Topic:

Regulatory

Latest Headlines

Latest Headlines

EU's third pay-for-delay action nails Servier, Teva, Mylan and others

European regulators are getting the hang of levying pay-for-delay penalties, rolling up 6 companies in its latest action and fining them more than half a billion dollars in the process.

Zimmer, Biomet hit regulatory speedbump in pending merger

Zimmer's planned acquisition of Biomet may have hit a speedbump, as the U.S. Federal Trade Commission requested additional information regarding the companies' pending deal.

NeuroMetrix gains on FDA clearance of over-the-counter wearable chronic pain device

NeuroMetrix CEO Dr. Shai Gozani told FierceMedicalDevices that the now-FDA-cleared, over-the-counter version of its wearable therapeutic, the Sensus Pain Management System, will enable the company to pursue further innovations to the device that are not possible in the prescription market.

As FDA regulations tighten, report says antimicrobial market headed for a crash

As the FDA continues its effort to phase out antimicrobials, the numbers aren't looking so good for the contracting market.

FDA prepares to weigh risks of uterine fibroid removal tool

After months of warnings and a debate over the safety of laparoscopic power morcellators, the FDA begins its formal decisionmaking process July 10, when the Obstetrics and Gynecology Devices Advisory Committee convenes for two days in what will be one of the agency's most prominent meetings of the year.

Move by French government encourages docs to use Roche's Avastin over Lucentis

Roche's Avastin is often prescribed off label as a cheaper alternative to its Lucentis for treating wet age-related macular degeneration. Now French lawmakers are encouraging the practice as a way to save the country money.

Novartis accused again of kickback tactics in new whistleblower suit

Kickback accusations have yet again been raised against Novartis, a company that four years ago promised to live by a new integrity code. A former exec now suggests she was fired for suggesting similar methods in the way Novartis planned to award a contract to wholesaler and health services company McKesson.

Ulthera device clears FDA for décolleté on heels of Merz acquisition plans

Merz already committed to buying Ulthera for up to $600 million in cash and milestones. Now it will get another FDA-cleared indication as part of the bargain. The company's system has cleared the FDA to improve the lines and wrinkles of the décolleté.

Novartis' leading CAR-T cancer therapy gains breakthrough status at the FDA

The FDA has provided its special 'breakthrough' status for Novartis' closely-watched development program for a personalized CAR-T cancer therapy, promising to help speed development for engineered T cells.

Bristol-Myers' hep C combo wins Japanese OK, leading the pack

Bristol-Myers Squibb has become the first drugmaker to win regulatory approval for a combination hepatitis C treatment that doesn't require painful injections, picking up a Japanese nod for its all-oral cocktail.