Biotech Business - December 16, 2021
FDA approves Calliditas’ TARPEYO
Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval. It has not been established […]
Pharma Business - August 11, 2021
Calliditas receives Fast Track designation
The US Food and Drug Administration has granted Fast Track Designation for the company’s lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis (PBC). Setanaxib has previously been granted orphan drug designation for PBC in the US and Europe. “We are delighted to receive Fast […]
Business article - March 9, 2021
Q&A: Renée Aguiar-Lucander, CEO, Calliditas Therapeutics
Calliditas Therapeutics is about to bring its treatment for IgA nephropathy to the market – addressing a significant unmet medical need. Calliditas, formed in 2004, is a Swedish clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases. The company’s lead product […]
Agreement - June 10, 2019
Calliditas Therapeutics in agreement with Everest Medicines
The two companies have entered into a license agreement to develop and commercialize Calliditas’ leading drug candidate Nefecon in Greater China and Singapore for the chronic autoimmune kidney disease IgA Nephropathy (IgAN). Under the terms of the agreement, Calliditas will receive an initial upfront payment of 15M USD at signing of the agreement, as well […]
