Recon: Prasad regains FDA chief medical and scientific officer title; FDA panel to review AI mental health devices
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Vaccine policy threatens to put Kennedy at odds with Trump (STAT)
- Dropping hepatitis B shots for newborns would ignore history and endanger children, scientists warn (STAT)
- AbbVie shares hit record high as key immunology drug set for exclusivity until 2037 (Reuters) (Pharmaphorum)
- J&J claims FDA okay for bladder cancer drug TAR-200 (Pharmaphorum)
- Intercept pulls liver disease drug from market as FDA puts clinical trials on hold (Endpoints)
- Vinay Prasad regains role as FDA chief medical officer (Reuters)
- How RFK Jr. Is Pushing the CDC to the Brink (Bloomberg)
- RFK Jr.'s 'historic changes' to drug ads would trigger range of ripple effects (Endpoints)
- EU Critical Medicines Act: Parliament Clarifies ‘Significant Proportion’ Rule (Pink Sheet)
- Pharma says UK is 'tumbling down' rankings for investment (Pharmaphorum)
- Fresh blow to UK life sciences as MSD abandons £1bn project (Pharmaphorum)
- Argentina's Milei vetoes pediatric hospitals funding law (Reuters)
- Congo’s Ebola Virus Outbreak Seen Posing Major Threat to Angola (Bloomberg)
- Child dies after receiving new experimental gene therapy (STAT)
- Psychedelics are suddenly drawing interest from big drugmakers (STAT)
- Piercing the hype around Patrick Soon-Shiong’s ‘Bioshield’ cancer treatment (STAT)
- Zentiva set to change hands in €4.1bn private equity deal (Pharmaphorum)
- Q&A: Lasker Award winner Michael Welsh on the science that led to life-saving cystic fibrosis drugs (Endpoints)
- Avidity shares fall after $500M offering, dimming hopes of a Novartis buyout (Endpoints)
- Maze’s SLC6A19 inhibitor moves to Phase 2; GenFleet to go public in Hong Kong (Endpoints)
- Exclusive: Sophont raises $9.2M to build multimodal foundation models (Endpoints)
- Novo Nordisk tells staff to return to office full-time amid CEO's revival effort (Reuters)
- Merck's pneumococcal shot shows promise in at-risk children and teens (Reuters)
- FDA will convene an advisory committee to tackle AI mental health device regulation (STAT) (Reuters)
- Patients call for more medical device user fee funding, FDA staffing (MedTech Dive)
- GE HealthCare inks Icometrix buyout to acquire brain MRI software (MedTech Dive)
- Masimo, Philips extend patient monitoring partnership (MedTech Dive)
- The MAHA kids’ health report missed an important opportunity on children and non-sugar sweeteners (STAT)
- Can Eating Only Meat on a Carnivore Diet Be a Good Thing? (Bloomberg)
- Eli Lilly loses appeal of $183.7 million Medicaid fraud award (Reuters)
- HPM Fact Sheet: Ensuring FDA and HHS Are Held Accountable For “Radical Transparency” and Communicating Truthful and Non-Misleading Information About DTC Rx Drug Ad “Crackdown” (FDA Law Blog)
- SEC files charges against former FibroGen CMO for manipulating clinical trial data (Endpoints)
- Just 1 in 4 Americans think vaccine policy shifts are based on science, Reuters/Ipsos poll finds (Reuters)
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