Oxygen Biotherapeutics Inc. has decided to stop a phase IIb trial of Oxycyte for traumatic brain injury after difficulty recruiting patients made it clear the company wouldn't be able to complete the program as soon as it had hoped.
Just a day after the FDA cleared a fourth drug to treat obesity, the agency's Metabolic Drugs Advisory Committee (adcom) on Thursday voted 14-1 to recommend that the agency approve Saxenda, a 3-mg dose of the Novo Nordisk A/S drug liraglutide for adult obesity ahead of its Oct. 20 PDUFA date.
A Mylan Inc. subsidiary will pay up to $300 million to acquire U.S. commercialization, marketing and IP rights for the anticoagulant Arixtra (fondaparinux) and an authorized generic (AG) of the drug from Aspen Global Inc. in a deal it said will be immediately accretive to adjusted earnings.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets Thursday to review Saxenda (liraglutide) to treat obesity. If the drug passes muster, it could give Novo Nordisk A/S a new entry into the market for weight loss therapies and extend use of the drug, which is already sold at a lower dose as Victoza for type 2 diabetes.
Replicel Life Sciences Inc. is ramping up its pipeline of autologous cell therapies with intentions to file within the next several weeks its plans to initiate early stage trials of its therapies for chronic Achilles tendinosis and aging and sun-damaged skin ahead of pre-trial meetings with Shiseido Co. Ltd., the world's fourth largest cosmetics company and its partner on a developing hair regeneration therapy.
Global pharma sales are on track to exceed $1 trillion for the first time in 2014 as drugmakers refine their abilities to explore new scientific opportunities and learn to let go of faltering projects earlier rather than later, according to analysis by CMR International, a Thomson Reuters business.
Abbvie Inc. and Google-backed California Life Sciences LLC, better known as Calico, have agreed to pour up to $750 million each into a new discovery and development collaboration devoted to advancing neurodegeneration and cancer therapies through phase IIa and beyond.
United Therapeutics Corp. has prevailed in a legal effort to slow Sandoz Inc.'s plans to launch a generic version of the pulmonary arterial hypertension (PAH) therapy Remodulin (treprostinil), a drug that accounted for 44 percent of its revenue last year. The patent case ruling forestalls generic competition from Sandoz for at least three years and may block an additional challenge from Teva Pharmaceutical Industries Ltd. until then as well.
Isis Pharmaceuticals Inc. initiated a six-month global phase III study of ISIS-APOCIIIRx, a triglyceride-lowering drug it plans to submit for FDA review in 2016. About 50 patients with the rare genetic condition familial chylomicronemia syndrome (FCS) will participate in the trial, which will measure as its primary endpoint percent change in fasting triglycerides from baseline at 13 weeks.
Riding high on a string of successful exits, Arch Venture Partners said Wednesday it closed its eighth fund with more than $400 million in subscriptions, exceeding its $250 million target by more than $150 million. The venture capitalist (VC) traditionalist plans to deploy the fund exclusively in early stage technologies it believes will fundamentally change the health care, energy and materials sectors.
