Y2020

WHO to create a Priority Pathogen List for Fungi! / RFP to build the list

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

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PASTEUR Act (re)introduced: A delinked Pull award advances in the US!

Dear All (with thanks to Kevin Outterson for leading this note), HUGE news today: Senator Michael F. Bennet and Senator Todd Young have introduced an updated PASTEUR Act that (if enacted) would create a predictable path to rewarding new #FireExtinguishersOfMedicine for their value to society via a subscription contract (valued at $750m to $3b) that prepays

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Help (re)validate WHO’s Priority Pathogens List and Essential Medicines List

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

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BARDA seeks information: Are you creating an antibiotic for Yersinia or other biothreat Gram-negatives?

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

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Help Alan Carr with a point survey on COVID-19 vaccines!

Dear All, Once again, we’re going to have a brief change from our usual programming with this newsletter. I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries:

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In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): There’s been a lot of recent discussion about “lessons learned from COVID-19.” Indeed, there are many valuable points: global cooperation, preparedness, supply chains, and so forth. As an example, I note the 17 Sep 2020 communique from the G20 Health Ministers (link): it was heavily

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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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