PHARMA LITERATI

Pfizer Inc. announced the launch of its Vaccines Division’s Centers of Excellence Network, a global programme of collaborations with academic institutions to conduct real-world epidemiologic research to accurately identify and measure the burden of specific vaccine-preventable diseases and potentially evaluate vaccine effectiveness affecting adults. Pfizer Vaccines has designated the University of Louisville as its first Center of Excellence with a second global center anticipated in the first half of 2020. “ The Centers of Excellence will complete comprehensive, disease surveillance and real-world vaccine effectiveness studies, which are distinctly different from clinical safety and efficacy research ,” said Luis Jodar, Pfizer Vaccines, chief medical and scientific affairs officer. “ With strategically located research centers around the world, we anticipate being able to better define and understand global disease burden in adults and vaccine effectiveness, which will help prov...

New Delhi: In a setback to major domestic pharma companies like Cipla, Torrent, Emcure, Alkem, the Delhi High Court has granted an injunction restraining them from selling a medicine used for prevention and treatment of thromboembolic diseases, the patent for which is held by Bristol-Myers Squibb (BMS). BMS filed its claims for patent infringement in Delhi HC, arguing that its anticoagulant product, Apixaban, is patented till September 2022. The drug was granted a patent in 2011. BMS, along with partner Pfizer, has been selling the drug used in the prevention and treatment of blood clots under the brand name Eliquis. The US firm stated that it came to know on December 6 that Cipla was planning to launch the generic version of Apixaban under the probable brand name Apigy. BMS carried out an extensive market survey in Delhi to ascertain whether Cipla’s product was launched in the market or not, and it was revealed that the product was not available in the domestic market. ...

Dilip Shanghvi, MD of India's most valuable drug firm Sun PharmaceuticalNSE 0.85 % Industries and one of the richest first-generation billionaires in the country with a net worth of $7.8 billion, is now looking at new markets to fire the company's growth engine. The Gujarati businessman started his entrepreneurial journey from Kolkata with about Rs 10,000 nearly four decades ago. Today, he runs the world's fourth-largest specialty generics maker, generating revenues of over Rs 30,000 crore.  Shanghai now plans to steer the company into the specialty business (novel, innovative drugs), and towards expanding markets like China and Japan for growth, both through acquisitions and partnerships. Excerpts from an exclusive interview: How is the economic slowdown affecting the sector in general, and Sun Pharma in particular? The Indian pharma industry has registered good growth in the first half of the year, and Sun Pharma has also performed well. We have taken multiple ...

India is a global leader for technology embedded medical devices. As med-tech companies develop novel technologies and new business models, India’s large patient pool can maximise access to accurate diagnosis at a faster pace. There is considerable focus on enhancing the capability of medical devices with technologies that are safe and efficient, said Dr Ayelet Akselrod-Ballin, director of AI, Zebra Medical Vision, in an interaction with Nandita Vijay. Excerpts: Regulations are getting stringent across the world for medical devices. Please comment. The regulatory authority, FDA is constantly evolving now and is eager to see that approval of medical technologies are safe and effective for patients. This will enable companies to introduce the product faster in the market so the patient benefits with faster diagnosis and access to treatment. The US FDA insists that artificial intelligence/machine learning embedded medical device now need to come under its proposed regulatory frame...

The Union Cabinet has approved the Memorandum of Cooperation (MoC) between the Department of Health and Family Welfare (DOHFW), Government of India and Bill and Melinda Gates Foundation (BMGF) on cooperation in the field of health. The MoC was signed in November, 2019 during the visit of Bill Gates, Co-Chair and Trustee of BMGF to Delhi. The MoC covers the areas of cooperation to reduce maternal, neonatal and child morbidity and mortality, to improve key nutrition outcomes, by improving the reach, coverage and quality of essential primary health, immunization and nutrition services, to increase the basket of choice and quality for family planning methods, specially for reversible methods, and increase access amongst younger women, to reduce the burden of select infectious diseases [TB, Visceral Leishmaniasis (VL), Lymphatic Filariasis(LF)] and to strengthen health systems, including aspects such as budget utilization, management and skills of human resources for health, digital h...

