Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo
Stada To Commercialize In EU
Executive Summary
The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.
You may also be interested in...
Stada Recruits Ex-Sandoz Exec To Help Steer Biosimilars
Stada has announced the appointment of former Sandoz executive Christine Berndt as head of global development for specialty and biosimilar products, replacing Michael Mack.
Calliditas’ Nephrology Gem Tarpeyo Faces EU Regulatory Delay
The Swedish biotech’s oral corticosteroid for a kidney disorder has left the EMA’s CHMP with questions on its manufacturing, delaying an EU approval opinion that had been slated for the first quarter.
Argenx, Calliditas Hit The Ground Running After FDA Approvals
Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.