The U.S. FDA needs to strengthen the guardrails along the accelerated approval pathway to ensure its “appropriate and consistent use,” the Health and Human Services Office of Inspector General (OIG) said in a report released Jan. 14.
The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T-cell lymphomas, with these CAR T cells. I think this year, we are feeling reassured in this regard,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told the Alliance for Regenerative Medicine briefing at the J. P. Morgan Healthcare Conference on Jan. 13.
Can the market justify the hundreds of GLP-1 developers that are working to eventually reach the market? When the dust settles, Minji Kim, CEO of Cross Border Partners and Advisory Service, told attendees at the Biotech Showcase in San Francisco, only a few leading companies will end up dominating the field.
With positive data in hand from its phase IIb trial testing immunotherapy candidate OST-HER2 in osteosarcoma, OS Therapies Inc. anticipates a regulatory filing this year seeking accelerated approval from the U.S. FDA, putting the firm on track to receive a potentially profitable rare pediatric disease priority review voucher that could help fund further R&D work. Should OST-HER2 go on to win approval, it would mark the first new therapy in more than 40 years for osteosarcoma, an aggressive bone cancer characterized by high rates of metastases, often to the lungs, and disease recurrence.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Astrazeneca, Bioarctic, Biogen, Daiichi, Eisai, Hutchmed, Mereo, Santhera, Talphera.
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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