Lunit Inc. is the latest South Korean firm to gain the U.S. FDA’s 510(k) clearance for Lunit Insight DBT, its artificial intelligence (AI)-powered breast cancer diagnostic tool that analyzes digital breast tomosynthesis (DBT) images, boosting its efforts to enter the U.S. market. The company also reported that it secured $150 million in a public offering.
Solid Biosciences Inc. has received FDA clearance of its IND application for SGT-003, the company’s next-generation gene therapy candidate for Duchenne muscular dystrophy (DMD). The planned first-in-human phase I/II trial will enroll pediatric patients with DMD to receive SGT-003 as a one-time intravenous infusion.
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.
South Korea may soon gain its first domestically developed anthrax vaccine by GC Biopharma Corp., with the Korean biotech having filed Nov. 1 with the MFDS for approval of its novel recombinant protein anthrax vaccine called GC-1109.
In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.
Inflammasome Therapeutics Inc. has received FDA clearance to begin a phase I/II trial of the company’s inflammasome inhibitor for the treatment of geographic atrophy, the most severe form of dry age-related macular degeneration. This is the first clinical trial of an inflammasome inhibitor to treat geographic atrophy. The company’s sustained-release implant contains the first of a new class of inflammasome inhibitor drugs, Kamuvudines, developed by the company and designed to halt the multiple processes that cause geographic atrophy.
Olympus Corp., of Center Valley, Pa., reported Nov. 9 a voluntary field corrective action for bronchoscopes prompted by complaints of endobronchial combustion during procedures that involve the use of high-frequency (HF) therapy equipment.
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