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)
- 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)
- 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)
- 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)
- West Virginia artificial dye ban temporarily blocked by court (Food Dive)
- Tyson agrees to $82.5M settlement in beef price-fixing lawsuit (Food Dive)
- 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)
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