Recon: Novartis sues over IRA drug pricing negotiation; Novo’s Wegovy launches in UK to pent-up demand
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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