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Calliditas Therapeutics AB
Calliditas Therapeutics AB
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Trending Articles
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Research & Development
Calliditas’ partner Everest Medicines announces China NMPA’s approval of Nefecon
China's National Medical Products Administration (NMPA) has approved Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression
Regulatory
EMA issues positive opinion on Calliditas' orphan drug
Calliditas' application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome has received a positive opinion from European Medicines Agency
Ingredients
Full details from Calliditas Therapeutics’ Phase 3 study released
Calliditas Therapeutics has announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon delayed release capsules in adults with Primary IgA nephropathy
Drug Delivery
Chinese NMPA accepts Calliditas' partner Everest Medicines NDA
Chronic kidney disease is one of the most serious public health problems in China, where IgAN is estimated by Everest to affect around five million people
Calliditas budesonide therapy approved to reduce proteinuria
Proteinuria is associated with IgAN, however it has not yet been established whether the therapy slows kidney function decline in patients with the condition
Regulatory
Calliditas receives fast track FDA designation for PBC candidate
The FDA program facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions
Manufacturing
Calliditas and Everest Medicines enter $120m development deal in China
The agreement gives Everest Medicines exclusive rights to develop and commercialise Nefecon in five countries in East Asia
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