Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.
PTC Therapeutics Inc.’s accelerated go-ahead from the U.S. FDA for Kebilidi (eladocagene exuparvovec-tneq), a recombinant adeno-associated virus serotype 2-based gene therapy to treat aromatic L-amino acid decarboxylase (AADC) deficiency, came with a priority review voucher (PRV) that the company intends to monetize.
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
Antelope Surgical Solutions Inc. has received commercial IND approval from the FDA for its novel prostate cancer technology, AS-1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, will be evaluated in trials with the aim of addressing prostate cancer identification and surgical margin delineation.
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.
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.
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