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Amicus Therapeutics, Inc.

Latest From Amicus Therapeutics, Inc.

US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

Pink Sheet Perspectives US FDA Performance Tracker

FTC Suit Kills Sanofi/Maze Licensing Deal; Will It Doom The Pompe Candidate?

Faced with a lawsuit asserting it had acquired an asset because it was a potential threat, Sanofi bows out of agreement to develop Maze’s GYS1 inhibitor. A test for FTC’s competition theory will be whether MZE001 eventually makes it to the market through other means.

Legal Issues Deals

BIO’s New CEO Is Biotech Industry Veteran With Compelling Family Story, Ready To Take On The IRA

John Crowley will take the reins at BIO in March, about a year and a half after the departure of former CEO Michelle McMurry-Heath was announced.

Policy Lobbying

EU’s ‘Significant Benefit’ Metric For Orphan Drugs Still A Thorn In Industry’s Side

Ipsen’s Bylvay is one of six medicines that the European Medicines Agency has said should be stripped of their orphan drug designation over the last three years, leading the company to criticize the agency’s approach to “significant benefit” assessments.

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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Drug Discovery Tools
      • ADMET
      • Molecular Diversity
  • Other Names / Subsidiaries
    • Callidus Biopharma
    • Celenex
    • MiaMed, Inc.
    • Scioderm, Inc.