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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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Second Time’s The Charm: Amylyx’s ALS Drug Wins US FDA Panel Nod

In switching their votes from the first panel review in March, advisory committee members cited supportive additional analyses of a survival benefit, framing of the issues in the context of unmet need and regulatory flexibility, and the company’s statement that it would withdraw AMX0035 if the Phase III PHOENIX trial does not succeed.

US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs

Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.

Personal Care Next Target For UK Competition Authority ‘Greenwashing’ Audit

Manufacturers of UK personal care products watch out, the Competition and Markets Authority is on the look-out for false, exaggerated and/or vague sustainability claims, and may be targeting bigger players to make an example for the rest of the sector. And consumer health might be next. HBW Insight returns to advice from marketing expert Jo Stephenson on how to avoid greenwashing, based on the CMA's own extensive Green Claims Code.

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