilance support to the global pharmaceutical industry. PV247 is E2B and 21 CFR Part 11 compliant. It is capable of electronic reporting to all regulatory authorities across the globe, including EMA and USFDA. Oviya MedSafe represents Assured in India & the Asia Pacific region.
Oviya MedSafe and Assured have jointly announced a free webinar & demo session on PV247 to share the advantages of this hosted application with its prospective users. This session has been exclusively designed to showcase the user-friendliness of PV247 and to educate the end-user of its capabilities. This free webinar & demo has been scheduled on Wednesday 10th September 2014 between 3 pm and 4 pm IST.
Pharmacovigilance professionals working in pharmaceutical companies are invited to register to attend the webinar & demo. For registration, the professionals are requested to write to register@oviyamedsafe.com with their name, designation, organization name, official e-mail address and mobile numbers. The deadline for the registration will be 6 pm IST on 08-September-2014. Early registration is preferred, as the number of places is limited. For queries, please call Karthik @ +918220763222.
Adopting a Risk-Based Approach to Drug Safety and Pharmacovigilance
Interview with Matthew Dormarunno, PharmD, Sr. Director, U.S. Risk Identification, Surveillance, and Communication at Sanofi
With growing government and public concern over drug safety, pharmacovigilance has never been more important. To ensure patient safety, minimize costs and ease regulatory compliance, pharmaceutical firms must aggressively detect and manage emerging safety risks. Yet early risk detection can be undercut by manual processes and a lack of integration across information outlets. This increased concern for drug safety has caused pharmaceutical companies to adopt more proactive risk management strategies.
Matthew Dormarunno, Sr. Director at Sanofi recently spoke with marcus evans about key topics to be discussed at their upcoming 4th Pharmacovigilance, Risk Management & AER Conference, September 17-18, 2014 in Philadelphia, PA.
Passive vs. Active Surveillance: What are the benefits of each?
MD: Passive surveillance uses existing adverse event data sources that are typically designed specifically to capture adverse events. Active surveillance often requires using new data sources that may provide insight for events not frequently reported or captured in typical adverse event databases. Often it does not rely on spontaneous reporting of adverse events, which is largely voluntary in the post-market setting. An additional goal is to provide more real-time insights and avoid lag time sometimes associated with passive surveillance.
What useful information can come from leveraging data from Individual Case Study Reports (ICSRs)?
MD: It is dependent heavily on the quality of the report, which can vary greatly. However, frequent (as close to real-time as possible) medical review of ICSRs is an important part of any safety signal detection program. In some cases, a single, well-documented event can be captured in an ICSR that is strong enough to establish a relationship to treatment, leading to changes in the label and associated product- related information documents.
Why is post-market safety surveillance so important?
MD: Mainly due to the fact that clinical studies, the other major source of safety data, are often limited in a variety of ways, including:
MD: The FDA Adverse Event Reporting System provides a larger, more diverse background than most company safety databases, on which proactive quantitative signal detection can be conducted. However, quantitative signal detection in FAERS is generally limited to hypothesis generation and interpretation can be difficult with frequent false positives.
What do you hope to gain/learn from attending this conference?
MD: Understanding of current practices and trends in pharmacovigilance and gain perspectives from others to enhance and improve my own skill set. I hope to share my experience and insight gained from a variety of safety roles in multiple companies and across varied product portfolios (pharmaceutical, vaccines, and consumer).
For more information regarding the highly anticipated marcus evans 4th Pharmacovigilance, Risk Management & AER Conference, please check out the conference website or contact Tyler Kelch, Marketing Coordinator, Media & PR, marcus evans at 312-894-6310 or Tylerke@marcusevansch.com.
Matthew Dormarunno is Senior Director, US Drug Safety at Sanofi and has been working in Pharmacovigilance, Safety Signal Detection, and Risk Management for more than 8 years at both Johnson & Johnson and Sanofi, in positions of increasing responsibility. Following undergraduate training in Microbiology at the University of Arizona and completion of his PharmD at the University of Michigan, he worked as an Operating Room Pharmacist at St Joseph Mercy Health System in Ypsilanti, Michigan.He also completed a Post-doctoral fellowship in Benefit Risk Management at Johnson & Johnson. His experience in Pharmacovigilance spans multiple therapeutic areas, including oncology, cardiovascular, biologics, neurology, infectious disease, diabetes, internal medicine, and vaccines, covering products from early clinical development through post-marketing. He has served as a guest lecturer at Temple University, as Director of the Post-doctoral fellowship in Safety Signal Detection at Johnson & Johnson, and as a preceptor for PharmD students at Wilkes University.
Interview with Matthew Dormarunno, PharmD, Sr. Director, U.S. Risk Identification, Surveillance, and Communication at Sanofi
With growing government and public concern over drug safety, pharmacovigilance has never been more important. To ensure patient safety, minimize costs and ease regulatory compliance, pharmaceutical firms must aggressively detect and manage emerging safety risks. Yet early risk detection can be undercut by manual processes and a lack of integration across information outlets. This increased concern for drug safety has caused pharmaceutical companies to adopt more proactive risk management strategies.
Matthew Dormarunno, Sr. Director at Sanofi recently spoke with marcus evans about key topics to be discussed at their upcoming 4th Pharmacovigilance, Risk Management & AER Conference, September 17-18, 2014 in Philadelphia, PA.
Passive vs. Active Surveillance: What are the benefits of each?
MD: Passive surveillance uses existing adverse event data sources that are typically designed specifically to capture adverse events. Active surveillance often requires using new data sources that may provide insight for events not frequently reported or captured in typical adverse event databases. Often it does not rely on spontaneous reporting of adverse events, which is largely voluntary in the post-market setting. An additional goal is to provide more real-time insights and avoid lag time sometimes associated with passive surveillance.
What useful information can come from leveraging data from Individual Case Study Reports (ICSRs)?
MD: It is dependent heavily on the quality of the report, which can vary greatly. However, frequent (as close to real-time as possible) medical review of ICSRs is an important part of any safety signal detection program. In some cases, a single, well-documented event can be captured in an ICSR that is strong enough to establish a relationship to treatment, leading to changes in the label and associated product- related information documents.
Why is post-market safety surveillance so important?
MD: Mainly due to the fact that clinical studies, the other major source of safety data, are often limited in a variety of ways, including:
- Limitations in the number of patients exposed
- Rare adverse events are often not detected until a larger group of individuals are exposed;
- Conversely, an event may be so common in the background of the treated patient population that a difference between treatment and placebo/comparator groups is not large enough to detect a difference during registration trials
- Restrictive enrollment
- Often many types of patients are excluded from clinical studies, therefore it is ultimately not fully representative of real-world use
- Medication errors, misuse, and quality issues
- These events will not be detected in trials, and ongoing monitoring is required to ensure product labeling is accurate and clear
- Quality issues may also be observed in post-market safety surveillance where an investigation can be requested and intervention taken to protect patients
MD: The FDA Adverse Event Reporting System provides a larger, more diverse background than most company safety databases, on which proactive quantitative signal detection can be conducted. However, quantitative signal detection in FAERS is generally limited to hypothesis generation and interpretation can be difficult with frequent false positives.
What do you hope to gain/learn from attending this conference?
MD: Understanding of current practices and trends in pharmacovigilance and gain perspectives from others to enhance and improve my own skill set. I hope to share my experience and insight gained from a variety of safety roles in multiple companies and across varied product portfolios (pharmaceutical, vaccines, and consumer).
For more information regarding the highly anticipated marcus evans 4th Pharmacovigilance, Risk Management & AER Conference, please check out the conference website or contact Tyler Kelch, Marketing Coordinator, Media & PR, marcus evans at 312-894-6310 or Tylerke@marcusevansch.com.
Matthew Dormarunno is Senior Director, US Drug Safety at Sanofi and has been working in Pharmacovigilance, Safety Signal Detection, and Risk Management for more than 8 years at both Johnson & Johnson and Sanofi, in positions of increasing responsibility. Following undergraduate training in Microbiology at the University of Arizona and completion of his PharmD at the University of Michigan, he worked as an Operating Room Pharmacist at St Joseph Mercy Health System in Ypsilanti, Michigan.He also completed a Post-doctoral fellowship in Benefit Risk Management at Johnson & Johnson. His experience in Pharmacovigilance spans multiple therapeutic areas, including oncology, cardiovascular, biologics, neurology, infectious disease, diabetes, internal medicine, and vaccines, covering products from early clinical development through post-marketing. He has served as a guest lecturer at Temple University, as Director of the Post-doctoral fellowship in Safety Signal Detection at Johnson & Johnson, and as a preceptor for PharmD students at Wilkes University.
Cancer Genetics to Buy BioServe
Cancer Genetics, Inc, a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, has announced the agreement to acquire BioServe Biotechnologies (India) Pvt Ltd for approximately USD 1.9 million, primarily in CGIX stock and other deferred consideration. The transaction is expected to close during the third quarter of 2014 and is subject to customary closing conditions and government approvals in India.
Under the terms of the agreement, BioServe Biotechnologies (India) Pvt Ltd, headquartered in Hyderabad, India, will become a subsidiary of CGI, and will be renamed Cancer Genetics India Pvt Ltd. CGI plans on retaining all 33 current employees of BioServe India, and further expanding and strengthening the sales and clinical teams in India. BioServe India currently operates out of a state-of-the-art 14,000-square-foot genomics facility in Hyderabad. BioServe India is backed by Ventureast, a pioneering venture capital institution based in India, which has enabled over 80 seed, early and growth stage businesses in a broad array of sectors including technology, life sciences and clean environment.
