Recon: Sanofi in talks to sell its consumer business Opella; Novo’s Rybelsus cut heart risks in Phase III trial

• Perplexing results from Duchenne muscular dystrophy trial raise questions about gene therapies (STAT)
• Sales from controversial drug discount program rose to $63 billion last year (STAT)
• Biden administration to propose expanding access to over-the-counter contraception at no cost (CNN)
• Gilead, Merck's experimental long-acting HIV treatment heads to Phase 3 (Endpoints)
• Lilly sues online vendors, medical spa over copycat weight-loss drugs (Reuters)
• Gilead pulls Trodelvy's approval in bladder cancer after trial flop, FDA discussions (Fierce Pharma)
• Takeda details another round of layoffs in Massachusetts as restructuring drive rolls on (Fierce Pharma)
• Baxter aims to restore new dialysis patient access to pre-hurricane levels by year-end (Reuters)

• Sanofi in exclusive talks with CD&R over sale of $17 billion Opella (Reuters)
• GSK to put £50M into Cambridge University partnership; Angelini’s new deal (Endpoints)
• Make Sure EU SPC Applications Cite The ‘First’ Marketing Authorization, Firms Told (Pink Sheet)
• EU Extends Pilot On Using Raw Data In Medicines Reviews ‘Until Further Notice’ (Pink Sheet)
• NHS England 10 Year Plan Enters Next Stage With Broad Consultation (MedTech Insight)

• Novo declares Phase 3 cardiac outcomes trial win for oral GLP-1 (Endpoints)
• FDA approves Astellas' gastric cancer therapy (Reuters)
• After shingles damaged her vision, this former eye surgeon looked for a way to keep it from happening to others (STAT)
• Karen Lynch took over CVS with a story of trauma. Her ouster is another twist (STAT)
• Can the new CVS CEO handle the Aetna challenge? (Reuters)
• Catalent tries to reassure customers about its deal with Novo Holdings (STAT)
• Sanofi Enters Exclusive Talks With CD&R Over Consumer Business Stake Sale (The Wall Street Journal)
• Seaport Therapeutics adds another $225 million to coffers to embrace the ‘golden age of neuroscience’ (STAT)
• Q3 biotech roundup: The 2024 turnaround sputters into a critical Q4 finale (Endpoints)
• Nurix says protein degrader shows potential in Waldenstrom’s patients in early trial (Endpoints)
• Regenxbio shares new mid-stage data for its wet AMD gene therapy (Endpoints)
• Septerna outlines $157M IPO after entering the clinic with GPCR pipeline (Endpoints)
• Vertex shares full pivotal non-opioid pain data, showing better safety than placebo (Endpoints)
• 5 Sickle Cell Therapies to Watch Following Pfizer’s Oxbryta Exit (BioSpace)

• Boston Scientific wins FDA approval for Farapulse cardiac mapping (MedTech Dive)
• 5 steps to navigate the FDA’s new lab developed test rule (MedTech Dive)
• Boston Scientific blood-blocking agent tied to additional 2 deaths, 8 injuries (MedTech Dive)
• Intuitive readies da Vinci 5 for broader launch after placing 110 robots in Q3 (MedTech Dive)
• Novocure wins FDA approval for electric field device in lung cancer (MedTech Dive)
• SVB Report Finds 2024 Resurgence In Healthtech Investment, Driven Largely By Investments In AI (MedTech Insight)

• Mileage of FTC Suit Against PBMs May Vary, Experts Suggest (Pink Sheet)
• After Ocaliva: US FDA Sees Breakthrough Potential In New Approaches To Liver Disease (Pink Sheet)
• Bring Out Your Meds! Bring Out Your Meds! (FDA Law Blog)
• Identifeye Working To Put Automated Diabetic Retinopathy Screening In Primary Care Settings (MedTech Insight)