Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo
Stada To Commercialize In EU
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.
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Stada has announced the appointment of former Sandoz executive Christine Berndt as head of global development for specialty and biosimilar products, replacing Michael Mack.
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.
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.