T-knife Therapeutics Inc. has filed a clinical trial application (CTA) to initiate a phase I trial of TK-6302, a PRAME-targeted T-cell receptor (TCR) T-cell therapy in solid tumors. Pending CTA approval, the ATLAS trial is planned to begin next year.
Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to an article published in the Nov. 17 JAMA Internal Medicine. That’s 383 trials that lost funding.
The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.
Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.
Akeso Inc. has received clearance from China’s National Medical Products Administration (NMPA) to initiate clinical trials with AK-152 for Alzheimer’s disease.
Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.
Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.
The U.S. Environmental Protection Agency has moved to relax reporting requirements for perfluoroalkyl and polyfluoroalkyl substances used in a variety of applications, including medical devices.
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
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