With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030.
Though it’s largely viewed by analysts as a simple delay rather than a setback, Disc Medicine Inc.’s unexpected complete response letter (CRL) for bitopertin in the rare genetic disorder erythropoietic protoporphyria (EPP) raises more questions regarding consistency and stability at the U.S. FDA.
Following through on efforts initiated in November 2025, the U.S. FDA approved drug labeling changes for six menopausal hormone replacement therapies (HRTs) that removes the risk statements related to cardiovascular disease, breast cancer and probable dementia from the boxed warnings.
More than a decade after it was first proposed, the U.S. Precision Medicine Initiative that grew into the NIH’s All of Us dataset has reached its target of collecting genetic and health-related data from 1 million Americans representative of the diversity across the country.
After two decades of work with Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. withdrew its bid for approval of the compound upon hearing from the U.S. FDA. Regulators told Warren, N.J.-based PTC that the data package for Translarna is “unlikely to meet the agency's threshold of substantial evidence of effectiveness.”
Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.
The pressure to replace animal testing with human-relevant assays that are more predictive of human-drug responses has now reached a tipping point, and there is a movement toward greater acceptance of these potentially more translatable tests.
Viking Therapeutics Inc. said after-market hours Feb. 11 that it plans to advance its oral dual GLP-1/GIP receptor, VK-2735, into a phase III trial for obesity in the third quarter of 2026. VK-2735 is a novel dual glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist.
Citing an increase in safety events and evidence of futility, the U.S. NIH stopped an investigational low-dose rivaroxaban arm of its Comparison of Anticoagulation and Antiplatelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.
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