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15 July 2025
by Jason Scott

Recon: FDA reviewers flag eye risks with GSK’s blood cancer therapy; FDA ends import screening exemption for low-value goods

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

In Focus: US
  • FDA staff flags eye safety risks for GSK's blood cancer drug (Reuters)
  • The end of animal testing? Transitioning to models is promising — but no silver bullet (STAT)
  • Weight-loss drug use in kids surged after doctors' recommendation (Axios)
  • The Trump administration disbanded a newborn screening panel. Advocates now face a harder path (Endpoints)
  • FDA employees let go in April receive final termination notices (Endpoints)
  • HHS Formally Lays Off Employees Following Supreme Court Ruling (Bloomberg)
  • Judge rejects AbbVie’s fight against Missouri 340B contract pharmacy law (Endpoints)
  • FDA chief calls for lower user fees as negotiations begin for eighth round of PDUFA (Endpoints)
  • Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII (Pink Sheet)
  • FDA to screen all imports, exemptions for low-value shipments revoked (Reuters)
In Focus: International                                                                                                       
  • After Phase 3 obesity success, Hengrui plans China approval filing for Kailera-partnered drug (Endpoints)
  • Global childhood vaccination shows slight improvement but challenges remain (Reuters)
  • Sino Biopharmaceutical to acquire LaNova Medicines for up to $951 million (Reuters)
  • Anthem Biosciences' $395 million IPO fully subscribed as investors bet on Indian pharma (Reuters)
  • ViiV expands license to allow generic HIV treatment production for low-income countries (Reuters)
  • Kailera touts late-stage win for weight-loss drug in China (Reuters)
  • Indira IVF Said to Revive India IPO That May Raise $408 Million (Bloomberg)
  • Vaccination Rates Lag in Europe as Measles Cases Rise, WHO Says (Bloomberg)
Pharma & Biotech
  • SpaceX Plans Starship Program for In-Orbit Drug Research (Bloomberg)
  • An AstraZeneca Exit Wouldn’t Doom London (Bloomberg)
  • How Hims Became the King of Knockoff Weight-Loss Drugs (Bloomberg)
  • Bayer's Kerendia wins FDA label expansion to treat 2 types of heart failure (Fierce Pharma)
Medtech
  • Quest to offer Fujirebio’s FDA-cleared Alzheimer’s blood test (MedTech Dive)
  • Zimmer agrees to distribute Getinge products to expand ASC offering (MedTech Dive)
  • Zimmer to buy robotics firm Monogram for about $177M (MedTech Dive)
  • Waters’ Purchase Of BD Biosciences & Dx Brings Growth Potential Alongside Trade-Offs (MedTech Insight)
Food & Nutrition
  • FDA approves natural blue color, urges accelerated phaseout of synthetic red dye (Food Dive)
  • US ice cream makers commit to artificial dye phase-out by 2028 (Food Dive)
Government, Regulatory & Legal
  • Study finds no evidence aluminum salts in vaccines are tied to higher risk of asthma, other childhood diseases (STAT)
  • After long saga, 23andMe's deal with Anne Wojcicki's nonprofit finally closes (Endpoints)
  • West Virginia abortion ban upheld over drugmaker's challenge (Reuters)
  • Ex-Pfizer Doctor Tells Congress He Didn’t Delay Covid Shot Data (Bloomberg)
  • Stealth Stake Sales Helped UnitedHealth Beat Wall Street Targets (Bloomberg)
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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