Heplisav-B Approval Has Dynavax Going It Alone On US Launch In Early 2018

Hepatitis B vaccine's favorable efficacy data relative to GSK's Engerix-B and neutral safety language mean that any partnership opportunity 'would need to be a highly attractive one to alter our current course,' Dynavax CEO Gray says.

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Dynavax Technologies Corp. believes Heplisav-B labeling that is favorable on efficacy and neutral on safety should allow it to extract greater value from any potential commercial partnership on the hepatitis B vaccine in the US.

For now, however, Dynavax is planning to launch the two-dose vaccine on its own in the 2018 first quarter, creating a new competitor to GlaxoSmithKline PLC's entrenched three-dose vaccine...

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