European Medicines Agency
AstraZeneca, Daiichi Sankyo Withdraw EU Application for Dato-DXd in Nonsquamous NSCLC
The decision follows a similar one in the US and is due to the drug's failure to significantly improve overall survival versus chemo in the TROPION-Lung01 trial.
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's drug but reconsidered after a review.
In Brief This Week: BMS, AstraZeneca, Daiichi Sankyo, Opus Genetics, Mindera Health
News items for the week of Aug. 19, 2024.
EMA's CHMP Recommends Against Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The committee said the drug's modest clinical benefit doesn't outweigh its significant safety risks, but Eisai will ask the CHMP to reexamine its opinion.
Pfizer's Hemophilia B Gene Therapy Nabs Conditional Marketing Authorization in Europe
The one-time gene therapy, marketed as Durveqtix in Europe, will be available in all 27 EU member states, Iceland, Liechtenstein, and Norway.