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Dynavax plans Phase III for hepatitis B vaccine after FDA hold lifted

This article was originally published in Scrip

Executive Summary

Dynavax plans to soon initiate a pivotal Phase III trial testing its investigational hepatitis B vaccine, Heplisav, in chronic kidney disease patients, as well as a second Phase III trial in healthy adults aged over 40 in early 2010. The moves come after the US FDA lifted its clinical hold on the vaccine following a refinement of the company's strategy to address these populations first.



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