Busy Days For Hep B Drug Development
Activity in the hepatitis B field is heating up, as evidenced by recent announcements from J&J, Gilead and Dynavax.
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Two deals have resulted in the formerly shingles-focused biotech beginning to build an HBV pipeline and look ahead to therapeutic advances similar to those seen in HIV and hepatitis C. But the New Jersey biotech will be competing with some deep-pocketed competitors in the space.
Company says it now has enough safety data to support a new FDA filing in the first quarter of 2016, and that it expects a superiority claim for diabetics.
FDA Panel Will Have To Weigh Pediatric Cancer Drug’s ‘Higher Level’ Of Uncertainty Against Rare, Devastating Disease
US WorldMeds NDA package for eflornithine for high-risk neuroblastoma provides “a higher level of uncertainty than is typically seen in oncology applications,” agency says. Though FDA seems largely satisfied with the sponsor’s externally controlled study, confirmatory evidence may be lacking.