Dynavax Licenses Coley’s Toll-Like Receptor Adjuvant For Hep B Vaccine Candidate Heplisav
This article was originally published in The Pink Sheet Daily
Executive Summary
BLA asking approval of one-month, two-dose vaccine regimen anticipated in second half of 2008.
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FDA Lifts Clinical Hold On Dynavax's Hep B Vaccine Heplisav, Narrows Population
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FDA Lifts Clinical Hold On Dynavax's Hep B Vaccine Heplisav, Narrows Population
The firm is hoping to gain licensure for chronic kidney disease patients first, and eventually to expand the indication to the broader hepatitis B vaccination population.
FDA Lifts Clinical Hold On Dynavax's Hep B Vaccine Heplisav, Limits Population
FDA has lifted the clinical hold on development of Dynavax's Hepatitis B vaccine Heplisav, allowing the firm to proceed with Phase III development - but in a smaller market than originally proposed: patients with chronic kidney disease