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October 28, 2025
by Jason Scott

Recon: Lilly produces billions of weight-loss pills ahead of FDA approval; Philips gets FDA warning letter over issues at 3 facilities

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

In Focus: US
  • US Fires Top Health Official Who Opposed Widely Used Covid Shot (Bloomberg)
  • Lilly partners with Nvidia on AI supercomputer to speed up drug development (Reuters)
  • Lilly Makes Billions of Weight-Loss Pills Before US Approval (Bloomberg)
  • CSL Plunges to 7-Year Low After US Vaccine Slump Hits Seqirus (Bloomberg)
  • FDA rejects Eylea HD for ongoing manufacturing issues (Fierce Pharma)
  • US FDA flags quality issues at three Philips' facilities (Reuters) (Bloomberg)
  • US appeals court revives $2.5 billion opioid lawsuit in West Virginia (Reuters)
In Focus: International
  • Global security is impossible without sufficient support for global health (STAT)
  • UK gives drugmakers more time to consider exiting medicine rebate scheme (Endpoints)
  • Novartis shares fall as generics dent blockbuster heart drug (Reuters)
  • Canada poised to lose measles elimination status, a possible harbinger of more disease outbreaks (Reuters)
  • As Novo buyout anniversary nears, CDMO Catalent refines brand to highlight 'missions that matter' (Fierce Pharma)
Pharma & Biotech
  • Miriam Merad’s 20-year quest to understand one cell is starting to rewrite the rules of cancer immunotherapy (STAT)
  • America needs a trusted national patient registry for leucovorin and autism (STAT)
  • Psychedelic-like therapy posts encouraging early data, as regulators clear at-home testing (STAT)
  • GSK to license Empirico’s COPD candidate for $85M upfront (Endpoints)
  • Novartis could sell more drugs through direct-to-patient service (Endpoints)
  • Regeneron discloses CRL; AbbVie stops work on Dragonfly asset (Endpoints)
  • GHO Capital gets $2.9B for fourth healthcare PE fund (Endpoints)
  • Startup launches with $80M and a plan to teach the immune system to make better Tregs (Endpoints)
  • Organon CEO exits after internal probe over 'channel stuffing' to boost sales (Endpoints)
  • 'Poor children of very rich parents': How Verily plans to grow out of Alphabet's shadow (Endpoints)
  • Gerresheimer appoints Uwe Röhrhoff as new interim CEO (Reuters)
  • Merck-Eisai's kidney cancer drug combo shows mixed results in late-stage study (Reuters)
  • BioMarin resigned to ending journey with hemophilia A gene therapy Roctavian, seeks divestiture amid sales struggle (Fierce Pharma)
  • After lupus nephritis nod, Roche keeps Gazyva momentum rolling with phase 3 win in another kidney condition (Fierce Pharma)
  • Eli Lilly teams up with basketball legend Shaquille O'Neal to take sleep apnea awareness campaign to new heights (Fierce Pharma)
Medtech
  • Olympus execs talk about import alert, GI robot and AI (MedTech Dive)
  • Medtronic links renal denervation to 3-year blood pressure reduction (MedTech Dive)
  • Health systems are racing to adopt AI. But can they prove its value? (MedTech Dive)
Food & Nutrition
  • When SNAP benefits run out, ‘people can die,’ say health experts (STAT)
  • Meat costs continue to surge (Food Dive)
Government, Regulatory & Legal  
  • Blue Cross plans to target doctors for overcharging. Physicians are furious (STAT)
  • Cigna says it will move to end drug rebates beginning in 2027 (Endpoints)
  • UnitedHealth Sees 2026 Growth as It Navigates Historic Meltdown (Bloomberg)
  • Texas sues Tylenol makers J&J and Kenvue, claiming they hid drug's autism risks (Reuters)
  • Onshoring Drug Manufacturing: Insights from FDA’s PreCheck Initiative and Public Meeting (FDA Law Blog
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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