Topic: European Medicines Agency
After a tough year in the competitive MS field, Sanofi’s Lemtrada could hardly afford another setback. But that’s exactly what it got.
Tesaro is in strong position to win another regulatory victory for its drug Zejula, which could boost its standing in the market for PARP inhibitors to treat ovarian cancer.
Another U.S. contract manufacturer has run into problems with European authorities for failing manufacturing standards, leading the European Medicines Agency to announce that its manufacturing certification has been pulled and a recall has been recommended.