BioServe India is a state-of-the-art genomics services provider and molecular kit manufacturer serving both the research and clinical markets. By utilising BioServe India's molecular services, researchers can identify genetic markers, validate drug targets and correlate clinical and molecular data to accelerate the development of new and effective drugs. Additionally, BioServe India’s growing clinical diagnostics capabilities in oncology and next-generation sequencing are well-positioned to serve the needs of improving oncology diagnostics care and management throughout India.
Cancer Genetics, Inc, a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, has announced the agreement to acquire BioServe Biotechnologies (India) Pvt Ltd for approximately USD 1.9 million, primarily in CGIX stock and other deferred consideration. The transaction is expected to close during the third quarter of 2014 and is subject to customary closing conditions and government approvals in India.
Under the terms of the agreement, BioServe Biotechnologies (India) Pvt Ltd, headquartered in Hyderabad, India, will become a subsidiary of CGI, and will be renamed Cancer Genetics India Pvt Ltd. CGI plans on retaining all 33 current employees of BioServe India, and further expanding and strengthening the sales and clinical teams in India. BioServe India currently operates out of a state-of-the-art 14,000-square-foot genomics facility in Hyderabad. BioServe India is backed by Ventureast, a pioneering venture capital institution based in India, which has enabled over 80 seed, early and growth stage businesses in a broad array of sectors including technology, life sciences and clean environment.
BioServe India is a state-of-the-art genomics services provider and molecular kit manufacturer serving both the research and clinical markets. By utilising BioServe India's molecular services, researchers can identify genetic markers, validate drug targets and correlate clinical and molecular data to accelerate the development of new and effective drugs. Additionally, BioServe India’s growing clinical diagnostics capabilities in oncology and next-generation sequencing are well-positioned to serve the needs of improving oncology diagnostics care and management throughout India.
Biocon CMD Receives Othmer Gold Medal 2014
Pic: Kiran Mazumdar-Shaw, CMD, Biocon
Biocon Ltd, Asia's premier biotechnology company, has announced that its Chairperson and Managing Director, Kiran Mazumdar-Shaw, received the ‘Othmer Gold Medal 2014’ on Thursday, May 15, in Philadelphia, Pennsylvania, USA.
Established by the Chemical Heritage Foundation (CHF) in 1997, the annual award honors outstanding individuals who have made multifaceted contributions to chemical and scientific heritage through outstanding activity in such areas as innovation, entrepreneurship, research, education, public understanding, legislation or philanthropy.
Kiran Mazumdar-Shaw is the third woman to receive the Othmer Gold Medal and the first Indian to make it to this prestigious group. Nineteen people have been conferred with this honor till date, including Arnold O Beckman, Carl Djerassi, Mary Lowe Good, Harry B Gray, Jon M Huntsman, Kazuo Inamori, Robert S Langer, P Roy Vagelos, James D Watson, George Whitesides and Ahmed Zewail.
Carsten Reinhardt, President & CEO, CHF, handed over the Foundation's top award to Mazumdar-Shaw during CHF’s Chemical Heritage Day celebration that culminated with the presentation of the Othmer Gold Medal.
Pic: Kiran Mazumdar-Shaw, CMD, Biocon
Biocon Ltd, Asia's premier biotechnology company, has announced that its Chairperson and Managing Director, Kiran Mazumdar-Shaw, received the ‘Othmer Gold Medal 2014’ on Thursday, May 15, in Philadelphia, Pennsylvania, USA.
Established by the Chemical Heritage Foundation (CHF) in 1997, the annual award honors outstanding individuals who have made multifaceted contributions to chemical and scientific heritage through outstanding activity in such areas as innovation, entrepreneurship, research, education, public understanding, legislation or philanthropy.
Kiran Mazumdar-Shaw is the third woman to receive the Othmer Gold Medal and the first Indian to make it to this prestigious group. Nineteen people have been conferred with this honor till date, including Arnold O Beckman, Carl Djerassi, Mary Lowe Good, Harry B Gray, Jon M Huntsman, Kazuo Inamori, Robert S Langer, P Roy Vagelos, James D Watson, George Whitesides and Ahmed Zewail.
Carsten Reinhardt, President & CEO, CHF, handed over the Foundation's top award to Mazumdar-Shaw during CHF’s Chemical Heritage Day celebration that culminated with the presentation of the Othmer Gold Medal.
Bristol-Myers Squibb, Syngene Extent Collaboration
Bristol-Myers Squibb and Syngene International, India’s largest contract research organisation, have announced a five-year extension of their drug discovery and development collaboration in India. Financial terms were not disclosed.
Since 2007, Bristol-Myers Squibb has been working with Syngene and its corporate parent, Biocon Ltd, to develop integrated capabilities in medicinal and process chemistry, biology, biotechnology, biomarkers, drug metabolism and pharmacokinetics, analytical research, and pharmaceutical development at the Biocon Bristol-Myers Squibb Research Center (BBRC) in Bengaluru.
The US-India collaboration has produced six drug candidates for further study and also helped Bristol-Myers Squibb reduce the time and costs associated with advancing new compounds to first-in-human studies. One drug candidate currently in clinical trials was discovered at BBRC and early nonclinical development work done at BBRC has enabled most of Bristol-Myers Squibb’s small molecule assets to advance to later stages of development over the last five years.
Bristol-Myers Squibb and Syngene International, India’s largest contract research organisation, have announced a five-year extension of their drug discovery and development collaboration in India. Financial terms were not disclosed.
Since 2007, Bristol-Myers Squibb has been working with Syngene and its corporate parent, Biocon Ltd, to develop integrated capabilities in medicinal and process chemistry, biology, biotechnology, biomarkers, drug metabolism and pharmacokinetics, analytical research, and pharmaceutical development at the Biocon Bristol-Myers Squibb Research Center (BBRC) in Bengaluru.
The US-India collaboration has produced six drug candidates for further study and also helped Bristol-Myers Squibb reduce the time and costs associated with advancing new compounds to first-in-human studies. One drug candidate currently in clinical trials was discovered at BBRC and early nonclinical development work done at BBRC has enabled most of Bristol-Myers Squibb’s small molecule assets to advance to later stages of development over the last five years.
NuLEAP, Venostic Sign Partnership Deal
NuLEAP Technologies and Venostic Solutions announced a new strategic partnership to support Indian pharmaceutical companies’ needs for Computer Systems Validation and IT Compliance as per international global requirements.
Under the terms of the collaboration, NuLEAP and Venostic will provide a comprehensive set of services that will enable Indian pharmaceutical companies to develop regulatory processes for their computer systems validation and IT policies to ensure data integrity as per international norms. Several regulatory actions in recent months are driving the requirement for an in-depth review and solutions to meet international standards for data integrity and IT policies. NuLEAP’s local presence combined with Venostic’s international team will provide Indian organisations with the tools and services to effectively streamline their infrastructure, work practices and validation policies to meet international IT regulatory requirements that have been the subject of much attention in recent times.
NuLEAP Technologies and Venostic Solutions announced a new strategic partnership to support Indian pharmaceutical companies’ needs for Computer Systems Validation and IT Compliance as per international global requirements.
Under the terms of the collaboration, NuLEAP and Venostic will provide a comprehensive set of services that will enable Indian pharmaceutical companies to develop regulatory processes for their computer systems validation and IT policies to ensure data integrity as per international norms. Several regulatory actions in recent months are driving the requirement for an in-depth review and solutions to meet international standards for data integrity and IT policies. NuLEAP’s local presence combined with Venostic’s international team will provide Indian organisations with the tools and services to effectively streamline their infrastructure, work practices and validation policies to meet international IT regulatory requirements that have been the subject of much attention in recent times.
A Rise in IPOs Revive Investments for the Global Pharma and Biotech Industry
The heightened private equity and venture capital (PEVC) deal activity in the global healthcare industry during the recession years, 2008-2010, witnessed a decline post-2010. However, the fall in deals was not uniform among the constituent sectors, with the pharmaceutical, biotechnology and healthcare equipment sectors experiencing a much sharper decline in investor interest than the healthcare technology and provider segments. Investors started to bet on providers based with the conviction they can provide quicker and safer returns than the pharmaceutical and biotechnology space, which is ridden with regulatory challenges and patent expires.
New analysis from Frost & Sullivan’s Private Equity and Venture Capital Investment in the Global Pharmaceutical and Biotechnology Industry reveals the total number of PEVC deals in the pharmaceutical and biotechnology industry decreased from 1063 in 2010 to 480 in 2013. Though the returns from the pharmaceutical and biotechnology industry have been dwindling, they are better compared to the performance of other industries.
The heightened private equity and venture capital (PEVC) deal activity in the global healthcare industry during the recession years, 2008-2010, witnessed a decline post-2010. However, the fall in deals was not uniform among the constituent sectors, with the pharmaceutical, biotechnology and healthcare equipment sectors experiencing a much sharper decline in investor interest than the healthcare technology and provider segments. Investors started to bet on providers based with the conviction they can provide quicker and safer returns than the pharmaceutical and biotechnology space, which is ridden with regulatory challenges and patent expires.
New analysis from Frost & Sullivan’s Private Equity and Venture Capital Investment in the Global Pharmaceutical and Biotechnology Industry reveals the total number of PEVC deals in the pharmaceutical and biotechnology industry decreased from 1063 in 2010 to 480 in 2013. Though the returns from the pharmaceutical and biotechnology industry have been dwindling, they are better compared to the performance of other industries.
