Syenza News — health technology assessment, market access and health economics
Adverse reaction reports in Portugal rise with GLP-1 use
Infarmed has logged 695 suspected adverse reactions to GLP-1 drugs in Portugal since 2024, most linked to Mounjaro.
Recent Posts
Foundayo Oral GLP-1 Tablet Gets Positive EU Opinion
Oct 19
EMA Draft Reflection Paper Sets Rules for Confirmatory Platform Trials
Oct 19
Reinforcement learning rTMS for depression treatment
Oct 19
AI operating room scheduling: LLM agent teams reach feasible plans
Oct 16
Most favored nation drug pricing: why US patient groups push back
Oct 16Syenza's Top Picks
PhRMA’s GLOBE Drug Pricing Lawsuit Seeks to Block the Medicare Rule
Oct 8, 2026
The Strategic Health Economy: Why Finance Ministries Still See Health as a Cost
Oct 12, 2026
AI in Medical Education: Responsible Integration Across the Training Continuum
Oct 12, 2026
Multiple Sclerosis Health Utilities Decline With Disability
Oct 9, 2026
Clinical trial applications advice becomes permanent from 2027
Oct 9, 2026
Uptake of New Cancer Medicines in Europe Still Varies
Oct 9, 2026
Latest News
Clinical Guidelines And Protocols Free account
FDA Rare Disease Framework Initiative Would Tailor Review to Small Populations
What steps is the FDA taking to accelerate rare disease treatments?
The FDA’s new Rare Disease Framework Initiative aims to streamline regulatory pathways, enhance collaboration with sponsors, and improve patient access to innovative therapies.
Explore how this could reshape drug development for underserved patient populations.
#SyenzaNews #regulatoryaffairs #drugdevelopment #innovation #healthcarepolicy
Clinical Practice
Semaglutide for Opioid Use Disorder: $13.3M Trial Planned in Allegheny County
Researchers and Allegheny County plan a $13.3 million trial of weekly semaglutide to reduce opioid and alcohol use and justice involvement.
Artificial Intelligence And Machine Learning
AI guidance in clinical development: what industry is asking for
Regulators at the HMA-EMA AI group on 5 October 2026 outlined AI guidance in clinical development, with a concept paper and public consultation to follow.
Clinical Practice
Social prescribing in Portugal: pilots, gaps and the cost of time
Social prescribing is not yet part of Portugal’s national health system. Economists are asking whether it works, and who pays for it.
Innovative Medicines And Medical Devices
EMA Expert Panel Consultation for Medical Devices Adds an Orphan Pathway
EMA has updated its business process for expert panel consultations on high-risk medical devices. The revision, effective 12 October 2026, adds orphan device advice as a new sub-process. #SyenzaNews #MedicalDevices #MarketAccess #HTA
Clinical Practice
BNT113 head and neck cancer trial misses first endpoint
BioNTech’s AHEAD-MERIT trial did not reach significance on progression-free survival. The overall survival read-out is still to come.
Cost Effectiveness Analysis
Rapid-Acting Insulin Analogue Cost-Effectiveness in Type 1 Diabetes: What the Evidence Shows
Insulin analogue cost-effectiveness studies for adults with type 1 diabetes mostly point the same way: the newer products usually come out ahead of human insulin. A new systematic review says that headline rests on thinner ground than it looks. The paper, by Shiwa Yaghoubi Bina, Steve Njokuocha and the T1D Economic Evidence Synthesis Group, has been accepted for Value in Health. The version available now is a pre-proof, so figures could still change at copyediting. The World Health Organization funded […]
Clinical Practice
Denosumab Ascend Biosimilar Wins EU Authorisation for Bone Complications
The EMA has authorised Denosumab Ascend, a biosimilar of Xgeva. Here is what the assessment shows on safety, efficacy and use. #SyenzaNews #biotechnology #MarketAccess
Europe
Health Security in Europe: Why Resilience Starts Before a Crisis
Health security in Europe is being redefined from emergency response to national resilience, and the EFPIA View argues it starts with funded health systems.
Health Policy
Health Investment Returns: What Berlin’s Funding the Future Panel Argued
Ministers, development banks and industry at the World Health Summit argued that health investment returns should be measured in lives saved, jobs and tax revenue, not budget size. #SyenzaNews #HealthEconomics #MarketAccess
Value Science Weekly
The week in health technology assessment, market access and health economics — what moved, and what it means.
