Latest News — Page 7
Cost Effectiveness Analysis
Spain’s New HTA Law Gives Patient Involvement in HTA a Legal Footing
Spain’s Real Decreto 415/2026 makes patient involvement in HTA a legal requirement. Speakers from POP, Cancer Patients Europe, BMS and NICE explain how plain-language summaries keep that involvement meaningful.
Big Data Analysis
The Data Act puts device data in the hands of hospitals
From 12 September 2026, new connected medical devices on the EU market must be designed for default data access, handing hospitals control of the data their equipment generates. #SyenzaNews #DataAct #MedicalDevices #MarketAccess
Clinical Practice
Obesity Medicines Move Into Elementary School After Novo’s STEP Young Result
Novo Nordisk’s STEP Young trial reports 40.4% of children aged 6 to under 12 left the obesity range on semaglutide, the first Phase 3 win in elementary-age obesity. #SyenzaNews #obesity #GLP1 #MarketAccess
Clinical Practice
WHO and St. Jude Launch Market-Shaping Strategy for Childhood Cancer Medicines
WHO and St. Jude, with UNICEF and PAHO, have launched a 2026 to 2030 market-shaping strategy to improve access to childhood cancer medicines in low- and middle-income countries. #SyenzaNews #ChildhoodCancer #MarketAccess #Oncology
Diabetes
Novo Nordisk Rebrands to Novo as Obesity Becomes a Consumer Market
Novo Nordisk rebrands to Novo and drops the dual name as obesity shifts to a consumer market. What changes, what is left behind, and what the 21 September Capital Markets Day must deliver. #SyenzaNews #NovoNordisk #MarketAccess #Obesity
Clinical Practice
Definium’s DT120 Generalized Anxiety Disorder Trial Meets Primary Endpoint in Phase 3 Panorama Study
Definium Therapeutics’ DT120 ODT met its primary endpoint in the Phase 3 Panorama trial, delivering a 5.1-point placebo-adjusted improvement on the HAM-A anxiety scale. #SyenzaNews #GAD #MentalHealth #MarketAccess
Clinical Practice
FDA Hearing Puts Psychedelic Drug Access and Reimbursement in Focus
The FDA’s landmark hearing on psychedelic medicines drew 80 speakers and 1,800 registrants, and the market access message was clear: approval is not access, and reimbursement is the binding constraint. #SyenzaNews #MarketAccess #Psychedelics #HealthPolicy
Sub Saharan Africa
SAHPRA’s Friday deadline: why companies should, and should not, join the device-registration test
SAHPRA has opened Phase 2 of its medical device registration feasibility study, with expressions of interest due by 16:30 on Friday 18 September 2026. The test is voluntary and unpaid, but it is a rare chance to shape how South Africa registers devices before the process becomes mandatory. #SAHPRA #MedicalDevices #RegulatoryAffairs #MarketAccess
Diseases
Pretoria Court Calls iDexis Appeal an ‘Abuse of Process’, Keeps Semaglutide Compounding Ban
South Africa’s High Court has kept the semaglutide compounding ban in place, dismissing iDexis’s appeal as an ‘abuse of process’ while SAHPRA and SAPC finish their investigations. #SyenzaNews #MarketAccess #Pharma
Artificial Intelligence And Machine Learning
Multi-Agent AI Improves AI-Generated Medical Exams
A new open-source framework splits medical exam-item writing across specialist AI agents. In a blinded evaluation, multi-agent output won 57.7% of expert preferences against 42.3% for a single model. #SyenzaNews #DigitalHealth #AIinHealthcare
Clinical Practice
Enhertu HER2-Mutant NSCLC Trial Meets PFS Endpoint but Overall Survival Remains Unsettled
Enhertu’s DESTINY-Lung04 trial cut the risk of progression versus chemo-immunotherapy in first-line HER2-mutant NSCLC, but an immature overall-survival trend and a 20.8% ILD rate complicate the path to a first-line label. #SyenzaNews #Oncology #NSCLC #MarketAccess
Clinical Practice
US Cancer Drug Shortages Persist at Every Major Cancer Center, NCCN Finds
Every NCCN academic cancer center now reports a shortage of at least one anticancer medicine, led by ifosfamide (94%) and carboplatin (71%). Pharmacy directors say three years of policy have not moved the problem. #SyenzaNews #DrugShortages #Oncology #MarketAccess
Clinical Practice
NICE Draft Guidance Rejects Lenacapavir for HIV PrEP in England
NICE has opened consultation on draft guidance that does not recommend lenacapavir for HIV PrEP, finding the six-monthly injection is not value for money for the NHS in England. #SyenzaNews #HTA #HIV #PrEP #MarketAccess
Artificial Intelligence And Machine Learning
AI in health technology assessment: what stays human
Alec Morton of NUS explains how AI is changing health technology assessment, what stays human, and why cheaper analysis could mean more health economics.
Europe
Rewarding Quality, Not Just Price: What the EU Public Procurement Act Means for Medicines
The European Commission’s EU Public Procurement Act would make quality, not price, the default for public tenders. EFPIA supports the shift, with one warning: resilience should not become local-content rules. #SyenzaNews #EUProcurement #Medicines #MarketAccess #HealthPolicy
Artificial Intelligence And Machine Learning
UK Commission Sets Out a Framework for AI Healthcare Regulation
An independent UK commission has published its recommendations for regulating AI in healthcare. The report calls for staged approvals and continuous real-world monitoring, alongside stronger enforcement powers for the MHRA. #SyenzaNews #AI #Healthcare #MarketAccess