Pharma News

In recognition of January 2020 as National Biotechnology Month, the U.S. Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

The U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keeps the cancer cells from growing.

Indian researchers have received first Merck Young Scientist Award 2019 in Chemical Sciences recently at Bangalore instituted by Merck, a science and technology company operating worldwide. Merck Young Scientist Award is given to researchers with less than ten years of experience with expertise in solving some of the toughest problems in chemical sciences.

Dietary supplements containing zinc and folic acid — marketed as a treatment for male infertility — do not appear to improve pregnancy rates, sperm counts or sperm function, according to a study conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The study appears in the Journal of the American Medical Association.

A clinical trial has begun testing an experimental stem cell treatment against the best available biologic therapies for severe forms of relapsing multiple sclerosis (MS). The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will compare the safety, efficacy and cost-effectiveness of the two therapeutic approaches.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate, is now available by prescription in the U.S.

MSD outside the United States and Canada, announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., (“Taiho”) and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. (“Astex”), focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S.FDA) 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.

Scientists at Department of Biotechnology’s Thiruvananthapuram-based Rajiv Gandhi Centre for Biotechnology have developed a new system that promises to improve the delivery of growth factors to help in healing wounds.

Eisai Co., Ltd announced today that it has launched the in-house discovered and developed antiepileptic drug (AED) Fycompa®,  generic name perampanel) for use in adjunctive treatment of partial onset seizures (with or without secondarily generalized seizures) in epilepsy patients 12 years of age and older.