R&D Insight

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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16 Nov FDA AdComm – Inhaled ciprofloxacin for non-CF bronchiectasis

Dear All:  A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from

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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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Health Security underpins Economic Security: Fabulous webinar chaired by Dame Sally

Dear All, I want to call your attention to the replay available on YouTube of the excellent 24 Sep 2020 webinar entitled “The global movement of microorganisms:Tracking the spread of difficult-to-treat infections.” Chair by Dame Sally, this 90-minute webinar (link) had 4 global speakers: (Geneva) Hanan Balkhy, Assistant Director-General, World Health Organization (Addis Ababa) John Nkengasong,

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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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US DoD SBIR grants to develop small molecules for MDR Pseudomonas aeruginosa

Dear All, The US Department of Defense (DoD) is offering funds through the Small Business Innovation Research (SBIR) program for a “Novel Antibiotic for the Treatment of Multidrug-Resistant Pseudomonas Aeruginosa Infections.” Antibody, phage, and vaccine approaches are out of scope and the business must be located in the United States. To find the funding offer, navigate

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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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In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to

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