Pharma News

Synthetic Biologics, Inc., a developer of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA).

Novel biological markers have discovered by researchers from Finland and Estonia  that are strongly indicative of risk of dying from any disease within the near future. Blood samples from over 17000 generally healthy people were screened for more than a hundred different biomolecules. The health status of these study volunteers was followed for several years. The researchers looked for measures in the blood that could reflect who had died within the following 5 years after the blood sample was taken. In a study published in PLOS Medicine, they describe identification of four such biomarkers of death.

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,

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.

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.