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Sage Impresses With Second Postpartum Depression Therapy

Executive Summary

Positive top-line Phase III data with Sage's second lead positive allosteric modulator at GABA receptors, SAGE-217, in postpartum depression continues to back the US biotech's approach to the devastating condition.

 

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Sage Still Sees Approval Path After Depression Drug Fails In Phase III Trial

Sage Therapeutics points to patient compliance and selection as factors in its failed trial of SAGE-217. The company sees positive implications in the data as it waits for other SAGE-217 studies. 

Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval

After an advisory committee recommended approval for the postpartum depression treatment if administered under a REMS program at certified centers, Sage submitted a proposed REMS, causing the agency to extend the PDUFA date three months.

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