Recon: White House reviewing 3 candidates for FDA chief; GSK exits Alector deal after Alzheimer’s, dementia flops
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- White House reviewing top contenders to lead FDA (STAT)
- FDA halts release of new drug rejection letters while working to formalize policy (Fierce) (Endpoints)
- RFK Jr. plans to create list of injuries caused by Covid-19 vaccines (STAT)
- ARPA-H launches $160 million effort to develop custom gene editing drugs (STAT)
- Lilly was already pharma's biggest company. Now it's doing deals to match (Endpoints)
In Focus: International
- Alector and GSK partnership to end after dementia, Alzheimer's drug failures (Reuters)
- China adds second GLP-1 diabetes drug to essential medicine list (Reuters)
- Novo Nordisk launches weekly insulin shot Awiqli in India (Reuters)
- India's Torrent Pharma recalls select semaglutide pens after Dr. Reddy's notice (Reuters)
- UK MHRA Inspectors Want The ‘Story’ Behind Clinical Trial Priorities, Not Just The List (Pink Sheet)
- China Doubles Down On Market Access Speed For Cell And Gene Therapies (Pink Sheet)
Pharma & Biotech
- 931 days. The drug approval scandal hiding in plain sight (STAT)
- AstraZeneca, Ionis report major trial failure with heart disease drug (STAT) (Reuters)
- Space station bioprinting experiment advances quest for lab-grown tissues, company says (Reuters)
- Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships (Endpoints)
- Biosimilar Development Fees Dropped As US FDA And Industry Concluded BsUFA IV Negotiations (Pink Sheet)
- The quest to save Grace — and clear the way for rare disease patients everywhere (STAT)
Medtech
- J&J wins FDA approval for dual-energy ablation catheter (MedTech Dive)
- Resmed to sell MatrixCare for $490M to private equity firm (MedTech Dive)
- Physicians’ wearable data use hampered by reimbursement, workflow barriers: survey (MedTech Dive)
- Penumbra starts trial of clot removal device in stroke subgroup (MedTech Dive)
- Roche Turns To Industrial Robotics Partner ABB Robotics In Lab Automation Push (MedTech Insight)
- VB Spine Bets On Fluoroscopy Fix To Bring AR Navigation To More Ors (MedTech Insight)
- Team-NB Pushes Back Against Lighter MDR/IVDR Oversight In New Position Paper (MedTech Insight)
Food & Nutrition
- As MAHA clashes with courts, is RFK Jr’s food policy agenda on life support? (Food Dive)
- Walmart cuts prices on groceries and other goods (Food Dive)
Government, Regulatory & Legal
- OpenEvidence backs study that finds it beats LLMs (STAT)
- Barn-Burned: Fifth Circuit Finds FDA Tobacco Civil Monetary Penalty Unconstitutional (FDA Law Blog)
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.
