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news.Biota Holdings has selected AMRI to further develop and manufacture the influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor.
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Biota will establish the US manufacturing of laninamivir, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations.
AMRI will initially involve in the development and manufacture of the active pharmaceutical ingredient for use in trials.
The services provided by AMRI are expected to support a new drug application for laninamivir to the United States Food and Drug Administration (FDA).
AMRI chairman, president and CEO Thomas E D’Ambra said: "The agreement with Biota demonstrates AMRI’s global reputation as a preferred partner for delivering best-in-class drug discovery, development and manufacturing services."