Category
Innovative Tech
Technology changing how care is delivered and evaluated, from diagnostics to digital therapeutics. This coverage follows adoption, evidence requirements and reimbursement pathways rather than product launches alone.
597 articles in this topic.
Articles in this category
11/12/2026
US MFN Drug Pricing: A 25% German Price Rise Would Cut Medicaid Savings by 3.8%
A preprint led by Thomas Hwang models how German price changes affect US Medicaid MFN savings and German statutory health insurance spending.
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11/12/2026
Artificial Intelligence in Medicine Regulation: From Concept to Practice
EMA says it is moving artificial intelligence in medicine regulation from concept to practice. Its timeline runs from a 2021 joint workshop to research priorities published in August 2026. #SyenzaNews #MarketAccess #drugregulation
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11/12/2026
EMA Draft Guideline on Predictive Biomarker Assays Opens Public Consultation to 31 March 2027
The European Medicines Agency has opened public consultation on its draft guideline on predictive biomarker assays. Comments are accepted from 9 November 2026 until 31 March 2027.
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11/10/2026
Factor XIa Inhibitor for Stroke Prevention: FDA Approves Sunharbo
The FDA approved Sunharbo (asundexian), the first factor XIa inhibitor for stroke prevention, for adults after a recent ischemic stroke or high-risk TIA. #SyenzaNews #MarketAccess
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11/10/2026
Enzutrix Patent Dispute Heads to Constitutional Court: Hearing Set for 23 November
The Enzutrix patent dispute goes to South Africa's Constitutional Court on 23 November 2026. UC and Astellas are pursuing damages over the generic prostate cancer drug, while Eurolab argues the patent was never validly obtained. #SyenzaNews #MarketAccess
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11/9/2026
CMS Finalizes GLOBE Model Drug Pricing for Medicare Part B Drugs
CMS finalizes the GLOBE Model drug pricing rule, benchmarking Medicare Part B drug rebates against international prices from April 2027. #SyenzaNews #MarketAccess
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11/9/2026
Medicare drug price negotiation: CMS sets permanent rules
The final rule also covers a temporary price floor for small biotech drugs and Part D plan payments to dispensing entities. #SyenzaNews #DrugPricing #MarketAccess
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11/6/2026
Recent Zolgensma safety concerns: what Novartis has reported
SMA Europe has relayed Novartis's figures on tumour reports in patients previously treated with Zolgensma, including two cases of vector DNA integration.
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11/6/2026
Dupilumab Chronic Spontaneous Urticaria: G-BA Finds No Proven Added Benefit
The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.
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11/4/2026
State AI Liability in Health Care: Lawsuits Test Insurers, Apps and Chatbots
A Congressional Research Service sidebar maps the state lawsuits over AI in health care, from insurer claim denials to wellness apps and chatbots.
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11/4/2026
EMA Mid-Year Report 2026: Reform, Supply and the First Joint Clinical Assessment
The EMA mid-year report 2026 records 485 scientific advice requests in the first half, the first joint clinical assessment under the HTA Regulation and progress on the new pharmaceutical law. #SyenzaNews #MarketAccess
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11/3/2026
FDA Potency Assurance Guidance: What It Asks of Cell and Gene Therapy Makers
FDA has finalized its potency assurance guidance for cell and gene therapy products. It covers lot-release testing, potency assays, acceptance criteria and how sponsors should build a strategy from the IND stage onward. #SyenzaNews #CellAndGeneTherapy #FDA
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