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Keeping Track: Thumbs Up For Abbvie and GSK; Thumbs Down For Insys

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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60 Degrees’ Arakoda Gets US FDA Panel Nod For Malaria Prophylaxis

Postmarketing studies are needed to assess tafenoquine’s efficacy in children, older adults and heavier individuals, and to answer questions about psychiatric safety and other adverse events, advisory committee says.

AbbVie Prices Oral Endometriosis Drug Orilissa In Value Range, Focusing On Access

In addition to endometriosis, Orilissa (elagolix), developed by Neurocrine and licensed to Abbvie, is in Phase III for treating heavy bleeding associated with uterine fibroids.

Tafenoquine Redux: 60 Degrees Pharma’s Malaria Drug Gets Its Turn At US FDA Panel

Extended dosing required for prophylactic indication could raise more advisory committee concerns about safety than the one-time dose of GlaxoSmithKline’s formulation, which was recently approved for prevention of relapse.

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