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The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

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Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?→

Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides

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The development history of glycopeptide drugs is anything but normal.  Daptomycin (Cubicin®) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration.  The drug did superbly in a landmark endocarditis trial and everything looked rosy.  Then we learned Continue reading Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides→