Pharma News

Pharma major Cadila Healthcare on Thursday clarified that products from its Moraiya and Ahmedabad plants in Gujarat were safe in the market and effective.

Taking a high dose of vitamin D could be an inexpensive and easy way to treat people with multiple sclerosis (MS), an autoimmune disorder that affects the brain and spinal chord, suggests promising new research.

The city-based Asian Institute of Gastroenterology on Wednesday claimed that it successfully used a new technique for treatment of gastro-esophageal reflux disease (GERD), usually termed as acidity.

Formulating drugs as liquid salts may provide a safe and efficient strategy for topical delivery of drugs that cause skin toxicity, say researchers, including one of Indian-origin. A novel formulation of the drug propranolol as a liquid salt enables delivery through skin with reduced toxicity, the findings showed.

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BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for KyndrisaTM (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.

Faron Pharmaceuticals Ltd (Faron), the clinical stage biopharmaceutical company, has announced the enrollment of the first patient in the phase III INTEREST clinical programme for Traumakine for the treatment of acute respiratory distress syndrome (ARDS). Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs.

REGENXBIO Inc.  a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy,  announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-111, the Company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis Type I (MPS I).

Amarantus Bioscience Holding Inc. , a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.