Shots: The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & adolescents aged ≤18yrs. with PNH […]readmore
Shots: The approval is based on P-III head-to-head PEGASUS study assessing Empaveli vs Soliris (eculizumab) in 80 adults with PNH. Participants should be Soliris stable for at least 3mos. with […]readmore
Shots: The US FDA has granted BTD in paroxysmal nocturnal hemoglobinuria and RPDD in C3 glomerulopathy The BTD is based on results from two ongoing P-II studies, where iptacopan showed […]readmore
Shots: The P-III study involves assessing of SB12(600/900 mg, IV) vs Soliris (eculizumab, 600/900 mg, IV) in 50 patients with PNH, evaluating the efficacy, safety, immunogenicity and PK The primary […]readmore
Shots: Generium’s biosimilar of Eculizumab is developed using Selexis’ SUREtechnology Platform which is based on Selexis SGE (Selexis Genetic Elements) consist of human DNA based element, controlling the chromatin across […]readmore
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