Recon: FDA investigating safety of infant RSV therapies; Lilly to build $6B Alabama plant
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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