Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capsida, Electra, Foresee, Fresenius, Henlius, Novartis, Organon, Prolong, PTC, Scilex, Tharimmune.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biogen, CSL Behring, Eterna, Genmab, Revitope, Sage, Spero.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Celltrion, Cognition, Eli Lilly, Lexeo, Promis, Roche, Saol, Spero.
Biopharmas raising money in public or private financings, including: Archon, Axonis, Blue Earth, Eyepoint, Leal, Protagenic, Shuttle, Thioredoxin, Vera.
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
The prospect of a gene therapy for Alzheimer’s disease has kept Wall Street steadily interested in Lexeo Therapeutics Inc., and another increment of intrigue was added when the New York-based firm offered positive interim results from the 52-week, 15-subject phase I/II study of LX-1001 for the treatment of the condition when APOE4-associated.
Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.
Synox Therapeutics Ltd. extended its series B by a further $17 million as it announced the first patients have been dosed in a phase III study of emactuzumab in the treatment of tenosynovial giant cell tumor, a rare condition in which benign tumors grow in the soft tissue lining of joints and tendons.
RSS