Lucrative Biosimilars Space to Erode Biologics Market from 2019
The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market beyond 2019, despite an initial projected Compound Annual Growth Rate (CAGR) of 8.3 per cent, taking the overall biologics market value from USD 162 billion in 2013 to more than USD 262 billion by 2019, says research and consulting firm GlobalData.
The company’s latest report states that patent expirations of branded biologics and the introduction of clearer regulatory frameworks for biosimilars after 2019 will see the latter capturing the market share from biologics.
Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, says: “There are a number of factors driving the initiative towards the global adoption of biosimilars, from austerity measures and slow economic growth in the US, to an aging population and increasing demand for healthcare in countries such as Japan.
The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market beyond 2019, despite an initial projected Compound Annual Growth Rate (CAGR) of 8.3 per cent, taking the overall biologics market value from USD 162 billion in 2013 to more than USD 262 billion by 2019, says research and consulting firm GlobalData.
The company’s latest report states that patent expirations of branded biologics and the introduction of clearer regulatory frameworks for biosimilars after 2019 will see the latter capturing the market share from biologics.
Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, says: “There are a number of factors driving the initiative towards the global adoption of biosimilars, from austerity measures and slow economic growth in the US, to an aging population and increasing demand for healthcare in countries such as Japan.
TGA Okeys Venus to Market Meropenem in Australia
Pic: Pawan Chaudhary, CMD, Venus Remedies
Venus Remedies Limited, a leading research-driven global pharmaceutical company, has received marketing authorisation for meropenem from Australia’s Therapeutic Goods Administration (TGA). The company has tied up with Lupin to sell this drug in Australia. Eyeing a sizeable share in Australia’s USD 15 million meropenem market in the first year of launch, it plans to market the drug by the third quarter of this year.
With marketing approvals from more than 35 countries, Venus Remedies is poised to capture a significant share in the USD 1.3-billion global meropenem market.
Hailing the achievement, Venus Remedies Chairman and Managing Director Pawan Chaudhary said, “The marketing authorisation from TGA has once again proved the company's capabilities in developing world-class products that meet the most stringent regulatory requirements. This is yet another milestone for Venus Remedies in its journey of obtaining a significant share in the meropenem market globally. Having established strategic tie-ups to market the drug in countries where Venus Remedies has a presence, we enjoy an edge over other competitors.”
Meropenem is an off-patented antibacterial agent of the carbapenem class of antibiotics that caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children.
Pic: Pawan Chaudhary, CMD, Venus Remedies
Venus Remedies Limited, a leading research-driven global pharmaceutical company, has received marketing authorisation for meropenem from Australia’s Therapeutic Goods Administration (TGA). The company has tied up with Lupin to sell this drug in Australia. Eyeing a sizeable share in Australia’s USD 15 million meropenem market in the first year of launch, it plans to market the drug by the third quarter of this year.
With marketing approvals from more than 35 countries, Venus Remedies is poised to capture a significant share in the USD 1.3-billion global meropenem market.
Hailing the achievement, Venus Remedies Chairman and Managing Director Pawan Chaudhary said, “The marketing authorisation from TGA has once again proved the company's capabilities in developing world-class products that meet the most stringent regulatory requirements. This is yet another milestone for Venus Remedies in its journey of obtaining a significant share in the meropenem market globally. Having established strategic tie-ups to market the drug in countries where Venus Remedies has a presence, we enjoy an edge over other competitors.”
Meropenem is an off-patented antibacterial agent of the carbapenem class of antibiotics that caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children.
US FDA Approves Addivant Weston 705 Liquid Antioxidant
Addivant, a global leader in polymer additive technologies, announced that Weston 705 liquid antioxidant, the next generation of nonylphenol-free phosphite technology, has received approval from the US Food and Drug Administration (FDA) for food contact applications. Extensively researched and supported with comprehensive toxicology testing, Weston 705 antioxidant provides superior safety as well as enhanced polymer performance and higher processing productivity vs. conventional solid phosphites. The product delivers major benefits across the entire value chain, from resin producers and converters to retailers and consumers.
Further, Addivant’s Weston 705 antioxidant is produced in multiple facilities worldwide ensuring security of supply for customers around the globe.
Addivant, a global leader in polymer additive technologies, announced that Weston 705 liquid antioxidant, the next generation of nonylphenol-free phosphite technology, has received approval from the US Food and Drug Administration (FDA) for food contact applications. Extensively researched and supported with comprehensive toxicology testing, Weston 705 antioxidant provides superior safety as well as enhanced polymer performance and higher processing productivity vs. conventional solid phosphites. The product delivers major benefits across the entire value chain, from resin producers and converters to retailers and consumers.
Further, Addivant’s Weston 705 antioxidant is produced in multiple facilities worldwide ensuring security of supply for customers around the globe.
Global Anti-Hypertensive Market Value to Decline
Multiple major drug patent expiries will cause the global anti-hypertensive market value to decline from USD 40 billion in 2013 to USD 37.6 billion by 2020, at a negative Compound Annual Growth Rate (CAGR) of 0.9 per cent, says business intelligence provider GBI Research.
The company’s latest report states that while the anti-hypertensive market value is first expected to increase to USD 44.5 billion by 2017, representing a CAGR of 2.6 per cent, it will then fall at a negative CAGR of 5.4 per cent through to 2020.
Arti Singh, Analyst for GBI Research, says: “The initial expansion of this market will result from the increased penetration of fixed-dose combination drugs, such as Amturnide, Exforge, Tribenzor, Azor, Tekamlo and Valturna. A rise in the prevalence of hypertension, from a population of 181 million to 190 million, combined with the anticipated launches of azilsartan + amlodipine and AHU377 + valsartan, will also contribute.”
However, the hypertension market growth will be countered by significant drug patent expirations both prior to and during the forecast period, including those of Cozaar in 2010, Diovan, Avapro and Atacand in 2012, Exforge in 2014, Benicar in 2016 and Tekturna and Tekturna HCT in 2018. A low diagnosis rate, teamed with a rise in generic penetration, will also drive the decline.
Multiple major drug patent expiries will cause the global anti-hypertensive market value to decline from USD 40 billion in 2013 to USD 37.6 billion by 2020, at a negative Compound Annual Growth Rate (CAGR) of 0.9 per cent, says business intelligence provider GBI Research.
The company’s latest report states that while the anti-hypertensive market value is first expected to increase to USD 44.5 billion by 2017, representing a CAGR of 2.6 per cent, it will then fall at a negative CAGR of 5.4 per cent through to 2020.
Arti Singh, Analyst for GBI Research, says: “The initial expansion of this market will result from the increased penetration of fixed-dose combination drugs, such as Amturnide, Exforge, Tribenzor, Azor, Tekamlo and Valturna. A rise in the prevalence of hypertension, from a population of 181 million to 190 million, combined with the anticipated launches of azilsartan + amlodipine and AHU377 + valsartan, will also contribute.”
However, the hypertension market growth will be countered by significant drug patent expirations both prior to and during the forecast period, including those of Cozaar in 2010, Diovan, Avapro and Atacand in 2012, Exforge in 2014, Benicar in 2016 and Tekturna and Tekturna HCT in 2018. A low diagnosis rate, teamed with a rise in generic penetration, will also drive the decline.
Jubilant Bags USD 147.5 Mln from IFC
Pic: Shyam S Bhartia, CMD, Jubilant Life Sciences
IFC, a member of the World Bank Group, is lending USD 147.5 million to Jubilant Pharma Limited to enable better access to quality and affordable pharmaceuticals in underserved markets in India and across the world. Jubilant Pharma, a wholly owned subsidiary of Jubilant Life Sciences Limited, is incorporated in Singapore, with manufacturing operations in India, USA, and Canada.
Of the total financing package, USD 110 million is from IFC’s own account. The remaining USD 37.5 million is from IFC’s Managed Co-Lending Portfolio Program, which provides additional long-term financing through co-financing partners. The loan will help Jubilant Life Sciences increase focus on the pharmaceutical sector and strengthen its generic drug manufacturing facilities in India.
"We consider IFC a long-term partner with significant healthcare expertise across emerging markets. IFC’s contribution goes beyond financing. IFC will also help us strengthen our quality assurance and risk mitigation mechanisms and make the company systems more robust,” said Shyam S Bhartia, Chairman and Managing Director, Jubilant Life Sciences. “IFC’s long-term financing package will consolidate our entire pharmaceuticals business under Jubilant Pharma and build global competitiveness.”
Pic: Shyam S Bhartia, CMD, Jubilant Life Sciences
IFC, a member of the World Bank Group, is lending USD 147.5 million to Jubilant Pharma Limited to enable better access to quality and affordable pharmaceuticals in underserved markets in India and across the world. Jubilant Pharma, a wholly owned subsidiary of Jubilant Life Sciences Limited, is incorporated in Singapore, with manufacturing operations in India, USA, and Canada.
Of the total financing package, USD 110 million is from IFC’s own account. The remaining USD 37.5 million is from IFC’s Managed Co-Lending Portfolio Program, which provides additional long-term financing through co-financing partners. The loan will help Jubilant Life Sciences increase focus on the pharmaceutical sector and strengthen its generic drug manufacturing facilities in India.
"We consider IFC a long-term partner with significant healthcare expertise across emerging markets. IFC’s contribution goes beyond financing. IFC will also help us strengthen our quality assurance and risk mitigation mechanisms and make the company systems more robust,” said Shyam S Bhartia, Chairman and Managing Director, Jubilant Life Sciences. “IFC’s long-term financing package will consolidate our entire pharmaceuticals business under Jubilant Pharma and build global competitiveness.”
