Recon: FDA investigating safety of infant RSV therapies; Lilly to build $6B Alabama plant

• FDA drug center’s new acting director fits a pattern of risky, internal contradictions among agency leadership (STAT)
• Exclusive: US FDA launches fresh safety scrutiny of approved RSV therapies for infants (Reuters)
• FDA probes possible link between COVID vaccines and related deaths across age groups (Reuters) (Bloomberg)
• Eli Lilly to build $6 billion Alabama plant as part of US manufacturing push (Reuters)
• CVS forecasts 2026 profit above estimates as turnaround plan takes effect (Reuters)
• US FDA qualifies first AI tool to help speed liver disease drug development (Reuters)
• CAR-T Standards Raised As US FDA Continues Policymaking Via Journal Article (Pink Sheet)
• Sponsor Inspection Readiness Issues Emerge In Complete Response Letter Deficiencies (Pink Sheet)
• FDA Slow Walking a Long-Awaited Abortion Pill Safety Study (Bloomberg)
• US Senate to vote Thursday on Republican healthcare plan (Reuters)

• China's SanegeneBio raises $110M in follow-up to metabolic deal with Lilly (Endpoints)
• Insilico Medicine Is Said to Aim for Hong Kong Listing in Coming Weeks (Bloomberg)
• UK Pilot On Clinical Trial Modifications Delivers Approvals In Under A Week (Pink Sheet)
• Why comparing the US vaccine schedule to European countries’ is a red herring (STAT)

• PDUFA VIII: US FDA Proposes Closing Orphan Drug User Fee Loophole (Pink Sheet) 
• J&J’s two-drug combo blocked tumors in advanced multiple myeloma (STAT)
• Results in Terns leukemia drug study suggest it could be a successor to Novartis blockbuster (STAT)
• Biotech IPOs might be frozen, but investors are snapping up stock from existing companies (Endpoints)
• Early in vivo CAR-T results like Kelonia's elicit excitement across the field (Endpoints)
• Exclusive: London gene therapy biotech gets $33M for epilepsy clinical trial (Endpoints)
• Pfizer to pay $150M upfront for small molecule GLP-1 from Fosun subsidiary (Endpoints)
• Novartis to partner with AI-focused Relation on atopic diseases (Endpoints)
• General Catalyst-backed Radial raises $50M to treat mental health in non-traditional ways (Endpoints)
• BioNTech, Bristol Myers unwrap Phase 2 data for PD-L1xVEGF-A bispecific in breast cancer (Endpoints)
• Women with PCOS seek relief in weight-loss drugs (Reuters)
• Pfizer partners with YaoPharma to develop weight management drug (Reuters)
• Swiss eyecare giant Alcon lifts bid for rival Staar (Reuters)
• Bain Is Said to Mull Selling Tanabe Pharma’s Non-Japanese Assets (Bloomberg)

• Medical device maker Teleflex to divest three units for $2.03 billion (Reuters)
• What medtech firms can learn from Whoop’s warning letter (MedTech Dive)
• GE HealthCare, Mayo Clinic expand partnership around radiology research (MedTech Dive)
• Medtronic changes investor relations leadership ahead of diabetes spinout (MedTech Dive)
• SS Innovations submits robotic system for FDA clearance (MedTech Dive)

• Trump orders investigation into food supply chains for possible price fixing (Food Dive)
• Mars to close $36B Kellanova acquisition following EU approval (Food Dive)

• It’s past time to update the rules intended to slow the FDA’s revolving door (STAT)
• You Better Move Fast: ACCESS to TEMPO (FDA Law Blog)