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Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Vinay Prasad (YouTube/FDA)

News that oncologist Vinay Prasad will be the new head of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) division sent biopharma shares tumbling on 6 May, as investors feared the effects on tougher approval standards on companies’ commercial prospects.

Although Prasad has now moved to sooth concerns over upheaval to review processes at CBER, which oversees regulation of vaccines,...

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