Think tank: Let EMA-approved drugs onto U.S. market

Over the last two years the EMA and the FDA have approved a total of 39 new drugs. But 11 of those drugs are only available in Europe, where regulators also scored significantly faster approval times, shaving 97 days off the FDA average. And those stats spurred a think tank called the Pacific Research Institute to suggest that the U.S. would be far better off if it allows pharma companies the right to go ahead and start marketing drugs here once they get an approval over there. "Clearly,...

Basilea sees another ceftobiprole rejection, isavuconazole delay

Swiss biotech Basilea Pharmaceutica saw its shares decline Friday after the European Committee for Medicinal Products for Human Use confirmed its previous negative opinion on the marketing authorization application for ceftobiprole to treat complicated skin and soft tissue infections. The news comes as Basilea's Japanese partner Astellas Pharma said it was expanding a late-stage trial of the antifungal isavuconazole, delaying the release of data up to 18 months. For ceftobiprole, the CHMP...

EMA recommends Merck heart drug

The European Medicines Agency has recommended Merck's drug Brinavess, or vernakalant, as a treatment for acute atrial fibrillation, or irregular heart beats, the London-based regulator said on Friday. Release |...