Bosch Expands PreVAS Portfolio
At Interpack 2014, Bosch Packaging Technology, a leading supplier of process and packaging technology, presented the expanded portfolio of the single-use filling system PreVAS. “The existing system has been successfully introduced to the market. Now the time has come to offer our customers additional solutions for their existing line concepts and to consequently extend our portfolio,” Klaus Ullherr, product manager at Bosch Packaging Technology said. The name PreVAS stands for pre-validated, pre-assembled and pre-sterilized single-use filling systems, which Bosch Packaging Technology has developed in cooperation with Sartorius Stedim Biotech (SSB).
At Interpack 2014, Bosch Packaging Technology, a leading supplier of process and packaging technology, presented the expanded portfolio of the single-use filling system PreVAS. “The existing system has been successfully introduced to the market. Now the time has come to offer our customers additional solutions for their existing line concepts and to consequently extend our portfolio,” Klaus Ullherr, product manager at Bosch Packaging Technology said. The name PreVAS stands for pre-validated, pre-assembled and pre-sterilized single-use filling systems, which Bosch Packaging Technology has developed in cooperation with Sartorius Stedim Biotech (SSB).
Oviya MedSafe & Assured Information Systems Partner to Provide Pharmacovigilance Solutions
Indian pharmacovigilance consulting and drug safety services company Oviya MedSafe Pvt Ltd has signed an agreement with British software development company Assured Information Systems Ltd to combine the former's drug safety services with the latter's hosted pharmacovigilance database product PV247, to offer intuitive end-to-end pharmacovigilance support to the global pharmaceutical industry. This strategic alliance aspires to promote the adoption of drug safety systems, especially among small and mid-sized pharmaceutical companies throughout the world, by delivering comprehensive pharmacovigilance solutions in a cost-effective and user-friendly manner.
Dr J Vijay Venkatraman, Managing Director & CEO of Oviya MedSafe indicated that the alliance has happened at the right time. "As drug safety regulations begin to tighten globally, investing in pharmacovigilance becomes inevitable for all pharmaceutical companies", he said. He added "With Oviya MedSafe’s increasing recognition as a quality-conscious yet cost-effective pharmacovigilance service provider in the market since the past two years, our strategic partnership with Assured Information Systems, an established company with similar values, will help in achieving our shared goal of providing affordable,simplified yet reliable drug safety support.
Dr Alan K Rawling, Managing Director of Assured Information Systems said "This partnership with Oviya MedSafe recognises the need to provide a total pharmacovigilance solution that addresses the challenges of regulatory compliance, electronic reporting and signal detection. Combining our software and services expertise offers a unique proposition to pharmaceutical companies of all sizes within the Asian continent and globally to companies wishing to outsource to India".
Indian pharmacovigilance consulting and drug safety services company Oviya MedSafe Pvt Ltd has signed an agreement with British software development company Assured Information Systems Ltd to combine the former's drug safety services with the latter's hosted pharmacovigilance database product PV247, to offer intuitive end-to-end pharmacovigilance support to the global pharmaceutical industry. This strategic alliance aspires to promote the adoption of drug safety systems, especially among small and mid-sized pharmaceutical companies throughout the world, by delivering comprehensive pharmacovigilance solutions in a cost-effective and user-friendly manner.
Dr J Vijay Venkatraman, Managing Director & CEO of Oviya MedSafe indicated that the alliance has happened at the right time. "As drug safety regulations begin to tighten globally, investing in pharmacovigilance becomes inevitable for all pharmaceutical companies", he said. He added "With Oviya MedSafe’s increasing recognition as a quality-conscious yet cost-effective pharmacovigilance service provider in the market since the past two years, our strategic partnership with Assured Information Systems, an established company with similar values, will help in achieving our shared goal of providing affordable,simplified yet reliable drug safety support.
Dr Alan K Rawling, Managing Director of Assured Information Systems said "This partnership with Oviya MedSafe recognises the need to provide a total pharmacovigilance solution that addresses the challenges of regulatory compliance, electronic reporting and signal detection. Combining our software and services expertise offers a unique proposition to pharmaceutical companies of all sizes within the Asian continent and globally to companies wishing to outsource to India".
Bionomics Wins Innovative Asian Biotech of the Year Award
Bionomics Limited has been named as the Innovative Asian Biotech of the Year at this week’s BioPharma Asia Industry Awards during the BioPharma Asia Convention, at the Suntec Convention and Exhibition Centre in Singapore.
BioPharma Asia Convention is Asia’s largest biopharmaceutical event drawing almost 3,000 attendees from across the world with interests in biotech and pharmaceutical company partnering, industry trends and investment opportunities.
The citation underpinning the Innovative Asian Biotech of the Year award made reference to Bionomics’ ability to adopt innovative technologies to develop novel drugs. It is also acknowledged the company’s approach to drug development including the implementation of new processes, technologies or applications that achieve quantifiable and sustainable results.
Further, CEO & Managing Director Dr Deborah Rathjen was awarded the Life Science Woman Executive of the Year award for her contribution to both the biopharma industry and society. Conference leaders cited achievement of excellent results while demonstrating high levels of professionalism.
Bionomics Limited has been named as the Innovative Asian Biotech of the Year at this week’s BioPharma Asia Industry Awards during the BioPharma Asia Convention, at the Suntec Convention and Exhibition Centre in Singapore.
BioPharma Asia Convention is Asia’s largest biopharmaceutical event drawing almost 3,000 attendees from across the world with interests in biotech and pharmaceutical company partnering, industry trends and investment opportunities.
The citation underpinning the Innovative Asian Biotech of the Year award made reference to Bionomics’ ability to adopt innovative technologies to develop novel drugs. It is also acknowledged the company’s approach to drug development including the implementation of new processes, technologies or applications that achieve quantifiable and sustainable results.
Further, CEO & Managing Director Dr Deborah Rathjen was awarded the Life Science Woman Executive of the Year award for her contribution to both the biopharma industry and society. Conference leaders cited achievement of excellent results while demonstrating high levels of professionalism.
Jubilant Life Sciences Increase Price of Niacin by 18%
Jubilant Life Sciences, a significant player in the Nutrition market and ranked amongst the largest manufacturers of Vitamin B3 (Niacin & Niacinamide) in the world announces a price-increase of 18 per cent for Niacin feed-grade, with immediate effect, for non-contract customers and wherever existing contracts permit.
Jubilant delivers unmatched advantages of consistent quality and availability of Vitamin B3 (Niacin & Niacinamide) to its customers globally. The Company’s nutrition business is backward integrated up to the initial raw material stage with global scale of operations.
Jubilant Life Sciences, a significant player in the Nutrition market and ranked amongst the largest manufacturers of Vitamin B3 (Niacin & Niacinamide) in the world announces a price-increase of 18 per cent for Niacin feed-grade, with immediate effect, for non-contract customers and wherever existing contracts permit.
Jubilant delivers unmatched advantages of consistent quality and availability of Vitamin B3 (Niacin & Niacinamide) to its customers globally. The Company’s nutrition business is backward integrated up to the initial raw material stage with global scale of operations.
Macroeconomic Developments Currently Looming Over Turkey's Pharmaceutical Market Development
Business Monitor has just released its latest findings on Turkey’s Pharmaceuticals & Healthcare sector in its newly-published Turkey Pharmaceuticals & Healthcare Report.
Turkey's pharmaceutical market has faced stifling regulatory control over the last five years, which drugmakers have largely borne in return for access to a growing market. With market growth in question over the short-term and Business Monitor’s 2014 forecast posing downside risk, macroeconomic developments are currently looming over pharmaceutical market development.
In Business Monitor’s Pharmaceutical Risk/Reward Rating table Turkey is ranked the ninth most attractive business environment out of the 20 markets surveyed in Emerging Europe, declining from fifth in the previous quarter on account of a declining assessment of both market potential and regulatory risk. Turkey's large drug market, coupled with the sector's long-term growth potential, means that the country scores above the average for the region in spite of a slight downward adjustment to Business Monitor’s appraisal. In terms of risks, several rounds of pricing reforms mean that the country scores slightly below the regional average.
Business Monitor has just released its latest findings on Turkey’s Pharmaceuticals & Healthcare sector in its newly-published Turkey Pharmaceuticals & Healthcare Report.
Turkey's pharmaceutical market has faced stifling regulatory control over the last five years, which drugmakers have largely borne in return for access to a growing market. With market growth in question over the short-term and Business Monitor’s 2014 forecast posing downside risk, macroeconomic developments are currently looming over pharmaceutical market development.
In Business Monitor’s Pharmaceutical Risk/Reward Rating table Turkey is ranked the ninth most attractive business environment out of the 20 markets surveyed in Emerging Europe, declining from fifth in the previous quarter on account of a declining assessment of both market potential and regulatory risk. Turkey's large drug market, coupled with the sector's long-term growth potential, means that the country scores above the average for the region in spite of a slight downward adjustment to Business Monitor’s appraisal. In terms of risks, several rounds of pricing reforms mean that the country scores slightly below the regional average.
Piramal Imaging’s Neuraceq Gets FDA Nod
Piramal Imaging announced that the US Food and Drug Administration (FDA) has approved Neurace. This approval comes only four weeks after receiving marketing authorization for Neuraceq from the European Commission.
Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.
There are an estimated 7.7 million new cases of dementia each year worldwide. Alzheimer’s disease accounts for 60-80 per cent of all dementia diagnoses. However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10–30 per cent of cases.
The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programmes. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.
The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation programme. Images were analysed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.
Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.
Piramal Imaging announced that the US Food and Drug Administration (FDA) has approved Neurace. This approval comes only four weeks after receiving marketing authorization for Neuraceq from the European Commission.
Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.
