Pneumonia Guidances Revisited: FDA Cmte. To Weigh Study Design Issues Again
FDA’s Anti-Infective Drugs Advisory Committee will take its third look in less than four years at standards for developing antibacterial agents to treat community-acquired bacterial pneumonia, at a meeting on Nov. 3.
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Public/private working group’s “interim considerations” of how best to design clinical trials for VABP and hospital-acquired bacterial pneumonia would add symptom improvement to a mortality endpoint for the latter.
Mortality Vs. Clinical Cure: Telavancin Review Expected To Renew Debate On Nosocomial Pneumonia Endpoints
FDA’s Anti-Infective Drugs Advisory Committee will take up Theravance’s Vibativ NDA on Nov. 29 following two “complete response” letters and the sponsor’s rejected requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.
Pfizer On “Pausing” Anti-Infectives Research In China, And Taking A Long View On Asian Partnerships: An Interview With PharmAsia News (Part 2 of 2)
On the way back to his old job in the U.S., after a stint in Shanghai as head of research in Asia, VP Richard Connell, head of Preclinical Outsourcing says Pfizer is “pausing” plans for an anti-infectives research unit in China after hitting a few speed bumps.