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Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease

Shots:The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MASApproval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06),…

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Apellis and Sobi

Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN

Shots:Apellis & Sobi have reported data from the open-label period of P-III (VALIANT) trial of Empaveli for the treatment of C3G & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN); regulatory review is ongoing in the US & EUThe P-III (VALIANT) trial assessed Empaveli (Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124)…

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Ionis & Sobi

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Shots:Ionis has granted Sobi global exclusive rights of olezarsen excl. the US, Canada & China to treat familial chylomicronemia syndrome (FCS) & severely elevated triglycerides; Ionis to independently market Olezarsen in the US, whereas Theratechnologies holds the rights in CanadaAs per the deal, Ionis will get an upfront, with potential milestone payments &…

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