Tag Archives: Vicuron

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→

Why Some Did Not Make It

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There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It→

Dalbavancin Sale to Actavis

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When Pfizer bought dalbavancin and anidulofungin from Vicuron in 2005, it shelled out USD 1.9 billion for both Phase 3 drugs.  One can argue whether each drugs had the same commercial value for Pfizer but it is safe to assume that dalbavancin was valued at approx. USD 1 billion at Continue reading Dalbavancin Sale to Actavis→