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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

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Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

US FDA Cancels Panel Review Of Two ‘Delinquent’ Cancer Drug Accelerated Approvals

Confirmatory trial for Secura Bio’s Farydak has been delayed for several years, while the study for Acrotech’s Marqibo was terminated early; a 2 December advisory committee meeting to consider the drugs’ fate was cancelled, which could mean the sponsors reached new study agreements with the FDA or plan to withdraw the drugs.

Shionogi's Oral COVID Drug Set For Global Access Through MPP

Agreement with UN-affiliated body set to expand global availability in lower income countries of Japanese firm’s protease inhibitor, which has faced approval road bumps at home but now looks set to move forward on positive new Phase III data.

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