Recon: Lilly hits $1 trillion valuation; Notified bodies have capacity…for now

• More drama surrounds FDA as top aide to Makary faces pushback from White House (Endpoints)
• Lilly becomes first drugmaker to hit $1 trillion valuation on weight-loss demand (Reuters)
• US FDA Cancer Office Keeps Hemorrhaging Staff, Most Land At Industry (Pink Sheet)
• US FDA’s Advertising Enforcement Crackdown Expands To Generic Drugs (Pink Sheet)

• UK Tests Standardized Site Selection Process For Streamlining Clinical Trial Setup (Pink Sheet)
• Pharma Needs Incentives To Optimize Cancer Drugs, EMA Oncology Chair Says (Pink Sheet)
• How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech (MedTech Insight)
• Notified Bodies Have Availability Now - But The Situation Won’t Last (MedTech Insight)

• J&J’s novel Alzheimer’s drug fails in key trial, dimming hopes for a hot target (STAT)
• Novo Nordisk’s semaglutide fails to slow Alzheimer’s progression (STAT)
• Analysts, investors say Alzheimer's miss adds to Novo's challenges, but fundamentals intact (Reuters)
• Bayer’s stock rallies as next-gen blood thinner beats the odds with Phase 3 win (Endpoints)
• Kelun's TROP2 ADC plus Keytruda improved outcomes in lung cancer study (Endpoints)
• Biogen pens I&I deal with new Versant macrocycle developer Dayra Therapeutics (Endpoints)
• Sarepta to pay $200M milestone to Arrowhead; Enlivex reports osteoarthritis data (Endpoints)
• Exclusive: Craig Crews, Mikael Dolsten get $32M for Quarry Thera, with plans for more biotechs (Endpoints)
• Nobel laureate Carolyn Bertozzi to rejoin Lilly board (Endpoints)
• Bausch Seeks to Push Out 2028 Debts in $3.4 Billion Bond Exchange (Bloomberg)
• Americans Are Microdosing Obesity Drugs, Driven by 'Thin Is In' Marketing Blitz (Bloomberg)

• Abbott issues US device correction for some glucose monitors over faulty readings risk (Reuters)
• Insulet unveils plans for new diabetes devices (MedTech Dive)
• GE HealthCare to buy Intelerad for $2.3B (MedTech Dive)
• Health tech venture capital investment rebounds in 2025: report (MedTech Dive)
• Solventum inks $725M Acera takeover (MedTech Dive)
• Shockwave’s Nick West on shaking up treatment for blocked arteries (MedTech Dive)
• Rarity Bioscience Sees Way Forward For superRCA Liquid Biopsy Platform, Despite Challenges (MedTech Insight)

• US removes tariffs on Brazil coffee, beef (Food Dive)
• Georgia importer warned about violations of federal law (Food Safety News)

• ‘Hemp loophole’ closure pits patient access against a runaway marijuana industry (STAT)
• Is Slingshot’s mental health chatbot safe? Its first study raises questions about evaluating AI (STAT)
• HPV Research Bolsters Case for Vaccine in Misinformation Battle (Bloomberg)
• Getting Comfortable With The Black Box: Explainable AI Techniques Build Trust (Pink Sheet)