Friday 10 April 2015

FDA modifies partial clinical hold on Tekmira Ebola study

(Reuters) - Tekmira Pharmaceuticals Corp said the U.S. Food and Drug Administration would allow the company to continue testing its experimental Ebola treatment at a lower dose, altering the terms of a partial clinical hold on the study. The company's application to study the treatment, TKM-Ebola, remains on partial clinical hold for doses above 0.24 mg/kg per day, Tekmira said on Friday. The FDA placed Tekmira's early-stage study on a clinical hold in July, asking the company for data on how the therapy works and requesting a change to design of the study related to multiple dosing. The clinical hold was modified in August into a partial hold asking only for a change in the study design. via Health News Headlines - Yahoo News Read More Here..

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