Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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 Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI – Part 1
The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary Continue reading Commenting on Comments: The Ceftaroline Trial Program in CABP
If you were developing a new antibiotic with a novel MoA, one that covers most GPC, most GNR, most anaerobes and atypicals, including many MDR pathogens like MRSA, enterococci (both E. faecalis and E. faecium), and one that has also Continue reading Nominating Thiamphenicol for IDSA’s 10 x ’20 Campaign
The recent discussion whether fluoroquinolones (FQ) cause retinal detachment was short-lived and soon put to rest. The issue was raised by 2 observational studies but no signal was seen in a larger and better designed Danish study. So it seems Continue reading Antibiotics with Ocular Toxicity
Several antibiotic classes are associated with QTc prolongation: macrolides, quinolones, the antimalarials that share the quinine structure, and many azole antifungals. FDA warned about the proarrhythmic effects of azithromycin in 2013 [i] but it is a recent publication by Rao Continue reading QT Prolongation with Azithromycin and Levofloxacin