17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
18:02 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

FDA approves Bayer's recombinant Factor VIII for hemophilia A

FDA approved a BLA from Bayer AG (Xetra:BAYN) for Jivi damoctocog alfa pegol (BAY94-9027) to treat hemophilia A in patients ages 12 and older. Bayer told BioCentury the product will be launched the first week...
19:00 , Nov 3, 2017 |  BC Week In Review  |  Clinical News

FDA accepts for review Bayer's BAY 94-9027 to treat hemophilia A

Bayer AG (Xetra:BAYN) said FDA accepted for review a BLA for BAY 94-9027 to treat hemophilia A in adults and children aged 12 and older. The company declined to disclose the therapy's PDUFA date. The...
22:04 , Oct 30, 2017 |  BC Extra  |  Company News

FDA accepts Bayer’s BLA for hemophilia A candidate

Bayer AG (Xetra:BAYN) said FDA accepted for review a BLA for BAY94-9027 to treat hemophilia A in adults and children aged 12 and older. The company declined to disclose the therapy's PDUFA date. The BLA...
23:30 , Sep 26, 2017 |  BC Extra  |  Company News

GSK, Gilead, Shire gain RDPAC membership

China’s R&D-based Pharmaceutical Association Committee (RDPAC) approved new member applications from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Gilead Sciences Inc. (NASDAQ:GILD) and Shire plc (LSE:SHP; NASDAQ:SHPG). In 2013, media outlets reported that GSK voluntarily withdrew its membership...
00:41 , Mar 25, 2017 |  BioCentury  |  Strategy

Mountain climbing

U.S. pricing pressure on insulin and hemophilia products have caused Novo Nordisk A/S to guide for negative sales and operating profit growth for the first time ever. While newly launched diabetes and obesity products are...
02:38 , Feb 11, 2017 |  BioCentury  |  Strategy

Building Bioverativ

Biogen Inc. ’s newly minted hematology spinout Bioverativ Inc. will have at least three years to build market share for its hemophilia therapies and flesh out its pipeline before gene therapies potentially hit the market....
20:48 , Jan 13, 2017 |  BC Week In Review  |  Clinical News

Afstyla regulatory update

The European Commission approved an MAA from CSL for Afstyla lonoctocog alfa for treatment and prophylaxis of bleeding in patients with hemophilia A. CSL plans to launch Afstyla in Europe “in the coming months.” The...
00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are...