AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in light of new post-approval safety issues. The document is 617 Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

Making The News:  Something Hilarious, Something Ominous…

Hilarious:  Chicks and Kids Antibiotic use in animals is defended as infection prophylaxis, but the honest reason why chickens are exposed for most days of their short life to antibiotics of various kinds is for growth promotion.  Antibiotic use keeps those chicks healthy which in turn makes them eat more Continue reading Making The News:  Something Hilarious, Something Ominous…

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

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)