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…
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
When Pfizer bought dalbavancin and anidulofungin from Vicuron in 2005, it shelled out USD 1.9 billion for both Phase 3 drugs. One can argue whether each drugs had the same commercial value for Pfizer but it is safe to assume that dalbavancin was valued at approx. USD 1 billion at Continue reading Dalbavancin Sale to Actavis