Keeping Track: Approvals For Addyi, Adcetris; Merck Bulks Up Keytruda Filings
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Novel COPD Exercise Claims Eluded Boehringer In Bid to Differentiate Striverdi
Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.
Novavax’s ’23-’24 COVID Vaccine Can Bypass Another CDC Cmte Meeting – If FDA Authorizes It
CDC’s universal recommendation for XBB COVID vaccines means that Novavax’s protein-based vaccine can enter the market immediately upon FDA authorization, but some final questions from the agency are keeping the review going.
Pediatric Data Concerns Can’t Derail US CDC’s Universal ’23-’24 COVID Vaccine Recommendation
FDA approval was swiftly followed by CDC advisory committee recommendation of the XBB.1.5. variant-based vaccines for all people aged 6 months and older.