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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

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US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close

Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.

It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease

Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.

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