Recon: Novartis to acquire Myricx Bio for $1.1B; Republican lawmakers press FDA to ensure trials are diverse

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• I spoke to Anthropic’s CEO about how AI may affect biotech. Here’s what I learned (STAT)
• Medicare takes another swing at 340B cuts to hospitals (STAT)
• Lawmakers urge HHS to force Eli Lilly to provide 340B drug discounts to hospitals (STAT)
• GOP lawmakers push Trump’s FDA to make sure clinical trials are diverse (STAT)
• FDA probes anesthesia-linked neurological complications in some patients of Venezuelan ancestry (Reuters)

In Focus: International

• Novartis to pay $1.1B upfront for UK biotech Myricx to expand the pharma's ADC pipeline (Fierce Biotech)
• BioNTech has held talks with buyers over four German sites set to close, Handelsblatt says (Reuters)
• Race for rapid Ebola test narrows to five potential manufacturers (Reuters)
• EU’s AI Medtech Rules Are Set; The Machinery To Deliver Them Isn’t (MedTech Insight)
• Congo says confirmed Ebola cases rise to 1,561, including 506 deaths (Reuters)
• Trial for Bundibugyo Ebola treatment starts in DRC, WHO says (Reuters)
• Australia's New South Wales confirms H5N1 bird flu case, third state (Reuters)

Pharma & Biotech

• AI company Anthropic announces it will begin developing drugs of its own (STAT)
• Bristol Myers details Krazati confirmatory study failure in colorectal cancer (Endpoints)
• Roche's $25M Astex deal is small money upfront, but a big signal for breast cancer goals (Endpoints)

Medtech

• Guardant’s Shield colon cancer blood test snags UnitedHealth coverage (MedTech Dive)
• Medtronic starts to notify people affected by cyberattack (MedTech Dive)
• Terumo recalls stent-graft system linked to three deaths (MedTech Dive)
• MDIC Lays Out Five-Step Cybersecurity Penetration Testing Process For Connected Device Makers (MedTech Insight)
• Medtech’s 2026 Cybersecurity Breaches Spared The Devices — And Hammered Everything Else (MedTech Insight)
• FDA Classifies Insulet’s Omnipod Correction As Class I Recall Over Cannula Defect (MedTech Insight)

Food & Nutrition

• Food giants defeat lawsuit calling ultraprocessed products addictive (Food Dive)
• FDA adds caffeine labeling to regulatory priority list (Food Dive)

Government, Regulatory & Legal

• Medicare slashes 340B payments, broadens site-neutral policies in proposed 2027 payment rule (MedTech Dive)
• Elevance sues government over $115 million tied to Medicare Advantage star ratings (STAT)
• The smart way to regulate the peptide boom (STAT)
• Stopping doctors from ordering unnecessary diagnostic tests requires a structural fix (STAT)
• Salk Institute’s president on NIH cuts, being ‘all in’ on AI, and the Year of the Brain (Endpoints)

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.