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  • Collaboration in pharmacovigilance strengthen by FDA and EMA

    A new "cluster" have set up on medicinal safety topics by join efforts of U.S. Food and Drug Administration and the European Medicines Agency (EMA). Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.

  • Government releases National Guidelines for Stem Cell Research

    Basic guidelines for stem cell research were released in 2007 by joint efforts of DBT & ICMR which are revised in December 2013 after evaluating development in field of stem cell research. These newer guidelines are termed as 'National Guidelines for Stem Cell Research'.

  • Expert Committee recommends amendment of D&C act and include SCCPs as new drug

    The expert committee submitted report to ministry of health and family welfare, Government of India on amendment of relevant rules in the Drugs and Cosmetics Act 1940 to include stem cells and other cell based products (SCCPs) as New Drugs.

  • Appointment of Dr. Kiran Mazumdar Shaw as the Chairperson of IIM-B

    Indian Institute of Management, Bangalore (IIM-B) is announced the appointment of Dr. Kiran Mazumdar Shaw, Chairman and Managing Director of Biocon Limited, as the Chairperson of its Board of Governors. She takes over from Mr. Mukesh D Ambani and became the first woman Chairperson of any IIM Board.

  • New Drug Approval for treatment of neurogenic orthostatic hypotension

    The USFDA approved Chelsea Therapeutics's product Northera capsules (droxidopa), orphan-product, for the treatment of neurogenic orthostatic hypotension (NOH) which is rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy,

  • Government to introduce Third Line Treatment of HIV/AIDS in 10 ART Centres across the country

    Presently, the first line and second line antiretroviral therapy (ART) is given to HIV/AIDS patients free of cost in all ART Centres across the country. The Technical Resource Group on ART on 27th December, 2013 recommended providing third line antiretroviral therapy for HIV/AIDS patients through 10 centres of excellence across the country. The process for the same has been initiated at Department of AIDS Control.

  • IMBRUVICA™ gets nod from USFDA for treatment of Chronic Lymphocytic Leukemia - rare blood and bone marrow disease

    The U.S. Food and Drug Administration expanded the approved use of Imbruvica™ which contains ibrutinib, for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy on Wednesday, 12 Feb, 2014. Imbruvica™ is manufactured by Pharmacyclics based at Sunnyvale, California.

  • Lower-intensity statin combination therapy may utilize for high-risk atherosclerotic cardiovascular disease

    For atherosclerotic cardiovascular disease risk reduction, American College of Cardiology and the American Heart Association guidelines recommend initiating moderate or high-intensity statin monotherapy as the first-lin

  • Mast Therapeutics acquire Aires Pharmaceuticals, Inc.

    Mast Therapeutics, Inc., publicly traded biopharmaceutical company headquartered in San Diego, California, announced on 10th feb, 2014 that it has entered into a definitive agreement to acquire Aires Pharmaceuticals, Inc. (Aires), a privately-held, clinical stage pharmaceutical company developing therapies to treat pulmonary vascular disorders such as pulmonary arterial hypertension and pulmonary hypertension due to heart failure.

  • Indian company just did it ! - Zydus pioneers a breakthrough with LIPAGLYN - first molecule from the Indian company

    The Zydus Group announced a breakthrough in its research efforts with Lipaglyn TM (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia or Hypertriglyceridemia in Type II diabetes, not controlled by statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, Lipaglyn TM is the first Glitazar to be approved anywhere in the world.

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