There are an estimated 7.7 million new cases of dementia each year worldwide. Alzheimer’s disease accounts for 60-80 per cent of all dementia diagnoses. However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10–30 per cent of cases.
The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programmes. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.
The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation programme. Images were analysed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.
Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.
EMA Begins Adaptive Licensing Pilot Project
The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases. A framework to guide discussions of individual pilot studies has been published.
The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicines. It is a prospectively planned process, starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.
As a holistic approach, adaptive licensing requires the involvement of all stakeholders who have a role in determining patient access, including the EMA, the industry, health technology assessment (HTA) bodies, organisations issuing clinical treatment guidelines and patient organisations. All discussions will take place in a ‘safe harbour’ environment to allow free exploration of the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilisation pathways in a confidential manner and without commitment from either side.
The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases. A framework to guide discussions of individual pilot studies has been published.
The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicines. It is a prospectively planned process, starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.
As a holistic approach, adaptive licensing requires the involvement of all stakeholders who have a role in determining patient access, including the EMA, the industry, health technology assessment (HTA) bodies, organisations issuing clinical treatment guidelines and patient organisations. All discussions will take place in a ‘safe harbour’ environment to allow free exploration of the strengths and weaknesses of all options for development, assessment, licensing, reimbursement, monitoring, and utilisation pathways in a confidential manner and without commitment from either side.
BioClinica Signs USD 30 Million eClinical Contracts with 2 Major Pharma Companies
BioClinica, Inc, a leading provider of specialized outsourced clinical trial services, recently penned USD 30 million in multi-year contract renewals with two major pharmaceutical companies. Collectively these engagements encompass cloud-based technologies and professional services and training across BioClinica’s full eClinical product suite: OnPoint CTMS, Express EDC, Trident IRT, and clinical supplies Optimiser.
Under the contracts BioClinica will support several hundred clinical studies annually through 2017.
The contracts extend partnering arrangements that originated a decade ago. Since then, BioClinica has supported the two organisations in clinical trials across thousands of investigative sites worldwide.
In the first agreement, BioClinica will provide resources and subject matter expertise in clinical supply chain distribution systems and processes that extend to several thousand investigators using Interactive Response Technology (IRT) worldwide.
In the second agreement, BioClinica’s easy-to-use OnPoint CTMS and Express EDC technologies will provide the foundation for their clinical operations. Data management, study design, and related professional services that support clinical studies globally will also be provided.
Enterprise-wide implementation of cloud-based technologies is currently underway with BioClinica employees contracted to be embedded within each organisation, augmenting the pharmaceutical companies’ internal resources.
BioClinica, Inc, a leading provider of specialized outsourced clinical trial services, recently penned USD 30 million in multi-year contract renewals with two major pharmaceutical companies. Collectively these engagements encompass cloud-based technologies and professional services and training across BioClinica’s full eClinical product suite: OnPoint CTMS, Express EDC, Trident IRT, and clinical supplies Optimiser.
Under the contracts BioClinica will support several hundred clinical studies annually through 2017.
The contracts extend partnering arrangements that originated a decade ago. Since then, BioClinica has supported the two organisations in clinical trials across thousands of investigative sites worldwide.
In the first agreement, BioClinica will provide resources and subject matter expertise in clinical supply chain distribution systems and processes that extend to several thousand investigators using Interactive Response Technology (IRT) worldwide.
In the second agreement, BioClinica’s easy-to-use OnPoint CTMS and Express EDC technologies will provide the foundation for their clinical operations. Data management, study design, and related professional services that support clinical studies globally will also be provided.
Enterprise-wide implementation of cloud-based technologies is currently underway with BioClinica employees contracted to be embedded within each organisation, augmenting the pharmaceutical companies’ internal resources.
Praj Renames NeelaSystems as Praj HiPurity Systems
Praj Industries, global process solutions Company has changed the name of its subsidiary Neela Systems as Praj HiPurity Systems Limited. Praj Industries had acquired majority stake in Mumbai headquartered Neela Systems in 2012. The change of identity is in line with the growth plan of Praj HiPurity to go beyond pure water solutions for Pharma Industry to end-to-end, integrated solutions for pharma, biotech and cosmetics industriesand the enhanced shareholding of Praj in the subsidiary.
As part of the integrated solutions, Praj HiPurity will also offer wastewater treatment systems and Zero Liquid Discharge Systems in association with Praj Industries Limited. Additionally, the Company is working towards increased international business. Recently the Company bagged big ticket order from an American Multinational Pharma company for supply of integrated systems for a state-of-the-art facility at Vizag, Andhra Pradesh and also another client in Central Asia. The efforts are underway to repeat the success overseas.
Over the past three years, Praj has steadily increased its shareholding in Praj HiPurity Systems to the current 70 per cent. Praj HiPurity Systems has an impressive client profile with marquee customers from pharma, biotech and cosmetics industries. The parent brand “Praj†will help the company to grow its horizon further and increase its market reach. Praj Industries already has a global spread across 5 continents. Praj HiPurity will also benefit from the R & D efforts and the technology and process know-how. Praj HiPurity offers water treatment solutions & modular systems, and process engineering & design capability.
Praj Industries, global process solutions Company has changed the name of its subsidiary Neela Systems as Praj HiPurity Systems Limited. Praj Industries had acquired majority stake in Mumbai headquartered Neela Systems in 2012. The change of identity is in line with the growth plan of Praj HiPurity to go beyond pure water solutions for Pharma Industry to end-to-end, integrated solutions for pharma, biotech and cosmetics industriesand the enhanced shareholding of Praj in the subsidiary.
As part of the integrated solutions, Praj HiPurity will also offer wastewater treatment systems and Zero Liquid Discharge Systems in association with Praj Industries Limited. Additionally, the Company is working towards increased international business. Recently the Company bagged big ticket order from an American Multinational Pharma company for supply of integrated systems for a state-of-the-art facility at Vizag, Andhra Pradesh and also another client in Central Asia. The efforts are underway to repeat the success overseas.
Over the past three years, Praj has steadily increased its shareholding in Praj HiPurity Systems to the current 70 per cent. Praj HiPurity Systems has an impressive client profile with marquee customers from pharma, biotech and cosmetics industries. The parent brand “Praj†will help the company to grow its horizon further and increase its market reach. Praj Industries already has a global spread across 5 continents. Praj HiPurity will also benefit from the R & D efforts and the technology and process know-how. Praj HiPurity offers water treatment solutions & modular systems, and process engineering & design capability.
Jubilant Chemsys, IDRI Extends Partnership
Jubilant Chemsys, a wholly-owned subsidiary of Jubilant Life Sciences, and one of the most recognised drug discovery research services organizations from Asia, announced an extension of collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery. Jubilant Chemsys offers drug discovery research services on Full Time Equivalent and Fees- for-services basis.
The collaboration in chemistry support has been in existence since 2009 as part of a joint effort with the Lilly TB Drug Discovery Initiative (LTI) and so far has generated hundreds of Novel Chemical Entities (NCEs) – some of which have now been identified for further exploration. Jubilant Chemsys, under the terms of agreement, so far had been offering philanthropic support and expertise in synthesis of NCEs to support the early research in TB.
IDRI is a founding member of both the LTI and the TB Drug Accelerator, a unique partnership funded by the Bill & Melinda Gates Foundation that targets the discovery of new TB drugs by collaborating on early-stage research. The Foundation recently awarded IDRI USD 3.4 million in additional funding to Tanya Parish, PhD, IDRI Vice President of Drug Discovery, and supplements an earlier grant awarded in 2010, for a total of USD 7.8 million. The grant is focused on identifying new leads and drug targets for tuberculosis with the ultimate goal of producing new drugs to treat TB.
With this association, Jubilant will continue to provide chemistry and medicinal chemistry support to IDRI. The company is also evaluating further liaisoning with IDRI in key functional areas like computational chemistry and Drug Metabolism and Pharmacokinetics (DMPK) Services.
Jubilant Chemsys, a wholly-owned subsidiary of Jubilant Life Sciences, and one of the most recognised drug discovery research services organizations from Asia, announced an extension of collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery. Jubilant Chemsys offers drug discovery research services on Full Time Equivalent and Fees- for-services basis.
The collaboration in chemistry support has been in existence since 2009 as part of a joint effort with the Lilly TB Drug Discovery Initiative (LTI) and so far has generated hundreds of Novel Chemical Entities (NCEs) – some of which have now been identified for further exploration. Jubilant Chemsys, under the terms of agreement, so far had been offering philanthropic support and expertise in synthesis of NCEs to support the early research in TB.
IDRI is a founding member of both the LTI and the TB Drug Accelerator, a unique partnership funded by the Bill & Melinda Gates Foundation that targets the discovery of new TB drugs by collaborating on early-stage research. The Foundation recently awarded IDRI USD 3.4 million in additional funding to Tanya Parish, PhD, IDRI Vice President of Drug Discovery, and supplements an earlier grant awarded in 2010, for a total of USD 7.8 million. The grant is focused on identifying new leads and drug targets for tuberculosis with the ultimate goal of producing new drugs to treat TB.
With this association, Jubilant will continue to provide chemistry and medicinal chemistry support to IDRI. The company is also evaluating further liaisoning with IDRI in key functional areas like computational chemistry and Drug Metabolism and Pharmacokinetics (DMPK) Services.
StemCyte to Expand Operations in India
StemCyte India Therapeutics, a unit of StemCyte Inc - USA, has emerged as the only company in India in stem cell business to offer private banking, public banking and stem cell transplants with Umbilical Cord Blood (UCB) stem cells. Company plans to expand its operations in India by opening new collection centres across the country and build 5,000 plus public inventory of UCB units with focus on more transplants in next 2-3 years.
