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Latest From Biogen, Inc.
The Swiss major is close to its first submission for ‘pipeline in a pill’ iptacopan but has conceded defeat with branaplam as a potential treatment for Huntington’s disease.
US Medicare Payment Advisory Commission likely to recommend that drugs granted Accelerated Approval be subject to some form of price cap when confirmatory clinical data is lacking. The idea has a lot of supporters, but even they seem a bit unclear about how it could actually work.
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
Investigational drugs from Outlook Therapeutics and Vertex/CRISPR could become first-of-their-kind products if they win marketing approval.
- Specialty Pharmaceuticals
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
- Biogen Idec
- Convergence Pharmaceuticals Ltd
- Nightstar Therapeutics plc
- Stromedix, Inc.
- Syntonix Pharmaceuticals
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