China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
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.
Pharmacy benefit managers (PBMs) are under the microscope again, this time for the price markups their affiliated specialty pharmacies charge for generic drugs used to treat cancer, HIV, multiple sclerosis and other serious conditions.
CSPC Pharmaceutical Group Ltd. on Jan. 13 gained the National Medical Products Administration’s approval of Shanzeping (prusogliptin tablets; DBPR-108) as a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor to treat adult patients with type 2 diabetes.
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The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of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.
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.
Dyne Therapeutics Inc. is eyeing accelerated approval for its myotonic dystrophy type 1 treatment after reviewing new results from a phase I/II study. DYNE-101, an oligonucleotide antisense and DMPK gene modulator, produced results on disease biomarkers that included DMPK and splicing correction, disease progression reversal on several functional endpoints and a favorable safety profile. The accelerated approval submission could come in the first half of 2026.
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