rf-fullcolor.png

 

November 18, 2025
by Jason Scott

Recon: CSL to invest $1.5B on US drug production; FDA approves Arrowhead’s Redemplo for rare genetic disorder

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • US FDA approves Arrowhead's genetic disorder drug (Reuters)
  • How RFK Jr., America’s celebrity health secretary, is steamrolling science (STAT)
  • FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk (STAT)
  • NIH funding cuts have affected over 74,000 people enrolled in experiments, a new report says (Associated Press)
  • Drugmakers say HHS' 340B pilot is limited as they fight for their own rebate models (Endpoints)
  • Australia’s CSL to Invest $1.5 Billion on US Drug Manufacturing (Bloomberg)
In Focus: International
  • Many poor countries where experimental drugs are tested fail to benefit after approval, analysis finds (STAT)
  • Trump administration touts moves to provide HIV prevention drug, but refuses to include South Africa (STAT)
  • First doses of HIV prevention drug lenacapavir delivered to Zambia, Eswatini (Reuters)
  • New US trade deal caps Switzerland, Liechtenstein pharma tariffs at 15% (Endpoints)
  • WHO to lose a quarter of its workforce by mid-2026, document shows (Reuters)
  • Novo Holdings exits UK's Convatec after discounted share sale, bookrunner says (Reuters)
Pharma & Biotech
  • SixPeaks CEO talks about $170M sale to AstraZeneca and what comes next in obesity (Endpoints)
  • Exclusive: Lifordi gets new funding from Sanofi as it preps to test ADC in rheumatoid arthritis (Endpoints)
  • Merck, Bristol Myers disclose layoffs in New Jersey (Endpoints)
  • Roche’s oral SERD delays early breast cancer recurrence in late-stage trial (Endpoints)
  • Merck advances Winrevair in subset of heart failure patients (Fierce Pharma)
  • Exclusive: Thrivory raises $3.5M to help clinics get paid upfront within seconds (Endpoints)
  • Exclusive: AI Proteins raises $42M Series A, and will launch miniproteins into hub-and-spoke model (Endpoints)
  • Vanda says its drug can halve vomiting risk in patients using GLP-1s (Endpoints)
  • Zymeworks and Jazz tout HER2 bispecific success in first Phase 3 readout (Endpoints)
  • Pfizer Eyes $5 Billion High-Grade Bond Sale for Metsera Deal (Bloomberg)
  • Regeneron to invest $2B in new Saratoga Springs production plant (Fierce Pharma)
Medtech
  • FDA clears spinal cord stimulator for home use (STAT)
  • Medtronic raises annual sales growth forecast on heart devices demand (Reuters)
  • Medtronic’s PFA business is heating up (MedTech Dive)
  • Massive PAD Patient Study Finds No Enhanced Risk From Drug-Coated Devices (MedTech Insight)
  • Boston Scientific, Siemens Healthineers partner on cardiac catheter (MedTech Dive)
Food & Nutrition
  • As wellness trends go upscale, Nestle's mass-market vitamins lose some shine (Reuters)
  • Food and beverage trends loom large over packaging earnings (Food Dive)
Government, Regulatory & Legal
  • Cassidy pitches his alternative to extending extra ACA subsidies (STAT)
  • Trump Tells Congress Don’t ‘Waste’ Time on Obamacare Credits (Bloomberg)
  • Trump and RFK Jr. are mulling their most disruptive vaccine policies yet — alarming manufacturers (STAT)
  • UnitedHealth names former US FDA chief Scott Gottlieb to its board (Reuters)
  • Republican Support for Key Childhood Vaccines Is Backsliding (Bloomberg)
  • FDA takes issue with AstraZeneca TV ad for Farxiga (Fierce Pharma)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.