Clinical Practice

A once-weekly selective amylin agonist added to tirzepatide cut 23.3% of body weight in 367 adults with obesity and type 2 diabetes, against 14.8% for tirzepatide 15 mg alone. Lilly plans Phase 3 of a co-formulated EloraTZP by the end of 2026. Discontinuation rates that reach 27% in the highest-dose arm will be the detail payers study first. #SyenzaNews #obesity #type2diabetes #MarketAccess

HHS and ARPA-H have launched SURPASS, a program to rebuild clinical trials around real-time analysis, shared control groups and automated site operations. Three companion projects, STACK, COMMONS and CINCH, take on site capacity, national data infrastructure and patient navigation. Clinical development still takes more than a decade, costs up to $2 billion on average, and fails more than 90 percent of the time. #SyenzaNews #ClinicalTrials #MarketAccess #HealthEconomics

Zorginstituut Nederland has ruled that the Inreda AP stays out of the Dutch basic package. The DARE trial found no clinically relevant gain in glucose control or quality of life, serious adverse events were about three times more common, and half of the patients stopped using the device. #SyenzaNews #MedTech #MarketAccess #HealthEconomics

A randomized trial in 268 men awaiting radical prostatectomy found AI preoperative communication cut GAD-7 anxiety scores and nearly halved surgeon consultation time. The AI answered 2,847 of 3,507 patient questions. #SyenzaAI #SyenzaNews #MarketAccess #ProstateCancer #AIinHealthcare

Sweden's pharmaceutical injury insurance logged 33 semaglutide adverse reactions claims in the first eight months of 2026, up from 13 in all of 2025. More prescribing and more awareness explain the rise better than any new risk. #SyenzaNews #pharmaceuticals #drugsafety #regulatoryaffairs

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

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

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

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

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

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

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