Topic:

Regulatory

Latest Headlines

Latest Headlines

Novo's next-gen insulin clears a pediatric hurdle amid renewed U.S. hope

Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.

U.K. picks a controversial brain cancer vaccine as its first new 'innovative medicine'

Anxious to prove that U.K. drug regulators aren't as slow and stodgy as they're often accused of being, British officials today announced the first in a new category of experimental drugs to earn the title of "Promising Innovative Medicine."

Baxter and Halozyme sway the FDA after a painful rejection

Two years after safety concerns torpedoed their first pitch, partners Baxter and Halozyme Therapeutics have locked up FDA approval for HyQvia, a treatment for immunodeficiency.

NPS slides as faint panel praise puts FDA approval in jeopardy

NPS Pharmaceuticals walked away from an FDA panel meeting with a recommendation to approve its orphan drug, but a lukewarm reception and nagging safety concerns have investors fearing the worst.

FDA seeks input on conditional approvals for new animal health products

The FDA last week issued two separate notices that it is looking for public comment on how the regulatory agency decides conditional approvals for new animal drugs as well as how it proceeds on giving its okay for combination drugs in medicated feeds.

Application of regulatory handbrake to 23andMe offers cautionary tale to Silicon Valley

Observers tipped the arrival of Apple's long-awaited Watch to bring the worlds of health and tech closer than ever, but this week's announcement was notably light on medical uses. The failure to even mention HealthKit in the presentation has sparked discussion of Silicon Valley's wariness of healthcare regulators in the wake of 23andMe's run-in with the FDA.

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.