Recon: Roche inks $1.2B deal with China's Rona for obesity drug; Stryker invests $400M in CMR Surgical
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA eyes adaptive rare disease framework to replace piecemeal flexibilities (Pink Sheet)
- Moderna founder calls for urgent regulation of Al agents (Bloomberg)
- FDA’s NDA/BLA approval pace back on track, slowdown concerns appear averted for now (Pink Sheet)
- Revive regulatory creativity to clear disease heterogeneity hurdles, Woodcock says (Pink Sheet)
- Formycon and Zydus’s Keytruda biosimilar BLA accepted by FDA (The Pharma Letter)
- CVS to pay $315 million to settle unlawful opioid prescription claims, Justice Department says (Reuters )
In Focus: International
- Russia registers new drug for treatment of aggressive forms of female cancer (The Pharma Letter)
- EMA names 16 experts to support confidential reviews of animal testing alternatives (Pink Sheet)
- EU trial activity is shrinking and shifting, first EudraCT-CTIS analysis finds (Pink Sheet)
- England targets local budget barriers to quicken uptake of reimbursed drugs (Pink Sheet)
- Together not divided – how EU member states should counter US drug policy challenges (Pink Sheet)
- Congo's Ebola infections surpass 9,000, government report shows (Reuters)
- Guinea-Bissau says it has not approved hepatitis B vaccine trial in newborns (Reuters)
Pharma & Biotech
- Roche inks $1.2B deal with China's Rona to enter emerging ALK7 obesity race (Fierce Biotech) (Reuters)
- Pfizer pens $500 million+ deal with Enodia to destroy disease-causing proteins (BioSpace)
- Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug (STAT)
- Bristol Myers reveals a pair of phase 3 wins for fibrosis, RayzeBio drugs (Endpoints)
- Walmart to offer 250-plus free medications, including GLP-1s, to employees (Reuters)
- Merck reports mixed data for Lucentis competitor in diabetic macular edema (Endpoints)
- Roche sets sights on FDA approval decision of July 2027 with updated eye drug data (Fierce Biotech)
- Syndax says mid-stage trial of lung disease treatment fails main goal, ends development (Reuters) (BioSpace)
- BioNTech’s mRNA cancer vaccine fails phase 3 test, significantly denting analysts’ confidence (Fierce Biotech) (Reuters)
- Tortugas’ schizophrenia drug proves worth in phase 2 Hansoh trial in China (Fierce Biotech) (The Pharma Letter)
- Paragon spins out ninth biotech, sending cardiopulmonary drugs to Alaunos (Endpoints)
Medtech
- Stryker enters soft tissue robotics with $400 million investment in CMR Surgical (MedTech Dive)
- Agilent to buy pathology software maker Proscia for $240 million (Reuters)
- J&J beats earnings estimates, eyes mid-2027 hip and knee unit spinoff (Reuters) (Bloomberg)
- Philips updates instructions for ultrasound system linked to 4 deaths (MedTech Dive) (Medtech Insight)
- Galleri panel aftermath: What investors and rivals see next for MCEDs as FDA decision looms (Medtech Insight)
- Humotech hopes blinded data will draw insurance coverage for tobotic prosthetic foot trial service (Medtech Insight)
Food & Nutrition
- USDA to expand testing at deli counters (Food Safety News)
- EU-wide seasonal Salmonella outbreak strikes again (Food Safety News)
Government & Legal
- Shkreli faces contempt for breaking pharmaceutical industry ban (Bloomberg) (Reuters)
- The bonus track survives; PMA preemption cuts the rest (Drug & Device Law)
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.
