Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Lundbeck strikes positive note with NICE nod for alcoholism med Selincro

Here's some good news for Lundbeck in an otherwise bleak week: The U.K.'s cost watchdog has endorsed its alcohol-dependence treatment, Selincro.

FDA updates Tecfidera label with info on patient's death from PML

The FDA has decided that the death last month of a patient taking Biogen Idec's hot multiple sclerosis pill Tecfidera was important enough to mention on Tecfidera labels.

Opponents of FDA's LDT regulations lawyer up, get in combat mode

The battle is heating up over the FDA's draft guidance on the oversight of lab-developed tests, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.

FDA adds PML death scenario to Tecfidera label

When Biogen Idec reported last month that a patient taking its hot multiple sclerosis pill Tecfidera had developed a rare brain infection and died, the drugmaker said it believed the safety profile of the drug remained solid. Perhaps so, but the FDA has decided the death was important enough to add a description of it on Tecfidera labels.