Recon: Lilly’s Zepbound reduces obstructive sleep apnea in phase 3 trials; Sage abandons Parkinson's candidate after mid-stage study flop
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Eli Lilly’s Zepbound eases obstructive sleep apnea in trials (STAT)
- Former HHS secretaries: Congress should adopt site-neutral payments for health care (STAT)
- Microsoft is selling AI in health care, and helping to set its standards. Is that a problem? (STAT)
- J&J, Bristol Myers race to amplify CAR-T manufacturing to meet label expansion in multiple myeloma (Endpoints)
- Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length (Pink Sheet)
- Sage Therapeutics scraps plans for Parkinson's drug after mid-stage failure (Reuters)
- Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116 (Pink Sheet)
- Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir (Fierce Pharma)
- How BIO CEO’s cozy relationship with WuXi soured (STAT)
- After COVID, WHO defines disease spread 'through air' (Reuters)
- EU Stakeholders Devise Six-Point Plan To Improve Cross-Border Clinical Trials (Pink Sheet)
- Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings (Pink Sheet)
- China’s Public Payer Wants To Define Innovative Drugs As Those With ‘Novel Benefits’ (Pink Sheet)
- India's Biocon developing its own version of Wegovy, clinical trial likely next year (Reuters)
- German HTA Queries Polivy Benefits Amid Lack Of Evidence (Pink Sheet)
- German watchdog approves Novo's acquisition of Cardior Pharmaceuticals (Reuters)
- UK drug shortages swell amid Brexit supply woes, think-tank data shows (Reuters)
- 23andme CEO Anne Wojcicki moves to take company private (STAT)
- Cancer vaccine startup launches with $54 million, Spark veteran as CEO (STAT)
- Cerevel drug for Parkinson’s disease improved symptom control in trial (STAT)
- ARCH, Medicines Co. veterans raise $290 million for in-licensed obesity drugs (STAT)
- Amylyx’s Relvyvrio data was, as promised, disappointing (STAT)
- Biohaven’s $230M offering; Plus, three new PIPEs (Endpoints)
- Bristol Myers pitches in to Pathios’ $25M Series B for GPCR inhibitor (Endpoints)
- Canaan adds $100M+ to boost biopharma investing, brings on former Pfizer exec (Endpoints)
- The next frontier in data privacy? Your brain (STAT)
- Teladoc became a household name under Jason Gorevic. Investors wanted more (STAT)
- Boston Scientific recalls blood-blocking agent linked to 2 deaths (MedTech Dive)
- ‘An incredible undertaking’: 5 takeaways from Philips consent decree (MedTech Dive)
- Abbott looks to ‘highly productive’ device pipeline for future growth (MedTech Dive)
- Files taken from Orasure systems in cybersecurity incident (MedTech Dive)
- FDA warns Soulaire to stop selling device outside authorized uses (MedTech Dive)
- Animal rights group urges SEC to investigate Charles River over monkey purchases (STAT)
- Health disparities and premature deaths run deep, even in best-performing states (STAT)
- Medicaid should cover donor breast milk for vulnerable infants (STAT)
- Viral hepatitis is a silent killer. It can’t be eliminated if it isn’t tracked (STAT)
- Kids can’t wait any longer for social media safety (STAT)
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