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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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Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

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.

Quick Listen: Scrip’s Five Must-Know Things

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.

Abingworth Offers Home For Big Pharma Pipeline Projects

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.

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