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Latest From Ipsen SA
Sponsors Aim To Avoid Confirmatory Trial Hurdles That Plagued Ocaliva In Primary Biliary Cholangitis
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion.
Stock Watch: When Development Goes Too Far
R&D managers can sometimes drive a drug’s development despite evidence of its unviability. This has recently resulted in a scramble to adjust in-progress trial protocol and post-approval cost-effectiveness concerns.
News We’re Watching: New OPEQ Head, Constructive Bio Funding Round, Natera Wins Injunction In Patent Suit
This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.
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.
Company Information
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- Biotechnology
- Pharmaceuticals
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Pharmaceuticals
- OTC, Consumer
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
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- Clementia Pharmaceuticals, Inc.
- Epizyme, Inc.
- Ipsen Bioscience, Inc.
- Sterix
- Tercica, Inc.
- Syntaxin Ltd.
- OctreoPharm Sciences GmbH
- Octagen Corporation
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