Recon: Roche to buy MASH biotech 89bio for $2.4B; Kennedy’s ACIP weighs changes to childhood vaccines
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Federal vaccine adviser says former CDC officials can’t be trusted unless they agree to ‘public debate’ (STAT)
- Key takeaways on CDC hearing: Vaccine moves, experts sidelined, GOP attacks (The Hill)
- Kennedy's hand-picked CDC panel weighs changes to children's vaccines (Reuters)
- Despite fear of retaliation, hundreds of federal workers urge Congress to protect medicine and science (STAT)
- HHS abruptly cancels CDC meeting with RFK Jr., anti-vaccine activist as scrutiny mounts (STAT)
- Kennedy is rewriting US vaccine policy — fast and on his terms (Reuters)
- New US global health plan prioritizes drugs, recipients' self-reliance (Reuters)
- US Shutdown Risks Rise as Democrats Dig In on Health-Care Fixes (Bloomberg)
- WHO says 31 of 38 Ebola cases in Congo have resulted in deaths (STAT)
- Alcohol, tobacco and food giants block health reforms, says WHO (Reuters)
- Logistics real estate company promises £3.9B in UK life sciences investment (Endpoints)
- GE Healthcare Said to Weigh Selling Stake in China Business (Bloomberg)
- J&J launches IVL device in Europe; Medtronic looks at pacing for more patients (MedTech Dive)
- Have Your Say On EU Digital Regulation Overkill (MedTech Insight)
- Roche to enter FGF21 space with $2.4B buyout of MASH biotech 89bio (Endpoints)
- Sangamo’s Fabry therapy partner search looks futile (STAT)
- Wegovy-maker Novo Nordisk starts 'fight back' as investors return (Reuters)
- Novo Jumps Most in Month as Ozempic Beats Older Lilly Drug (Bloomberg)
- Replimune's stock sinks on rocky path forward for cancer drug's accelerated approval (Endpoints)
- Nektar’s stock rallies on eczema data; Novo to lay off 263 workers in NJ (Endpoints)
- Pfizer, Arvinas sell rights to lead PROTAC one month after filing for FDA review (Endpoints)
- After trial win, Lilly's Mounjaro primed for expansion in kids 10-17 with type 2 diabetes (Fierce Pharma)
- Fresh data on hospital AI use & Califf dishes on tech (STAT)
- House committee advances Medicare coverage bill for breakthrough devices (MedTech Dive)
- Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown (MedTech Insight)
- RFK Jr.’s Assault on Ultra-Processed Foods Puts Companies on Edge (Bloomberg)
- JM Smucker to raise coffee prices again in the face of tariffs (Food Dive)
- I’m a former CDC director. I’m deeply concerned about the future of vaccines in the U.S. (STAT)
- NIH outlines new system for awarding research grants to foreign scientists (STAT)
- Here’s who will be hit with higher premiums if ACA enhanced subsidies expire (STAT)
- The coming fragmentation of vaccination social order (STAT)
- FDA’s New Cosmetic Adverse Event Dashboard Presents Challenges and Opportunities (FDA Law Blog)
- Obamacare Subsidy Extension Would Cost $350 Billion, CBO Finds (Bloomberg)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
