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.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.