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news.Innovive reaches agreement with FDA for leukemia drug trial
Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia (AML). The SPA is an agreement between Innovive and the FDA on the pivotal Phase II study
Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia (AML). The SPA is an agreement between Innovive and the FDA on the pivotal Phase II study
The drug, ARRY-380, is a selective, orally-active ErbB-2 inhibitor which has shown good efficacy in preclinical models of human breast cancer resulting in significant anti-tumor activity, according to
Hana Biosciences is developing and commercializing Marqibo under a licensing partnership agreement with Tekmira. Hana Biosciences is paying development costs and will also pay milestones to Tekmira based
In the study, rats treated with a single bolus injection of rat AKIi-5, Quark’s proprietary siRNA compound targeting the p53 gene, were significantly protected from ischemia/reperfusion-induced acute kidney
The Canadian biopharmaceutical company previously announced in June that it had also received clearance from Health Canada for the long term use of the anti-rejection drug, ISA247, in
The CD20 antibody is expected to have target specificity similar to Genetech’s Rituxan (rituximab) and to have relatively higher antibody dependent cell-mediated cytotoxicity. The existing relevant CD20 antibody
This multi-center open label Phase II safety and efficacy study is designed to enroll up to 40 glioblastoma patients who have experienced a first relapse. The study’s primary
In January 2007, Pozen and GSK responded to the FDA’s first approvable letter, submitting additional safety data from clinical trials, data from GSK’s database, and additional in vitro
The EC approval results in marketing authorization with unified labeling that will be valid in the 27 current EU member states as well as in Iceland and Norway.
In the primary endpoint analysis, Vidaza treatment was associated with a median survival of 24.4 months versus 15 months for those receiving conventional care regimens (CCR), an improvement