Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: Boehringer's Pradaxa fights to regain ground with new clot-fighting approval

Boehringer Ingelheim, determined not to let clot-fighter Pradaxa be outdone by Bayer and Johnson & Johnson's Xarelto, has added a couple of new uses to the drug's label, snagging the FDA's okay to treat deep vein thrombrosis (DVT) and pulmonary embolism (PE) in some patients. But it still has a long way to go--and some safety concerns to dispel--before it can retake the anticoagulant throne.

Zogenix sues Massachusetts over ban on controversial painkiller Zohydro

In late March, Massachusetts Governor Deval Patrick banned the newly approved purely hydrocodone pain pill Zohydro--and now the maker of that drug is fighting back. Zogenix filed a lawsuit in a Boston federal court seeking a restraining order against the governor's Zohydro ban.

FDA is adding inspectors in China but for now it has only 2

The FDA has been trying for several years to expand its inspection staff in China, a country that accounts for many of the active pharmaceutical ingredients used in U.S. drugs. But according to testimony in a hearing last week, the agency currently has only two drug inspectors stationed in the country.

If GSK's chief wants to be Mr. Clean, he needs to get out the broom

GlaxoSmithKline says it's rolling out sales and marketing reforms around the world. Apparently, the changes come none too soon. The British drugmaker opened another bribery investigation, this time in Iraq, to check out allegations that it paid government-employed physicians to promote its products.

Edwards Lifesciences wins CE mark for aortic valve system

Edwards Lifesciences won a CE mark for its innovative aortic valve system. European approval for the device comes at a critical moment for the company, as it attempts to strengthen its hold on foreign markets and stay a step ahead of its competition.

Novartis' Bexsero wins FDA 'breakthrough' status

A couple of weeks ago, the FDA handed Pfizer's meningitis B candidate its breakthrough therapy designation, setting it up for a race to market with Novartis' Bexsero. Now, the Swiss company's jab has one to match, meaning it may not be long before it can start contributing some much-needed sales to Novartis' vaccines unit.

Sanofi misled investors with rosy Lemtrada predictions, lawsuit alleges

Sanofi investors are fed up with disappointing news on the multiple sclerosis drug Lemtrada. Vaunted as a potential blockbuster, the drug hasn't even made it to market in the U.S. Now, some investment funds are suing the French drugmaker, saying executives talked up Lemtrada in public--and kept bad news from the FDA private.

Sanofi decides to take a second shot on Lemtrada app

Sanofi is walking away from any plans to appeal the FDA's emphatic rejection of the multiple sclerosis drug Lemtrada, at least for now. But rather than launching the added trial that the FDA demanded ahead of any possible approval, the company thinks it has a shot at answering the FDA's concerns with a new application.

British cost watchdog backtracks again on Roche's Tarceva

After intitially recommending Roche's targeted cancer drug Tarceva for use by Britain's National Health Service, the U.K.'s National Institute for Health and Care Excellence said in February it was reviewing the recommendation. Now, it looks likely to revert back to its original stance--a reversal of fortune the Swiss drugmaker is pleased with.

AbbVie gets out of the way as the EU prepares for trial transparency

Amid a continental push to make more clinical trial results available to the public, the European Medicines Agency has apparently assuaged a former foe in AbbVie, as the drugmaker dropped a lawsuit designed to block the release of data on its blockbuster Humira.