AstraZeneca (Japan)

From Phase Ib/ II to Seamless Phase II / III : A Simulation‐Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase

The emergence of targeted therapies and immunotherapies has challenged the traditional "more is better" paradigm underlying maximum tolerated dose (MTD)-based trials, as dose escalation beyond receptor saturation often yields limited additional efficacy while substantially increa...

Quality of life in hyperkalemia: baseline analysis of a cohort study of management of hyperkalemia in patients with chronic kidney disease or heart failure in Japan

Abstract Background Hyperkalemia is common in chronic kidney disease (CKD) and chronic heart failure (CHF), often leading to treatment dilemmas regarding renin–angiotensin–aldosterone system (RAAS) inhibitors. Although potassium binders and dietary restrictions are central to chr...

Real-world perioperative systemic treatment patterns and postoperative mortality in patients with upper tract urothelial carcinoma undergoing radical nephroureterectomy in Japan: WAKKA-UTUC study

Abstract Background To characterize the longitudinal changes in perioperative systemic treatment patterns and postoperative mortality among Japanese patients with stage II–IV upper tract urothelial carcinoma (UTUC) who underwent radical nephroureterectomy (RNU). Methods This retr...

Safety, Pharmacokinetics, and Predicted Neutralizing Activity of the SARS-CoV-2 Monoclonal Antibody Sipavibart: Results from Little DIPPER and the SUPERNOVA Substudy

The rapid evolution of SARS-CoV-2 has necessitated efforts to accelerate the clinical evaluation of neutralizing monoclonal antibodies. Little DIPPER and the SUPERNOVA substudy explored the feasibility of immunobridging efficacy from tixagevimab–cilgavimab to sipavibart using pre...

Incidence of New Malignancies in Severe Asthma: Comparison of Real-World Patients Treated with Benralizumab, Other Biologics, or Non-biologics

Clinical trials report no increased malignancy risk with benralizumab in severe asthma; however, trial populations are highly selective. To better define real-world safety, malignancy risk was compared among patients treated with benralizumab, other (non-benralizumab) biologics,...