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Latest From Eisai Co., Ltd.

Keeping Track Of AdComms: US FDA Puts Donanemab On Schedule, Delays COVID-19 Meeting

Newly announced US FDA advisory committee meetings on Lilly’s Alzheimer’s antibody, Lykos’ pioneering psychedelic therapy for PTSD relieve drought in non-oncology AdComms as the 2024-‘25 COVID vaccine strain selection meeting is postponed.

US FDA Performance Tracker Advisory Committees

Chinese Drug Makers Trim, Boost Pipelines In New R&D Drive

The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.

China Research & Development

Asia Deal Watch: Ono Calls On PRISM BioLab’s Capabilities

Plus transactions involving Nissan Chemical/Sanwa Kagaku, Memel/Therabest, Chugai/Alnylam, Takeda/Kumquat, Nxera/Handok, 3SBio/CStone and deals in brief.

Deal Watch Business Strategies

Need Advice About Advisory Committees, US FDA? Try Having Some

FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

Advisory Committees Prescription To OTC Switch
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