StemCyte India Therapeutics Pvt. Ltd. is a joint venture between StemCyte Inc - USA, Apollo Hospitals Enterprises Ltd and Cadila Pharmaceuticals Ltd. Company started its operations in India in 2010 and has stored 1000 plus public umbilical cord blood units till date. StemCyte has a wide network of collection centres spread across Delhi, Rajasthan, Gujarat, Maharashtra, Andhra Pradesh, Karnataka and Tamil Nadu. The storage and processing centre is based out of it’s headquarter in Ahmedabad.
Kenneth J Giacin, Chairman & Director of StemCyte Inc - USA, said, “The success of Stem Cell Technology is not just in banking, but in its therapeutic application as well. StemCyte has released almost 2,000 cord blood units across 235 transplant centres worldwide, including 29 transplants in India. Operating a hybrid model of UCB stem cell banking, StemCyte worldwide has a public inventory of over 35,000 Umbilical Cord Blood Units.â€
StemCyte India Therapeutics, a unit of StemCyte Inc - USA, has emerged as the only company in India in stem cell business to offer private banking, public banking and stem cell transplants with Umbilical Cord Blood (UCB) stem cells. Company plans to expand its operations in India by opening new collection centres across the country and build 5,000 plus public inventory of UCB units with focus on more transplants in next 2-3 years.
StemCyte India Therapeutics Pvt. Ltd. is a joint venture between StemCyte Inc - USA, Apollo Hospitals Enterprises Ltd and Cadila Pharmaceuticals Ltd. Company started its operations in India in 2010 and has stored 1000 plus public umbilical cord blood units till date. StemCyte has a wide network of collection centres spread across Delhi, Rajasthan, Gujarat, Maharashtra, Andhra Pradesh, Karnataka and Tamil Nadu. The storage and processing centre is based out of it’s headquarter in Ahmedabad.
Kenneth J Giacin, Chairman & Director of StemCyte Inc - USA, said, “The success of Stem Cell Technology is not just in banking, but in its therapeutic application as well. StemCyte has released almost 2,000 cord blood units across 235 transplant centres worldwide, including 29 transplants in India. Operating a hybrid model of UCB stem cell banking, StemCyte worldwide has a public inventory of over 35,000 Umbilical Cord Blood Units.â€
GSK's Eperzan Uses Novozymes Technology
Novozymes Biopharma DK A/S, a subsidiary of Novozymes A/S, a world leader in bioinnovation, has announced that its albumin-based VELTIS half-life extension technology is being used by GlaxoSmithKline in the recently authorised Eperzan (albiglutide) for the treatment of type 2 diabetes in Europe.
The application of Novozymes' VELTIS technology in the drug delivers an extended half-life which will enable patients to inject only once per week.
"The first approval for a product based on Novozymes' VELTIS technology, and marketed by one of the largest pharmaceutical companies in the world, marks a significant milestone for our half-life extension platform", says Thomas Videbæk, Executive Vice President, Business Development, Novozymes. “We consider this authorisation real proof that VELTIS can offer true benefits to patients, reducing the inconvenience with daily drug dosing."
VELTIS technology is a series of native and engineered human albumins. When combined with a drug candidate it offers the potential for tunable control of therapeutic half-life in a manner previously unachievable with other half-life extension platforms. In particular, the technology opens the door towards weekly, bi-weekly, or even monthly dosing regimens, a monumental shift away from the daily dosing regimens currently necessary to manage medical conditions.
Novozymes Biopharma DK A/S, a subsidiary of Novozymes A/S, a world leader in bioinnovation, has announced that its albumin-based VELTIS half-life extension technology is being used by GlaxoSmithKline in the recently authorised Eperzan (albiglutide) for the treatment of type 2 diabetes in Europe.
The application of Novozymes' VELTIS technology in the drug delivers an extended half-life which will enable patients to inject only once per week.
"The first approval for a product based on Novozymes' VELTIS technology, and marketed by one of the largest pharmaceutical companies in the world, marks a significant milestone for our half-life extension platform", says Thomas Videbæk, Executive Vice President, Business Development, Novozymes. “We consider this authorisation real proof that VELTIS can offer true benefits to patients, reducing the inconvenience with daily drug dosing."
VELTIS technology is a series of native and engineered human albumins. When combined with a drug candidate it offers the potential for tunable control of therapeutic half-life in a manner previously unachievable with other half-life extension platforms. In particular, the technology opens the door towards weekly, bi-weekly, or even monthly dosing regimens, a monumental shift away from the daily dosing regimens currently necessary to manage medical conditions.
HRA Pharma, Afaxys to Supply UPA to US Market
HRA Pharma and Afaxys Pharmaceuticals, a division of Afaxys, Inc, have formed a commercial partnership to supply ulipristal acetate (UPA), a selective progesterone receptor modulator, to the US market. The product is commonly known as ella in the US where it has been available since 2010.
Ella is a next-generation emergency contraceptive developed by HRA Pharma specifically for emergency contraceptive use. Ella was originally approved as an emergency contraceptive by the European Medicines Agency (EMA) in 2009 and subsequently by the Food and Drug Administration (FDA) in 2010. It is anticipated that the partnership of these two companies working closely together in the contraceptive field will make ella more widely available to women all over the US.
Commenting on the newly formed association between the two organisations, Erin Gainer, CEO of HRA Pharma, said, ‘‘We are looking forward to this collaborative relationship that we anticipate to prove successful in improving women’s access to ulipristal acetate emergency contraception in the USA. Having the same mission and goals as Afaxys with regards to empowering women with choice and options means we will achieve positive results, together.â€
HRA Pharma and Afaxys Pharmaceuticals, a division of Afaxys, Inc, have formed a commercial partnership to supply ulipristal acetate (UPA), a selective progesterone receptor modulator, to the US market. The product is commonly known as ella in the US where it has been available since 2010.
Ella is a next-generation emergency contraceptive developed by HRA Pharma specifically for emergency contraceptive use. Ella was originally approved as an emergency contraceptive by the European Medicines Agency (EMA) in 2009 and subsequently by the Food and Drug Administration (FDA) in 2010. It is anticipated that the partnership of these two companies working closely together in the contraceptive field will make ella more widely available to women all over the US.
Commenting on the newly formed association between the two organisations, Erin Gainer, CEO of HRA Pharma, said, ‘‘We are looking forward to this collaborative relationship that we anticipate to prove successful in improving women’s access to ulipristal acetate emergency contraception in the USA. Having the same mission and goals as Afaxys with regards to empowering women with choice and options means we will achieve positive results, together.â€
Piramal's Mumbai R & D Facility Wins GLP Certification from NGCMA
Piramal Enterprises Limited (PEL) announced that its Good Laboratory Practices (GLP) Department at Research & Development (R & D) facility in Goregaon, Mumbai has received the GLP Compliance Certification from the National Good Laboratory Practice Compliance Monitoring Authority (NGCMA), Government of India.
GLP is a quality system concerned with the organisational process and conditions under which non-clinical health and environmental safety studies are performed. The R & D facility in Goregaon, Mumbai is engaged in drug discovery and development of New Chemical Entities (NCE) in the area of Oncology and Metabolic Disorders.
Dr. Owe Owar, President - NCE Research, Piramal Enterprises Limited said, "The GLP certification is a testament to high quality research through thorough SOP-driven Good Laboratory Practices, competent well-trained personnel and systematic documentation at Piramal's NCE R & D facility in Mumbai. Piramal's NCE R & D unit is committed to realise its mission towards serving patients globally with medicines that matter.â€
The certification states that specified studies in the areas of toxicity, mutagenicity, analytical and clinical chemistry testing, and others like hERG, bioanalysis and toxicokinetic evaluation conducted at Piramal Enterprises Ltd are compliant with GLP under OECD principles.
Piramal Enterprises Limited (PEL) announced that its Good Laboratory Practices (GLP) Department at Research & Development (R & D) facility in Goregaon, Mumbai has received the GLP Compliance Certification from the National Good Laboratory Practice Compliance Monitoring Authority (NGCMA), Government of India.
GLP is a quality system concerned with the organisational process and conditions under which non-clinical health and environmental safety studies are performed. The R & D facility in Goregaon, Mumbai is engaged in drug discovery and development of New Chemical Entities (NCE) in the area of Oncology and Metabolic Disorders.
Dr. Owe Owar, President - NCE Research, Piramal Enterprises Limited said, "The GLP certification is a testament to high quality research through thorough SOP-driven Good Laboratory Practices, competent well-trained personnel and systematic documentation at Piramal's NCE R & D facility in Mumbai. Piramal's NCE R & D unit is committed to realise its mission towards serving patients globally with medicines that matter.â€
The certification states that specified studies in the areas of toxicity, mutagenicity, analytical and clinical chemistry testing, and others like hERG, bioanalysis and toxicokinetic evaluation conducted at Piramal Enterprises Ltd are compliant with GLP under OECD principles.
DIA Annual Conference to Address Current Situation of
New Drug Development in East Asia
Professionals from across East Asia will discuss the latest hot topics in all stages of drug development at the 8th DIA Annual Conference in Japan for Asian New Drug Development.
The event will return for its eighth year on May 22 to 23, at Sola City Hall, Ochanomizu in Tokyo. Expert speakers will share information and experiences regarding the current situation of new drug development in the emerging East Asia region, and provide advice on how to improve the value and quality of new drugs.
Sessions will focus on the latest regulatory information, early phase clinical trial, collaboration between academic organisations, regulatory inspection, regional study communications and late phase development strategy.
