After a touch-and-go review from FDA staff, Takeda's inflammatory bowel disease drug had an easier time convincing an agency advisory panel of its safety and efficacy. But while an FDA committee took little issue with vedolizumab's risk profile, Takeda may have a hard time convincing regulators to make its treatment a first-line therapy.
Biogen Idec has encountered its share of manufacturing headaches because of the multiple sclerosis drug Tysabri that it acquired from Elan. It will now have to add to that list some limited FDA concerns over its API manufacturing.
Doctors and patients have been waiting impatiently for the big FDA approval on Friday: Gilead Sciences' breakthrough hepatitis C treatment sofosbuvir, now dubbed Sovaldi. But so have some of Gilead's fiercest critics, and those groups came out swinging.
India's Jubilant Life Sciences has received a second warning letter this year for its operations in North America. This time, the company landed in hot water for problems at its Jubilant HollisterStier sterile manufacturing plant in Spokane, WA.
When MedImmune won approval for its quadrivalent nasal flu vaccine back in February 2012, it kicked off the battle to claim a share of the next-generation influenza immunization market. Now, almost two years later, its parent company AstraZeneca has the race underway in Europe, too.
The FDA backs a market that lets consumers easily gain information about their genomes and genetic risks, an agency official said, despite its move to stop 23andMe from selling its direct-to-consumer health-related genetic tests until they obtain formal regulatory approval.
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 European Medicines Agency has decided to look again at the clotting risks of Ariad Pharmaceuticals' troubled cancer drug Iclusig.