The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide.
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures.
Abstract ideas are not generally eligible for patents in the U.S., but a recent dispute heard by the U.S. Patent Trial and Appeal Board adds a new twist to the question.
Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
Rapt Therapeutics Inc. has decided to shut down its zelnecirnon (RPT-193) program in asthma and atopic dermatitis, causing the company’s stock (NASDAQ:RAPT) to sharply decline Nov. 11.
Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.
Hyperfine Inc. gained CE mark approval for the latest generation of its artificial intelligence-powered software for its Swoop portable magnetic resonance imaging system, under the European Medical Device Regulation.
The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed.
Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.
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