CDC Panel Backs Heplisav-B Use, May Consider Preferential Recommendation
Dynavax's hepatitis B vaccine could end up as preferred choice for certain groups once safety and cost-effectiveness studies are completed.
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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.
Dynavax's Hep B Vaccine Finally Clears US FDA With Clean Label But Larger Safety Study
Heplisav-B labeling notes myocardial infarction imbalance in one trial but also apparent absence of a causal relationship; sponsor will conduct a postmarketing safety cohort study involving 50,000 subjects, 10,000 more than initially planned.
CDC Panel (Barely) Prefers Shingrix Shingles Vaccine Over Zostavax
In 8-7 vote, Advisory Committee on Immunization Practices recommends GSK's Shingrix as preferred shingles vaccine given its higher efficacy compared to Merck's Zostavax.