Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.
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With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.
Public Company Edition: Prometheus brought in $500m from a follow-on offering after reporting positive mid-stage results for its TL1A inhibitor. Even Novavax, struggling to make money from its COVID-19 vaccine, raised cash in dual offerings, but its valuation dropped significantly afterward.
The German firm’s monoclonal antibody has received a US thumbs-up for a severe skin disease with high unmet need but it must address diagnostic and educational hurdles.