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Vericel Corporation

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Latest From Vericel Corporation

Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

FDA Drug Approval Standards

Sandoz: Big Cap Biosimilar Rivals Lack Clarity On Commitment

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Biosimilars Strategy

Amylyx Relyvrio: Pricing, Compounding, And The Shadow Of Makena

The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.

Approvals Intellectual Property

Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim

The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals
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Company Information

  • Industry
  • Pharmaceuticals
  • Medical Devices
    • Biomaterials
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
  • Other Names / Subsidiaries
    • Aastrom Biosciences, Inc.
    • Genzyme Biosurgery
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