July 28, 2017 / 9:06 PM / 2 years ago

BRIEF-Dynavax announces FDA advisory committee vote in favor of Heplisav-B

July 28 (Reuters) - Dynavax Technologies Corp:

* Dynavax announces FDA advisory committee vote in favor of Heplisav-B (tm)

* Dynavax Technologies Corp - committee provided commentary on design of Dynavax’s proposed post-marketing pharmacovigilance plan for Heplisav-B.

* Dynavax Technologies Corp- Dynavax plans to launch vaccine commercially in U.S. in early 2018 on its own or through a commercial partner

* Dynavax - ‍if FDA approves Heplisav-B, Dynavax will seek recommendation from CDC advisory committee on immunization practices​

* Dynavax Technologies - FDA ‍ advisory committee voted 12 to 1 that safety data for Heplisav-B support licensure for immunization against Hepatitis B​ Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below