Home » FDA » Page 13

Tag Archives: FDA

Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

Posted on by — No Comments ↓

VABP is clearly the main indication to be pursued by a drug like POL7080.  Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum?  Which is actually no spectrum at all.  Existing guidelines for the development of ID drugs are indication-driven, with Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)→

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Posted on by — No Comments ↓

Roche’s current Phase 2 program is strangely ambiguous. RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” is enrolling. Well, good luck finding those patients! At best, Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)→

Two New Antifungals Presented at ICAAC San Diego

Posted on by — No Comments ↓

As noticed by many other colleagues, ICAAC 2015 was a shadow of its former self.  Few participants overall, fewer posters, and even fewer exhibitors.  Reviewing the posters, there were relatively few from industry, most came from university or small research labs.  In a way, ICAAC 2015 was a true reflection of Continue reading Two New Antifungals Presented at ICAAC San Diego→