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)
- 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)
- 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)
- 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)
- 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)
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