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July 3, 2025
by Jason Scott

Recon: FDA approves Regeneron's blood cancer drug; House passes Trump spending bill

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

In Focus: US
  • Summit Is in Talks for $15 Billion Partnership With AstraZeneca (Bloomberg)
  • House Republicans pass Trump's megabill, sending the package to his desk to be signed (NPR)
  • Tariffs can’t defeat the fentanyl problem in the US (STAT)
  • Memo said to describe biotech industry meeting calls RFK Jr. a ‘direct threat to public health’ (STAT)
  • RFK Jr. Is Playing With Babies’ Lives (Bloomberg)
  • US CDC accepts ousted vaccine panel's recommendations for RSV, meningococcal shots (Reuters)
  • The OTC Fee Fallout: Are Hundreds of Companies Ignoring FDA’s User Fee Requirements? (FDA Law Blog)
In Focus: International                                                                                                       
  • Britain launches 10-year plan to save health service in crisis (Reuters)
  • Carlyle to sell up to 10% stake in Piramal Pharma, Moneycontrol reports (Reuters)
  • China approves 4 new drugs, including global 1st-in-class (Fierce Pharma)
  • Sandoz, on a $1.1B investment spree in Slovenia, breaks ground at new $440M biosimilar plant (Fierce Pharma)
  • Intuitive Surgical’s da Vinci 5 robot wins CE mark (MedTech Dive)
  • Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations (MedTech Insight)
  • EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’ (MedTech Insight)
  • Questions Over UK Prevention Agenda Within NHS 10-Year Plan (MedTech Insight)
Pharma & Biotech
  • US FDA approves Regeneron's blood cancer therapy (Reuters)
  • The year is half over. Here’s where the biotech industry stands (STAT)
  • Number of megarounds drop 38% in first half as biotechs struggle against worsening slump (Endpoints)
  • Novartis' Cosentyx fails Phase 3 study for autoimmune disease (Endpoints)
  • Structure in partnering talks for GLP-1 pill as mid-stage readout nears (Endpoints)
  • Sperm Freezing Is a New Hot Market for Startups (Bloomberg)
  • Boehringer backs education drive to improve bronchiectasis management (Fierce Pharma)
  • Sage’s Search for Lifeline Ran Into Defiant Biogen CEO (BioSpace)
Medtech
  • The Trump administration is promoting wearable health devices — with or without evidence (Endpoints)
  • Judge approves 23andMe sale to nonprofit led by Anne Wojcicki (MedTech Dive)
  • Field Medical raises another $35M for PFA system (MedTech Dive)
  • Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls (MedTech Insight)
Food & Nutrition
  • Hershey joins food makers in commitment to remove artitficial dyes (Food Dive)
  • Foodborne Illness Costs Australia $3 Billion Each Year, Up $200 Million From 2023 (Food Safety)
Government, Regulatory & Legal
  • US FTC workshop criticizing medical care for transgender youth draws staff opposition (Reuters)
  • Supreme Court Refuses to Require Parent Consent for Abortion (Bloomberg)
  • COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes (Pink Sheet)
  • Why 'emboldened' activist investors are taking the fight to biotechs (Fierce Pharma)
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.
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