AMRI Announces Deal with Biota
AMRI’s role will initially involve the development and manufacture of the active pharmaceutical ingredient for use in clinical trials.
AMRI has signed with Biota Holdings Limited to further develop and manufacture the influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor.
AMRI will provide these services to support a New Drug Application for laninamivir to the FDA.
Biota is working to establish the U.S. manufacturing of laninamivir, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for FDA approval of the drug.
AMRI’s role will initially involve the development and manufacture of the active pharmaceutical ingredient for use in
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