Recon: FDA OKs Geron’s anemia therapy for specific cancer patients; Moderna reports positive Phase 3 results for COVID/flu combo

• FDA expands approval for GSK’s RSV vaccine to cover younger at-risk adults (STAT)
• NIH will bring clinical research into primary care offices with $30 million pilot (STAT)
• Vanda Pharmaceuticals has another suitor (STAT)
• Curing rare childhood diseases will falter unless Congress steps up (STAT)
• Moderna’s Covid and flu combo vaccine succeeds in Phase 3 study (Endpoints) (STAT)
• FDA raises questions about Lilly's Alzheimer's drug; Adcomm votes against MDMA therapy; Inside Walmart Health's challenges; and more (Endpoints)
• Federal judge dismisses antitrust claims brought against Bristol Myers by insurers (Endpoints)
• FDA greenlights Geron’s imetelstat to treat anemia in certain cancer patients (Endpoints)
• AbbVie and Alphabet's Calico added to Operation Warp Speed for rare diseases (Endpoints)
• AbbVie's tight grip on Humira market raises concerns about biosimilars (Reuters)

• UK medtech raises $100M for two-in-one urinary incontinence treatment (Endpoints)
• Italian antitrust agency investigates Novartis, Biogen and others over Lucentis biosimilar (Endpoints)
• German radiopharma nabs €188M to boost isotope manufacturing, advance cancer pipeline (Endpoints)
• Project Orbis, 'Cluster' Calls Validate Global Regulators’ Drug Application Concerns (Pink Sheet)
• A Success But Room For Improvement: Canada’s Conditional Approval Pathway (Pink Sheet)

• Alumis files for IPO ahead of Phase 3 studies for second-gen TYK2 inhibitor (Endpoints)
• Added health benefits of Wegovy, Zepbound could attract more men, doctors say (Reuters)
• GSK nixes SpringWorks licensing deal focused on Blenrep-Ogsiveo for blood cancer (Endpoints)
• Google's parent company Alphabet poaches Eli Lilly CFO; More changes at Exscientia (Endpoints)
• J&J-backed Rapport Therapeutics valued at $636.8 mln in lukewarm debut (Reuters)
• Geron surges after winning first US FDA approval for blood disorder drug (Reuters)
• The inside story of how Lykos’ MDMA research went awry (STAT)

• Watch: How Harvard researchers boosted an ALS patient’s independence with a box and a balloon (STAT)
• Abbott wins CE mark for dual-chamber leadless pacemaker (MedTech Dive)
• Abbott secures FDA clearance for two over-the-counter glucose monitors (Reuters)
• CISA warns of cybersecurity risks in Baxter products (MedTech Dive)
• Danaher names Martin Stumpe as chief data and AI officer (MedTech Dive)
• Medtronic recalls neurosurgery navigation system for software error (MedTech Dive)

• Top law firms in US opioid lawsuits to get hundreds of millions in fees (Reuters)
• Canada, UK launched joint probe into 23andMe data breach, says Canada (Reuters)
• Humana can challenge Medicare clawback rule in Fort Worth, Texas – judge (Reuters)
• Healthcare payments firm Waystar's shares slip in Nasdaq debut (Reuters)
• Lawsuits over Change Healthcare data breach centralized in Minnesota (Reuters)
• Kroger Health revamps weight management program to include GLP-1 drugs (Reuters)
• US Supreme Court backs insurers' right to speak up in bankruptcy (Reuters)
• Lykos’ MDMA Trial Conduct Allegations Influence US FDA Advisory Committee (Pink Sheet)
• AI Assurance Lab Concept Leaves Potential Regulatory Gap (Pink Sheet)