Recon: Trump threatens 200% tariffs on drugs; Novo seeks EU authorization for higher Wegovy dose
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Inside the Collapse of the FDA (NYTimes)
- Inside the staff exodus and tanking morale that threaten Makary’s FDA (STAT)
- Trump threatens to impose up to 200% tariff on pharmaceuticals ‘very soon’ (CNBC)
- US CDC ends emergency bird flu response as infections decline (Reuters)
- As Chinese-developed drugs draw U.S. interest, a regulatory chill threatens to dampen new investment (STAT)
- Concentra extends biotech shopping spree by collecting Cargo (Fierce)
- Advocacy groups, health networks and others back bill seeking to nix 'interchangeable' biosim tag (Fierce)
- Novo Nordisk submits higher Wegovy dose to the European Medicines Agency for approval (Reuters)
- Novartis wins approval for first malaria drug for newborns and babies (Reuters)
- Government ignoring pelvic mesh reforms – advocate (BBC)
- EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation (Pink Sheet)
- Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor (Pink Sheet)
- Korea Pre-Review Consultations Help Accelerate R&D (Pink Sheet)
- Psychiatric medication is in dire need of innovation (FT)
- Biopharma's 20 highest-paid CEOs of 2024 with $20M+ paydays (Endpoints)
- Dizal to challenge J&J with FDA approval for lung cancer drug Zegfrovy (Fierce)
- US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News? (Pink Sheet)
- Biopharma layoffs for first half of the year jump 32% YOY (Fierce)
- Drug Sponsors Can Help Shape Agenda For FDA/EMA Pediatric ‘Cluster’ Calls (Pink Sheet)
- Recursion takes full rights to rare genetic disorder drug; CStone out-licenses cancer drug in Europe (Endpoints)
- ProKidney's stock shoots higher after mixed Phase 2 data (Endpoints)
- Stock Watch: US CAR-T And Vaccine Actions: Net Negative For Access (Scrip)
- HIV drugmaker Theratechnologies agrees to $254M buyout by CDMO Future Pak (Fierce)
- Quanterix closes Akoya deal after competing bid (Endpoints)
- Startup raises $45M for universal flu vaccines made with mRNA (Endpoints)
- Singaporean biotech gets China thumbs-up for study of potentially curative HBV cell therapy (Endpoints)
- Duke Street Bio receives FDA fast track designation for brain metastases treatment (Pharmafile)
- Thinking About Covalent Drug Reactivity (In the Pipeline)
- Mendaera wins FDA clearance for robotic needle placement (MassDevice)
- Medtronic Diabetes names CFO with consumer experience ahead of separation (MassDevice)
- Boston Scientific gets expanded PFA label for persistent AFib (MedtechDive)
- Kardium pulls in an additional $250M to advance PFA tech (MedtechDive)
- FDA warns company about violations of seafood safety procedures (Food Safety News)
- Nationwide Gummies Recall Update as FDA Issues Highest Risk Warning (Newsweek)
- FDA Issues Most Serious Risk Warning for Cheese Recall (Newsweek)
- Even low doses of CBD may cause harm to the liver in some people, FDA study finds (NBC)
- Judge orders CVS' Omnicare unit to pay $949 million over invalid prescriptions (Reuters)
- California fails to stop 23andMe founder from re-acquiring company (Reuters)
- The Supreme Court passed on a state PBM case. Lawyers say a broader legal fight is brewing (Endpoints)
- Southwest Airlines accuses drugmakers of price-fixing conspiracy in new lawsuit (Reuters)
- USPTO Ups Number Of Prioritized Patent Applications (Law360)
- J&J Unit Looks To Wipe Out $442M Catheter Antitrust Loss (Law360)
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