Sanofi SA is to acquire Blueprint Medicines Inc. in a $9.5 billion deal that will give the French pharma ownership of a marketed rare disease immunotherapy heading toward blockbuster status, a follow-on product in phase II/III, and a phase II clinical program relevant to a number of autoimmune diseases.
Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
Biontech SE and Bristol Myers Squibb Co. are teaming up to develop Biontech’s BNT-327 in a deal possibly worth over $11 billion. BNT-327 is in the hot new class of bispecific antibodies targeting programmed death-1 (PD-1) or its ligand (PD-L1) and vascular endothelial growth factor (VEGF). The bispecifics take advantage of two well established mechanisms of action that help tumors grow; PD-1/PD-L1, which tells immunogenic T cells not to attack the tumor, and VEGF, which tumors excrete to produce new blood vessels to supply oxygen and other nutrients to the tumor.
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuredit, Alcon, Bayer, Capsida, Daiichi, Eton, Jiangsu Hengrui, Merck, Stealth.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biohaven, Corestemchemon, Keros, Moderna, Neurocrine, Oric, Pepgen, Taysha, Uniqure.
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