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March 4, 2014
08:03 EDTKMDAKamada completes enrollment in KamRAB U.S. clinical trial
Kamada announced that it has completed enrollment in its U.S. Phase 2/3 clinical trial of KamRAB as a post-exposure prophylaxis for rabies. Kamada has a strategic agreement with Kedrion for the clinical development and marketing of KamRAB in the U.S. The Phase 2/3 clinical trial is a prospective, randomized, double-blind, non-inferiority study of 118 healthy subjects to evaluate the safety and effectiveness of KamRAB. The study assesses whether KamRAB interferes with the development of self-active antibodies. The primary and secondary endpoints of this study are pharmacokinetic parameters of anti-rabies IgG levels in serum at different time points. In addition, safety and tolerability are assessed. The company said, "We look forward to completing this pivotal study in the coming months and, pending a favorable outcome, to filing a submission for approval with the FDA thereafter.
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March 23, 2015
09:28 EDTKMDAOn The Fly: Pre-market Movers
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07:17 EDTKMDAKamada receives EU orphan designation for Alpha-1 Antitrypsin
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