Merck & Co., Inc.’s molnupiravir has drawn split opinions from the US Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee. On 30 November, the committee voted 13-10 in favor of the drug’s risk-benefit profile when used for the treatment of mild to moderate COVID-19 in adult patients within five days of symptom onset and at high risk of severe COVID-19, including hospitalization or death. (Also see "Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies" - Pink Sheet, 1 December, 2021.)
Coronavirus Update: Lukewarm US Panel For Molnupiravir, Inovio, Bharat Look At Omicron
Plus, J&J Nears S African Deal, Serum Exports Novavax Vaccine, Ocugen Trial On Hold
A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold.
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