Hemosol presses on with Hemolink development:
This article was originally published in Clinica
Executive Summary
Hemosol is pushing ahead with plans to resume its clinical programme in the US for its blood substitute Hemolink. The company has received FDA approval to start a key clinical trial of the product in primary heart bypass surgery. The 180-patient trial is expected to pave the way for a pivotal trial in the US and strengthen the company's regulatory application in the UK. The Toronto, Canada-based firm says it "recently redesigned its clinical programme to meet the anticipated requirements of European and US regulatory agencies".