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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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December 11, 2014
08:40 EDTGALEGalena presents HER2 screening data results from NeuVax Phase 3 clinical trial
Galena Biopharma announced that initial immunohistochemistry, or IHC, screening data from 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, trial was presented at the 2014 San Antonio Breast Cancer Symposium, or SABCS. The poster, entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry System for Low and Intermediate Levels of HER2 Protein Expression as a Companion Diagnostic," demonstrated that with the implementation of the Leica Bond Oracle HER2 IHC assay, preliminary limited data indicated additional patients met HER2 eligibility for PRESENT and the assay identified more precisely patients at HER2 1+ and 2+. As part of the PRESENT trial, Galena has implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.
December 8, 2014
09:20 EDTGALEOn The Fly: Pre-market Movers
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07:08 EDTGALEGalena GALE-401 Phase 1 results show reduced platelet counts, tolerable safety
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