February 2016

Researchers have identified a new group of powerful Ebola-fighting antibodies from the blood of a survivor of the 2014 outbreak of the deadly disease.

A team of US researchers, including an Indian-origin scientist, has developed a simple blood test that can accurately diagnose active tuberculosis (TB) - a disease that globally infects 9.6 million people each year and kills 1.5 million.

Researchers from Belgium have discovered a mechanism for the better survival of implanted cells that improves in the healing of bone fractures.

Scientists have shown that a hormone instrumental in the ageing process is under genetic control, introducing a new mechanism by which genetics regulate ageing and disease.

Impax Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg.

Portola Pharmaceuticals announced  that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for andexanet alfa for filing under a priority review. Portola submitted the BLA in December 2015 under an Accelerated Approval pathway. The FDA is expected to take action on the application by the Prescription Drug User Fee Act (PDUFA) action date of August 17, 2016.

Roche announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM) for the treatment of people with primary progressive multiple sclerosis (PPMS). There are currently no approved treatments for PPMS, a debilitating form of MS characterised by steadily worsening symptoms and typically without distinct relapses or periods of remission.