Recon: Peter Marks joins Eli Lilly to head infectious disease unit; AstraZeneca blood pressure drug hit main goal in Phase 3 trial
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly (STAT)
- Parents are flocking to natural and ‘clean medicine’ brands. Medical experts are worried (STAT)
- Acting CDC director calls for MMR vaccine to be broken up into three shots (STAT)
- J&J ordered to pay $966 million in talc cancer case after jury finds company liable (Reuters)
- Novo Nordisk cuts hit production line jobs at key US plant (Reuters)
- Inside Warning Letters: A Statistical Update (FDA Law Blog)
- Trump Opens Door to Talks GOP Has Resisted as Shutdown Extends (Bloomberg)
- White House memo says furloughed federal workers aren't entitled to back pay (Axios)
- With much to win (or lose), drugmakers and European officials bear down on major policy overhaul (STAT)
- Case Study: Pushing The EU’s IVD Regulation To Its Limits With Next Generation Sequencing (MedTech Insight)
- Eli Lilly earmarks $1B to boost India manufacturing footprint (Endpoints)
- AstraZeneca drug baxdrostat cuts blood pressure in key late-stage trial (Reuters)
- Defining Unmet Medical Need: EU Debate Sparks Concern Over Innovation And Access (Pink Sheet)
- ‘Urgent Need’ To Scale Up Advice Slots Under EU HTA Regulation – EUCOPE (Pink Sheet)
- Novo Ex-CEO Jorgensen Gets New Job at Danish Health-Care Lobby (Bloomberg)
- Prosthetics maker Ottobock plans to raise $941 million in German IPO (Reuters)
- Drug developer MapLight eyes $704.3 million valuation in US IPO (Reuters)
- Soufflé Therapeutics, co-founded by Bob Langer, launches with $200M (Endpoints)
- Mark Alles’ biotech gets $96M for ADCs from UCLA lab (Endpoints)
- Lexeo eyes faster path to approval for Friedreich's ataxia gene therapy (Endpoints)
- Adicet reveals Phase 1 data for lupus therapy; Arcus’ ‘best-in-class’ kidney cancer drug (Endpoints)
- Biopharma makes little progress on gender diversity, as women make up 11% of CEO ranks (Endpoints)
- Biomea shares early Phase 2 diabetes data from repurposed cancer candidate (Endpoints)
- AeroRx closes $21M Series A in bid to capitalize on COPD momentum (Endpoints)
- Engineered Protein That Responds to Light Could Help Restore Sight (Bloomberg)
- How the FDA’s crackdown on cybersecurity affects medtech firms (MedTech Dive)
- How 4 medtech CEOs are using AI (MedTech Dive)
- AdvaMed Warns Of Challenges With Remote Devices While Noting Their Potential (MedTech Insight)
- Convatec plans $1B investment in R&D in the US and UK (MedTech Dive)
- AI is set to transform the way consumers shop for food (Food Dive)
- Tyson agrees to record $85M settlement in pork price-fixing lawsuit (Food Dive)
- They advised federal health agencies on the ethics and impact of scientific research. They’re no longer wanted (STAT)
- What RFK Jr. gets wrong about medical school and nutrition education (STAT)
- US health official calls for separating measles combination shots, pulls broad COVID vaccine support (Reuters)
- Gilead inks Biktarvy settlements with 3 generic drug makers (Fierce Pharma)
- TV drug ad spending picked up in September despite federal crackdown (Fierce Pharma)
- Massachusetts Effort to Offset Trump’s Research Cuts Stalls (Bloomberg)
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