Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, and how this all matters in clinical practice, on the Continue reading What is the “Niche” for Ceftolozane / Tazobactam?
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
For the latest QIDP listing, please click HERE Since FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’. Which should not come as a surprise: QIDP status confers significant benefits – and there is no downside. While an official FDA list of drugs that have Continue reading Antibiotics with QIDP Designation – – – Updated 9-30-14