Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Beone, Celltrion, Daiichi, Incyte, J&J, Memo, Novo, Sangamo.
Biopharma happenings, including deals and partnerships, and other news in brief: Alnylam, Athira, Biontech, CAMP4, Cormedix, Curevac, Decoy, GSK, Peptidream, Prism, Salarius, Sermonix, Talus.
The U.S. FDA approved 18 drugs in November, down from 20 in October, bringing the total number of clearances to 199 through the first 11 months of the year. The number is about 5% lower than the 209 approvals recorded over the same period in 2024 but more than every prior year.
Focused on antibody-drug conjugates (ADCs), Neok Bio Inc. made a moderate splash by emerging from stealth mode in November with a $75 million series A financing led by Abl Bio Inc. – and one aspect of its drug development is gaining momentum in various other quarters, including big pharma.
Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5 interstitial lung disease events. The company did not say how many deaths there had been.
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