Radiance completes brachytherapy trial enrolment:
This article was originally published in Clinica
Executive Summary
Radiance Medical Systems has completed the enrolment phase of its pivotal intracoronary radiation therapy trial. The BRITE II study is assessing the firm's RDX coronary radiation delivery system as a treatment for in-stent restenosis. Some 423 patients from 26 sites in the US and Europe have received the treatment and will now be followed-up for nine months. The Irvine, California firm plans to use data generated from the study to support a marketing application for the product in the US.
You may also be interested in...
Investors Go Beserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.