The Patent Trial and Appeals Board: A Target for Prescription Drug Patent Reform?

JAMA

The Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.

Published: October 2024

Download full-text PDF

Source
http://dx.doi.org/10.1001/jama.2024.15510DOI Listing

Publication Analysis

Top Keywords

patent trial
4
trial appeals
4
appeals board
4
board target
4
target prescription
4
prescription drug
4
drug patent
4
patent reform?
4
patent
2
appeals
1

Similar Publications

Treatment options for recurrent high-risk non-muscle-invasive bladder cancer (HR NMIBC) and muscle-invasive bladder cancer (MIBC) are limited, highlighting a need for clinically effective, accessible, and better-tolerated alternatives. In this review we examine the clinical development program of TAR-200, a novel targeted releasing system designed to provide sustained intravesical delivery of gemcitabine to address the needs of patients with NMIBC and of those with MIBC. We describe the concept and design of TAR-200 and the clinical development of this gemcitabine intravesical system in the SunRISe portfolio of studies.

View Article and Find Full Text PDF

Finerenone and new-onset diabetes in heart failure: a prespecified analysis of the FINEARTS-HF trial.

Lancet Diabetes Endocrinol

January 2025

British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK. Electronic address:

Background: Data on the effect of mineralocorticoid receptor antagonist therapy on HbA levels and new-onset diabetes are conflicting. We aimed to examine the effect of oral finerenone, compared with placebo, on incident diabetes in the Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure (FINEARTS-HF) trial.

Methods: In this randomised, double-blind, placebo-controlled trial, 6001 participants with heart failure with New York Heart Association functional class II-IV, left ventricular ejection fraction 40% or higher, evidence of structural heart disease, and elevated N-terminal pro-B-type natriuretic peptide levels were randomly assigned to finerenone or placebo, administered orally.

View Article and Find Full Text PDF

Background: Valvular heart disease (VHD) management has evolved rapidly in recent decades, but disparities in health care access persist among countries with varying socioeconomic backgrounds.

Objectives: The purpose of this study was to investigate global mortality trends from VHD and assess the difference between middle- and high-income countries.

Methods: We obtained mortality data from the World Health Organization Mortality Database for VHD and its subgroups (rheumatic valvular disease [RVD], infective endocarditis [IE], aortic stenosis [AS], and mitral regurgitation [MR]) from 2000 to 2019.

View Article and Find Full Text PDF

Pulmonary arterial hypertension (PAH) is a rare and potentially fatal condition characterized by progressive increases in blood pressure in the arteries of the lungs. Oral selexipag, approved by the Food and Drug Administration (FDA) in 2015 for the treatment of PAH, targets prostacyclin receptors on pulmonary arterial vascular smooth muscle and endothelial cells to improve blood flow through the lungs and reduce pulmonary vascular resistance. Oral selexipag is effective, but may be discontinued due to factors like side effects, emergency conditions, or inability to take oral medication, potentially leading to severe adverse events, such as rebound pulmonary hypertension and right heart failure.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!