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…
Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available in Europe for a quite some time but not in the Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin
Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3. Hence, not surprisingly, few small companies tackle Phase 3 programs on their own. Unless an ‘angel investor’ with deep pockets commits to the compound and assures continuity of development, the Continue reading The Difficult Transition Into Phase 3