Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA cracks down on power morcellator devices in updated safety guidance

Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.

U.K. gatekeepers toughest on cancer meds--and getting tougher all the time

The U.K.'s cost gatekeeper is notoriously strict when it comes to approving drugs, shooting down meds based on strict cost-effectiveness standards or saddling them with restrictions. But cancer drugs could face the toughest road ahead, as a new report shows that the National Institute of Health and Care Excellence is less likely to green-light the meds compared to other classes of drugs.

Feds want more trial results made public

The Department of Health and Human Services and the National Institutes of Health are proposing new rules that would greatly expand the number of clinical trials required to publicize their results, a move that could change how CROs handle data.

CAR-T player Juno picks up 'breakthrough' status for lead cancer therapy

Biotech upstart Juno Therapeutics has added an FDA "breakthrough" drug title to its considerable list of accomplishments, gaining regulators' commitment to hurry along a lead cancer program to a potential approval.

FDA approves Avantis Third Eye device for colonoscopies

The FDA approved Avantis Medical's colonoscopy imaging device that is capable of showing a wide-angle image of more than 300 degrees during colorectal cancer screening procedures.

EMA, like FDA, says testosterone-raising drugs are not for lifestyle use

The European Medicines Agency has thrown more cold water on sales of testosterone-raising meds as a party drug for aging men. The agency said today that the evidence is inconsistent about the cardio risks of the drugs, but they should only be reserved to treat men whose level is low because of a medical condition.

Sanofi nears European Gaucher market shakeup with EMA recommendation

In August, Sanofi's Genzyme won the FDA's blessing to take brand-new orphan drug Cerdelga into the U.S. Gaucher disease market, where the company hoped the pill could show up older, intravenous treatments. And now, it could be on its way to the same opportunity in the EU.

Beware sketchy biotechs with big plans for Ebola, SEC says

The SEC has suspended the trading of a few microcap companies touting unverified Ebola treatments and tests, warning investors of penny stock peddlers looking to cash in on the West African outbreak that has killed thousands.

Novartis' Enbrel beater bounds toward psoriasis approval ahead of the crowd

Novartis is well on its way to leading a new class of anti-inflammatory treatments, convincing European regulators to recommend approving its injected therapy for psoriasis and putting the company in line for transatlantic launches next year.

Boehringer one step closer to challenging Roche in Europe with EMA IPF nod

Boehringer Ingelheim's Ofev and Roche's Esbriet became the first two U.S.-approved treatments for idiopathic pulmonary fibrosis when the FDA green-lighted them on the same day last month. And while Roche has the lead with Esbriet in Europe, Boehringer is now one step closer to leveling the playing field on the continent.