First and upfront, let’s call this virus WARS*, which stands for Wuhan Associated Respiratory Syndrome. President Xi Jingping called for a war against the new virus, and a war it is. Therefore our acronym makes intuitive sense. The naming of
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Posted in The News |
Tagged allphasepharma, chloroquine, coronavirus, COVID-19, cruise ships, face masks, facts and fiction, influenza, MERS, nCoV, NCV, NDM, novel corona virus, protection, quarantine, recirculated air, remdesovir, SARS, transmission, vaccine, WARS, WHO, Wuhan |
There once was a Scientific American section authored by science historian James Burke called ‘Connections”. In it James Burke, a true renaissance man, showed us how an ‘internet’ of serendipitous encounters, connections between persons, places and events led to advances
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Posted in Did you know...? |
Tagged Acinetobacter taxonomy, Andre Lwoff, antibiotic blog, bacteriophage, Beijerinck, CRAB, Feynman, H.P.R. Seeliger, Harald Reinhart, Jacob, James Burke, James Watson, L. seeligeri, Lingelsheimia, Listeria, lysogeny, Mima/Herellea, Monod, Moraxella, Nobel Prize, Paul Baumann, Scientific American, The Double Helix, von Lingelsheim |
At the recent FDA workshop on narrow-spectrum antibiotic development, the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the
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Posted in The Viewpoint |
Tagged 30-day mortality, antibiotic blog, antibiotic efficacy, bacteriological response, clinical response, FDA, Harald Reinhart, HBV, HCV, HIV, immunity, mortality endpoint, outcome variables for antibiotic efficacy, surrogate endpoints, survival, viral load, VL |
The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All
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Posted in The News, The Viewpoint |
Tagged ABECB, ABOM, ABS, acute otitis media, antibiotic blog, Bayesian statistics, bronchitis, CABP, CABP Guidance, CRO, delta, EMA, enrollment criteria for CABP, enrollment X-US, FDA, FDA commissioner, Harald Reinhart, Koseisho, M1, M2, non-inferiority margin, placebo-controlled trials, PMDA, Scott Gottlieb, sinusitis |
Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to
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Posted in Recent Literature, The News, The Viewpoint |
Tagged AIC246, Aicuris, anti-rejection drugs, antibiotic blog, brincidofovir, Chimerix, CMV terminase inhibitor, CMV therapy, cyclosporine, cytochrome P450, drug-drug interactions, ganciclovir, GCV, GvHD, Harald Reinhart, HSCT, Keytruda, Letermovir, maribavir, Merck, MK-8224, MK-8228, pembrolizumab, publication delay, ViroPharma |