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April 18, 2024
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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