Your fast, high-signal look at everything that moved biotech, medtech, and pharma today. The BioMed Nexus Daily Update delivers the most important regulatory moves, trial readouts, deals, and industry developments in one concise, easy-to-scan report. Updated every weekday morning.
GSK has re-entered the pulmonary arterial hypertension arena with a $950 million acquisition of 35Pharma, positioning itself to directly challenge Merck’s blockbuster Winrevair with a
Novo Nordisk announced it will reduce U.S. list prices of its semaglutide portfolio by up to 50% to a uniform $675 per month effective January
Gilead Sciences has ignited the 2026 M&A cycle with a $7.8 billion acquisition of Arcellx at a 79% premium, securing a dominant position in BCMA-directed
The FDA’s single-trial doctrine shifted from proposal to practice last week, while Friday delivered two approvals—Vanda’s Bysanti for bipolar I disorder and schizophrenia, and CStone’s
A structural regime change at the FDA has codified “one pivotal trial” as the new approval default in a landmark New England Journal of Medicine
The FDA has issued a rare regulatory U-turn, reversing its refusal-to-file decision for Moderna’s mRNA flu vaccine after a high-stakes Type A meeting and setting
A classic “sell the news” reaction has cratered Ocular Therapeutix shares by 25% despite a successful Phase 3 superiority trial, proving that beating the endpoint
Roche has secured a definitive lead in autoimmune kidney disease with a Phase 3 win for Gazyva in primary membranous nephropathy, cementing its “deep B-cell
Last week delivered a regulatory reckoning that reshaped biotech valuation frameworks: the FDA rejected Disc Medicine’s bitopertin despite meeting its primary endpoint, issued a Refusal-to-File
BridgeBio’s “Switch” Data, FDA De-Risks HRT, Centivax Universal Flu — Oral Dwarfism Drug Beats Injectable Benchmarks, Pancreatic Cancer Device Approved, Seres & Ultragenyx Cut Staff
