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Bristol-Myers submits NDAs for Hep C drugs

  • Bristol-Myers Squibb (BMY +0.2%) submits new drug applications to the FDA for its NS5A replication complex inhibitor daclatasvir (DVC) and its NS3 protease inhibitor asunaprevir (ASV) for the treatment of Hepatitis C.
  • The regulatory agency recently designated the drugs Breakthrough Therapies.
  • The European Medicines Agency and Japan's Pharmaceutical and Medical Devices Agency are also reviewing the products under accelerated processes.
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