The U.S. FDA’s draft rulemaking for regulation of lab-developed tests (LDTs) came with a conspicuously short comment period of 60 days, but the agency is unresponsive to requests to add another 30 days to the comment period.
Patients living with aggressive nasopharyngeal carcinoma (NPC) now have a new treatment option with the U.S. FDA approval of Junshi Biosciences Co. Ltd./Coherus Biosciences Inc.’s PD-1 inhibitor antibody Loqtorzi (toripalimab), which will likely become the new standard of care for NPC.
Singapore’s Health Science Authority is rolling out new drug substance evidence requirements following consultations with stakeholders, and drugmakers will have one year to comply with the new regulations.
The Biden administration has issued an executive order (EO) for artificial intelligence (AI), which addresses not only national security considerations, but public health considerations as well. One of the features of the EO is that any company developing AI for public health and safety must notify the federal government when training a foundation AI algorithm, which suggests that AI that is regulated by the U.S. FDA will now be subject to additional government scrutiny in the premarket phase.
Olympus Medical Corp. instituted a class I recall of its UHI-4 high flow insufflation device due to reports that the device may over-inflate and potentially create embolisms. The recall affects more than 3,100 units distributed in the U.S. between May 2012 and August 2023, all of which should not be used until the company resolves the problem.
Chimeric Therapeutics Ltd. has received FDA clearance of its IND application for CHM-2101, a first-in-class CDH17 chimeric antigen receptor (CAR) T cell therapy for gastrointestinal (GI) cancers.
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
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