Recon: UniQure pursues path forward for Huntington's treatment despite FDA block; Pfizer CEO critical of FDA’s Prasad

• A titan of vaccine development sees his field’s achievements slip away (STAT)
• Kennedy announces new vaccine advisory committee members after meeting rescheduled (STAT)
• How can HHS drive clinical AI adoption? The industry wish list is starting to take shape (STAT)
• Hims expansion may not come in time for risky GLP-1 business (Reuters)
• Pfizer CEO flags issues with FDA's vaccine leadership (Reuters)
• US FDA Use of ‘Potential Official Action Indicated’ Flag Raises Concerns About Facility-Based CRLs (Pink Sheet)
• Federal Court Preliminarily Enjoins Texas Labeling Law (FDA Law Blog)

• Trump’s drive to get Europe to pay more for drugs creates uncertainty for countries, patients (STAT)
• Phase 3 China obesity biotech gets $72M, including support from OrbiMed (Endpoints)
• Novo Nordisk to invest $506 million in Ireland plant expansion (Reuters)
• EU Pharma Reform: New Pathways Ahead For Platform Technologies (Pink Sheet)
• Intuitive expands in Europe with purchase of distributor operations (MedTech Dive)

• UniQure plans to seek approval for Huntington’s therapy still blocked by FDA (STAT)
• Henrietta Lacks’ estate settles with Novartis over the ‘stolen cells’ that advanced science (STAT)
• I analyzed 6 months of Reddit discussion about at-home ketamine therapy. The findings alarmed me (STAT)
• United Therapeutics to take pulmonary hypertension drug to FDA for approval (STAT)
• Roche gets third pivotal win with MS drug, but liver signal could be a problem (Endpoints)
• Candid to go public via reverse merger with Rallybio (Endpoints)
• Bavarian Nordic CEO Paul Chaplin exits, months after failed $3B takeover (Endpoints)
• Merck looks to expand Welireg label following combo readouts with Keytruda, Lenvima (Endpoints)
• Intellia gets FDA nod to resume second gene therapy trial after safety pause (Reuters)
• United Therapeutics' drug slows progression of rare lung condition in late-stage study (Reuters)

• FDA warns insulin infusion set maker Unomedical over leaks, mishandled complaints (MedTech Dive)
• Abbott wins FDA approval for updated heart failure monitoring device (MedTech Dive)
• GE HealthCare forms 10-year imaging alliance with UCSF Health (MedTech Dive)
• UFP Technologies investigating cyberattack that impacted company data (MedTech Dive)

• Novartis' Rhapsido shows promise in Phase 2 food allergy data (Endpoints)
• Target to stop carrying cereals with synthetic colors (Food Dive)

• Cannabis has become more legal. It’s time to update laws around use by pregnant people (STAT)
• Federal Medicaid audit finds massive overpayment for autism therapy in Colorado (STAT)
• ‘FDA Direct’ Podcast Ends Hiatus … And A Lot Has Happened (Pink Sheet)
• Trump administration targets DME suppliers in fraud crackdown (MedTech Dive)