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Latest From Sue Sutter
Siga is entitled to a $41m “hold back” payment under its contract with the Biomedical Advanced Research and Development Authority and potentially a $50m payment related to the US FDA's extended shelf-life determination for stockpiled Tpoxx; company also picks up first priority review voucher awarded for a medical countermeasure, which it likely will monetize.
Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.
GlaxoSmithKline's user fee date is July 22, four days before advisory committee review of 60 Degrees’ separate application for the compound.
Established efficacy endpoints may not be suited to assessing gene therapies’ clinically meaningful effects in some rare retinal disorders, US FDA says in draft guidance that gives a shout-out to Spark’s development of a functional vision endpoint for voretigene; guidance also includes recommendations on appropriate control groups and use of sham injections.
Approval could bring GlaxoSmithKline a tropical disease priority review voucher.
Co-primary endpoint was Axillary Sweating Daily Diary, a novel PRO instrument developed by Dermira with FDA input, assessed sweating severity and impact of sweating on a person’s daily activities; results complemented quantitative measure of sweat production in Phase III trials.