Recon: AbbVie strikes pricing pact with the White House; FDA seeks removal of suicide warnings from weight-loss drugs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Pazdur warns that politics, ‘chaos’ are damaging FDA (STAT)
- Trump administration strikes deal with AbbVie to cut costs of certain drugs (CNN)
- Sentynl gets the first US approval for rare copper absorption disease (Endpoints)
- Congress' biotech panel pitches FDA policy upgrades to help performance (Endpoints)
- US FDA requests removal of suicide warnings from weight-loss drug labels (Reuters)
- Health secretary Kennedy appoints two new members to CDC's vaccine advisory panel (Reuters)
- Unitaid will provide funds for South Africa and Zambia to widen access to Gilead’s HIV prevention drug (STAT)
- Novartis licenses mysterious radiopharma asset from Chinese biotech (Endpoints)
- Health Canada Calls On Stakeholders To Shape Future Of Decentralized Trials (Pink Sheet)
- New UK Cost-Effectiveness Thresholds ‘Modest’ In Nature, Will Not Benefit All Drugs (Pink Sheet)
- Andreessen Horowitz alum maps out new VC firm with focus on AI, consumer health (STAT)
- At JPM, doctors’ darling OpenEvidence says it’s pursuing ‘medical super-intelligence’ (STAT)
- Illumina launches massive cell atlas to fast-track drug discovery (STAT)
- Marea takes drug for rare hormone disease acromegaly to Phase 2 (Endpoints)
- Who’s afraid of OpenAI? (Endpoints)
- Treg biotech Sonoma sheds staff after getting new CEO (Endpoints)
- Pretzel Therapeutics buys Rome and its ‘dark genome’ work (Endpoints)
- US FDA extends review of Travere’s drug for rare kidney disease (Reuters)
- Thermo Fisher wins contracts as pharma shifts production to US, CEO says (Reuters)
- Medtronic gets FDA clearance for smart insulin pen app (MedTech Dive)
- Inspire appoints Matt Osberg as CFO (MedTech Dive)
- Medtronic Pivots Back to Tuck-In M&A as Board, Balance Sheet And Pipeline Align (MedTech Insight)
- Medtech 2026: Complexity, Bottlenecks And Cybersecurity Among Key Regulatory Concerns (MedTech Insight)
- Medtech 2026: Is Investor Confidence Back? (MedTech Insight)
- I’m a dietitian. The new federal dietary guidelines will make my job harder (STAT)
- I’m a designer. The new food pyramid is outdated and confusing (STAT)
- Epic sues health information network over nearly 300,000 illegally accessed records (STAT)
- As they brace for bigger challenges, hospitals at JPM say they’re going ‘back to the basics’ (STAT)
- More people are surviving cancer than ever before, according to new report (STAT)
- Democratic-led US states sue over HHS grant conditions targeting transgender people (Reuters)
- Measles cases in South Carolina rise by 124 to 434, state health department says (Reuters)
- FDA is Open to the Idea of Possible Regulatory Flexibility for Cell and Gene Therapies on a Case-by-Case Basis…Where Appropriate (FDA Law Blog)
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