Topic:

Regulatory

Latest Headlines

Latest Headlines

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The battle is heating up over the FDA's draft guidance on the oversight of lab-developed tests, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.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

With Duaklir nod in EU, AstraZeneca scores first new drug from Almirall buyout

With the EU approval of COPD med Duaklir, AstraZeneca is getting exactly what it wanted when it sealed a deal for Almirall's respiratory portfolio earlier this month. The only problem? Calling the market crowded is an understatement.

Covidien reveals that it is under federal subpoena

In its annual 10-K filing with the SEC, Covidien quietly noted that it is under a federal subpoena related to some of its  peripheral vascular products.

AstraZeneca's Almirall buy yields its first new drug--and now, AZ has to sell it

With the EU approval of COPD med Duaklir, AstraZeneca is getting exactly what it wanted when it sealed a deal for Almirall's respiratory portfolio earlier this month. The only problem? Calling the market crowded is an understatement.