UNICEF says Israel blocking one million syringes needed to vaccinate Gaza children (Reuters)
Pharma & Biotech
Merck’s pill to reduce cholesterol on top of statins matches results from injectables (STAT)
EnGene posts more pivotal data for bladder cancer gene therapy, plans 2026 filing (Endpoints)
Neurocrine reports Phase 2 fail for depression drug it licensed from Takeda (Endpoints)
Novo Nordisk posts mixed mid-stage data on cardiomyopathy drug with new mechanism (Endpoints)
Drugmakers Pile Into a Cancer Gold Rush With Questionable Payoff (Bloomberg)
Neuberg Diagnostics Said to Eye $350 Million India IPO in 2026 (Bloomberg)
Kezar Loses 70% of Staff After FDA Cancels Meeting on Autoimmune Asset (BioSpace)
AstraZeneca hits record high, cements lead as UK's biggest stock (Reuters)
Despite Obesity Drug Pricing Deal, GLP-1 Compounders Continue To Operate in the Shadows (BioSpace)
Medtech
Medicare will pay more than $1,000 for AI to analyze a heart scan. Is that too much? (STAT)
Health IT startup Fabric buys UCM Digital Health — its 5th acquisition in 3 years (Endpoints)
Can Chatbots Treat Depression? FDA Advisers Urge Caution on Generative AI Tools (MedTech Insight)
BCI Maker INBRAIN Inks Deal With Microsoft To Explore Agentic AI Use For Monitoring Patients (MedTech Insight)
Prosthetics: Firms Like Unhindr And Esper Shape Market On the Cusp of Great Change (MedTech Insight)
Deals Shaping The Medtech And Diagnostics Industries, October 2025 (MedTech Insight)
Food & Nutrition
TreeHouse Foods to be acquired for $2.9B (Food Dive)
Salmonella in sprouts sickens 44 in Australia (Food Safety News)
Australian firm fined for causing botulism illness (Food Safety News)
Researchers say Listeria biofilms are particularly dangerous (Food Safety News)
Government, Regulatory & Legal
Jury gives Novo Nordisk a win in decade-long hemophilia fraud case (Endpoints)
Activists Assemble for Big M&A Push in US (Bloomberg)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.