Cangene ditches European app for hemophilia drug

Canadian biotech Cangene has scuttled an application for approval of a hemophilia drug candidate called IB1001 in Europe, after regulators asked for more clinical data to support its submission. The FDA has also denied approval of the Factor IX therapy for patients with the rare bleeding disorder called hemophilia B. Cangene acquired the program from financially distressed Inspiration Pharmaceuticals and its partner Ipsen in February. It plans to re-file for approval in the European Union and answer questions raised by U.S. regulators. Release

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.