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September 16, 2025
by Jason Scott

Recon: Eli Lilly selects Virginia as $5B API site; CSL invests $117M in VarmX coagulation drug

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

In Focus: US
  • Hill staff gets briefed on implications of Trump’s drug pricing plan (STAT)
  • Lilly weight-loss pill could be FDA-approved by year-end (Reuters)
  • GOP Unveils Bill to Avert Shutdown, Daring Democrats to Oppose (Bloomberg)
  • CRLs Today, (Potential) Lawsuits Tomorrow (FDA Law Blog)
  • FDA Letters Flag Oprah Video, Morgan Freeman Ad in Crackdown (Bloomberg)
In Focus: International                                                                                                       
  • UK must spend more on medicines, minister says, as Big Pharma cuts investment (Reuters)
  • Ark, Atom file to go public in Hong Kong; Aptevo’s stock rallies on AML data (Endpoints)
  • Italy’s Chiesi Raises Annual Guidance on Drug Sales Growth (Bloomberg)
  • Medical-Device Maker Mindray Picks Huatai, JPMorgan for Hong Kong Listing (Bloomberg)
  • Chinese Biotech Stock’s 4,500% Surge Sparks Fear of Market Froth (Bloomberg)
  • EU’s Draft GMP Guideline Signals Major Cultural Shift In Pharma Quality Compliance (Pink Sheet)
  • First-In-Class Bronchiectasis Treatment Among 14 Drugs Awaiting EMA Verdict (Pink Sheet)
  • Australia's CSL invests $117 million for VarmX acquisition option, coagulation treatment (Reuters)
Pharma & Biotech
  • Critics call on Sarepta to show how it’s measuring gene therapy’s performance (STAT)
  • Novo Nordisk eyes broader role for its obesity drugs from sleep apnea to knees (Reuters)
  • Novo Nordisk Overhauls Senior Job Titles in Latest Shake-Up (Bloomberg)
  • Eli Lilly picks Virginia for $5B API site as part of $27B US pledge (Endpoints)
  • Former CinCor executives return with new ‘hub-and-spoke’ company, old Sanofi drug (Endpoints)
  • Genmab ends work on ADC from $1.8B acquisition of ProfoundBio (Endpoints)
  • Dualitas gets $65M in Series A to develop bispecifics for immunology (Endpoints)
Medtech
  • Amazon ropes in Fay to offer dietitian services on telehealth platform (Reuters)
  • Exclusive: Fred Hutch duo's startup launches with $10M to build AI generative genomics models (Endpoints)
  • How three companies are using foundation models in radiology (MedTech Dive)
  • Insulet names new CFO; Dexcom CEO on leave (MedTech Dive)
Food & Nutrition
  • Tyson to end use of high fructose corn syrup (Food Dive)
  • Grocery inflation hits a 2-year high (Food Dive)
Government, Regulatory & Legal  
  • The marijuana rescheduling debate is missing the point, experts say (STAT)
  • I’m a former CDC director. I’m deeply concerned about the future of vaccines in the U.S. (STAT)
  • Tylenol in pregnancy: A question of safety or control? (STAT)
  • At Wellness Resorts, Ozempic Becomes Part of the Treatment Menu (Bloomberg)
  • A Cheap Way to Protect Cancer Patients From Covid (Bloomberg)
  • Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands? (Pink Sheet)
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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