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Amicus Therapeutics, Inc.

http://www.amicusrx.com/

Latest From Amicus Therapeutics, Inc.

Is CREATES Act Equipped To Handle Biosimilar Complaints?

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

Biosimilars Legal Issues

Is CREATES Act Equipped To Handle Biosimilar Complaints?

Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.

Biosimilars Intellectual Property

Will FTC Injunction Against Shkreli’s Company Deter Brands From Pursuing Anti-Generic Actions?

Other companies have largely halted practices at issue in the ‘diabolical anticompetitive plan’ undertaken by Shkreli’s former firm. FTC did not challenge the price hike for Daraprim itself, but did cite an effort to block release of sales data and other tactics to discourage generics.

Legal Issues Enforcement

Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa

Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

Europe 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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