Pharma News

Glenmark  Pharmaceuticals  Limited,  a  research-led,  global  integrated pharmaceutical company, is concluding the final, national phase of its marketing approval application process to enable launch of its innovative nasal spray in 17 countries in the European Union.

Natco Pharma Limited has applied to the Central Drugs Standard Control Organization (CDSCO) in India for approval of Phase-III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 positive patients.

Syngene International, an integrated research, development and manufacturing services company, announced that it has extended its ongoing research collaboration with Bristol Myers Squibb. The collaboration has been extended through the end of 2030 and will expand the breadth of drug discovery research conducted, including chemistry, biology, drug metabolism and pharmacokinetics, as well as translational medicine research and pharmaceutical development, including chemical process development and analytical sciences, in the coming years.

A synthetic DNA vaccine candidate for Middle East respiratory syndrome coronavirus  MERS-CoV developed at The Wistar Institute induced potent immune responses and afforded protective efficacy in non-human primate models when given intradermally in abbreviated, low-dose immunization regimen. A similar vaccine candidate was previously shown to be safe and tolerable with a three-dose intramuscular injection regimen in a recently completed human phase 1 study and is currently in expanded studies of phase 1/2a trial.

LEO Pharma A/S, a global leader in medical dermatology announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

US-India Strategic Partnership Forum and members appreciate the efforts by leaders across the U.S. government at the highest level to identify concrete steps the United States can take to assist India through this crisis. The company looks forward to announcements soon that will support India’s efforts to fill needs like oxygen, medicines, medical supplies, and vaccines. This should include a waiver of current restrictions on the export of vaccine raw materials to ensure production of vaccine in India can continue uninterrupted.

Biocon Biologics Ltd., a subsidiary of Biocon Ltd has announced that Abevmy 100 and 400 mg, a biosimilar of Bevacizumab co-developed with Viatris Inc. has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Researchers from the University of Oxford and their partners have today reported findings from a Phase IIb trial of a candidate malaria vaccine, R21/Matrix-M, which demonstrated high-level efficacy of 77% over 12-months of follow-up. In their findings (posted on SSRN/Preprints with The Lancet) they note that they are the first to meet the World Health Organization's Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy.

Biological E. Limited, a Hyderabad-based vaccine and pharmaceutical company announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).