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January 28, 2025
by Jason Scott

Recon: FDA approves Ozempic to reduce kidney disease progression; CDC ordered to immediately halt work with WHO

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

In Focus: US
  • US FDA approves Novo Nordisk's Ozempic to reduce diabetic kidney disease progression (Reuters)
  • The Trump administration’s latest decisions on federal health agencies, summarized and explained (STAT)
  • The RFK question: Trump's HHS nominee splits biopharma before moment of truth (Endpoints)
  • RFK Jr.’s step-by-step blueprint to question the safety of vaccines (STAT)
  • RFK Jr. Says He’s Not Anti-Vaccine, Sees Critical Role for Shots (Bloomberg)
  • CDC ordered to stop working with WHO immediately, upending expectations of an extended withdrawal (STAT)
  • States say Medicaid access cut, White House says program exempt from funding freeze (Reuters)
  • Weight-loss drug developer Metsera targets up to $1.78 billion valuation in US IPO (Reuters)
In Focus: International                                                                                                       
  • Sarepta shares two-year DMD study data that could inform European approval decision (Endpoints)
  • Trump order set to halt supply of HIV, malaria drugs to poor countries, sources say (Reuters)
  • Philips to Sell Emergency Care Unit to Bridgefield Capital (Bloomberg)
  • Philips CEO Warns EU Not to Block AI Innovation With Regulation (Bloomberg)
  • EU Public-Private Partnership Invests €66.8M To ‘Transform Clinical Studies’ By Boosting Diversity (MedTech Insight)
  • Moderna, Novo Nordisk slammed for breaching UK drug marketing code yet again (Fierce Pharma)
  • Trump order set to halt supply of HIV, malaria drugs to poor countries, sources say (Reuters)
Pharma & Biotech
  • Akero, 89bio disclose public offerings; BioAge drops Phase 2 obesity drug (Endpoints)
  • Lantheus to buy radiopharma CDMO and diagnostic assets for $250M upfront (Endpoints)
  • Versant's fourth obesity biotech starts with $65M and a GIP antagonist (Endpoints)
  • Atalanta gets $97M boost to take two siRNAs into clinic for rare neuro disorders (Endpoints)
  • ITM aims to compete with Novartis after Phase 3 radiopharma win (Endpoints)
  • Cell therapy biotech Affini-T Therapeutics appears to cut staff (Endpoints)
  • Top 10 most anticipated drug launches of 2025 (Fierce Pharma)
  • Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June (Fierce Pharma)
  • AZ, Daiichi’s Enhertu nabs 7th FDA nod, including in 'HER2-ultralow' use, in breast cancer first (Fierce Pharma)
  • Lantheus lays out $250M+ to get its hands on radiopharma developer and CDMO Evergreen (Fierce Pharma)
  • Novartis' first Super Bowl ad aims to 'create a movement' with breast cancer awareness blitz (Fierce Pharma)
  • Gearing up to challenge Lilly in obesity, Kailera picks Zepbound brand leader as new commercial chief (Fierce Pharma)
Medtech
  • FDA webpages on clinical trial diversity removed after Trump orders (MedTech Dive)
  • Neko Health raises $260M to expand body scan service, fund R&D (MedTech Dive)
  • Doctors expect Boston Scientific to lead PFA race, survey finds (MedTech Dive)
  • RWE Meeting Pulled From Calendar As Trump Changes Continue (MedTech Insight)
  • Quibim $50m Series A To Fund High-Performance Computing And US Expansion (MedTech Insight)
Government, Regulatory & Legal
  • Trump’s CMS freeze, and the Cole Schmidtknecht lawsuit (STAT)
  • Non-profits, health groups sue over Trump's freeze on grants, loans (Reuters)
  • Latest Trump memo orders freeze on federal assistance, throwing health programs into confusion (STAT)
  • RFK Jr. campaign uses HHS freeze as a fundraising tool (STAT)
  • Researchers reel as Trump administration moves quickly to cut funding and end DEI health programs (STAT)
  • Who is protecting Americans from Marburg right now? (STAT)
  • Pharmacy middlemen lose bid to toss new Hawaii complaint (Endpoints)
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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