Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria
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
Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir. When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP. When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?