FDA panel to discuss Dynavax's Heplisav-B

Dynavax Technologies Corp. (NASDAQ:DVAX) said FDA's Vaccines and Related Biological Products Advisory Committee will meet July 28 to discuss the company's BLA for Heplisav-B, its vaccine to prevent HBV infection. Its PDUFA date is Aug. 10.

In November, Dynavax received its second complete response letter for Heplisav-B, following an initial CRL in 2013. In the second letter, FDA requested information regarding adverse events, new analyses of its safety database, and clarification of postmarketing commitments, according to Dynavax (see BioCentury Extra, Nov. 14, 2016)...