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All
  • All
  • Incentives
  • Jobs
  • Media & Graphics
  • PK & PK-PD
  • R&D Insight
  • Wonkish
  • Y2017
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R&D InsightWonkish

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 InsightY2020

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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IncentivesY2020

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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IncentivesR&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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IncentivesWonkish

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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IncentivesR&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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IncentivesR&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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IncentivesR&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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JobsY2020

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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R&D InsightY2020

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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IncentivesY2020

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 InsightY2020

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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IncentivesWonkish

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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IncentivesY2020

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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R&D InsightWonkish

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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R&D InsightWonkish

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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R&D InsightWonkish

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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R&D InsightY2020

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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JobsY2020

Six-month consultancy with WHO to support antibiotic stewardship

Dear All, Wow, a news-heavy day … at least two more newsletters this weekend, I think. See below my signature …

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IncentivesY2020

SAVE THE DATE: 9 July launch of a major global AMR Initiative

(Updated on 8 July 2020) Dear All, Mark your calendars now for a major global AMR initiative that will be …

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