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August 4, 2025
by Jason Scott

Recon: Pazdur reportedly intervened in Replimune decision; Eli Lilly to sell New Jersey facility

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

In Focus: US
  • The murkiness of drug companies’ price transparency reports (STAT)
  • FDA’s top cancer drug regulator played key role in rejection of Replimune therapy, officials say (STAT)
  • After surprise CRL, Replimune says it's waiting for FDA on a path forward for cancer treatment (Endpoints)
  • FDA to stress opioids’ risk of overdose, death in new medication safety labels (STAT)
  • The FDA’s plan on fluoride supplements is bad science (STAT)
  • Trump Administration Blocks Funding for CDC Health Programs (The Wall Street Journal)
  • Wegovy maker Novo hit with investor class action over revenue forecast cut (Reuters)
In Focus: International                                                                                                      
  • Gates Foundation pledges $2.5 billion to women’s health initiatives (STAT)
  • Swiss Stocks Decline on US Tariffs, Push for Lower Drug Prices (Bloomberg)
  • Denmark’s Economy Runs on Novo. Will the Drugmaker’s Troubles Slim It Down? (Bloomberg)
  • UK MHRA Takes Stock, Seeks CMSO And Reveals Device Innovation Early Access Thinking (MedTech Insight)
  • India's Aurobindo Pharma reports profit fall as cost rise outweighs sales growth (Reuters)
Pharma & Biotech
  • Eli Lilly confirms plan to sell NJ plant (Fierce Pharma)
  • Uncertainty clouds the San Diego biotech hub, with jobs and capital scarce (STAT)
  • The U.S. needs a revolution to harness the potential of GLP-1s for weight loss (STAT)
  • Hims and Hers beats quarterly profit on steady subscription growth (Reuters)
  • Biogen is building a 'ventures' team to 'keep early portfolio externalized' (Endpoints)
  • Hansa says small trial shows its investigational drug could expand use of Sarepta’s Elevidys (Endpoints)
  • BioNTech sales grow, braces for FDA decision on updated Covid vaccine (Endpoints)
  • Lilly’s Push to $1 Trillion Derailed by Trade Risks and Obesity Drug Speedbumps (Bloomberg)
  • Noom launches low dose of compounded weight-loss drug for $119 (Reuters)
  • Lenz's Vizz wins FDA approval to crack 'large, untapped' market for presbyopia (Fierce Pharma)
Medtech
  • Eating disorder telehealth startup Equip raises $47M (Endpoints)
  • Heartflow prices IPO, aiming to net about $180M (MedTech Dive)
  • Dexcom Builds Momentum Ahead of 15-Day G7 Launch, Eyes AI and G8 for Growth (MedTech Insight)
  • J&J MedTech’s Digital Head Pushes for Smarter, Standardized ORs With AI and Open Tech (MedTech Insight)
Food & Nutrition
  • Beverages become essential to consumer wellness routines: report (Food Dive)
  • Utz Brands to close facility as part of supply chain transformation (Food Business News)
Government, Regulatory & Legal  
  • State AGs sue Trump, HHS over gender-affirming care restrictions (STAT)
  • AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills (STAT)
  • Representatives of expert groups to be barred from work supporting CDC’s vaccine advisers (STAT)
  • MAGA influencers take a sudden interest in Medicare Advantage reforms, echoing a dark money group (STAT)
  • White House has no plan to mandate IVF care, despite campaign pledge (The Washington Post)
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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