Recon: BioNTech, BMS tout positive Phase 2 readout for lung cancer; FDA OKs trial of gene-edited pig kidneys for transplantation

• FDA greenlights trial of gene-edited pig kidneys as treatment for end-stage kidney disease (STAT)
• US FDA tightens control over obesity drug ingredient imports amid safety concerns (Reuters)
• US FDA to fast-track nicotine pouch reviews amid White House pressure (Reuters)
• AstraZeneca's rivalry with J&J in certain lung cancer patients heats up as it reports Tagrisso combo survival data (Endpoints)
• Commissioner Makary and Center Directors Tidmarsh and Prasad Announce 2 New Programs for Ultra-Rare Disease Therapies: RDEP and Bespoke (FDA Law Blog)
• RFK Jr.'s Vaccine Moves Put Insurance Coverage in Doubt (Bloomberg)

• April 2026 Start For UK MHRA’s Revised Device Fees Covering Post-Market Surveillance (MedTech Insight)
• Facts And Figures: EU Medtech Industry Grows 6.3% In 2024 Despite Trade Tensions (MedTech Insight)
• Brazil Asks Stakeholders To Weigh In On Ways To Improve Country’s Trial Environment (MedTech Insight)
• Clinical Trial Approvals In Spain Now 30% Faster For Eligible Phase I Studies (Pink Sheet)

• Rapport shares soar after successful mid-stage seizure trial (STAT)
• Summit Therapeutics hits possible snag on lung cancer drug seen as a blockbuster (STAT)
• Alkermes, Takeda show encouraging data on narcolepsy drugs (STAT)
• Biotech veteran Harvey Berger takes over as CEO of billionaire-backed Arena Bioworks (STAT)
• Lilly's blood cancer drug shows promise in trial as early treatment (Reuters)
• Pfizer, partner BioNTech say updated COVID shot shows better immune response (Reuters)
• BioNTech, Bristol Myers' immunotherapy shows encouraging tumour shrinkage in Phase II trial (Reuters)
• Biotech vet Harvey Berger steps into CEO role at Arena BioWorks, as billionaire-backed R&D center retools (Endpoints)
• LB Pharma seeks $228M in proposed IPO with hopes to be industry's first since February (Endpoints)
• Exclusive: Cancer care startup Daymark Health raises $20M (Endpoints)
• Rapport reveals promising open-label study data for epilepsy pill, heads to Phase 3 (Endpoints)
• Saol CRL Suggests Gap Between US FDA Rare Disease Flexibility Promises And Outcomes (Pink Sheet)
• Liver Injury REMS Delays US FDA Approval Of Agios’s Pyrukynd In Thalassemia (Pink Sheet)

• Beyond Dr. Google: How patients are using chatbots to shape their health stories (STAT)
• Philips faces French criminal investigation over sleep apnea recall (Reuters)
• Ronovo Surgical raises $67M, led by J&J venture arm (MedTech Dive)
• Senseonics inks deal to bring CGM commercialization back in-house (MedTech Dive)
• Medtronic trial of Hugo robot in hernia repair hits primary endpoints (MedTech Dive)

• Lab-grown meat makers sue Texas over ban on cultivated protein (Food Dive)
• Nestlé scandal sticks corporate affairs in the spotlight — again (Food Dive)

• Reforming NIH: A blueprint for 21st century medical research (STAT)
• RFK Jr. ally sets off furor in U.K. with anti-Covid vaccine remarks (STAT)
• Ohio to tighten oversight of weight-loss copies by limiting inventory (Reuters)
• Sticker Shock? Cost Of Orphan Drug Medicare Negotiation Relief May Complicate Future Fixes (Pink Sheet)