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News Breaks
July 22, 2014
07:21 EDTGALEGalena enters into licensing agreement with MonoSol Rx
MonoSol Rx announced that it has licensed Zuplenz to Galena Biopharma. Zuplenz is an oral soluble film, or OSF, for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting. The licensing agreement includes an undisclosed upfront payment from Galena, as well as double digit royalty payments from sales of Zuplenz. Zuplenz is the first oral soluble lingual film product approved by the FDA as a prescription medication, based on MonoSol Rx's proprietary PharmFilm technology.
News For GALE From The Last 14 Days
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August 24, 2015
07:07 EDTGALEIDMC recommends reduction of cardiac toxicity monitoring in Galena NeuVax trial
Galena Biopharma announced that the Independent Data Monitoring Committee, or IDMC, has recommended to the company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax Phase 3 Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, or PRESENT, clinical trial. The trial is being run under a Special Protocol Assessment, or SPA, approved by the FDA. Following its most recent IDMC meeting in June, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram, or ECHO, or multiple-gated acquisition, or MUGA, scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.

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