Latest News — Page 6

Clinical Practice
Roche’s Enicepatide Type 2 Diabetes Trial Meets HbA1c and Weight Goals
Roche’s dual GLP-1/GIP agonist enicepatide met both Phase II endpoints in type 2 diabetes, cutting HbA1c 2.65% and weight 15.5% at 48 weeks. #SyenzaNews #type2diabetes #GLP1 #obesity

Clinical Practice
COMP Recommends 12 EMA Orphan Drug Designations in July
COMP’s July 2026 sitting recommended 12 orphan drug designations, withdrew four, and sharpened the test for significant benefit against authorised therapies. #SyenzaNews #OrphanDrugs #MarketAccess #RareDiseases

Europe
European Pharmaceutical Investment Losing Ground, Nine Chairs Warn
Nine pharma chairs, from AstraZeneca to Sanofi, warn Europe is losing the pharmaceutical investment race to the US and China, and call on governments to treat medicines as strategic infrastructure. #SyenzaNews #pharmaceuticals #MarketAccess #drugdevelopment

Health Policy
SAHPRA Annual Report: Clean Audit and WHO ML3 Vaccine Milestone
SAHPRA reports a clean audit, WHO ML3 vaccine maturity, and ICH membership in its 2025/26 annual report, with R515.7 million in revenue and a R33.7 million surplus. #SyenzaNews #MarketAccess #SAHPRA

Artificial Intelligence And Machine Learning
Responsible AI Regional Networks: The Missing Link for Low-Resource Health Systems
Regional networks anchored to local contexts are the missing link for responsible AI in low-resource health systems, a new npj Digital Medicine Perspective argues. #ResponsibleAI #DigitalHealth #GlobalHealth #HealthEquity

Clinical Practice
FDA Grants Full Approval to Inluriyo Plus Verzenio for ESR1-Mutated Breast Cancer
The FDA has granted full approval to Inluriyo plus Verzenio for ESR1-mutated metastatic breast cancer. In the Phase 3 EMBER-3 trial, the all-oral combination doubled median progression-free survival versus Inluriyo alone, at 11.1 months versus 5.5 months. #SyenzaNews #Oncology #MarketAccess

Asia
What HTAsiaLink 2026 showed about the future of HTA in Asia-Pacific
HTAsiaLink 2026 brought HTA agencies, researchers and patient representatives together in Taipei to weigh real-world evidence, AI and patient involvement against the realities of different Asia-Pacific health systems. #HTA #HealthEconomics #MarketAccess

HTA
Nigeria Health Technology Assessment: NHIA Inaugurates Steering Committee
Nigeria’s NHIA has inaugurated a national health technology assessment steering committee to anchor healthcare spending in evidence. #SyenzaNews #HTA #HealthEconomics #Nigeria

Europe
European Commission Publishes Joint Clinical Assessment Templates for Patient and Clinician Input
The European Commission has published three templates that formalise written input from patients, carers and clinicians in EU Joint Clinical Assessments, locking it onto the scope proposal and the draft report. #HTA #JCA #MarketAccess

Europe
Portugal Pharmaceutical Exports Jump 42.9% to €5 Billion in 2025
Portugal pharmaceutical exports climbed 42.9% in 2025 to €5.0 billion. Without that increase, national goods exports would have contracted. #SyenzaNews #MarketAccess #Pharma

Europe
Infarmed Launches INOV@INFARMED Network to Unite Science and Regulation
Infarmed has launched INOV@INFARMED, a new network connecting Portugal’s medicines regulator with 26 universities and research institutes to advance regulation and health technology assessment. #SyenzaNews #HTA #RegulatoryScience #HealthInnovation

Clinical Practice
CHMP September 2026 Recommends 12 New Medicines
EMA’s CHMP September 2026 meeting ended with positive opinions for 12 new medicines and 11 indication extensions. New approvals cover haemophilia A, ALK-positive lung cancer, myasthenia gravis, ovarian cancer, hidradenitis suppurativa and short bowel syndrome, plus the first biosimilar cleared under the tailored clinical pathway.
#SyenzaNews #pharmaceuticals #drugdevelopment #innovation #MarketAccess

Clinical Practice
Kerendia Type 1 Diabetes Approval: First New CKD Treatment in 30 Years
FDA approved finerenone (Kerendia) for CKD associated with type 1 diabetes, the first new treatment for this population in 30 years. The label rests on a six-month UACR reduction, not hard kidney outcomes, so payers and HTA agencies will each have to decide how much credit the surrogate deserves. #SyenzaNews #MarketAccess #CKD #Type1Diabetes

Asia
Building an Asian Brain Economy Strategy Around Brain Capital
EMEA and GBEI brought China, Malaysia, Japan and India together to map an Asian brain economy strategy, framing brain capital as core economic infrastructure and introducing the Asian Brain Economy Index. #BrainEconomy #BrainCapital #Asia #BrainHealth

Clinical Practice
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

Diabetes
Novo Nordisk and Anthropic Team Up to Accelerate Drug Discovery
Novo Nordisk and Anthropic have announced a partnership to speed drug discovery. Novo will use Claude Science across R&D and for agentic software engineering, with robust data governance and human oversight built in. #SyenzaNews #DrugDiscovery #AI #MarketAccess

