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- CARB-X
- CDC
- FDA
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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 ...
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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 ...
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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 ...
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Treating resistant Gram-negatives: IDSA provides pragmatic expert advice
Dear All, IDSA (Infectious Diseases Society of America) have today released an eagerly awaited new guidance document on treating infections ...
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New antibiotics are not being registered or sold in Europe in a timely manner
Dear All (and with thanks to Kevin for leading the charge on this newsletter), While listening to last week’s BEAM-sponsored ...
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Dame Sally and #RescueTheLobster: Meetings past and present worth your time
Dear All, There’s a tidal wave of meetings for you to note! Some have already occurred but can easily be ...
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Reimbursing for innovative antibiotics / Encouraging updates from the AMR conference
Dear All (with thanks to Kevin as the lead author on this note and also with a wonkish note alert ...
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EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep
Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for ...
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Global AMR Hub launches Incentives Gallery / AMR Conference is underway
Dear All, In case you missed it, the 4th AMR Conference sponsored by BEAM, CARB-X, Novo REPAIR, Wellcome Trust, the ...
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Alan Carr’s August ’20 Antibiotic-Antifungal update: Required reading!
Dear All, I hope everyone is finding a bit of time to go off-line during August … always a good ...
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Important WHO job opportunity: Global governance structures for AMR-related work
Dear All, Just below my signature, you will find the details of WHO’s search for a consultant to help them ...
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Final FDA LPAD guidance: Same substance, useful clarifications
Dear All, FDA have released the final version of their LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs, really ...
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Beyond the AMR Action Fund: PBS NewsHour and Things for us all to do!
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), While we’re all thrilled with the announcement of ...
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Estimating attributable mortality of resistant bloodstream infections: GLASS (WHO) recommended method
Dear All, WHO’s GLASS Secretariat (Global Antimicrobial Resistance Surveillance System, link) have recently released a standardized method for estimating attributable ...
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Plazomicin EU marketing application is withdrawn: Near zero market value of newly approved antibacterials
Dear All (with thanks to Kevin Outterson for co-authoring this newsletter), Last week’s announcement of the AMR Action Fund was ...
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AMR Action Fund: A $1b down payment from Industry; A call for creation of strong Pull incentives
“The world is changed by your example, not by your opinion” (Paulo Coelho) Dear All, The AMR Action Fund (https://www.amractionfund.com/) ...
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Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
Dear All (wonkish alert … the first 3 segments are non-wonkish but the last 2 are in the wonkish zone ...
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FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
Dear All (wonkish note alert … top-up your coffee and settle in!), Today we have a tour of a recent ...
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FDA analysis of 40-years of antibacterial development: Dheman et al.
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Just out in CID is a paper in ...
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SPIDAAR & ATLAS: Data sharing via AMR Surveillance partnerships
Dear All, Building on the ATLAS database (link) that provides open access to data from 2004 to the present out ...
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