Recon: Lilly hits $1 trillion valuation; Notified bodies have capacity…for now
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
In Focus: International
- 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)
Government, Regulatory & Legal
- ‘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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
