Novartis' Zolgensma study halted by FDA amid safety questions

U.S. regulators have halted a trial of Novartis’s Zolgensma treatment after an animal study raised safety concerns, the company said on Wednesday, in a setback for the drugmaker’s plan to expand its use to older patients. The U.S. Food and Drug Administration’s partial hold on the so-called STRONG trial impacts patients aged up to five with spinal muscular atrophy (SMA) who were to receive a higher dose of the gene therapy via a spinal infusion. The hold was issued after Novartis told health authorities about the animal study’s findings that showed dorsal root ganglia (DRG) mononuclear cell inflammation, …read more

Source:: Yahoo Finance

      

Did you enjoy this article? Join our FREE Newsletter!
I agree to have my personal information transfered to MailChimp ( more information )
Join over 100,000 investors and business leaders worldwide. Get the latest actionable business and investing intelligence before the rest of the crowd.
We hate spam. Your email address will not be sold or shared with anyone else.