FDA clears Novoste's modified BRAVO trial:
This article was originally published in Clinica
Executive Summary
The US FDA has given Novoste the green light to modify a trial of its Corona catheter-based radiation system for treating stenoses in arterial-venous dialysis grafts. Modifications to the trial - a European and US study called BRAVO - will allow physicians to treat patients with thrombosed grafts, which represent a majority of the potential patients, says the Norcross, Georgia firm. They also change the primary endpoint of the trial from a measure of dialysis flow at six months to the absence of reintervention after three months.
You may also be interested in...
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.
Cidara Offloads Rezzayo, Will Focus On Universal Flu Preventative
Cidara conferred global rights to its novel antifungal to marketing partner, Mundipharma, while reacquiring a flu prophylaxis it licensed to J&J in 2021 and gaining $240m in new funding to back development.