Topic:

Regulatory

Latest Headlines

Latest Headlines

Amarin loses a second FDA appeal over omega-3 pill Vascepa

Amarin and its omega-3 pill have struck out with the FDA again. The Irish company said today that the agency has again turned down its appeal to reconsider its clinical data it hoped would help it win a label extension for Vascepa, dealing a new blow to its efforts and its financial well being. This FDA first rejected Amarin's request in January.

Medtronic receives 510(k) for new balloon catheter

Medtronic yesterday announced FDA 510(k) clearance of the NC Euphora Noncompliant Balloon Dilatation Catheter to encourage stent apposition to the artery wall.

FDA panel backs Novo's weight-loss plan with new liraglutide nod

Novo Nordisk convinced a group of FDA advisers that its liraglutide, already a blockbuster diabetes treatment, can effectively combat obesity, clearing the way for a second indication that could add $1 billion to its annual sales.

Pre-chemo nod for Medivation's Xtandi sets up showdown with J&J's Zytiga

Johnson & Johnson's next-gen prostate cancer pill, Zytiga, has been cruising since it hit the market back in April 2011, but now, it may be vulnerable to market share losses for the first time. The FDA has approved Medivation and Astellas' rival, Xtandi, for use in prostate cancer patients before chemo, giving the pill a head-to-head shot at J&J's blockbuster.

Takeda preps to launch Orexigen's obesity drug Contrave as Novo's Saxenda looms

Yesterday, Orexigen won FDA approval for its obesity drug Contrave, but with a "black box" warning on side effects. And patients could have yet another weight-loss choice, as a panel of FDA advisers meet today to weigh Novo Nordisk's rival drug, Saxenda.

ACT, ex-CEO hit with $550K in SEC penalties for keeping mum on insider stock sales

Between 2010 and 2012 Gary Rabin, then CEO of the stem cell player Advanced Cell Technology, sold $1.5 million worth of his shares in 27 transactions. But according to the SEC, Rabin never told investors of his stock sales--a strict no-no that is now costing the ex-CEO a $175,000 penalty, with the Marlborough, MA-based biotech company agreeing to fork over $375,000 as it reviews its compliance policy.

FDA approves Sanofi's Menactra as meningococcal booster

The new nod could boost sales of the French drugmaker's vaccine, a lift it could use after Menactra's top-line haul in 2013 sank to €424 million in a 21.5% slide.

Takeda on track for dengue vaccine nods in 2017-18

Sanofi's dengue vaccine isn't slated to hit the market until late next year, pending approval, but it already has some competition on the horizon. Takeda has its eye on nods in the U.S. and Europe for its own candidate by the 2017-18 fiscal year, it says.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.

UPDATED: Orexigen nabs long-awaited FDA approval for obesity drug Contrave

More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug.