Syenza News — health technology assessment, market access and health economics
Aspen Gets Approval for Generic Semaglutide in Brazil and South Africa
Aspen Pharmacare has received approval for generic semaglutide in Brazil and South Africa, following Canada in July. Launches in all three markets are expected over the coming months. #SyenzaNews #MarketAccess
Recent Posts
US MFN Drug Pricing: A 25% German Price Rise Would Cut Medicaid Savings by 3.8%
Nov 12
The EU HTA Regulation: What Latin America Can Learn
Nov 12
Artificial Intelligence in Medicine Regulation: From Concept to Practice
Nov 12
EMA Draft Guideline on Predictive Biomarker Assays Opens Public Consultation to 31 March 2027
Nov 12
FDA Adds Warning on NAION Risk with GLP-1 Receptor Agonists
Nov 10Syenza's Top Picks
FDA Grants Accelerated Approval to Voceryq for Recurrent Respiratory Papillomatosis
Nov 2, 2026
Truqap prostate cancer withdrawal: AstraZeneca pulls EU bid
Nov 4, 2026
Mayo Clinic’s TV question for the home blood pressure monitor
Nov 3, 2026
Second Cochlear Implant Now Covered for Adults in the Netherlands
Nov 3, 2026
Global Drug Regulators Summit in Seoul Takes Up AI and Animal Testing Alternatives
Nov 3, 2026
FDA Potency Assurance Guidance: What It Asks of Cell and Gene Therapy Makers
Nov 3, 2026
Latest News
Cardiovascular And Metabolic Diseases
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
Cost Effectiveness Analysis
Neuquén Health Technology Assessment Agency: What Law 3563 Sets Up
Law 3563 creates a Neuquén health technology assessment agency. Guadalupe Montero explains how it will weigh safety, benefit, equity and budget impact.
Clinical Guidelines And Protocols Free account
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
Health Policy Free account
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
Health Policy
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
Clinical Practice
Zepbound and Foundayo telehealth access via Hims & Hers
Eli Lilly and Hims & Hers Health agreed to widen Zepbound and Foundayo telehealth access, with self-pay prices starting at $149 per month. #SyenzaNews #obesity #telehealth
Asia
M72 tuberculosis vaccine approval in Indonesia: BPOM weighs a fast track
BPOM is drafting a conditional approval route for the M72 TB vaccine and a joint review with the European Medicines Agency, ahead of Phase 3 results.
Cost Effectiveness Analysis Free account
Refixia Nonacog Beta Pegol: INFARMED Recommends Funding for Children Under 12 With Haemophilia B
INFARMED recommends public funding for Refixia nonacog beta pegol in children under 12 with haemophilia B, based on two single-arm trials. #SyenzaNews #MarketAccess
Clinical Practice
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.
Cost Effectiveness Analysis Free account
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.
Value Science Weekly
The week in health technology assessment, market access and health economics — what moved, and what it means.
