Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA lifts a hold on Flexion pain drug

Burlington, MA-based Flexion says that the FDA has lifted its clinical hold on its lead pain drug candidate, FX006.

NICE changes its attitude on Roche's Gazyvaro

Months after the U.K.'s drug price watchdog the National Institute for Health and Care Excellence gave a preliminary thumbs-down to Roche's Gazyvaro for chronic lymphocytic leukemia, the agency is now set to recommend the drug in new draft guidance with a few strings attached.

Cepheid wins FDA nod for norovirus test

Cepheid scored an FDA OK to market its next-generation in vitro test for norovirus, helping the company generate some upward momentum as it ramps up its molecular diagnostic platform.

FDA approves Animas insulin pump, continuous glucose monitor combo device

The U.S. Food and Drug Administration has approved the Animas Vibe, a combination insulin pump and continuous glucose monitor. It allows patients with Type 1 diabetes to monitor blood glucose levels and adjust insulin delivery based on that data.

FDA slaps Dr. Reddy's with a Form 483

The FDA has slapped Dr. Reddy's Laboratories with a Form 483 letter, outlining concerns about the drugmaker's manufacturing plant in southern India, the company said.

Takeda scores a 'breakthrough' tag for PhIII rare disease drug

The FDA has branded Takeda's top late-stage drug prospect--ixazomib (MLN9708), a multiple myeloma treatment designed to succeed the top-selling blockbuster Velcade--as a "breakthrough" therapy deserving VIP status with regulators.

Medtronic gets EU regulatory green light for $43B merger with Covidien

Medtronic scored EU regulatory approval for its $43 billion acquisition of Covidien, days after U.S. antitrust authorities signed off on the deal subject to certain conditions.

FDA slaps down Bristol-Myers' marketing pitch for hep C drug daclatasvir

The FDA has slapped down Bristol-Myers Squibb's closely watched hep C drug daclatasvir, handing out a complete response letter for the linchpin drug in its cocktail strategy.

Japan begins regulating medical devices separately from drugs, aims to approve them faster than U.S.

Industry applauded Japan's initiative to create a medical device regulatory regime distinct from that for pharmaceuticals.

Valeant CEO touts R&D output with new dermatology approval

Less than two weeks after losing longtime acquisition target Allergan--which happily sold itself to Actavis to dodge Valeant's hostile bid and the R&D cuts it feared would come along with it--the Canadian pharma is talking up the productivity of its own labs.