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Dalbavancin Approval Issues: A Case of Much Ado About Nothing

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Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.  Pfizer acquired dalbavancin as a “Phase 3 completed” drug ready for world-wide marketing on June 15, 2005. The Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing→

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

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It is no secret that most existing antibiotic guidelines are not getting much use these days.  The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.  Yes, the occasional HABP/VABP trial is being undertaken by the intrepid but no company has taken Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)→

Brilacidin – QIDP Drug At a Critical Juncture

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At around this time (July 2015), Cellceutix is expected to hammer out a Phase 3 program for brilacidin, its defensin-mimetic and host-defense protein (HDP) mimic structurally similar to magainin, with FDA. Brilacidin is certainly an interesting novel compound, coming from a new class, with a unique mode of action.  It has Continue reading Brilacidin – QIDP Drug At a Critical Juncture→