The conference will feature presentations on the latest regulatory trends and regional clinical trials in Asia from industry leaders and high-profile representatives from Asian regulatory authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA), China Food and Drug Administration (CFDA), and the Ministry of Food and Drug Safety in Republic of Korea. Academic speakers from Japan, China and Korea will also provide their future visions of new drug development and the role of academia collaboration in East Asia.
Program chair Hidetoshi Shuto, Corporate Executive for Astellas Pharma Inc.,said : "Drug development in East Asia has become extremely vigorous as the interests of organisations related to drug development expand. Such organisations are now not only interested in the advancement of drug development, but also the maximisation of generated value and the improvement of quality in new drug development.
Professionals from across East Asia will discuss the latest hot topics in all stages of drug development at the 8th DIA Annual Conference in Japan for Asian New Drug Development.
The event will return for its eighth year on May 22 to 23, at Sola City Hall, Ochanomizu in Tokyo. Expert speakers will share information and experiences regarding the current situation of new drug development in the emerging East Asia region, and provide advice on how to improve the value and quality of new drugs.
Sessions will focus on the latest regulatory information, early phase clinical trial, collaboration between academic organisations, regulatory inspection, regional study communications and late phase development strategy.
The conference will feature presentations on the latest regulatory trends and regional clinical trials in Asia from industry leaders and high-profile representatives from Asian regulatory authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA), China Food and Drug Administration (CFDA), and the Ministry of Food and Drug Safety in Republic of Korea. Academic speakers from Japan, China and Korea will also provide their future visions of new drug development and the role of academia collaboration in East Asia.
Program chair Hidetoshi Shuto, Corporate Executive for Astellas Pharma Inc.,said : "Drug development in East Asia has become extremely vigorous as the interests of organisations related to drug development expand. Such organisations are now not only interested in the advancement of drug development, but also the maximisation of generated value and the improvement of quality in new drug development.
EL Seminar organized by Intertek held in Mumbai
Intertek, a leading quality solutions provider to industries worldwide organised and presented a seminar "Manage your Extractable & Leachables Risk" on Wednesday , 9th April 2014 at The Lalit, Mumbai. This one day seminar focused on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies. An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals. E/L studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product. The seminar provided insightful details regarding analytical approaches for evaluating E/L from different sources such as packaging or printing inks and also expert guidance on how to interpret analytical data in order to gain insight into risk assessment and validation of different manufacturing processes from an extractables and leachables perspective.
During his inaugural address at the seminar Dr. Armin Hauk, Senior Consultant, Head of GLP organisation, GMP responsible person acc. Swiss Pharma law said. "Studies of extractable and leachable components within packaging and closures are required to meet the safety requirements for marketed medicines. Intertek undertakes extractables /leachables studies for a wide range of drug products in a variety of packaging types, conducted in accordance with GLP and cGMP requirements." He further added, "The seminar was an excellent platform to share Intertek's valuable knowledge and experience as a global leader in testing services. This will allow companies to gather the information and perspective which they need to make a difference in their business".
Intertek provides expertise in E/L studies from our centres of excellence in India (Mumbai, Europe (Basel) and the USA (Whitehouse, New Jersey).
Intertek, a leading quality solutions provider to industries worldwide organised and presented a seminar "Manage your Extractable & Leachables Risk" on Wednesday , 9th April 2014 at The Lalit, Mumbai. This one day seminar focused on providing detailed information and practical guidance on the issues associated with extractables and leachables (E/L) studies. An important part of pharmaceutical development is the assessment of substances that could potentially leach (leachables) into the drug product from packaging, components of printing ink, catalyst residues and heavy metals. E/L studies provide qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product. The seminar provided insightful details regarding analytical approaches for evaluating E/L from different sources such as packaging or printing inks and also expert guidance on how to interpret analytical data in order to gain insight into risk assessment and validation of different manufacturing processes from an extractables and leachables perspective.
During his inaugural address at the seminar Dr. Armin Hauk, Senior Consultant, Head of GLP organisation, GMP responsible person acc. Swiss Pharma law said. "Studies of extractable and leachable components within packaging and closures are required to meet the safety requirements for marketed medicines. Intertek undertakes extractables /leachables studies for a wide range of drug products in a variety of packaging types, conducted in accordance with GLP and cGMP requirements." He further added, "The seminar was an excellent platform to share Intertek's valuable knowledge and experience as a global leader in testing services. This will allow companies to gather the information and perspective which they need to make a difference in their business".
Intertek provides expertise in E/L studies from our centres of excellence in India (Mumbai, Europe (Basel) and the USA (Whitehouse, New Jersey).
Jubilant Biosys Extends Drug Discovery Alliance with Janssen Pharmaceutical
Jubilant Biosys, a Bengaluru based subsidiary of Jubilant Life Sciences, has expanded its drug discovery alliance with Janssen Pharmaceutica NV, Beerse, Belgium. The alliance was forged initially in the year 2011 and aims to deliver preclinical candidates to Janssen. The new agreement into multiple therapeutic areas has been expanded owing to Jubilant’s diversified skill sets in various therapeutic areas. Most of the research will be undertaken at Jubilant Biosys, India and some parts at Jubilant Discovery Center, USA.
Janssen Pharmaceutica, Belgium is part of the 'JanssenPharmaceutical Companies of Johnson & Johnson'. The collaboration between the two organisations has been expanded to leverage Jubilant’s drug discovery capabilities on selected drug discovery targets to advance programmes in multiple disease areas. Jubilant will carry out research services and will deliver preclinical candidates to Janssen for potential development and commercialisation. In addition to research funding, Jubilant will also receive milestones and royalties should Janssen successfully progress the assets into clinical development and commercialisation .
"We are pleased to announce the expansion of the Janssen- Jubilant collaboration and look forward to discovering Novel Chemical Entities (NCE's) that address the unmet medical needs in these important disease areas", said Dr Subir K Basak, President, Jubilant Biosys (Global Drug Discovery Services)". Over the past several years, we have been strengthening our disease franchises from a scientific perspective, and this collaboration serves as a validation of those efforts. We look forward to a long, and mutually beneficial, partnership."
Jubilant Biosys, a Bengaluru based subsidiary of Jubilant Life Sciences, has expanded its drug discovery alliance with Janssen Pharmaceutica NV, Beerse, Belgium. The alliance was forged initially in the year 2011 and aims to deliver preclinical candidates to Janssen. The new agreement into multiple therapeutic areas has been expanded owing to Jubilant’s diversified skill sets in various therapeutic areas. Most of the research will be undertaken at Jubilant Biosys, India and some parts at Jubilant Discovery Center, USA.
Janssen Pharmaceutica, Belgium is part of the 'JanssenPharmaceutical Companies of Johnson & Johnson'. The collaboration between the two organisations has been expanded to leverage Jubilant’s drug discovery capabilities on selected drug discovery targets to advance programmes in multiple disease areas. Jubilant will carry out research services and will deliver preclinical candidates to Janssen for potential development and commercialisation. In addition to research funding, Jubilant will also receive milestones and royalties should Janssen successfully progress the assets into clinical development and commercialisation .
"We are pleased to announce the expansion of the Janssen- Jubilant collaboration and look forward to discovering Novel Chemical Entities (NCE's) that address the unmet medical needs in these important disease areas", said Dr Subir K Basak, President, Jubilant Biosys (Global Drug Discovery Services)". Over the past several years, we have been strengthening our disease franchises from a scientific perspective, and this collaboration serves as a validation of those efforts. We look forward to a long, and mutually beneficial, partnership."
FDA, EMA to Discuss Pharmacovigilance and Clinical
Safety at DIA's Annual Meeting
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) will discuss common objectives and challenges in pharmacovigilance and clinical safety at DIA’s Annual Meeting from June 15 to 19 in San Diego.
The June 17 session, "FDA-EMA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges," will focus on joint efforts in drug-specific evaluation, drug development, effective implementation of new pharmacovigilance (medicine safety) tools and addressing common challenges. The session, to be chaired by Peter Richard Arlett, head of pharmacovigilance at EMA, is one of 35 educational sessions at the Annual Meeting focusing on pharmacovigilance and clinical safety.
"Ensuring the safety of medical innovations is a top priority for professionals involved in medical product development," said DIA Global Chief Executive Barbara Lopez Kunz. "We are bringing the premier voices in industry and regulatory agencies to work closely on this issue in addition to encouraging a stronger patient voice in our education."
The two agencies jointly announced on Feb. 21 the creation of a new "cluster" for a more systematic and focused exchange of information on the safety of medicines. Clusters are regular meetings among the FDA, EMA and other world drug regulatory agencies on specific topics identified as requiring intensified sharing of information and collaboration. The FDA and EMA have clusters on biosimilars, medicines to treat cancer, orphan medicines, medicines for children and more already in place.
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) will discuss common objectives and challenges in pharmacovigilance and clinical safety at DIA’s Annual Meeting from June 15 to 19 in San Diego.
The June 17 session, "FDA-EMA Collaboration in Pharmacovigilance: Common Objectives and Common Challenges," will focus on joint efforts in drug-specific evaluation, drug development, effective implementation of new pharmacovigilance (medicine safety) tools and addressing common challenges. The session, to be chaired by Peter Richard Arlett, head of pharmacovigilance at EMA, is one of 35 educational sessions at the Annual Meeting focusing on pharmacovigilance and clinical safety.
"Ensuring the safety of medical innovations is a top priority for professionals involved in medical product development," said DIA Global Chief Executive Barbara Lopez Kunz. "We are bringing the premier voices in industry and regulatory agencies to work closely on this issue in addition to encouraging a stronger patient voice in our education."
