Recon: FDA rejects Camurus’ rare hormone disorder drug; Amgen to launch Eylea biosimilar in US after appeals court decision

• Senators demand answers on telehealth platforms from Pfizer and Eli Lilly (STAT)
• Pharma execs donated more to Democrats in campaign’s final stretch (STAT)
• UPDATED: Pfizer's activist says board must 'hold management accountable' for R&D shortcomings (Endpoints)
• Ahead of Novo’s CagriSema readout, Lilly returns to a promising new class of obesity drugs (Endpoints)
• Samsung Bio inks largest deal yet worth $1.24B with unnamed Asian pharma (Endpoints)
• 'It’s not right.' Califf slams pharma over weight loss drug prices (Endpoints)
• Walmart to deliver US prescription medications in as soon as 30 minutes (Reuters)
• US FDA declines to approve Camurus' rare hormone disorder drug (Reuters)
• Starboard says Kenvue's skin health segment is weighing on performance (Reuters)

• Germany identifies its first case of new mpox variant (Reuters)
• Nordic HTA Collaboration: Feel the Fear And Do It Anyway (Pink Sheet)
• EU Needs ‘Agile & Enabling Ecosystem’ To Address Decline In Clinical Trials (Pink Sheet)
• ‘Unicorn’ Startup Owkin On EU’s AI Act, Funding Needs: ‘Europe Doesn’t Want To Be Under-Competitive’ (Endpoints)
• European Commission Receives Contradictory Messages Over MDR Revision (MedTech Insight)

• Amgen to launch US Eylea biosimilar after ruling in Regeneron patent case (Reuters)
• Editas tacks again, steering from lead sickle cell treatment to new one (STAT)
• Switchable’ CAR-T startup raises $112 million (STAT)
• In a bid to treat their children’s rare diseases, these three parents founded companies (STAT)
• Otsuka’s cytokine-targeting drug for IgAN clears Phase 3 hurdle (Endpoints)
• MacroGenics sells rights to breast cancer drug; Rice’s new biotech accelerator (Endpoints)
• MacroGenics passes off struggling breast cancer med Margenza to TerSera for $40M plus milestones (Fierce Pharma)

• Experts debate the way AI can transform mental healthcare (Endpoints)
• Former Amazon leader is betting the future of healthcare will blend in-person and online care (Endpoints)
• Boston Scientific, Edwards and Dexcom usher in second week of earnings (MedTech Dive)
• GE Healthcare opens AI Innovation Lab to grow new projects (MedTech Dive)

• Behind CVS CEO’s ouster, a question: Do a pharmacy and a health insurer make sense together? (STAT)
• ICER slightly softens its recommendation on Pfizer's ATTR-CM drug price (Endpoints)
• US FDA ‘Thinking Deeply’ On ‘Digital Twins’ As Placebo Control, But OCE Not Quite Ready To Embrace It (Pink Sheet)
• Medicare Part D Cost Sharing Relief Driving Surge In Specialty Drug Prescribing – UnitedHealth (Pink Sheet)
• DOJ challenges Johnson & Johnson's talc bankruptcy attempt in Texas (Fierce Pharma)