Category
Europe
Health technology assessment, pricing and access across Europe, including EU-level joint clinical assessment and the national systems that still decide funding. Coverage spans the major markets and the smaller systems that often move first.
700 articles in this topic.
Articles in this category
10/28/2026
Orphan Medical Devices Pilot Closes With 13 Positive Status Opinions
The EMA orphan medical devices pilot ran from August 2024 to March 2026. All 13 finalised procedures gave positive orphan status advice, and the service is now established. #SyenzaNews #MedTech #MarketAccess
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10/28/2026
EMA Expert Panel Advice Pilot Ends With a Streamlined 60-Day Procedure
EMA's expert panel advice pilot for high-risk medical devices closed in February 2026 with 27 advice procedures finalised. Average advice time fell from 112 days in phase one to 86 in phase two, and a 60-day procedure followed. #SyenzaNews #MedicalDevices #HTA #MarketAccess
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10/28/2026
KRAS G12C inhibitor divarasib outperforms approved drugs
The KRAS G12C inhibitor divarasib improved survival versus sotorasib or adagrasib in the phase III Krascendo 1 trial. #SyenzaNews #oncology #NSCLC
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10/27/2026
Novartis core operating income rises, 2026 outlook raised
Novartis core operating income rose 10% at constant exchange rates in Q3 2026, and 2026 guidance for the measure was raised. #SyenzaNews #MarketAccess
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10/27/2026
Izalontamab brengitecan breast cancer: 59% lower risk of progression
Phase 3 PANKU-Breast01 data show izalontamab brengitecan cut the risk of disease progression or death by 59% versus chemotherapy in HR-positive, HER2-negative breast cancer. #SyenzaNews #breastcancer #oncology
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10/27/2026
Keytruda Monotherapy Endometrial Cancer: 43% Risk Reduction
Keytruda monotherapy cut the risk of progression or death by 43% against platinum chemotherapy in dMMR endometrial cancer, in the KEYNOTE-C93 Phase 3 trial. #SyenzaNews #oncology #precisionmedicine #endometrialcancer
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10/27/2026
Endometriosis and fibroid tablets in England: prescriptions soar
NHS use of NICE-recommended endometriosis and fibroid tablets in England more than tripled in a year, from 1.2 million to 3.7 million tablets. #SyenzaNews #MarketAccess
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10/26/2026
JNJ-6143 prostate cancer: 75% tumor response in Phase 1 trial
JNJ-6143, an investigational first-in-class oral molecule, produced a 75% tumor response rate among patients with measurable disease in a Phase 1 study. #SyenzaNews #prostatecancer #oncology
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10/26/2026
Claudin 18.2 antibody-drug conjugate prolongs survival in gastro-oesophageal cancer
Sone-Ve doubled median overall survival versus investigator's choice in third-line and later gastro-oesophageal cancer; second-line PFS missed significance.
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10/26/2026
Obesity drug reimbursement in Portugal: new SNS terms
Portaria n.º 464/2026/1 limits state reimbursement for obesity medicines to SNS patients in a hospital obesity pathway. Cover is 15% for 12 months. #SyenzaNews #MarketAccess
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10/23/2026
Palbociclib Maintenance in HER2-Positive Breast Cancer: EMA Withdrawal
Pfizer has withdrawn its EU application for palbociclib in HER2-positive breast cancer. EMA questioned the open-label PATINA endpoint.
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10/21/2026
CagriSema Weight Loss in Women: Menopause Stages in REDEFINE 1
Two post hoc REDEFINE 1 analyses show CagriSema weight loss in women held across premenopausal, perimenopausal and postmenopausal stages. #SyenzaNews #obesity #MarketAccess
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