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Amicus Therapeutics, Inc.

http://www.amicusrx.com/

Latest From Amicus Therapeutics, Inc.

Teva Launches First-Ever CREATES Act Suit

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Legal Issues Generic Drugs

Pink Sheet Podcast: As Aduhelm Turns, Teva Sues Under CREATES Act, Neulasta Untitled Letter

Pink Sheet reporters and editors discuss another explanation of the FDA’s Aduhelm label, the first lawsuit attempting to force the sale of samples for generic development, and the agency questioning promotion of Amgen’s Neulasta.

Neurology Legal Issues

Teva, In First-Ever CREATES Act Suit, Seeks Help With Fabry Disease Generic Development

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Generic Drugs Legal Issues

3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals

Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.

Clinical Trials Review Pathway
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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.
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