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Biogen, Inc.

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Latest From Biogen, Inc.

Accelerated Approval Price Caps: Policy Has High Profile Support – But Can It Be Done?

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.

Pricing Debate Review Pathway

End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

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. 

Pink Sheet Perspectives US FDA Performance Tracker

Ophthalmic Bevacizumab & CRISPR-Based Gene Therapy Among Latest EU Filings

Investigational drugs from Outlook Therapeutics and Vertex/CRISPR could become first-of-their-kind products if they win marketing approval.

Europe Drug Review

Deal Watch: Sol-Gel To Tackle Gorlin Syndrome In Pact With BridgeBio’s PellePharm

Shoreline picks up technology platform rights and access from Editas, which recently reduced staff. Hyloris out-licenses commercial rights to Maxigesic in nine EU markets to Salus.

Deal Watch Business Strategies
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Company Information

  • Industry
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Macromolecule
  • Biotechnology
    • 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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