Micro Therapeutics
This article was originally published in The Gray Sheet
Executive Summary
Initiates a 40-patient European clinical trial at six centers for the EMBOLYX liquid embolic system for the treatment of arteriovenous malformations. To date, three patients have been treated, each with an AVM located in the area of the brain associated with motor skills. The company anticipates completing the trial by year-end, with a European product launch planned for the first half of 1999
You may also be interested in...
Dr Reddy’s Knocked Back On Rituximab In US
Dr Reddy’s has received a complete response letter from the US FDA, knocking back its proposed rituximab biosimilar rival to Rituxan.
Sandoz And Samsung Celebrate Stelara Rival’s EU Approval
Sandoz and Samsung Bioepis have received final European Commission approval for their partnered Pyzchiva biosimilar rival to Stelara. But with European competition on ustekinumab due to kick off in just a matter of months, further applicants are also waiting in the wings.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.