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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.
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'.
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.
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.
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, and pure autonomic failure.
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.
Avaxia Biologics, Inc., a clinical-stage biopharmaceutical company developing gut-targeted therapeutics, announced on 11th feb, 2014 that the company was awarded U.S. Patent No. 8,647,626, entitled “Compositions Comprising TNF-specific Antibodies for Oral Delivery.”
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-line strategy. But some patients do not tolerate or respond to high-intensity statin monotherapy due to adverse effects or those who have limited LDL cholesterol response.
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. Aires' lead product, AIR001, is an intermittently nebulized formulation of nitrite and has orphan drug status with the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of pulmonary arterial hypertension.