Pharma News

Sun Pharma and Rockwell Medical enter into licensing agreement for Triferic in India

  • Posted on: 16 January 2020
  • By: PharmaTutor News

Sun Pharmaceutical Industries Ltd 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.

Finance Commission receives presentation on the Health Sector

  • Posted on: 16 January 2020
  • By: Shalini.Sharma

The 15th Finance Commission today received a presentation on India’s Health Sector.  The presentation was given by Smt. Preeti Sudan, Secretary, Health & Family Welfare and Dr. V.K. Paul, Member, NitiAayog in a meeting held in New Delhi today.  Chairman, Sh. N.K. Singh and all Members of the Commission were present at this meeting along with senior officials.

Alcohol - related deaths increasing in the United States

  • Posted on: 13 January 2020
  • By: Shalini.Sharma

An analysis of U.S. death certificate data by researchers at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health, found that nearly 1 million people died from alcohol-related causes between 1999 and 2017. The number of death certificates mentioning alcohol more than doubled from 35,914 in 1999 to 72,558 in 2017, the year in which alcohol played a role in 2.6% of all deaths in the United States. The increase in alcohol-related deaths is consistent with reports of increases in alcohol consumption and alcohol-involved emergency department visits and hospitalizations during the same period. The new findings are reported online in the journal Alcoholism: Clinical and Experimental Research.

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP

  • Posted on: 13 January 2020
  • By: Shalini.Sharma

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. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

  • Posted on: 13 January 2020
  • By: Shalini.Sharma

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.

Training program to generate skilled human resources for hospitals

  • Posted on: 13 January 2020
  • By: PharmaTutor News

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.

FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

  • Posted on: 10 January 2020
  • By: Shalini.Sharma

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.

FDA approves Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor

  • Posted on: 10 January 2020
  • By: admin

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.

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