Argenx, Calliditas Hit The Ground Running After FDA Approvals
Green Lights For Vyvant and Tarpeyo
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.
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The Swedish biotech’s successful launch in the US of Tarpeyo for immunoglobulin A nephropathy is progressing well and a Chinese approval is on the horizon as partner Everest’s application is accepted by regulators.
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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.