AstraZeneca (Canada)

Measuring the Outcomes of International Oncology Regulatory Collaboration in Canada from 2019 to 2025: Project Orbis

Project Orbis, launched by the US FDA in 2019, enables collaboration among international regulatory agencies on cancer drug reviews. We assessed the regulatory impact of Project Orbis in Canada by analyzing publicly available data on marketing authorization applications (MAAs). W...

Assessing the consistency of overall survival extrapolations in Swedish health technology assessment reports of oncology treatments using extended follow-up data

BACKGROUND: Long-term overall survival (OS) extrapolations underpin cost-effectiveness appraisals, projecting survival beyond trial follow-up. We aimed to compare extrapolations presented in manufacturer submissions and appraisals published by the Swedish Dental and Pharmaceutica...