FDA receives biologics application for hepatitis B vaccine

The FDA received Dynavax Technologies' biologics license application for its Heplisav vaccine against infection from all hepatitis B virus subtypes in patients age 18 to 70. The company may file a supplemental BLA for chronic kidney disease patients. "We look forward to working with the FDA in moving Heplisav through the regulatory review process over the next few months," said Tyler Martin, Dynavax's president and chief medical officer. Pharmaceutical Business Review Online

Source: AABBsmartbrief