BioDelivery Sciences International, Inc.
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Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
Pink Sheet infographic breaks down the trends and surprises in 2022 approvals. Cancer therapies and non-malignant hematology exceeded the average use of expedited review programs but were weighted to orphan diseases, while dermatology saw first-in-class approvals for big markets.
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.
The promise of TIGIT as an oncology target in combination with PD-1/PD-L1 inhibitors has prompted an influx of investment into anti-TIGIT agents and five agents are already in advanced clinical trials. That initial enthusiasm has been dampened as of late, after disappointing Phase III data. Investors are hoping that 2023 will be the year that restores hope in the anti-TIGIT pipeline.
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