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6th January 2026
by Jason Scott

Recon: Amgen to acquire Dark Blue for $480M; CDC slashes recommendations for childhood vaccines

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Federal health officials slash recommended childhood vaccinations under Trump’s directive (STAT)
  • Medical groups challenge to Kennedy-backed vaccine policies can proceed, US judge rules (Reuters)
  • Why flu seems to be everywhere — even if ‘super flu’ is not a thing (STAT)
  • Nimbus, Lilly sign deal to develop new oral obesity drug (Reuters)
  • US FDA’s Rejection Letter Reveals New Barriers Sanofi Must Overcome for Tolebrutinib (Pink Sheet)
  • 2025 approvals: Biopharma delivered 55 new drugs, biologics (Fierce Pharma)
In Focus: International
  • Thailand Plans New Cannabis Rules to Rein in Dispensary Boom (Bloomberg)
  • TheraVectys Is Said to Mull Hong Kong IPO in Rare Move for Non-Chinese Biotech Firm (Bloomberg)
  • Eli Lilly Follows Novo in Slashing China Obesity Drug Price (Bloomberg)
  • EU RADIAL Study Reveals Price Tag Of Going Remote In Clinical Research (Pink Sheet)
  • Opportunity For Pharma To Shape UK Rules On AI In Health Care (Pink Sheet)
  • Nestle recalls infant formula batches in 25 countries over toxin risk (Reuters)
Pharma & Biotech
  • Arrowhead’s gene-silencing drugs cut fat in early obesity studies (STAT)
  • AI has finally started making drug-like antibodies. When will it revolutionize biopharma? (STAT)
  • Amgen to acquire Oxford spinout Dark Blue, tucking in a preclinical cancer drug (Endpoints)
  • Lilly enters second pact with Nimbus in $55M upfront deal for oral obesity drug (Endpoints)
  • Protagonist 'strongly leaning' toward opting out of Takeda profit-sharing deal (Endpoints)
  • CEO of Salonpas Maker Seeks to Take the $2.9 Billion Drug Firm Private (Bloomberg)
  • Variant Bio launches AI-powered platform for drug discovery using genetic data (Reuters)
  • Alumis' skin disease drug meets main goal in late-stage trials; shares surge (Reuters)
  • Pharma
  • 3 biopharma CEOs explain why they are 'authentically optimistic' for 2026 (Fierce Pharma)
  • AZ looks to grow reach in lupus with phase 3 win for self-administered Saphnelo (Fierce Pharma)
Medtech
  • Ōura’s Ricky Bloomfield proposes new regulatory pathway for wearable health features (MedTech Dive)
  • Vicarious inks software partnership as it streamlines operations (MedTech Dive)
  • STAAR shareholders reject Alcon’s revised buyout offer (MedTech Dive)
  • Abbott’s Libre Assist Pushes CGM AI Upstream, Challenging Dexcom’s Post-Meal Logging Strategy (MedTech Insight)
Food & Nutrition
  • West Virginia artificial dye ban temporarily blocked by court (Food Dive)
  • Tyson agrees to $82.5M settlement in beef price-fixing lawsuit (Food Dive)
Government, Regulatory & Legal
  • Federal appeals court upholds ruling blocking NIH cap on research overhead payments (STAT)
  • I oversaw the development of the ‘hospital at home’ CMS waiver. Congress must update the program (STAT)
  • With political savvy and outrage over drug prices, advocate David Mitchell was ahead of his time (STAT)
  • US builds case to retain measles elimination status as infections mount (Reuters)
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.