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.
Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal. The U.S. FDA recently provided a glossary of terms under the heading of recall – a move that comes short of industry’s preference that the term be jettisoned altogether.
Yuhan Corp., Oscotec Inc. and Genosco Inc. were three companies with Asian ties to reap benefit from Johnson & Johnson’s stellar top-line Mariposa study results, wherein J&J’s Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combo regimen beat out Astrazeneca plc’s standard of care in non-small-cell lung cancer (NSCLC).
Data from two out of three positive studies faced the U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee as members examined the package submitted by Seikagaku Corp., of Tokyo, for SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.
The sedate uptake of pulsed field ablation (PFA) in Europe failed to presage the enthusiasm that drove the technology’s extraordinarily rapid adoption in the U.S. in 2024. Used to treat atrial fibrillation, PFA received its first U.S. FDA approval in Dec. 2023. At the time, Clarivate estimated that PFA had 7% of the global cardiac ablation market. By year-end 2024, it had 20% and Boston Scientific Corp. projected that PFA would represent up to half of the market by the close of 2025.
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Ips Heart Inc. has been awarded orphan drug designation by the FDA for its GIVI-MPC stem cell therapy for Becker muscular dystrophy. GIVI-MPC has the unique ability to create new muscle with full length dystrophin in Becker muscular dystrophy.
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