Disappointing phase II antitumor results with a drug that is designed to preserve the bone marrow during chemotherapy have dashed G1 Therapeutics Inc.’s hopes of expanding Cosela’s label to include metastatic colorectal cancer patients, at least for now. Cosela (trilaciclib) is an intravenous-administered transient CDK4/6 inhibitor designed to mitigate the side effects patients experience with current cytotoxic drug regimens used to treat aggressive cancers by offering myeloprotection and by preserving immune system function, so enabling patients to receive chemotherapy for longer and at higher doses. Read More
A phase IIb clinical study has Frequency Therapeutics Inc. reeling and making big changes, including layoffs. The placebo-controlled phase IIb study of FX-322 in treating acquired sensorineural hearing loss by regenerating hair cells in the cochlea missed its primary efficacy endpoint, so the company is discontinuing the program. It’s also shutting down a phase Ib study of FX-345, a program for treating the same indication. Read More
Corbus Pharmaceuticals Holdings Inc. signed a back end-loaded licensing deal worth up to $692.5 million with CSPC Megalith Biopharmaceutical Co. Ltd, a subsidiary of CSPC Pharmaceutical Group Ltd., for the latter’s Nectin-4-targeting antibody-drug conjugate CRB-701 (SYS-6002). Read More
Updated MRI results from Clene Inc.’s phase II Visionary-MS trial testing gold nanocrystal therapy CNM-Au8 bolsters the company’s premise that targeting energy metabolism could protect neuronal function in patients with multiple sclerosis and lays the groundwork for a phase III trial as soon as a strategic partner is found. Read More
New drug technology may soon deliver a breakthrough to eliminate internal bleeding caused by drug overuse. Shaanxi Micot Technology Co. Ltd.’s MT-1011 is a synthetic water-soluble small-molecule anticoagulant antagonist. After a single intravenous dose, it can bind directly to other anticoagulants to stop anticoagulant effects and restore the clotting function. Data from clinical trials support its mechanism. Read More
With an eye toward the future, the U.S. Patent and Trademark Office (USPTO) is seeking comment on artificial intelligence (AI) technologies and inventorship issues that may arise as AI takes on a bigger role in innovation. Read More
To increase transparency at its advisory committee (adcom) meetings, the U.S. FDA is proposing asking guest speakers to voluntarily disclose their financial interests and professional relationships to determine their eligibility to give a presentation at an adcom meeting. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Basking, Blueprint, Essex, Galapagos, Genentech, Heartseed, Incyte, Kalvista, Kintor, Leo, Novo Nordisk, Pfizer, Pharmazz, Phio, Roche, Vaxxas, Vivacelle. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeon, Aristea, Astex, Biodelivery, Corcept, Eli Lilly, Hillstream, Hookipa, IABL, Lobe, Nantpharma, Novavax, Nurexone, Roche, Sanofi, Scilex, Sorrento,Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Everest, GSK, Phathom. Read More
