The FDA slapped GE Healthcare with a Class I recall--its most serious designation--for its infant resuscitation devices after the company found that malfunctions in the product could cause death.
It's fairly routine for the U.K.'s cost-effectiveness watchdogs to ask companies for more data to support approval for use by the country's National Health Service. Clinical data, price modeling, the works. But asking for information on R&D costs? That's something different altogether.
Shares of Oxygen Biotherapeutics shot up 30% Tuesday morning after the Morrisville, NC-based biotech announced that the FDA had lifted a clinical hold on Oxycyte, an experimental drug the military has been supporting as a possible treatment for traumatic brain injury.
Germany's Biotronik said it gained a new CE mark for a bipolar cardiac resynchronization therapy lead that is super-small and MRI-safe.
The German government has decided to extend a drug-pricing freeze through 2017.
Drugmaker Questcor has run into questions--sometimes from regulators--about sales and marketing for its high-priced drug for autoimmune disorders, H.P. Acthar Gel. And every step of the way, short seller Citron Research has been there to trumpet those mishaps.
Generic drug companies are fighting back against a new FDA proposal that would require them to update product labeling as soon as they learn of new safety information. The rule would essentially overturn a 30-year-old law--and put companies on the hook for liability lawsuits.
Covidien won CE mark approval in Europe for its new acute care ventilation system.
Jubilant Life Sciences says the FDA has given it a clean bill of health on a facility in Montreal, Canada, that was issued a warning letter in February 2013. The drugmaker has another facility in Spokane, WA, where the FDA still has concerns.
Amarin, which has faced a series of setbacks getting its fish oil pill to market, is lashing out at the FDA for some of its problems, Bloomberg reports.