FDA Is Still Lenient On COVID-19 EUAs, Veru’s Sabizabulin Advisory Panel Preview Docs Indicate
Agency poised to authorize Veru’s NME for COVID acute respiratory distress despite potential efficacy concerns and an unusually small safety database even by EUA standards. FDA assessment highlights continued burden of COVID despite political rhetoric downplaying current impact.
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Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
The Medicines Patent Pool has conducted a study on the impact of licensing and technology transfer on the timeline and costs of developing five biosimilars, including Merck’s Keytruda. While a licensing deal for pembrolizumab might not be a near-term possibility, the findings could help licensors, licensees and regulators increase access to medicines.
In a close but negative panel vote on the company’s acute respiratory distress syndrome treatment VERU-111 (sabizabulin), majority of US FDA advisory committee says more study should come ahead of an emergency use authorization, not as an authorization condition.