Reuters : reported that Dynavax hepatitis B vaccine works; raises safety issues: FDA

The review, posted on the FDA's website, comes two days ahead of a meeting of outside advisors who will discuss the vaccine, Heplisav-B, and recommend whether it should be approved. The second rejection, in November, sent Dynavax's facebook/" target="_blank">shares plunging roughly 70 percent to a year low of $3.20. Heplisav-B is designed to enhance the body's immune response to the hepatitis B virus, which can lead to cirrhosis of the liver, cancer and death. The FDA has twice rejected the vaccine citing unresolved safety concerns. (Reuters) - Dynavax Technologies Corp's experimental hepatitis B vaccine is effective, but there were more deaths and serious cardiac events in patients given the vaccine than in those given a rival product, according to a preliminary Food and addiction Administration report published on Wednesday.

Dynavax hepatitis B vaccine works; raises safety issues -FDA

ReutersUPDATE 1-Dynavax hepatitis B vaccine works; raises safety issues -FDA(Updates with details from FDA report) By Toni ClarkeJuly 26 (Reuters) - Dynavax Technologies Corp's experimental hepatitis B vaccine is effective, but there were more deaths and serious cardiac events in patients given the vaccine than in those given a rival product, according to a preliminary Food and addiction Administration report published on Wednesday. Heplisav-B is designed to enhance the body's immune response to the hepatitis B virus, which can lead to cirrhosis of the liver, cancer and death. The review, posted on the FDA's website, comes two days ahead of a meeting of outside advisors who will discuss the vaccine, Heplisav-B, and recommend whether it should be approved. The FDA has twice rejected the vaccine citing unresolved safety concerns. The FDA is not bound to follow the advice of its advisory panels but typically does so.

Dynavax up 21% ahead of Ad Com review of hepatitis B vaccine - Dynavax Technologies Corporation (NASDAQ:DVAX)

FDA briefing docDynavax briefing docErrata to Dynavax briefing doc Dynavax (NASDAQ:DVAX) is up 21% premarket on robust volume ahead of Friday's Ad Com review of its marketing application for hepatitis B vaccine HEPLISAV-B. Heplisav met pre-specified noninferiority criteria to an active comparator vaccine, Engerix-B, in these two phase 3 clinical trials. Numbers and rates of events are low, and the lack of prospectively defined monitoring and evaluation of cardiac events limits the causal interpretation of these observations." From page 7: "In summary, Heplisav was shown to have a robust immune response in healthy adults 18- 70 years of age in Studies DV2-HBV-10 and-16.


collected by :Lucy William

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