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Latest From Ipsen SA
Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
Intercept’s Ocaliva Falls At US FDA Panel; Is Accelerated Approval Withdrawal On The Horizon?
Obeticholic acid has not confirmed clinical benefit and the benefit-risk profile is not favorable in primary biliary cholangitis, the FDA advisory committee said. The agency must now decide whether to keep Ocaliva on the market with new study requirements or seek withdrawal.
Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
Advanz Gains Temporary Block On Ocaliva’s Removal From EU Market
Despite its legal stay of execution, lack of confirmatory data means the European Commission’s decision for market removal is likely to stand.
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- Clementia Pharmaceuticals, Inc.
- Epizyme, Inc.
- Ipsen Bioscience, Inc.
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