Recon: FDA approves GSK hepatitis B drug; EQT to buy molecular testing firm Qiagen for $10.8B

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

In Focus: US

• GSK gets FDA approval for hepatitis B drug that offers functional cure (Endpoints) (FDA)
• AstraZeneca says FDA approves drug for rare kidney disease in adults (Reuters)
• FDA approves once-weekly generic hormone therapy patch for women (FDA)
• Alexion’s Ultomiris granted FDA accelerated approval in IgAN (The Pharma Letter)
• FDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings (BioSpace)
• Digital endpoints: FDA says start with outcomes, not tech (Pink Sheet)
• FDA drops CIO, but keeps Sanjay Sahoo as acting head of new Mission IT office (Pink Sheet)
• Compounded GLP-1 drugs recalled amid rising concerns over unapproved weight-loss alternatives (The Boston Globe)
• Treasury expected to be harder on China biotech deals in new rules (Endpoints)
• ICER, West Health call out excessive US drug launch prices (Fierce Pharma)

In Focus: International

• EQT to buy molecular testing firm Qiagen for $10.8 billion (Reuters)
• Enhertu wins new approval in China (The Pharma Letter)
• Novartis wins EC approval for Cosentyx in polymyalgia rheumatica (The Pharma Letter)
• First human case of livestock virus Shamonda unlikely to lead to wider spread, WHO says (Reuters) (Bloomberg)
• UNICEF and Gavi agree to cut Mosquirix malaria vaccine price by 40% (Reuters)
• Pfizer's cost savings drive touches jobs at US, Europe plants (Fierce Pharma)
• WHO, Africa CDC say Nigeria Ebola patient not confirmed to have visited Congo (Reuters)
• Poland to become second EU member of global healthcare AI network (Reuters)
• New Zealand's Fisher & Paykel Healthcare hit by cyber breach (Reuters)
• UK antidepressant makers face new obligations on suicide risk warnings, patient cards (Pink Sheet)

Pharma & Biotech

• Cencora to buy American Oncology Network in $2.4 billion deal (Reuters)
• Redesign Health merges with ARC Global in $2B deal to help hospitals build startups (Endpoints)
• Georgiamune sells solid tumor drug to Italy's Menarini for up to $1.1B (Endpoints) (The Pharma Letter)
• Alcon buys Neurotech for $550 million to expand eye cell therapy portfolio (The Pharma Letter) (Fierce Pharma)
• Astellas links up with AI Proteins in $400M computational drug discovery deal (Fierce Biotech)
• Roche says experimental MS pill cuts relapses by 55% in late-stage trials (Reuters) (Fierce Biotech)
• AbbVie's skin disease drug reduces lesions in trial, company eyes weight-loss combination (Reuters) (Endpoints)
• Roivant's autoimmune drug succeeds in two pivotal trials, setting up 2027 filing (Endpoints) (BioSpace)
• CSL hires ViiV CEO Deborah Waterhouse after three decades at GSK (Endpoints) (Reuters)

Medtech

• UK recommends indefinite CE-marking for devices in Great Britain (Medtech Insight)
• Medtronic wins CE mark for Vitalis portfolio of cardiac pacemakers (MedTech Dive)
• Stakeholders: RAPID’s fast lane is too narrow, could slow other reviews (Medtech Insight)
• Saluda Medical's shares hit record low on Evoke device recall (Reuters)
• Intuitive’s US da Vinci procedure growth slows again (MedTech Dive) (Reuters)
• Thermo Fisher raises 2026 outlook amid stronger pharma demand, but diagnostics holds flat (Medtech Insight)
• 20% clinical adoption, 60% life sciences: Why Agilent sees upside in Proscia (Medtech Insight)
• Intuitive quantifies instrument pricing cuts, agrees to $450M settlement as Q3 revenue rises 22% (Medtech Insight)
• Resmed partners with consumer sleep-tech firm Eight Sleep, launches new fabric mask (Medtech Insight)
• NVIDIA partnership fuels Danaher’s ‘autonomous science’ push as it exceeds Q3 expectations (Medtech Insight)

Food & Nutrition

• EU Commission to propose restoring Brazil poultry, honey import access (Reuters)
• Abbott to spin off nutrition, leaving a diagnostics and devices core as formula suits linger (Medtech Insight)
• Nestle, Zydus, Abbott face India scrutiny over claims on children's products (Reuters)
• Virginia reporting more patients than CDC in outbreak traced to oysters (Food Safety News)
• UK links Salmonella outbreak to Moroccan tomatoes (Food Safety News)
• EFSA publishes guidance on safety assessment of BPA alternatives in food contact materials (Food Safety Magazine)

Government & Legal

• CDC ignored request from states to validate a new measles test (New York Times)
• Samsung Bio union to contest court ruling blocking worker strikes (Endpoints)
• New Zealand court strikes down puberty blocker ban (Reuters)
• Goliath versus Goliath: Courts, not Congress, may soon force litigation funders out of the shadows (Medtech Insight)
• State regulators move to seize licenses from nursing home chain that was focus of Boston Globe investigation (STAT)
• CMS extends fraud crackdown to New York’s adult day care program (STAT)
• Medicare Part D PBM ‘delinking’ exclusion for bona fide service fees builds on Part B policies (Pink Sheet)

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.