Recon: BioNTech, BMS tout positive Phase 2 readout for lung cancer; FDA OKs trial of gene-edited pig kidneys for transplantation
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
