Jiangsu Hengrui Pharmaceuticals Co. Ltd. struck another $1 billion-plus deal, this time for a HER2-targeting antibody-drug conjugate (ADC), trastuzumab rezetecan (SHR-A1811), with Glenmark Pharmaceuticals Ltd.’s subsidiary Glenmark Specialty SA.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: H. Lundbeck, Kelun-Biotech, Lexicon, Otsuka, Sanofi, Scholar Rock.
Biopharma happenings, including deals and partnerships, and other news in brief: Angelini, Boehringer Ingelheim, Merck, Sovargen, Tegmine, Variational AI.
The Human Cell Atlas project has delivered a fresh tranche of data mapping fibroblasts in healthy and diseased skin and pointing to drug targets with potential in multiple diseases across a range of tissues. Using single cell sequencing and spatial genomics, a technique for showing how gene expression varies at different locations within a tissue, nine different subpopulations of fibroblasts were identified, six in healthy skin and three in disease samples.
Word Sept. 4 from Agios Pharmaceuticals Inc. that the U.S. FDA extended the PDUFA date for the sNDA related to Pyrukynd (mitapivat), after the Cambridge, Mass.-based firm submitted a proposed risk evaluation and mitigation strategy (REMS), drew Wall Street’s attention to the regulatory approach.
After a phase III stumble, Acadia Pharmaceuticals Inc. will drop development of ACP-101, intranasal carbetocin, to treat hyperphagia in patients with the rare genetic disorder Prader-Willi syndrome. Top-line data from the 12-week, double-blind, randomized phase III study missed its primary endpoint by not producing a statistically significant improvement over placebo.