Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Acrotech, Astrazeneca, Breath Diagnostics, Daiichi, Dror Ortho Design, GE Healthcare, Hansa, Pilatus, Regeneron, Sibel, Skylinedx.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Angiodynamics, Briacell, Briapro, Cassava, Catheter Precision, Devonian, Johnson & Johnson, Senseonics, Sequel.
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January. The total falls below the 2025 monthly average of about 19 approvals and trails every month last year, which ranged from 12 to 27 approvals.
Hand wringing over what support Europe’s biopharma sector needs to stay competitive has intensified since the European Commission unveiled its proposal for an EU Biotech Act in December 2025, and the latest contribution to the debate is a comparative analysis of how 10 countries have strengthened their biopharmaceutical ecosystems post-COVID-19.
Grail Inc.’s share price dropped more than 50% in premarket trading Feb. 20 after it reported late the day before that the NHS-Galleri trial did not meet its primary endpoint. The U.K study, done though the National Health Service with 142,000 individuals enrolled, evaluated the ability of Grail’s Galleri multicancer early detection test to look for cancer-specific methylation patterns in blood.
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