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September 10, 2024
by Jason Scott

Recon: UnitedHealth to pull Humira from certain US drug reimbursement lists in 2025; US House passes Biosecure Act

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

In Focus: US
  • House passes bill that targets China biotechs (STAT)
  • Exclusive: Bain scoops up $3B for fourth life sciences fund after handful of M&A deals (Endpoints)
  • FDA sends warning letter to Indian drugmaker after finding glass in injections (Endpoints)
  • Employee of French drugmaker Ipsen to plead guilty to US insider trading (Reuters)
  • Lilly's weekly insulin hits primary endpoints in two more late-stage diabetes studies (Endpoints)
  • Roche's dual GLP-1/GIP results show promising weight loss, but also high rates of vomiting (Endpoints)
  • UnitedHealth to remove AbbVie's Humira from some US drug reimbursement lists next year (Reuters)
  • US FDA Advisors Want Iterum’s Antibiotic Indication Narrowed (Pink Sheet)
  • US FDA’s Marks Issues ‘Provocative’ Call For Target Gene Therapy Profile That Includes Costs (Pink Sheet)
  • AbbVie sues rival BeiGene over alleged theft of cancer therapy secrets (Reuters)
  • Weight-loss market to see 16 new drugs by 2029, report estimates (Reuters)
In Focus: International                                                                                                       
  • Teva faces EU fine for disparaging rival multiple sclerosis medicine, sources say (Reuters)
  • Spain Consults On Plans To Regulate HTAs (Pink Sheet)
  • New EU Filings Include A Range Of First-Of-Their-Kind Therapies (Pink Sheet)
  • Lilly And EVA Pharma Sign Voluntary License Deal For Baricitinib In Africa (Pink Sheet)
  • UPS to buy Germany-based healthcare logistics firm Frigo-Trans (Reuters)
Pharma & Biotech
  • Former Verily executives hatch plan to invest millions in high-tech medical data (STAT)
  • Pharma is still struggling to widen access to medicines — and reach patients — in low- and middle-income countries (STAT)
  • Viridian drug achieves study goals as treatment for thyroid eye disease (STAT)
  • Q&A: Atsena Therapeutics’ gene therapy for inherited blindness shows promise (STAT)
  • The little-known bill that made drugs more affordable (STAT)
  • Roivant acquires drug for pulmonary hypertension from Bayer (STAT)
  • Breakthrough therapies have given Duchenne muscular dystrophy families like mine hope — and new fears (STAT)
  • Exclusive: A male contraceptive may prevent 99% of pregnancies. Now it’s up to a small biotech to finish testing it (Endpoints)
  • Ionis’ $500M offering; Terns aims to raise $125M (Endpoints)
  • Centene forecasts Q3 profit below estimates on Medicaid hit (Reuters)
  • EQT to acquire GeBBS Healthcare Solutions for over $850 mln, sources say (Reuters)
  • MBX Biosciences seeks up to $482.5 mln valuation in US IPO (Reuters)
Medtech
  • Apple pushes into sleep apnea detection but health care integration remains unclear (STAT)
  • A race-free algorithm is merely the start for a safety net hospital confronting an onslaught of kidney disease (STAT)
  • Smiths Medical links 1 death, 35 injuries to defective airway tubes (MedTech Dive)
  • Lab group urges lawmakers to rescind FDA final rule on LDTs (MedTech Dive)
  • Does SCOTUS Chevron Decision Tip The Scales In Favor Of Industry? (MedTech Insight)
  • BD Sees Bright Future For Edwards’ Critical Care, Now BD Advanced Patient Monitoring (MedTech Insight)
Government, Regulatory & Legal
  • Yale settles claims of fertility clinic’s patients over diverted fentanyl (Reuters)
  • Opioid plaintiffs' committee urges US appeals court to toss fee bid by shut-out law firms (Reuters)
  • Baby bottle maker says microplastics inescapable, health risks unproven, in bid to toss lawsuit (Reuters)
  • More than 49 million in US covered by ACA over the past decade (Reuters
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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