Y2020

FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

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Japan’s antibacterial R&D landscape / Japan calls for Pull incentives

Dear All: Late last year, I had the opportunity to hear a presentation on antibiotic R&D in Japan by Norio Ohmagari. Based in Tokyo at the National Center for Global Health and Medicine Hospital (link), Norio is Director of its (i) AMR Clinical Reference Center, (ii) Disease Control and Prevention Center, and (iii)  WHO Collaborating

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Nature publishes superb 10-paper collection on all things AMR

Dear All,  Released on 21 Oct 2020, Nature has published an Outlook series on AMR. The papers are 2-4 pages long and provide an excellent survey of all things AMR from the perspective of R&D in support of new therapies and vaccines (diagnostics are not covered). See below the list of papers with brief comments

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FDA workshop: Insights on inhaled antifungals and antibacterials

Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to

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NIAID Small Business Application Assistance Program seeks applications!

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

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US National Action Plan for Combatting AMR: 2020-25 update!

Dear All (and with thanks to Kevin Outterson for doing the heavy lifting on this note), As you may recall, the US National Action Plan for Combatting Antimicrobial Resistant Bacteria (US NAP CARB) was launched in 2015 on the heels of the 2013 CDC report on antimicrobial threats (link to that report) and is/was a

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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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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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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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