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July 2, 2024
by Michael Mezher

Recon: FDA approves Lilly’s Alzheimer’s drug Kisunla; Biden calls on Novo, Lilly to reduce weight-loss drug prices

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • US FDA approves Lilly's Alzheimer's drug (Reuters)
  • Bird flu concern prompts US to award Moderna $176 million for vaccine development (Reuters)
  • Novo Nordisk, Lilly must cut US prices of weight-loss drugs, Biden says (Reuters)
  • US DOJ drops Viatris unit Mylan from industry-wide antitrust probe (Reuters)
  • US FDA warns website over unlawful sale of weight-loss drugs (Reuters)
  • FDA to expand total product life cycle program (MedtechDive)
In Focus: International
  • Pfizer v Moderna COVID vaccine patents battle set to continue after UK ruling (Reuters) (FT)
  • NHS gene check is helping children with cancer (BBC)
  • New Danish ‘Critical Medicine’ Stockpiling Rules Take Effect, With 6-Month Grace Period (Pink Sheet)
  • Spain's Rovi In Line For €3.4bn Windfall With CDMO Sale (Scrip)
  • WHO releases first-ever clinical treatment guideline for tobacco cessation in adults (WHO)
  • EMA To Update COVID-19 Vaccine Guides Amid Rapidly Changing Landscape (Pink Sheet)
Pharma & Biotech
  • INTERACT Meeting Timing Remains Point Of Confusion (Pink Sheet)
  • Clinical Trial Diversity: US FDA’s Califf Calls For Global Focus (Pink Sheet)
  • Takeda to cut another 220 jobs in Massachusetts, while Merck KGaA plots its own layoffs (Fierce)
  • J&J, Legend's Carvykti shows CAR-T can extend lives in multiple myeloma (Fierce)
  • Contraception Is Free by Law. So Why Are a Quarter of Women Still Paying for It? (NYTimes)
Medtech
  • FDA elevates ventilator recalls from Philips, Baxter, Zoll (Fierce)
  • FDA clears its first fingerstick hepatitis C diagnostic, enabling test-to-treat approach (Fierce)
  • Merit Medical pays Endogastric $105M for acid reflux treatment (MedtechDive)
  • Philips Disputes Additional Deaths Linked To May Recall Of Breathing Machines (MedtechInsight)
  • FDA continues crackdown on plastic syringes made in China (MedtechDive)
  • Amendments To Breakthrough Device Coverage Act Push Bill Out Of House Ways And Means Committee (MedtechInsight)
Government, Regulatory & Legal
  • Chevron, Fishing Boats, and the FDA (Science) (KFF)
  • US Supreme Court to hear fight over FDA denial of flavored vape products (Reuters)
  • Judge won't block Mississippi law on discounts for hospitals' contract pharmacies (Reuters)
  • Drugmakers' appeal to end Zantac cancer lawsuits rebuffed by judge (Reuters)
  • ‘A battle to the death’: The next abortion cases en route to the Supreme Court (Politico)
  • State AGs Get Stay Lifted In Generic Drug Pricing Litigation (Law360)
  • Apple Scores Some Patent Board Reviews In Watch IP Fight (Law360)
  • GSK Wants Lab's Zantac Whistleblower Suit Moved To Florida (Law360)
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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