Dear All, Howard Bauchner, the editor-in-chief of JAMA, regularly does 30-minute Q&A podcasts. Today’s Q&A was with Tony Fauci and is a superb review of current state of play. Yes, he is ready to get the vaccine and is going to be vaccinated in public! Go here to listen. For more, below my signature you
Dear All, National Institute of Allergy and Infectious Diseases (NIAID) put out a call on 22 Oct 2020 for applications for its Applicant Assistance Program (AAP). The AAP provides no cost support for US-based companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II Small Business Innovation Research (SBIR) or Small Business Technology
Dear All, WHO have been thinking about the threat of resistant fungi as well as resistant bacteria. An initial discussion by a small working group on approaches to priority fungal pathogens (April 2020, here’s the link to the report) concluded that Candida auris; azole-resistant Candida spp., azole-resistant Aspergillus fumigatus, Cryptococcus neoformans (& C. gattii), Pneumocystis jirovecii, Mucorales, and potentially Histoplasmosis were
Dear All, The Drug-Resistant Infections team at Wellcome Trust (link to their homepage) has launched a survey collecting data on current prescribing practices in low-, middle-, and high-income countries. The survey takes about 15 minutes and seeks answers to these questions: Does the WHO Pathogen Priority List (PPL, link), published in 2015, accurately reflect current pathogen
Dear All, BARDA is interested in hearing from antibiotic developers about antibiotics which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP (post-exposure prophylaxis) of a biothreat indication, specifically: Y. pestis, F. tularensis, and/or B. pseudomallei. Here’s the core message from the pre-solicitation notice: Topline: “The U.S. Government
Dear All, Some regulatory updates today. From FDA, we have final versions of their CABP and HABP-VABP guidance documents. My initial review suggests no big changes: CABP (Community-Acquired Bacterial Pneumonia) The draft from Jan 2014 has been updated with a final version dated June 2020 (link). I generated a comparison between the two (link). The
Dear All (wonkish note alert — refresh your coffee before proceeding — with thanks to Kevin Outterson for co-authoring this note!), The intertwined questions of (i) the cost to develop a new antibiotic and (ii) how much we should pay for such a new antibiotic have been an increasingly frequent newsletter topic, with a real
Dear All: “Good decisions come from experience, and experience comes from bad decisions … and paying attention.” You’ve probably heard the first part of that before, but the “… and paying attention” is my addition and reflection upon reading Lynn Silver’s most recent commentary in the Springer Series Topics in Medicinal Chemistry, edited by Jed Fisher, Marvin
Dear All (wonkish note alert … top-up your coffee and settle in!), Today we have a tour of a recent paper in Clinical Infectious Diseases in which FDA presents a very instructive analysis of endpoints used in recent CABP (Community-Acquired Bacterial Pneumonia) trials and how data such as these might permit further convergence of global
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Just out in CID is a paper in which FDA analyzes trends in antibacterial development from 1980-2019. To fully appreciate this paper, you need to look both at it and three other papers: FDA’s paper (https://doi.org/10.1093/cid/ciaa859): Dheman N, Mahoney N, Cox EM, Farley