Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FDA's OK of opioid overdose treatment doesn't quell backlash over Zohydro

In the wake of the controversy over the FDA's decision to approve Zohydro, a pure hydrocodone drug that has no tamper-resistant technology tied to it, FDA Commissioner Margaret Hamburg Thursday used the approval of a new overdose treatment that anyone can carry to make her case that the FDA is just as concerned as everyone else about opioid drug abuse in the country.

Canadian drugmaker's Indian plant joins FDA import ban parade

The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.

More scrutiny, less pay? U.K. docs collected less cash from pharma in 2013

Pharma's payments to doctors are diminishing on both sides of the Atlantic. A new report in Britain finds that drugmakers forked over £38.5 million ($63.9 million) to doctors last year. That's slightly less than the 2012 total of £40 million.

My sister, and life science's limits

On a cold January morning in 2013, my big sister, Gretchen, took her last, labored breath and died. She was 46. Over the course of her last month alive, I developed a growing sense of anger and desperation at how her doctors, as well as the drug and diagnostics industries, seemed to have failed her.