Tag Archives: adverse events

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

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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→

Brilacidin – QIDP Drug At a Critical Juncture

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At around this time (July 2015), Cellceutix is expected to hammer out a Phase 3 program for brilacidin, its defensin-mimetic and host-defense protein (HDP) mimic structurally similar to magainin, with FDA. Brilacidin is certainly an interesting novel compound, coming from a new class, with a unique mode of action.  It has Continue reading Brilacidin – QIDP Drug At a Critical Juncture→

Tenofovir, BMD and Monitoring of Renal Function

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The approved tenofovir / Viread label lists not only standard nucleoside-class side effects but also – since an update in 2012 – makes mention of diminished bone mineral density (BMD) in the Warnings / Precautions section. Demonstrating that a particular drug affects BMD in patients who are already at an increased risk Continue reading Tenofovir, BMD and Monitoring of Renal Function→