Clinical Trials

Vaxcyte's VAX-31 met every prespecified primary endpoint in the OPUS-1 Phase 3 trial in adults, including superiority for the three serotypes unique to the vaccine. The 31-valent candidate now heads toward a BLA filing in 2028. #SyenzaNews #vaccines #pneumococcal #MarketAccess

Jaypirca becomes the first non-covalent BTK inhibitor cleared for previously untreated CLL/SLL in the United States. BRUIN CLL-313 showed a hazard ratio of 0.20 against bendamustine plus rituximab, but the comparator is not the drug class that dominates first-line care. #SyenzaNews #MarketAccess #oncology #CLL

Clinical trials authorised across the EU and EEA fell 13.5% between the pre-pandemic years and 2022 to 2025, and the drop lands hardest on academic sponsors. Biologics now feature in nearly half of all new trials. #SyenzaNews #clinicaltrials #HTA #MarketAccess

FDA approval of the Autus Size-Adjustable Valve gives children with congenital pulmonary valve disease a pulmonary valve that can be widened as they grow, from 13 millimeters to 22 millimeters. The evidence base is 62 patients and six months of follow-up. #SyenzaNews #medicaldevices #pediatrics #MarketAccess

Rare disease care in Europe is settled in national capitals, not in Brussels. At #EHFG2026, Austria's Claas Röhl, Czechia's Markéta Foldyna Hellová, Italy's Giulia De Ponte and MetabERN's Maurizio Scarpa set out where national policy delivers and where families still do the coordinating. #SyenzaNews

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

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