Y2020

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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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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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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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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Tetraphase sold for $14m … and $600m goes up in smoke!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter): Wonkish and long note alert … top-up your coffee and settle in… We learned about a week ago that Tetraphase, despite having brought an antibacterial (eravacycline) to approval, has been sold for stock worth $14.4m (plus a potential $12.5m more if aggressive sales targets are achieved).

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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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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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