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July 24, 2025
by Jason Scott

Recon: Novartis, Matchpoint sign $1B deal to develop anti-inflammatory drugs; FDA reinstated a quarter of jobs cut by DOGE, Makary says

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

In Focus: US
  • FDA reinstated roughly a quarter of initial DOGE job cuts (Politico Pro)
  • HHS Secretary RFK Jr. accepts recommendations to drop thimerosal from U.S. flu vaccines (STAT)
  • Alnylam CEO: Congress must pass the MINI Act to protect future biotech breakthroughs (STAT)
  • Medical groups and US states work to circumvent Kennedy's vaccine decisions (Reuters)
  • Exclusive: Sarepta would have to conduct new studies to get back on market, FDA official says (Endpoints)
  • FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies (CNN)
  • FDA panel on the use of antidepressants during pregnancy is alarming experts (LA Times)
  • Do fluoride supplements harm children? FDA panel discussion turns into heated debate (NBC) (CNN)
In Focus: International
  • Novartis to pay Matchpoint up to $1 billion to develop anti-inflammatory therapies (Reuters)
  • Permira, Nordic in Takeover Talks for Vaccine Maker Bavarian (Bloomberg) (Reuters)
  • Weak regulation causing deaths due to contaminated medicines, WHO says (Reuters)
  • TCG Labs Soleil gets another $400M for single-asset biotechs, expands to China (Endpoints)
  • Medtronic receives Type 2 label expansion for MiniMed 780G in Europe (MedTech Dive)
  • Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation (MedTech Insight)
  • Roche pauses shipments of Elevidys gene therapy outside US (Reuters)
Pharma & Biotech
  • Why Sarepta may not survive its current gene therapy crisis (STAT)
  • Contract research firms' strong earnings signal stabilizing biotech, pharma spending (Reuters)
  • Political or professional? Makary's overhaul of CDER, CBER may reshape leadership norms (Endpoints)
  • Roche profit beats forecast on strong sales of cancer, allergy drugs (Reuters)
  • Roche May Sell Drugs Directly in US to Bypass Middlemen (Bloomberg)
  • Sun Pharma to Settle US Generics Pricing Case for $200 Million (Bloomberg)
  • AstraZeneca’s Autoimmune Medicine Reduced Disease Severity (Bloomberg)
  • Sarepta's licensing partner Arrowhead expects near-term payments despite setbacks (Reuters)
  • Rocket cuts 30% of staff as it plots path forward for gene therapies (Endpoints)
  • Still in flux, Galapagos hires new execs, adjusts deal with Gilead, and considers selling its cell therapy business (Endpoints)
  • Novo Nordisk to discontinue three insulin products; Thermo Fisher CFO to retire (Endpoints)
  • LEO Pharma’s eczema cream is approved in the US; Abivax’s $650M offering (Endpoints)
  • 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline (Fierce Pharma)
  • FDA delays Blenrep decision, putting GSK's multiple myeloma comeback dreams on ice (Fierce Pharma)
Medtech
  • Labcorp to buy some Community Health assets for $195M (MedTech Dive)
  • Boston Scientific halves expected tariff hit (MedTech Dive)
  • Intuitive Surgical tempers tariff impact expectations (MedTech Dive)
  • Baxter recalls certain Novum pumps over issues tied to 79 injuries, 2 deaths (MedTech Dive)
  • Medtech M&A Resurges: How To Define Startup Exit Strategy (MedTech Insight)
  • ForSight Sets Its Sights On Automating Delicate Eye Procedures (MedTech Insight)
Food & Nutrition
  • HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods (HHS)
  • Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase Out (FDA Law Blog)
  • How GLP-1 weight loss drugs are reshaping the food industry (Food Dive)
Government, Regulatory & Legal  
  • UnitedHealth confirms DOJ investigations into Medicare practices, says it’s cooperating (STAT)
  • How states can mitigate Trump’s Medicaid cuts – and set their health care systems on a better path (STAT)
  • Molina Drops After Lowering Guidance Twice in One Month (Bloomberg)
  • Missouri accuses Planned Parenthood of downplaying abortion drug risks (Reuters)
  • 10M people will lose insurance due to GOP policy law: CBO (MedTech Dive)
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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