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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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PI3K Inhibitors For Hematology Indications Need Randomized Data, FDA Panel Says

Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.

TG Therapeutics Pulls Ukoniq/Ublitiximab Combo Applications Due To Adverse Survival Trend

Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.

NYSCC Suppliers Day Features Biotech, Sun Care, Antimicrobials Among Ingredient Innovations

DSM’s Quali Vitamin B12 and Biosyntia’s sustainably sourced biotin were among biotech-based ingredients at the New York Society of Cosmetic Chemists’ Suppliers Day in New York. Other showcased products included antimicrobials, microbiome ingredients, and zinc oxide filters for sun protection.

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