FDA rejects Dynavax's hep B vaccine…again

The Food and Drug Administration recently rejected Dynavax Technology Corp.'s hepatitis B drug, Heplisav-B, for the second time in three years, reports Reuters.

Eddie Gray, CEO of Berkeley, Calif.-based Dynavax, said the company plans to meet with the FDA as soon as possible to discuss concerns regarding adverse events that occurred during clinical trials for the vaccine.

The agency first rejected Dynavax's application for Heplisav-B in February 2013.

Dynavax, which has no drugs on the market, expects the review period for a potential resubmission of the vaccine's application would be six months, according to Reuters.

"The time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own," said Mr. Gray in the report. "We are moving swiftly to identify a potential pharmaceutical or financial partner."

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