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After ICAAC: Some More Thoughts on Eravacycline in cUTI and IGNITE-2

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When a well-designed pivotal Phase 3 trial fails to show NI, it demands an explanation.  While awaiting the company’s analysis of the data, many possible explanations are bandied about.  So it was not surprising that the eravacycline cUTI study (IGNITE-2) was mentioned quite often during ICAAC 2015, in sessions and Continue reading After ICAAC: Some More Thoughts on Eravacycline in cUTI and IGNITE-2→

Mme Erava and The Mysterious Case of Auto-Combustion

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SH: My dear Watson, did you read the news of the astonishing debacle that befell Mme Erava and made the headlines, creating anxiety of hitherto unknown proportions in Tetraland? Dr.W.: A disaster of epic proportions, for sure, and a mystery, an explanation which will require some very expert investigation. There is Continue reading Mme Erava and The Mysterious Case of Auto-Combustion→

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→