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December 11, 2025
by Jason Scott

Recon: Eli Lilly’s experimental obesity drug slashes weight in study; FDA approves first at-home device for depression

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Postscripts from the frontlines of Trump’s attacks on science: no simple happy endings (STAT)
  • Lilly’s next-gen obesity drug delivers major weight loss in Phase 3 trial, but with many discontinuations (STAT)
  • US FDA approves first at-home device for depression (Reuters)
  • Fighting Dementia Could Be as Easy as the Shingles Vaccine (Bloomberg)
  • Senate Rejects GOP Health Plan as Insurance Premium Spike Looms (Bloomberg)
  • Here’s Looking at You, OTC Drugs: FDA Requests Information to Plan for Public Meeting on Increasing Access to Nonprescription Drugs and Issues New MaPP on OTC Switches and Generics (FDA Law Blog)
In Focus: International
  • Europe’s pharma policy shakeup moves forward toward enactment (STAT)
  • A weakened bill to cut off Chinese biotech firms nears passage, after years of changes (STAT)
  • Zealand inks deal with Chinese biotech as it spells out broader metabolic disease ambitions (Endpoints)
  • WHO chief still hopes Trump administration will rethink withdrawal (Reuters)
  • China’s Pushes for a Baby Boom With a New Tax on Birth Control (Bloomberg)
  • US Health Deal Halted by Kenyan Court on Privacy Concerns (Bloomberg)
Pharma & Biotech
  • J&J’s two-drug combo blocked tumors in advanced multiple myeloma (STAT)
  • Myocarditis is a rare but real Covid vaccine side effect. A new study sheds light on what might cause it (STAT)
  • Now is the time to launch mpox vaccine booster trials (STAT)
  • Wave’s ‘gym bro’ obesity drug is story over substance (STAT)
  • Umoja delays first readout for in vivo CAR-T therapy (Endpoints)
  • Rezolute crashes as its only drug fails in Phase 3 (Endpoints)
  • AC Immune says early biomarker data are promising in Parkinson's, but clinical benefit remains unclear (Endpoints)
  • Rhythm reports Imcivree’s key weight loss data from Phase 2 Prader-Willi trial (Endpoints)
  • Health tech investors are getting creative with exits (Endpoints)
  • Weight loss biotech gets $70M, snags Amgen's obesity commercial leader as CEO (Endpoints)
  • Medra Raises $52 Million to Speed Drug Discovery With AI Robots (Bloomberg)
  • Moderna Founder Warns US Doubts on Science Threaten Biotech Edge (Bloomberg)
  • Novo Nordisk Is Trading as If Obesity Drug Craze Never Happened (Bloomberg)
Medtech
  • Welsh Carson-backed Lumexa Imaging raises $463 million in US IPO (Reuters)
  • Intuitive wins 3 new indications for da Vinci SP system (MedTech Dive)
  • FDA pilots allowing digital health devices access to CMS payment program (MedTech Dive)
  • Natera acquires Foresight Diagnostics for up to $450M (MedTech Dive)
Food & Nutrition
  • Abbott Fired a Warning Shot on Baby Formula — Then Launched a Lobbying Blitz (Bloomberg)
  • San Francisco’s move against ultraprocessed food could lead to wave of lawsuits (Food Dive)
Government, Regulatory & Legal
  • HHS health IT chief hints at a new approach to EHR certification (STAT)
  • In expert panel, FDA says ‘door is open’ for testosterone labeling revisions (STAT)
  • Exclusive: NAACP pressing for ‘equity-first’ AI standards in medicine (Reuters)
  • US senators push USDA for urgent action on bird flu vaccine (Reuters)
  • Texas Files Antitrust Suit Against Epic Systems Over Health Data (Bloomberg)
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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