The two agencies jointly announced on Feb. 21 the creation of a new "cluster" for a more systematic and focused exchange of information on the safety of medicines. Clusters are regular meetings among the FDA, EMA and other world drug regulatory agencies on specific topics identified as requiring intensified sharing of information and collaboration. The FDA and EMA have clusters on biosimilars, medicines to treat cancer, orphan medicines, medicines for children and more already in place.
Jubilant Sort out FDA Issue with Montreal Plant
Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company announced has received a communication from the US Food and Drug Administration (FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada as 'Acceptable'. This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications.
The development follows completionof FDA's review of the Company's responses post the February letter and the subsequent re-inspection conducted at Jubilant's Montreal facility in September, 2013. This development successfully resolves the FDA issues at Montreal facility.
Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company announced has received a communication from the US Food and Drug Administration (FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada as 'Acceptable'. This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications.
The development follows completionof FDA's review of the Company's responses post the February letter and the subsequent re-inspection conducted at Jubilant's Montreal facility in September, 2013. This development successfully resolves the FDA issues at Montreal facility.
Phosphagenics Appoints Three New Non-executive Directors
Australian drug delivery technology company Phosphagenics Limited has appointed biotech industry veterans Lawrence Gozlan, Nathan Drona and Dr Geert Cauwenbergh as non-executive directors, with Gozlan assuming the role of Chairman of the Board on an interim basis.
Stuart James, Dr Sandra Webb, Don Clarke and Jonathan Addison have retired from the Board. The Company thanks them for their contributions over many years.
Australian drug delivery technology company Phosphagenics Limited has appointed biotech industry veterans Lawrence Gozlan, Nathan Drona and Dr Geert Cauwenbergh as non-executive directors, with Gozlan assuming the role of Chairman of the Board on an interim basis.
Stuart James, Dr Sandra Webb, Don Clarke and Jonathan Addison have retired from the Board. The Company thanks them for their contributions over many years.
SCHOTT to Track Pharmaceutical Tubing
SCHOTT is supporting the pharmaceutical industry in its efforts to track the tubing used to produce pharmaceutical packaging made of glass. The company issued its 1 millionth certificate for its FIOLAX glass tubing just recently. These certificates help to identify the products shipped as tubing that are subsequently processed into pharmaceutical packaging, vials or syringes, for example. These documents contain more detailed information on the dimensional quality and the quality of the glass. This enables pharmaceutical companies to track their packaging all the way back to the raw material "glass tubing," if necessary.
Traceability is currently one of the most pressing issues for the pharmaceutical industry. It is closely related to more stringent requirements for quality and safety in manufacturing, shipping and administering medicines. Packaging is thus an integral part of all safety considerations. SCHOTT became the first company in the industry to allow for all of the pharmaceutical tubing it manufactures to be identified back in 1999. The certificates are applied to the pallet in a clearly visible position and enable customers to inspect incoming shipments more easily because they contain plenty of detailed information. One part of the certificate can be detached and stored for documentation purposes and used to perform subsequent tracking & tracing inside the e-commerce portal.
SCHOTT is supporting the pharmaceutical industry in its efforts to track the tubing used to produce pharmaceutical packaging made of glass. The company issued its 1 millionth certificate for its FIOLAX glass tubing just recently. These certificates help to identify the products shipped as tubing that are subsequently processed into pharmaceutical packaging, vials or syringes, for example. These documents contain more detailed information on the dimensional quality and the quality of the glass. This enables pharmaceutical companies to track their packaging all the way back to the raw material "glass tubing," if necessary.
Traceability is currently one of the most pressing issues for the pharmaceutical industry. It is closely related to more stringent requirements for quality and safety in manufacturing, shipping and administering medicines. Packaging is thus an integral part of all safety considerations. SCHOTT became the first company in the industry to allow for all of the pharmaceutical tubing it manufactures to be identified back in 1999. The certificates are applied to the pallet in a clearly visible position and enable customers to inspect incoming shipments more easily because they contain plenty of detailed information. One part of the certificate can be detached and stored for documentation purposes and used to perform subsequent tracking & tracing inside the e-commerce portal.
Ghulam Nabi Azad Inaugurates Baxter Global Research
Centre at Syngene
Syngene, India's leading contract research organisation and Baxter International Inc, a leading global pharmaceutical company have collaborated to establish the Baxter Global Research Centre at Syngene, in Bengaluru.
The Centre was inaugurated by Ghulam Nabi Azad, the Honorable Minister of Health and Family Welfare, Govt of India, in the presence of U T Khader, Minister of Health & Family Welfare, Govt of Karnataka, S R Patil, Minister of IT, BT & ST, Govt of Karnataka, Keshav Desiraju, Secretary, Dept of Health & Family Welfare, Govt of India and Srivatsa Krishna, Secretary, Dept. of IT, BT & ST, Govt. of Karnataka.
The Baxter Global Research Centre (BGRC) at Syngene, is a part of Baxter’s global strategy of building R & D collaborations with strategic partners. This collaboration will support Baxter in the Research and Development of medical products and devices to serve patients both in India and around the world.
Syngene, India's leading contract research organisation and Baxter International Inc, a leading global pharmaceutical company have collaborated to establish the Baxter Global Research Centre at Syngene, in Bengaluru.
The Centre was inaugurated by Ghulam Nabi Azad, the Honorable Minister of Health and Family Welfare, Govt of India, in the presence of U T Khader, Minister of Health & Family Welfare, Govt of Karnataka, S R Patil, Minister of IT, BT & ST, Govt of Karnataka, Keshav Desiraju, Secretary, Dept of Health & Family Welfare, Govt of India and Srivatsa Krishna, Secretary, Dept. of IT, BT & ST, Govt. of Karnataka.
The Baxter Global Research Centre (BGRC) at Syngene, is a part of Baxter’s global strategy of building R & D collaborations with strategic partners. This collaboration will support Baxter in the Research and Development of medical products and devices to serve patients both in India and around the world.
US FDA, UL EduNeering Extend Partnership
UL EduNeering, a leading provider of compliance and knowledge management solutions, and the US Food and Drug Administration (FDA), have extended their Cooperative Research and Development Agreement (CRADA) for five additional years , extending the agreement to 2019. FDA's CRADA with UL is the only learning technology agreement of its kind between FDA and a private-sector company. This new agreement will expand the learning resources of the Office of Regulatory Affairs' virtual university, UL EduNeering and FDA originally collaborated and co-developed the ORA-U infrastructure in 1999, to train the agency's food, drug and medical device investigators. UL EduNeering, part of the Life & Health Division of UL is expanding its services to the Pharmaceutical, Medical Device and Biologics industries in India.
Global production of FDA-regulated products has quadrupled over the last decade and continues to grow. Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. 40 percent of finished drugs come from overseas, and 80 percent of active ingredients manufacturers are located outside the US. Further, half of all medical devices are imported. UL in India is well-positioned to serve the compliance and regulatory needs of the fast-growing life science community. The organization already works with India’s Central Drugs Standard Control Organization (CDSCO) to train inspectors on the ISO 13485 quality management system.
UL EduNeering, a leading provider of compliance and knowledge management solutions, and the US Food and Drug Administration (FDA), have extended their Cooperative Research and Development Agreement (CRADA) for five additional years , extending the agreement to 2019. FDA's CRADA with UL is the only learning technology agreement of its kind between FDA and a private-sector company. This new agreement will expand the learning resources of the Office of Regulatory Affairs' virtual university, UL EduNeering and FDA originally collaborated and co-developed the ORA-U infrastructure in 1999, to train the agency's food, drug and medical device investigators. UL EduNeering, part of the Life & Health Division of UL is expanding its services to the Pharmaceutical, Medical Device and Biologics industries in India.
Global production of FDA-regulated products has quadrupled over the last decade and continues to grow. Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. 40 percent of finished drugs come from overseas, and 80 percent of active ingredients manufacturers are located outside the US. Further, half of all medical devices are imported. UL in India is well-positioned to serve the compliance and regulatory needs of the fast-growing life science community. The organization already works with India’s Central Drugs Standard Control Organization (CDSCO) to train inspectors on the ISO 13485 quality management system.
Sun Pharma's Generic Temodar Get US FDA Approva
Sun Pharmaceutical Industries Ltd announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Temodar, Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg.
Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg are therapeutic equivalents of Merck Sharp & Dohme Corporation’s Temodar Capsules. These Capsules have annual sales of approximately USD 400 million in the US. In another development, The Board of Directors of Sun Pharmaceutical Industries Ltd announced appointment of Rekha Sethi as an additional independent director.
Rekha Sethi is the Director General of the All India Management Association (AIMA), the apex body for management in India. She took charge of AIMA in June 2008. She is a member of the Indo-Netherlands Joint Working Group on Corporate Governance and Corporate Social Responsibility set up by Ministry of Corporate Affairs, Government of India.
Sun Pharmaceutical Industries Ltd announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Temodar, Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg.
Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg are therapeutic equivalents of Merck Sharp & Dohme Corporation’s Temodar Capsules. These Capsules have annual sales of approximately USD 400 million in the US. In another development, The Board of Directors of Sun Pharmaceutical Industries Ltd announced appointment of Rekha Sethi as an additional independent director.
Rekha Sethi is the Director General of the All India Management Association (AIMA), the apex body for management in India. She took charge of AIMA in June 2008. She is a member of the Indo-Netherlands Joint Working Group on Corporate Governance and Corporate Social Responsibility set up by Ministry of Corporate Affairs, Government of India.
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