DURECT announced its licensee, Pain Therapeutics, has resubmitted the New Drug Application for REMOXY (oxycodone capsules CII) to the U.S. Food and Drug Administration.

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

November 18, 2015By Mark Terry, BioSpace.com Breaking News Staff   Waltham, Mass.-based Radius Health, Inc. (RDUS), announced yesterday that it has sent a Marketing Authorization Application (MAA) to European regulatory agencies for its abaloparatide-SC for postmenopausal osteoporosis. At the same time, the company indicated that it is delaying its New Drug Application (NDA) to the […]

PHILADELPHIA, Oct. 19, 2015 /PRNewswire/ — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016. Calcitonin has been available as […]

European pharmaceuticals group Sanofi on Tuesday said its application for review for its new drug, lixisenatide, a diabetes treatment, had been accepted by the U.S. Food and Drug Administration.   (Reporting by Astrid Wendlandt) Source: Reuters Health

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or […]