What is the “Niche” for Ceftolozane / Tazobactam?

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?

The Difficult Transition Into Phase 3

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

BC-3781 Passes Phase 2 with Flying Colors, Readies for Phase 3

The pleuromutilins are a relatively ‘old’ class of antibiotics that have seen much use in veterinary but not in human medicine.  According to EMA, Tiamulin is an “essential antibiotic” for the control of dysentery in pigs which is caused by Brachyspira hyodysenteriae, a macrolide-resistant pathogen.[1]  Retapamulin / Altabax® was introduced Continue reading BC-3781 Passes Phase 2 with Flying Colors, Readies for Phase 3