The U.S. Food and Drug Administration has asked George Tidmarsh, the recently installed head of its Center for Drug Evaluation and Research, to also serve as acting director of the Center for Biologics Evaluation and Research. The temporary appointment, disclosed in an internal agency email dated 30 July, comes less than two weeks after Tidmarsh joined the FDA from industry. Tidmarsh succeeds Vinay Prasad, who resigned abruptly the night before the announcement after less than three months leading the biologics center. The FDA said Scott Steele and Brittany Goldberg will serve as deputy directors while it conducts a search for a permanent CBER chief. Prasad’s exit follows mounting controversy over several high-profile reviews. Last week the agency issued a complete-response letter for Replimune Group’s experimental skin-cancer therapy RP1. A 4 August report by STAT said Oncology Center of Excellence director Richard Pazdur intervened late in the review process, overriding some staff who supported approval. Replimune shares fell about 38 percent in pre-market trading after the report. The leadership shuffle adds to turmoil within the FDA as it faces scrutiny over its handling of gene and cell-therapy safety issues and the consistency of its accelerated-approval decisions.
FDA’s top cancer drug regulator played key role in rejection of Replimune therapy, officials say @adamfeuerstein exclusively reports https://t.co/g6iBN7jEn1
$REPL down 38% this morning. On Friday, @ZacharyBrennan scooped Pazdur's role in the CRL, which would mean that the whole "Vinay's out" trade in this case is effed. @statnews has followed up this morning. And now $REPL has been whipsawed back down -38% this morning pre-market.
Vor Bio Appoints Seasoned Biotech Executive Dallan Murray as Chief Commercial Officer $VOR https://t.co/cVtlmEuc1y