Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.
In this week's podcast version of Five Must-Know Things, hear about IP waivers for coronavirus vaccines; launch records for Pfizer’s COVID-19 vaccine; new potential delivery routes for booster vaccines; newcomers in the BCMA-targeting field; and a snapshot of the current state of play in global pharma R&D.
The UK-headquartered life sciences investment firm has comfortably exceeded its target of $350m for a fund dedicated to taking on late-stage products, incurring all the clinical and regulatory risk and receiving a pre-negotiated return once the drug is approved.