Recon: Novartis sues over IRA drug pricing negotiation; Novo’s Wegovy launches in UK to pent-up demand

• Novartis sues US government over Medicare drug price regulation (Reuters)
• Judge withdraws from Medicare drug price case after stock ownership is revealed (CNBC)
• Analysis: FTC settlement could shelter Amgen from US price cuts, taxes (Reuters)
• CMS Chief Medical Officer Is Former Obama Administration Health Official Hughes (Pink Sheet)
• Tonix's long COVID drug fails to meet mid-stage trial goal (Reuters)

• Wegovy finally reaches the UK, in 'limited' quantities (Pharmaphorum) (Reuters)
• EU regulator recommends pregnant women not use epilepsy drug topiramate (Reuters)
• UK women cleared to sue Bayer over Essure contraceptive (Pharmaphorum)
• UK regulator approves updated Pfizer-BioNTech COVID vaccine (Reuters)
• Pent-up private Wegovy demand prompts UK availability concerns (Reuters)
• South Korea's Celltrion earmarks $94.5M for new manufacturing plant: reports (Fierce Pharma)
• Pharma Firms Can Sue Competitors For Violating Orphan Exclusivity, German Court Rules (Pink Sheet)
• EU Project To Evaluate Delays To Drug Trials Conducted In Combination With Studies For IVDs/Devices (Pink Sheet)
• EU To Simplify ‘Increasingly Complex’ Post-Authorization Variation Procedures (Pink Sheet)

• How Novartis’s CEO Learned From His Mistakes and Got Help From an Unlikely Quarter (The Wall Street Journal)
• Nestle divests peanut allergy business Palforzia (Reuters)
• BioCardia unveils interim data that led it to stop PhIII enrollment of heart failure stem cell therapy (Endpoints)
• Tivdak gets primary endpoint in PhIII confirmatory study (Endpoints)
• Lung cancer biomarker campaign, launched with AstraZeneca, boosts its reach and adds pharma supporters (Endpoints)
• MacroGenics gets $15M from Gilead; Zenas, Bristol Myers sign licensing deal in Asia-Pacific (Endpoints)
• Beam doses first patient with base-edited cell therapy (Endpoints)
• First RNA editing therapy nears clinic, as Wave ask regulators to greenlight human tests (Endpoints)
• Biogen secures $1.5B loan to fund Reata buyout, with three-year repayment schedule baked in (Endpoints)
• Novartis Confirms Sandoz Spin-Off Plans, Sets Oct. 4 Completion Date (BioSpace)
• Genmab, Seagen Notch Late-Stage Victory in Metastatic Cervical Cancer (BioSpace)
• Coveted GLP-1 Drugs Show Early Promise in Alzheimer’s Disease (BioSpace)

• Moving beyond ChatGPT: How generative AI is inspiring dreams of a health data revolution (STAT)
• Generative AI Tracker: A guide to the health systems and companies driving adoption (STAT)
• UK Regulatory Update: MHRA Adds More Medtech UK Approved Body Capacity in August (MedTech Insight)
• Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google (MedTech Dive)
• 23andMe wins FDA clearance to test for expanded set of BRCA cancer risk variants (MedTech Dive)
• Illumina names Agilent executive as new CEO (STAT)

• Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA (Courthouse News Service)
• Republicans say they’ll stop fentanyl at the border. But what are their plans for treatment? (STAT)