Eur Heart J
Cardio-Oncology Centre of Excellence, Royal Brompton Hospital, Sydney St, London SW3 6NP, UK.
Published: March 2025
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http://dx.doi.org/10.1093/eurheartj/ehaf052 | DOI Listing |
Expert Rev Pharmacoecon Outcomes Res
March 2025
The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, Washington, USA.
Introduction: In a previous publication, we provided an overview of the current situation of patient access to orphan drugs in the European Union (EU), of the evolving rare disease policy landscape and recommendations for areas of improvement throughout the lifecycle of orphan drugs. This article aims to provide an update on evolving new policies impacting access to orphan drugs in the European Union from a health technology developers perspective.
Areas Covered: We provide an update of the emerging competitiveness gap in the pharmaceutical sector between the EU and the United States.
Drug Saf
March 2025
Veterans Administration (VA) Center for the Study of Healthcare Innovation, Implementation, and Policy, VA Greater los Angeles Healthcare System, Los Angeles, USA.
Background: Significant methodological shortcomings have been documented to date in risk minimisation program evaluations for medicinal products, including overreliance on survey methods alone. Recently updated guidances from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recommend the use of frameworks and mixed methods designs to improve the rigor of these assessments.
Objective: The purpose of this paper was to exemplify how a mixed methods approach, guided by an implementation science framework, can be used to design the evaluation of a risk minimisation program.
Eur Urol
March 2025
Unit of Urology, Division of Experimental Oncology, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Eur Urol
March 2025
Division of Urology, Department of Surgical Sciences, Torino School of Medicine, Torino, Italy.
J Am Coll Cardiol
March 2025
Cedars Sinai Medical Center, Los Angeles, California, USA. Electronic address:
This updated Heart Valve Collaboratory framework addresses the growing concern for transcatheter valve failure (TVF) following transcatheter aortic valve replacement (TAVR). With the increasing volume of redo-TAV and surgical TAV explantation, there is a critical need for standardized pathways and protocols for evaluating TVF using echocardiography and cardiac computed tomography (CT) angiography. This document clarifies prior definitions of bioprosthetic valve deterioration and bioprosthetic valve failure in a practical, imaging directed context for TAVR.
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