Shots: The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with intermediate-2 or high-risk primary or secondary myelofibrosis with splenomegaly The P-II JAKARTA 2 study involves assessing of Inrebic (400mg, qd) in 97 patients with intermediate or high-risk primary or secondary […]Read More
Shots: The companies collaborated to evaluate ruxolitinib in combination with CK0804 in patients with MF and plan to initiate a P-Ib study. Incyte will fund the study while operationalized by Cellenkos Cellenkos to receive $20M as licensing fee, ~$294.5M as development, regulatory and commercialization milestones along with royalties on sales of therapies, if approved. Incyte […]Read More
Shots: The approval is based on JAKARTA and JAKARTA2 clinical trials. JAKARTA study involves assessing Inrebic (500mg) vs PBO for at least 6 cycles in 289 patients in patients with intermediate-2 or high-risk MF, post-polycythemia vera MF or post-essential thrombocythemia MF with splenomegaly and platelet count ≥50 x 109/L The P-II JAKARTA 2 study involves […]Read More
Shots: The approval is based on multiple studies including JAKARTA and JAKARTA2. The P-III JAKARTA study involves assessing of Inrebic (400mg) vs PBO in patients with intermediate-2 or high-risk, primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with splenomegaly and a platelet count of ≥50 x 109/L2 prior not treated with JAK inhibitor The […]Read More
Shots: Celgene announces the acceptance of Fedratinib’s NDA based on P-III JAKARTA study assessing Fedratinib (400mg/500mg) vs PBO in 289 patients with primary or secondary myelofibrosis across 24 countries The P-III JAKARTA study results: meeting its 1EPs & 2EPs i.e, reduction in spleen volume (35%) & reduction in Total Symptom Score (50%) after six one-month treatment […]Read More
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