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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→

Does The Taxpayer Get Rewarded For Funding Such Studies?

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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 suited for PrEP of HIV for high-risk patients who nowadays are Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?→