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)
- 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)
- 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)
- 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)
- The wellness industry needs to stop scaring people (Food Dive)
- Suspected botulism case prompts French warning (Food Safety News)
- 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)
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