Vaccine major Serum Institute of India Pvt. Ltd. on Thursday said it has launched a new variant of its World Health Organization prequalified rotavirus vaccine Rotasiil, called Rotasiil - Liquid. Available in a single dose tube, Rotasiil - Liquid can be directly administered in 2 ml dose orally, thus saving time as well as cold chain space. It can be stored at 2-8 degrees Celsius for up to 24 months,  Serum Institute of India said in a statement. Rotavirus is a very contagious virus that causes diarrhoea. Rotasiil - Liquid will be available across domestic and international markets. The initial production aim of the vaccine is around 25-30 million doses per annum, which will be augmented to over 80 million doses per annum, it added. "The new launch will propel us towards improving the health of our children and reduce hospitalization and conditions related with diarrhea such as malnutrition, delayed physical and mental development amongst children," Serum Instit...

It has been more than a decade since Indian pharmaceutical companies began looking at the biosimilar opportunity. It is not an easy space to be in and quite unlike their traditional stronghold of generics. However, it is a space that is linked to the nature of future drugs - today, as is often quoted by pharma experts, one out of every three new drugs approved in the global matkets is a biotech drug, specially in fields like cancer care. While over 50 (and counting) different biosimilars already exist in the Indian market, the big money lies launching these drugs in Europe and the United States. So far, hardly a couple of Indian companies have been able to do this and much of this happened in the decade that has just concluded. In February 2015, Intas Pharmaceuticals became the first Indian company to get a biosimilar registered - the biotech drug Filgratsim under the brand Accofil - in the European Union. It is now getting ready to foray into US with more products. " We...

Taking cue from the World Health Organisation’s revised list of essential medicines, popular biosimilars for cancer cure like bevacizumab or trastuzumab and treatments like immunotherapy may get incorporated in India’s revised National List of Essential Medicines (NLEM), thereby bringing a whole new set of oncology medicines and treatments under price control, said officials in the know. An expert group on oncology, which is slated to meet on Tuesday, is contemplating adding these to the NLEM, one of the experts told ET. The NLEM list is reviewed every 3 years to include or exclude drugs. “ Experts on oncology from all over the country are gathering tomorrow to finalise the list on oncology drugs, therapies. There are new therapies on cancer with the potential to improve outcomes in those with advanced cancer and hence the updated essential medicines list may incorporate biosimilars, if there is a consensus ,” said one of the officials, who is part of the expert committee.“ T...

The world scientific community is waging a difficult and prolonged war on cancer. New research in the field of immunogenic cell death can extend the area of drugs application and ensure patients' protection from relapse after therapy. Cancer treatment is not just the removal of the tumor cells from the body, and chemotherapy. The doctors' aim is to provide a scenario that would prevent tumor cells from proliferating and causing a new disease. For many years, scientists at the Lobachevsky State University of Nizhny Novgorod and the University of Ghent (Belgium) have been engaged in research aimed to minimize the harm to the body after cancer treatment and have been looking for new approaches to treating cancer patients. The project, supported by a grant from the Russian Science Foundation and headed by Dmitry Krysko, leading researcher of the Lobachevsky University's Institute of Biology and Biomedicine, professor at Ghent University, has yielded its first major...

Most of India's young entrepreneurs come from the IT sector, and not many from the pharma. However, a 17-year old 12th class student Arjun Deshpande is different. Earlier this year, Deshpande founded a pharmacy retailing chain Generic Aadhar with an aim to sell generic medicines to the masses at much cheaper rates than the market price (generics are sold at almost 40 per cent premium to the ex-factory cost). His unique pharmacy aggregator business model is to source generic drugs directly from the manufacturers and give it to the retail pharmacies, eliminating the 16-20 per cent wholesaler margin along with other layers of margins such as C&F agents in the trade. Already about a dozen retailers, who were finding it difficult to cope with the intense competition from established medical stores on one side and the deep discounted sales strategy of online pharmacies on the other, have joined the Generic Aadhar fold. The stores are offered a free face-lift with Generic Aadhar...