Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…
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’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?