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September 23, 2025
by Jason Scott

Recon: Lilly plans $6.5B Texas API site; Moderna says updated COVID jab induces strong immune response

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

In Focus: US
  • Trump, questioning vaccine safety, pushes major changes to how kids get shots (STAT)
  • Citing possible link to autism, Trump urges limiting use of Tylenol during pregnancy (STAT)
  • Tylenol-maker Kenvue shares bounce back, Trump claims face pushback (Reuters)
  • What the evidence tells us about Tylenol, leucovorin, and autism (STAT)
  • FDA aims to expand use of leucovorin as RFK Jr. touts it as autism treatment (STAT)
  • FDA hands Scholar Rock a CRL for spinal muscular atrophy drug (Endpoints)
  • FDA rejects Rexulti-Zoloft combo for PTSD (Endpoints)
In Focus: International                                                                                                       
  • Countering Trump, European health officials stress that acetaminophen is safe to use during pregnancy (STAT)
  • EU, WHO counter Trump's warnings on autism and pregnancy (Reuters)
  • Post-Hoc: Threatening the UK to send a message to the rest of Europe (Endpoints)
  • Invivo aims to raise €100M for fourth fund; SEED Therapeutics gets $30M (Endpoints)
  • Chinese police investigating app fraud case, says German drugmaker Merck KGaA (Reuters)
  • Emeis Strikes Deal With Investors to Cut Debt by €700 Million (Bloomberg)
  • UK MHRA: Gene Therapy Manufacturing Methods Need ‘Urgent Harmonization’ (Pink Sheet)
Pharma & Biotech
  • Bristol Myers said its next-gen multiple myeloma drug cut rates of detectable cancer. Will it get FDA approval? (STAT)
  • Neurocrine details Phase 2 results for depression drug (Endpoints)
  • Why Doximity wants to be the Bloomberg Terminal for doctors (Endpoints)
  • Eli Lilly sells New Jersey site to Celltrion for $330M (Endpoints)
  • Lilly reveals plans for $6.5B API production facility in Texas (Fierce Pharma)
  • Ionis says RNA drug for rare brain disorder succeeded pivotal trial, plans to ask for FDA approval (Endpoints)
  • Moderna says updated next-generation COVID shot shows strong immune response in patients (Reuters)
  • Tylenol-maker Kenvue shares bounce back, Trump claims face pushback (Reuters)
  • Biotech Real Estate Slump Has MIT’s Hometown Seeking Backups (Bloomberg)
Medtech
  • J&J to withdraw acid reflux device from certain markets (Reuters)
  • Multi-cancer blood tests aren’t ready for routine use, review says (MedTech Dive)
  • Olympus removes needles after patient death (MedTech Dive)
  • Sava Technologies Microsensing Milestone: 10 Days Continuous Wear, No Finger-Prick Calibration (MedTech Insight)
  • INBRAIN, Mayo Clinic To Test BCI With Standard Deep Brain Stimulation In Parkinson’s Patients (MedTech Insight)
Food & Nutrition
  • The wellness industry needs to stop scaring people (Food Dive)
  • Suspected botulism case prompts French warning (Food Safety News)
Government, Regulatory & Legal  
  • Longevity Science and Healthspan Hype Is Exhausting. Try a Lil Cheat Instead (Bloomberg)
  • White House asks Supreme Court to uphold Trump’s tariff powers (MedTech Dive)
  • 340B Reform Advocates Hail CBO Report, But ‘Scoreable’ Savings Still In Doubt (Pink Sheet)
  • Trump Upends Shutdown Talks With Democrats as Deadline Nears (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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