Recon: Trump threatens 200% tariffs on drugs; Novo seeks EU authorization for higher Wegovy dose

• 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)