Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug
In a much-quoted analysis, Lee found that most IDSA Guidelines were supported only by Level III quality data, the lowest category of evidence-based support. The article concludes that more well-designed trials were needed, and clinical judgement should ultimately guide patient Continue reading New Treatment Guidelines for Candidiasis – A Major Document to Study
Sometimes – for no obvious reason – there is a flurry of publications from a particular area which has been quiet for a long time. RSV is such an area where new drug development had a hard time getting started. Continue reading There is Momentum Building for RSV Therapeutics
Any FDA meeting is a high-stakes game for industry: One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective. At other times, simple issues seem to create Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?
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