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Latest From Sue Sutter
Puma’s tyrosine kinase inhibitor gains recommendation from US advisory committee but faces concerns that proposed indication for extended adjuvant treatment in HER2-positve breast cancer is overly broad given unfavorable subgroup results in pivotal trial.
Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance
Tyrosine kinase inhibitor has an effect in adjuvant breast cancer but ‘there remains some uncertainty regarding the true magnitude of the treatment effect,” FDA reviewers say; given incidence and severity of diarrhea, experts will be asked to consider whether there is a subpopulation with a more favorable risk/benefit profile.
If US FDA Commissioner Gottlieb allows use of in-dwelling ports in ESSENCE study, Office of Pediatric Therapeutics will assess whether the determination could serve as precedent for placebo-controlled trials of other exon-skipping compounds in Duchenne muscular dystrophy.
US agency’s experts unanimously support allowing use of in-dwelling ports to aid infusions in trial of two Duchenne muscular dystrophy compounds, while also endorsing the two-year, double-blind, placebo-controlled design, which was influenced by the clinical experience with Exondys 51 (eteplirsen).
AbbVie and Daiichi tell US FDA that manufacturers’ communications should not be considered protected speech if they infringe exclusivity rights of other companies; comments seem aimed at restricting what competitors can say about protected claims for Humira and MorphaBond.