ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All (and with thanks to Damiano for taking the lead on this newsletter),We wrote previously in (i) the 7 Dec 2023 newsletter ("How Italy should Push and Pull: New report as Italy takes the 2024 G7 chair"), (ii) the 17 Oct 2024 newsletter ("Italy funds CARB-X and announces pull incentive!"), and finally (iii) the 9 Jan 2025 newsletter ("Italy delivers a national pull incentive (with a budget of EUR 100 million a year)!") about Italy's incremental efforts to finance and implement a complementary set of Push and Pull incentivesExcitingly, Italy’s commitment to antimicrobial innovation has now taken an important step forward on this path! The publication of Determina Pres/966/2025 by the President of the Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency) on 12 July 2025 marked the formal activation of Italy’s national pull incentive, solidifying its legal and procedural foundation. Here are the links you need:The webpage for the Determina and its support documentsThe Determina itselfThe Determina clarifies that antibiotics which are reimbursed by the Italian national health service (Servizio Sanitario Nazionale, SSN) must meet all of the following three criteria to be included in the Fund:Be classified as “Reserve” in the World Health Organization’s (WHO) AWaRe list and/or be active against one of the bacteria in...
Dear All, BARDA have published...
Latest Government Action
Dear All,Referring back to the actions planned following the 2024 UNGA HLM on AMR (UN General Assembly High-Level Meeting on AMR; 1 Oct 2024 newsletter and our dedicated UNGA 2024 webpage), you will hopefully recall the commitment to create an Independent Panel on Evidence for Action against AMR (IPEA).The broad idea is the data from an independent panel would have great credence and encourage governmental action. The importance of creating of an IPEA was specifically noted in paper #4 from the 10-20-30 Lancet series (Mendelson et al. Lancet 2024 and the 23 May 2024 newsletter) and has been supported by funding promises of €2.5 million from the European Commission along with commitments of GBP 10 million each from the United Kingdom and Saudi Arabia.And the hope is that this will move quickly. A roadmap released 14 Mar 2025 calls for work to ensure that the IPEA "is established and commences its work as soon as practicable in 2025."So, how do you create an IPEA? How is it organized? How is it governed? To answer that question, we today have papers from the Quadripartite Joint Secretariat on AMR (QJS) on possible ways to create an IPEA ... and we are all invited to comment on the best approach. Here are the...
Dear All,Attention phage developers --...
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Dear All (and with thanks...
R&D Insight
Dear All: A Federal Register notice has...
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Dear All: Today we have...
Dear All (and with thanks to...
Dear All, Two quick updates...
Dear All,The June issue of...
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Can you help?
Dear All,I have just learned that Lifeline, the musical formerly known as The Mould that Changed the World, is seeking scientists, medics, and healthcare professionals to be part of the cast for a portion of a planned 5-week off-Broadway run of the show around the time of the High-Level Meeting (HLM) on AMR at UNGA 2024 in New York City...
Dear All, Heads up! Having...
Note: Be sure to take...
Update on 11 October 2023: The...
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Dear All, Two items for...
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Dear All, We are swimming...
Antimicrobial resistance poses a catastrophic threat. If we don’t act now, any one of us could go into hospital in 20 years for minor surgery and die because of an ordinary infection that can’t be treated by antibiotics. And routine operations like hip replacements or organ transplants could be deadly because of the risk of infection.
AMR Fireside Chats
1/18 videos
1
Episode 17 w/ Ella Balasa and Rob Purdie of WHO Task Force of AMR Survivors - AMR Fireside Chat
38:24
2
Episode 16 w/ Ramanan Laxminarayan, PhD - AMR Fireside Chat
32:59
3
Episode 15 w/ Mark Albrecht, PhD - AMR Fireside Chat
43:55
4
Episode 14 w/ Lynn Silver - AMR Fireside Chat
56:23
5
Episode 13 w/ Kevin Outterson - AMR Fireside Chat
30:01
6
Episode 12 w/ Tina Joshi, PhD - AMR Fireside Chat
34:22
7
Episode 11 w/ Martin Heidecker - AMR Fireside Chat
32:31
8
Episode 10 w/ Anna Govett - AMR Fireside Chat
14:54
9
Episode 9 w/ Fatema Rafiqi, PhD - AMR Fireside Chat
34:10
10
Episode 8 w/ Ghada Zoubiane, PhD - AMR Fireside Chat
35:04
11
Episode 7 w/ Trevor Lithgow, PhD - AMR Fireside Chat
35:41
12
AMR Snapshots: Episode 2 - John Rex (Editor-In-Chief, AMR.Solutions)
26:25
13
Episode 6 w/ Maryn McKenna - AMR Fireside Chat
45:50
14
Episode 5 w/ Christine Årdal - AMR Fireside Chat
43:44
15
Episode 4 w/ Peter Beyer - AMR Fireside Chat
39:21
16
Episode 3 w/ Kevin Outterson - AMR Fireside Chat
11:45
17
Episode 2 w/ Henry Skinner, PhD - AMR Fireside Chat
15:44
18
Episode 1 w/ Kevin Outterson - AMR Fireside Chat
52:56
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
Dear All (wonkish alert … get your coffee!), EFPIA have recently released a report estimating the value of a Transferable Exclusivity Extension (TEE, report, press ...
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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 paper in Clinical Infectious Diseases ...
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News from Davos 2020: Some positive signs, but overall a fragile antibiotic market at a tipping point
Dear All (and heads-up for a rather lengthy and wonkish note … settle in for the details), Last week saw substantial AMR-related news released in ...
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Plazomicin (Achaogen) financial post-mortem: #PassPASTEUR
Dear All (and with thanks to Kevin for co-authoring and also a wonkish alert … get your coffee and settle in for the details), If ...
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Lancet: 10-20-30 targets to address AMR by 2030
Dear All (wonkish alert … but definitely worth the effort! Refill your coffee!),Ramanan Laxminarayan and about 40 colleagues from around the world have just published in ...
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Lessons in Discovery from Lynn Silver + Pro-con on alternatives to antibiotics
Dear All: “Good decisions come from experience, and experience comes from bad decisions … and paying attention.” You’ve probably heard the first part of that ...
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Melinta goes bankrupt / Never let a good crisis go to waste
Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just ...
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IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano
Dear All (long note alert … there’s a lot of material below my signature): Just published today is an IDSA White Paper entitled “Developing Antimicrobial ...
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UK to expand NHS Subscription Pilot! Consultation Period launches
Dear All (and with thanks to Kevin for co-authoring), The UK NHS England Pilot is known to us all as the first real attempt at an antibiotic ...
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The 6 meanings of “Lack of Access” (UNSLAP)
Dear All, We often talk about the problem of lack of access to new antibiotics. In late 2021, for example, we explored data showing that multi-year ...
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Draft EMA antibacterial guidance: Analysis
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft ...
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Impact of PASTEUR: 9.9m lives saved, ROI of 125:1
Dear All (and with thanks to Kevin Outterson for being lead author on this newsletter), (wonkish alert on this one … refresh your coffee and ...
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The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism.
The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.
Summaries
Notes: Newsflash ... BARDA have...
Aside: If you've enjoyed the...
See also This related newsletter:...
Dear All (and with thanks...
Dear All (Wonkish alert! Coffee-up!),Today...