Allphase Pharma Consulting, LLC
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..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…
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It
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