Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.
Novo Nordisk Hopes To Gradually Build US Access To Obesity Therapy
With US FDA approval of Wegovy for obesity, Novo Nordisk prices the weekly injectable at par with its other obesity brand Saxenda. Ramping up sales will require patient, clinician and payer education, the company says.
Scynexis Will Use Contract Commercial Firm To Market Novel Antifungal
Scynexis obtained US FDA approval of ibrexafungerp, from the first novel class of antifungals in 20 years, and plans to use a contractor for US marketing of Brexafemme for vaginal yeast infections caused by Candida fungi.