J&J’s Sirturo Approval Tied To Expansive Post-Marketing Study Program
This article was originally published in The Pink Sheet Daily
Executive Summary
The first drug approved for multi-drug resistant tuberculosis, Sirturo obtained accelerated approval based on data from two Phase II studies, but has a troubling safety database, including 10 deaths in the treatment arm of its Phase II program.
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With the formation of the GPH group, Janssen joins GSK and Sanofi in putting corporate focus on developing and delivering affordable medicines for developing countries. But where GSK seeks to improve outcomes and turn a profit, for now Janssen’s first priority is human health.
Janssen Forms Global Public Health Group To Deliver Its Medicines To Developing World
With the formation of the GPH group, Janssen joins GSK and Sanofi in putting corporate focus on developing and delivering affordable medicines for developing countries. But where GSK seeks to improve outcomes and turn a profit, for now Janssen’s first priority is human health.