Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Ascendis, Bridgebio, Eli Lilly, Galderma, Geron, Gilead, Merck, Roche, Sanofi.
Beigene Ltd. struck a global licensing deal with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. worth up to $1.5 billion for its phase I selective methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH-2039, which is being explored for solid tumors.
GC Biopharma Corp. will buy plasma collector Abo Holdings Inc. in a ₩138 billion (US$96.28 million) cash acquisition as the vaccine and plasma-derived medicinal products developer works to accelerate entry of Alyglo (IVIG-SN 10%) in the U.S., where it was approved last year.
The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.