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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→

FDA Adboard on Tedizolid – Why?

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FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair:  Looking at the reviewer’s slides, there was really no question about the drug’s efficacy.  Did tedizolid cure as many patients as linezolid?  Yes, it did.  Did the sponsor follow the latest ABSSSI Guidance criteria for establishing non-inferiority?  Yes, they Continue reading FDA Adboard on Tedizolid – Why?→