
NICE Recommends Enhertu for HER2-Low Breast Cancer
NICE has reversed its earlier rejection and now recommends Enhertu (trastuzumab deruxtecan) as a routine NHS option for HER2-low metastatic breast cancer after chemotherapy. The change follows an updated commercial deal and new EQ-5D-5L utility values validated in the DESTINY-Breast04 trial. #SyenzaNews #HTA #MarketAccess #BreastCancer
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Rewarding Quality, Not Just Price: What the EU Public Procurement Act Means for Medicines
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AI in Portuguese Healthcare: What Should Portugal Want It to Do?
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Sep 9, 2026Latest News

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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

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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

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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

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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

News
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

News
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

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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

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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

News
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

News
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.
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