Panel Gives Mixed Reviews To Using Single Trial For Community-Acquired Pneumonia
The Anti-Infective Drugs Advisory Committee's failure to agree on a preferred approval pathway for antibiotics to treat community-acquired bacterial pneumonia opens the door for FDA to offer several options to industry.
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The antibiotic showed promising results in a late-stage study of the oral formulation, setting the company up as a potential target for acquirers and partnering opportunities – though for now it is signaling its intent to go it alone.
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requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.
At the annual anti-infectives meeting, experts consider revamping the business model to spur development of novel antibiotics, with cooperation of regulators in Europe and U.S.