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All
  • All
  • AMR Action Fund
  • Can you help?
  • CARB-X
  • CDC
  • FDA
  • Government Action
  • Jobs
  • Meetings
  • PK & PK-PD
  • Push/Pull
  • R&D Insight
  • RFPs
  • Something Different
  • Summaries
  • Wellcome Trust
  • WHO
  • Wonkish
Government ActionPush/Pull

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 ...
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Can you help?R&D Insight

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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R&D InsightSummaries

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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FDAGovernment Action

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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R&D Insight

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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R&D InsightSummaries

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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MeetingsR&D Insight

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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Wonkish

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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Government ActionR&D Insight

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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R&D Insight

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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R&D Insight

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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JobsWHO

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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FDAR&D Insight

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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R&D Insight

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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R&D InsightWHO

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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SummariesWonkish

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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Push/PullR&D Insight

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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FDAR&D Insight

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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FDAR&D Insight

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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FDAR&D Insight

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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