Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.
With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.
Perrigo is latest consumer health firm to note substantially slower flu rates slammed OTC drug sales during 2020 fourth quarter. Its total cough/cold product sales for the year were off $63m on decreases of $34m in the Americas and $29m in its international markets.