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Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

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Roche’s current Phase 2 program is strangely ambiguous. RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” is enrolling. Well, good luck finding those patients! At best, Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)→

Two New Antifungals Presented at ICAAC San Diego

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As noticed by many other colleagues, ICAAC 2015 was a shadow of its former self.  Few participants overall, fewer posters, and even fewer exhibitors.  Reviewing the posters, there were relatively few from industry, most came from university or small research labs.  In a way, ICAAC 2015 was a true reflection of Continue reading Two New Antifungals Presented at ICAAC San Diego→

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→