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BridgeBio, Geron follow U.S. approvals with nods from EMA’s CHMP
November meeting highlights also include a pair of firsts for rare genetic diseases, and label expansions for eight approved drugs
December 14, 2024 1:36 AM UTC
EMA’s CHMP has recommended approval of eight new medicines, including BridgeBio’s TTR stabilizer and Geron’s telomerase inhibitor.
On the heels of its U.S. approval last month, BridgeBio Pharma Inc. (NASDAQ:BBIO) has received a positive opinion from CHMP on its transthyretin amyloid cardiomyopathy therapy Beyonttra acoramidis. If approved, Beyonttra would compete in the EU with Vyndaqel tafamidis from Pfizer Inc. (NYSE:PFE). Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) submitted an application to EMA in October for would-be competitor Amvuttra vutrisiran...