Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FDA delays UDI labeling requirements by two years for some orthopedic devices

The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly.

AbbVie gets an EU green light for its next-gen hep C treatment

AbbVie is one step closer to challenging Gilead Sciences' dominance in the hepatitis C market, securing a likely European approval for its rival combo treatment as it awaits a U.S. nod.

NIH cites European precedent in call for disclosure of clinical trial data

If the U.S. National Institutes of Health gets its way, any researcher it funds will have to publish a summary of their clinical trial results and adverse events, regardless of whether the trial succeeded or failed.

FDA approves Purdue's abuse-resistant Hysingla, a hydrocodone pill aimed at knocking off Zohydro

The FDA has faced a firestorm of criticism since approving Zogenix's superstrength painkiller Zohydro last year, drawing outcry from lawmakers and industry groups concerned with the drug's all-hydrocodone formula. Now, discontent could swell even further as the agency signs off on Purdue Pharma's opioid treatment Hysingla for chronic pain.

Purdue wins a pain pill approval with Zohydro in its crosshairs

The FDA approved Purdue Pharma's latest pain drug, a hydrocodone formulation designed to prevent abuse, potentially spelling trouble for Zogenix and its controversial Zohydro.