(Reuters) – The U.S. Supreme Court on Monday brought to an end Bristol-Myers Squibb Co’s attempt to revive patent protection for its Baraclude treatment for hepatitis B. The high court declined to hear Bristol-Myers’ challenge to an appeals court ruling in favor of generic rival Teva Pharmaceutical Industries Ltd, which had successfully challenged the patent. […]

CHAPEL HILL, N.C., May 1, 2015 /PRNewswire/ — The breakthrough hepatitis C treatment, Sovaldi faced backlash from payers for its high price but manufacturer Gilead Sciences overcame initial market resistance through its patient support programs, strategic worldwide pricing, and effective public relations campaigns. Sovaldi’s high cure rate, short dosing period, and promise of less severe […]

MONMOUTH JUNCTION, N.J., May 1, 2015 /PRNewswire/ — Vernalis plc and Tris Pharma Inc. today announce that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII (DEA Schedule III).  Tuzistra XR is an extended-release oral suspension combination of […]

LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA–(Marketwired – Apr 30, 2015) – GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is […]

(Reuters) – The U.S. Food and Drug Administration on Thursday approved the sale of Breo Ellipta as a once-daily treatment for asthma in patients aged 18 and older, GlaxoSmithKline and Theravance Inc said.   The FDA declined to approve Breo for younger asthma sufferers. The agency, in a so-called complete response letter, told the companies […]

(Reuters) – The U.S. Food and Drug Administration on Thursday approved The Medicines Co’s dry powder blood-clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The treatment, Raplixa, is a combination of two human plasma-derived blood-clotting proteins – fibrinogen and thrombin. (1.usa.gov/1HVGQSd) Raplixa is used to control bleeding […]

LONDON and SAN FRANCISCO, April 30, 2015 /PRNewswire/ — GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the […]

WOODCLIFF LAKE, N.J., April 30, 2015 /PRNewswire/ — Eisai Inc. and Eisai Co., Ltd. have entered into a settlement agreement with Glenmark Pharmaceuticals, Ltd., Glenmark Generics Ltd., and Glenmark Generics, Inc., USA (“Glenmark”), to resolve their patent litigation relating to Eisai’s BANZEL® (rufinamide) in the United States. As a result of the settlement, Glenmark will be […]

(Reuters) – Celgene Corp’s dependence on its big-selling multiple myeloma drug Revlimid raised investor concerns on Thursday as sales of its other medicines fell short of expectations. Celgene shares fell 5 percent after the company reported quarterly results in which Revlimid shored up profits. Industry analysts see room for Revlimid to grow much further, with […]

(Reuters) – Four brand-name medications accounted for almost one-tenth of the $103 billion in prescriptions filled by older or disabled Americans under Medicare’s drug program in 2013, U.S. officials reported on Thursday. The Centers for Medicare and Medicaid Services (CMS) said AstraZeneca Plc’s Nexium “purple pill” for acid reflux topped the list with prescriptions totaling […]