Heplisav Postmarketing Worries Push PDUFA Date Back; FDA Seeks More Details
Dynavax's final pivotal trial for hepatitis B candidate was missing data from 150 patients, making its causality of myocardial infarctions unclear; the question now is whether the postmarketing trial can answer the question.
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The latest drug approval and development news from our US FDA Performance Tracker.
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.
Roivant will use the cash to fund other "Vants" that develop drugs or make the process more efficient. Also, Zealand launches its IPO, Apellis raises a $60m Series E and BioMarin tops recent offerings.