Recon: US Justice Department appeals Texas abortion drug ruling; Moderna says flu vaccine missed the mark in late-stage trial

• Moderna flu vaccine misses ‘early success’ bar, shares fall (Reuters) (Endpoints) (Bloomberg)
• White House launching $5 billion program to speed coronavirus vaccines (Washington Post) (Axios)
• Justice Department appeals Texas abortion ruling (Washington Post) (The Hill)
• Takeda Receives FDA Approval to Expand the Use of HYQVIA to Treat Primary Immunodeficient in Children (BioSpace) (Yahoo)
• Industry leaders warn that abortion pill ruling puts FDA in 'totally uncharted territory' (Endpoints)
• FDA Accepts Interim Analysis Plan for Ongoing Phase 2b Ibezapolstat Clinical Trial and Acurx Announces Presentations at ECCMID 2023 Scientific Conference (BioSpace)
• U.S. spending $5 billion to speed up development of new COVID vaccines (Reuters)
• Makena: Professional Societies Finally See Eye To Eye With US FDA’s Drugs Center (Pink Sheet)
• Medicare Pitches $3.3 Billion Payment Hike for Hospitals in 2024 (Bloomberg)
• Biden Plan to Fix Organ Transplant Network Promised More Support (Bloomberg)
• The Biomedical Revolution Needs a Few Economists: Tyler Cowen (Bloomberg)
• ‘It was my call’: Stanford president defends decision not to correct key paper in misconduct investigation (STAT)

• WHO Welcomes ‘Constructive Suggestions’ For Pandemic Treaty, But Timeline Remains Uncertain (Pink Sheet)
• Industry Body Develops Code To Guide Ethical Conduct By EU Qualified Persons (Pink Sheet)
• Collaborate Rather Than Compete: Korea’s Push Toward A Biopharma Powerhouse (Scrip)
• French Impexweb System To Speed Up Drug Import Procedures (Pink Sheet)
• How India’s birth control battle falters in rural district (Reuters)

• In upcoming skin disease clash, doctors see Novartis’ Cosentyx as an underdog (Fierce)
• A new cell therapy biotech emerges to find solid tumor-killing immune cells in patients' blood (Endpoints)
• In debt again, Glenmark seeks buyer for its stake in API business: report (Fierce) (Reuters)
• Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains (Pink Sheet)
• A biotech upstart takes on cancer by crowdsourcing the immune system’s natural killers (STAT)
• Catalent breaks ground on 420M expansion of clinical supply facility (Fierce)
• LyGenesis and Imagine Pharma Announce Joint Research Collaboration to Develop Novel Cell Therapies for Patients with Type 1 Diabetes (BioSpace)
• Where is PhRMA in the mifepristone debate? (STAT)
• A new biotech wants to ease a bottleneck in cell and gene therapy production (BioPharma Dive)
• Here’s a new data point for cancer patients to consider: ‘time toxicity’ (STAT)
• Caribou get FDA fast track for allogenic CAR-T (BioPharma Reporter)
• REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy for the Treatment of Duchenne Muscular Dystrophy (BioSpace) (Fierce)

• EPA to limit ethylene oxide emissions from medical device sterilizers (MedTech Dive) (STAT) (Reuters)
• Why EU Patients Need Regulation That Aids Access To Orphan Devices (MedTech Insight)
• Icentia CardioSTAT Cleared for Heart Monitoring and Diagnosing (FDANews)
• Medtech buyouts by private equity in Q4 shed light on deal-making trends in 2023: report (MedTech Dive)
• Ultima Genomics combines ‘$100 genome’ tech with Genome Insight’s AI-powered analysis (Fierce)

• Judge orders Merck to hand over adverse events database in Gardasil lawsuit (Endpoints)
• Bristol-Myers, Cancer Institute Settle Patent Ownership Lawsuit (Bloomberg)
• Bristol-Myers, Pfizer Sue to Block Copies of Blockbuster Eliquis (Bloomberg)
• Johnson & Johnson’s $8.9B bankruptcy settlement is ‘unworkable,’ talc plaintiff lawyer says (Fierce) (Reuters)
• Theranos founder Elizabeth Holmes cannot remain free during appeal, judge rules Reuters)