Recon: Pazdur to retire from FDA weeks after taking CDER job; CDC advisors to vote on delaying hep B vaccine

• Top drug regulator Richard Pazdur set to leave the FDA (STAT) (Washington Post) (CNN)
• FDA offers staff ‘agentic AI’ to support premarket reviews, administrative tasks (STAT)
• House passes bill to reauthorize rare pediatric PRV program; Senate next (Endpoints)
• Data supports current US policy of hepatitis B vaccine for newborns, as officials push for change (Reuters)
• US vaccine committee to vote this week on delay of hepatitis B shots (Reuters)
• CVS to pay $37.8 million to settle claims over insulin pens (Reuters)
• US FDA moves to curtail primate testing in drug trials (Reuters)

• Swiss biotech plots Series B raise to advance Alzheimer’s drug into Phase 2 (Endpoints)
• China’s 78-Cent Flu Shots Show Price Squeeze for Vaccine Makers (Bloomberg)
• Broad Korea Pricing Reforms Aim To Promote Innovation, Ensure Essential Drug Supply (Pink Sheet)
• China Adds Tax to Condoms as It Works to Boost Birth Rates (Bloomberg)
• Novo Nordisk to test next-gen obesity drug CagriSema in children (Reuters)

• Belite Bio aims for first approval of Stargardt disease treatment with Phase 3 success (Endpoints)
• Exclusive: ARCH, Parker Institute build next big oncology bet with suite of programs and startup acquisition (Endpoints)
• As approval date looms, Cytokinetics gears up for David-and-Goliath battle with Bristol Myers (Endpoints)
• Helicore stops work on clinical GIP antagonist after Phase 1 results, will focus on other drugs in pipeline (Endpoints)
• Exclusive: Trial Library raises $10M to sell clinical trial matching to insurers (Endpoints)
• Imvax shares Phase 2b data for glioblastoma treatment, plans to meet with FDA (Endpoints)
• New Pill Could Replace Shots for Chronic Hives (Bloomberg)

• FDA flags risk from dropped BD Alaris pumps after 2 injury reports (MedTech Dive)
• Cleveland Diagnostics wins FDA nod for prostate cancer test (MedTech Dive)
• Tech emerges as a new frontier for digital therapeutics (Endpoints)
• Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform (FDA)

• Marion Nestle still believes that ‘calories count’ (STAT)
• How much further can source reduction in packaging go? (Food Dive)

• States fail to require adequate cannabis product safety warnings (STAT)
• CMS to end historic kidney disease payment experiment two years early (STAT)
• Hospital groups sue the Trump administration to halt a 340B pilot program set to begin in January (STAT)
• CDC staff with disabilities feel stranded as HHS implements new policy (STAT)
• Anti-abortion 'crisis pregnancy centers' case goes to US Supreme Court (Reuters)
• Health Insurer Curative Valued at $1.28 Billion in Fund Raise (Bloomberg)
• Trump Signs Law to Unlock Billions for Drug Addiction Recovery (Bloomberg)