South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help establish standards on the technology’s applications in the medical field.
The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Apellis, Akeso, Astrazeneca, Biogen, Clearside, CSL Behring, GSK, Iaso, Impact, Innovent, Junshi, Kalvista, Telix, Vyluma, Zai Lab.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Adagene, Alerity, Ascletis, Merck, Recce, Taiho.
A global commission has proposed a fundamental change to the way obesity is defined and diagnosed. If the change is implemented, obesity would be considered a health risk in some contexts, and a disease in others. “The commission is reframing obesity... in a way that allows for the nuanced reality of obesity,” Robert Eckel told reporters at a press briefing announcing the proposal, which was published online in The Lancet Diabetes & Endocrinology on Jan. 14, 2025.
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