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April 14, 2025
by Jason Scott

Recon: FDA to replace some fired workers with contractors; Pfizer abandons development of GLP-1 weight-loss drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • The trade war hits pause, but the biotech doom loop carries on (STAT)
  • ‘Most-favored nation’ drug pricing has three significant problems (STAT)
  • Pfizer to discontinue its GLP-1 pill for obesity due to liver toxicity (STAT)
  • Inside U.S. health agencies, workers confront chaos and questions as operations come unglued (STAT)
  • Novartis plans to invest $23 billion in US sites as Trump renews drug tariff threats (Reuters)
  • FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’ (STAT)
  • FDA to replace laid-off employees with contractors, sources say (CBS News)
  • Pharma tariffs to arrive 'in the next month or two,' commerce secretary says (Endpoints)
  • Trump health policy uncertainty sends biotech sector into deeper slump (Reuters)
In Focus: International
  • European Commission plans emergency measures to combat bird flu in Poland (Reuters)
  • WHO members close to accord on tackling future pandemics, sources say (Reuters)
  • Canada launches antitrust probe into Cigna's Express Scripts unit (Reuters)
  • Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government (MedTech Insight)
  • EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives (Pink Sheet)
Pharma & Biotech
  • Gilead is urged to rework licensing deals for groundbreaking HIV prevention drug (STAT)
  • US FDA approves syringe version of Argenx's immune disorder drug (Reuters)
  • Novo Nordisk warns consumers about counterfeit versions of Ozempic in US (Reuters)
  • Verve gene-editing therapy lowers cholesterol without serious side effects in early study (STAT)
  • Biotech investors: Stop expecting CRISPR science to make big leaps (STAT)
  • Ironwood to look for alternative paths after FDA asks for another Phase 3 (Endpoints)
  • Bristol Myers' immunotherapy combo nets approvals in colorectal and liver cancer (Endpoints)
  • Recruiters say some biopharmas pause hiring as they struggle to make sense of ongoing uncertainty (Endpoints)
  • Third Harmonic Bio to shutter; Future Pak once again targets Theratechnologies (Endpoints)
Medtech
  • Tariff turmoil: Hospitals, device makers welcome pause, but fear long-term pain (MedTech Dive)
  • Dialysis firm DaVita hit by ransomware attack, says patient care continues (Reuters)
  • Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems (MedTech Insight)
  • Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations (MedTech Insight)
  • Roar Of Eargo-hearX Merger Echoes Through US OTC Hearing Aid Market (MedTech Insight)
Food & Nutrition
  • Trump to end federal funding of certain non-medical services in Medicaid (STAT)
  • Food manufacturers look to stay agile amid tariff uncertainty (Food Dive)
Government, Regulatory & Legal
  • Why CDC cuts are being called ‘the greatest gift to tobacco industry in the last half-century’ (STAT)
  • Closure of CDC hepatitis lab imperils U.S. outbreak response, prevention (STAT)
  • Tennessee officials find Express Scripts violated law governing commercial pharmacy claims (STAT)
  • Tech modernization at community health centers in limbo after federal workforce cuts (STAT)
  • Sandoz files US antitrust lawsuit against Amgen over arthritis drug (Reuters)
  • Measles cases in Texas rise to 541, state health department says (Reuters)
  • Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025 (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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