Syenza News — health technology assessment, market access and health economics
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
Recent Posts
EMA Expert Panel Advice Pilot Ends With a Streamlined 60-Day Procedure
Oct 28
Individualised gene therapies for rare diseases: FDA draft guidance
Oct 28
KRAS G12C inhibitor divarasib outperforms approved drugs
Oct 28
Novartis core operating income rises, 2026 outlook raised
Oct 27
Izalontamab brengitecan breast cancer: 59% lower risk of progression
Oct 27Syenza's Top Picks
Reinforcement learning rTMS for depression treatment
Oct 19, 2026
CagriSema Weight Loss in Women: Menopause Stages in REDEFINE 1
Oct 21, 2026
Medicaid Provider Taxes Raise Private Insurance Premiums, ASPE Finds
Oct 21, 2026
Biomarker laboratory in Portugal opens at University of Porto
Oct 20, 2026
Emvistegrast in ulcerative colitis hits Phase 2 primary endpoint
Oct 20, 2026
Jemperli rectal cancer approval may let some patients skip standard treatment
Oct 20, 2026
Latest News
Clinical Practice
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
Europe
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
Clinical Practice
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
Clinical Practice
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.
Diseases
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
Diseases Free account
Antiretroviral Tender Awards Declared Invalid by Pretoria Court
A Pretoria court has declared invalid the antiretroviral tender awards for two items and ordered the health department to redo the split within 120 days. Cipla’s review succeeded on all five grounds, while Hetero’s challenge was dismissed with attorney-and-client costs. #SyenzaNews #SouthAfrica #HIV
Clinical Practice
Intismeran Adjuvant Melanoma Trial Cuts Recurrence Risk by 42%
Merck and Moderna report a 42% reduction in recurrence or death for intismeran plus KEYTRUDA in resected stage IIB-IV melanoma, with full data at ESMO 2026. #SyenzaNews #melanoma #MarketAccess
Alzheimer's Disease
FDA Launches Neuroscience Medical Product Development Program
The FDA has launched the Neuroscience Advancement and Innovation Nexus, starting with an Alzheimer’s Prevention Accelerator. #SyenzaNews #Alzheimers #MarketAccess
Artificial Intelligence And Machine Learning
Clinical AI governance framework guides AI tool evaluation
A new npj Digital Medicine article in press from SCPMG proposes the C-TACT clinical AI governance framework, with weighted lifecycle scorecards and its limits stated.
Clinical Practice
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.
Value Science Weekly
The week in health technology assessment, market access and health economics — what moved, and what it means.
