The FDA late Friday approved Sovaldi, a highly anticipated hepatitis C drug from Gilead Sciences that is expected to change the face of treatment for the difficult condition while earning up to $7 billion a year for the company.
Auxilium Pharmaceuticals has nabbed a new indication for its Xiaflex injection. The FDA has approved it for treating Peyronie's disease, which causes a painful curvature of the penis, an indication that may add $100 million in sales in the next 5 years.
The FDA has stamped its approval on sofosbuvir for hepatitis C, perhaps one of the most anticipated new drugs of the year. Gilead's therapy, which will be marketed as Sovaldi, will open the door to a new generation of treatments that don't require interferon--freeing patients from an arduous regimen tied to a host of nasty side effects.
The industry has been talking about, and slowly working toward, track-and-trace for many years. Now Pharma faces real deadlines that require action.
The European Medicines Agency has decided to look again at the clotting risks of Ariad Pharmaceuticals' troubled cancer drug Iclusig.
Notching another CE mark in its cardiac cache, Italian devicemaker Sorin nabbed European approval for its Intensia family of implantable cardiac defibrillator and cardiac resynchronization therapy devices.
California's 23andMe has capitulated to the FDA, agreeing to regulators' demands to stop selling all health-related genetic tests while it submits them for a formal regulatory review.
Thursday, Sanofi's multiple sclerosis drug Lemtrada was stymied by the U.K.'s cost-effectiveness gatekeeper, which asked for more data on the med before it could determine its worth. But just one day later, the regulatory body gave Sanofi's MS franchise a boost: It has recommended Aubagio, its oral treatment, for use in Britain's National Health Service.
Jarvik Heart won Japanese regulatory approval for its left ventricular assist device, bringing its heart pump rivalry with Thoratec to Asia. Japan's Pharmaceuticals and Medicines Devices Agency signed off on the Jarvik 2000 Heart based on Japanese and U.S. clinical trial data, approving it as a bridge to transplant.
FDA staff has taken issue with Takeda Pharmaceutical's vedolizumab, warning that the treatment for inflammatory bowel diseases could put patients at risk for a rare but deadly brain infection, possibly outweighing its benefits.