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- R&D Insight
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- Y2017
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- Y2020
- All
- Incentives
- Jobs
- Media & Graphics
- PK & PK-PD
- R&D Insight
- Wonkish
- Y2017
- Y2018
- Y2019
- Y2020
In Praise of Non-Inferiority
Dear All (wonkish but intended for everybody to read and absorb): There’s been a lot of recent discussion about “lessons learned …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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/) …
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 …
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 …
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 …
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 …
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 …
