Pharma News

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.

Daiichi Sankyo Company, Limited announced that its wholly owned subsidiary, Daiichi Sankyo Korea Co., Ltd. (hereafter “DSKR;” headquarters: Jongno-gu, Seoul, South Korea), and Daewoong Pharmaceutical Co., Ltd. (hereafter “Daewoong Pharmaceutical;” headquarter: Gangnam-gu, Seoul, South Korea) have signed an agreement for the co-promotion of the oral, once-daily anti-coagulant, LIXIANA® (generic name: edoxaban).

Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement.

A new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy, also has potential to combat other types of cancer, new research has found.

The World Health Organisation on Tuesday declared the end of the Ebola outbreak in the West African nation of Guinea, two years after the beginning of the epidemic.

A newly created antibody could treat the decline in muscle mass and power associated with ageing, show results of a phase-two trial by an international research team.