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January 13, 2026
by Jason Scott

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Food & Nutrition
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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