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News Breaks
January 14, 2014
07:08 EDTRDY, GALEGalena, Dr. Reddy's announce strategic partnership for NeuVax in India
Galena Biopharma (GALE) and Dr. Reddy's Laboratories (RDY) announced a strategic development and commercialization partnership on NeuVax in India. Galena Biopharma is a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. Dr. Reddy's is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives.
News For GALE;RDY From The Last 14 Days
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April 21, 2015
09:34 EDTGALEGalena sent FDA warning letter following site inspection
A warning letter published by the FDA, dated April 3, states that the agency's inspection of Galena Biopharma's site in Portland, Oregon, conducted between November 17 and 21, 2014, revealed "serious violations" of FDAs PADE reporting requirements. Reference Link
April 14, 2015
07:26 EDTGALEGalena completes over-enrollment of NeuVax Phase 3 PRESENT clinical trial
Galena Biopharma announced the completion of enrollment in the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, clinical trial. NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat, or ITT, population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment, or SPA, called for 700 patients; and, the company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events occur, whichever comes later.

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