Pharma News

Mylan N.V. U.S. based Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.

Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.

India’s healthcare sector needs more skilled professionals. Under Central Drug Research Institute (CDRI) skill initiative program the institute is going to start a training course to generate skilled human resources ready for employment in the hospitals, diagnostic pathology centres, forensic laboratories, research industries and laboratories and academia.

With the death toll from the world’s worst measles epidemic in the Democratic Republic of the Congo (DRC) surpassing 6000, the World Health Organization (WHO) is calling for more funding to stop the outbreak.

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.