ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All,There are more details yet to come, but the EU Council ("the Council") and the EU Parliament (EP) yesterday announced an agreement on the update to the EU General Pharmaceutical Legislation that includes transferable exclusivity vouchers (TEVs or TEEVs, depending on your preferred abbreviation). Here's the key text from the EP's press release:Stepping up the fight against antimicrobial resistance (AMR)Negotiators agreed to introduce a “transferable data exclusivity voucher” for priority antimicrobials, giving the right to 12 additional months of data protection for one authorised product. The 12-month extension may be used once, for the priority antimicrobial or for another centrally authorised medicinal product of the same or different marketing authorisation holder.Among new measures to promote the prudent use of antimicrobials, the deal introduces stricter requirements, such as compulsory medical prescriptions for all antimicrobials, specific information requirements to be provided with the package leaflet, and an “awareness card” in paper format in case the leaflet is made available only electronically.When applying for marketing authorisation for antimicrobials, companies would also need to provide an “antimicrobial stewardship plan” and include an evaluation of the risk for antimicrobial resistance as part of the compulsory environmental risk assessment.As further background, here are the links...
Dear All,Integrating perspectives from EC...
Latest Government Action
Dear All, I am pleased to learn that BARDA is holding a one-day innovation symposium on 20 Nov 2025. As you know, BARDA is a consistently creative funder of diverse medical countermeasures, including new antibiotics. For background, see these prior newsletters:22 Jul 2025 newsletter: "BARDA RFP: Antibiotic for HABP/VABP or Bloodstream Infection"5 Nov 2024 newsletter: "BARDA seeks deep insight on antibacterials near/beyond end-of-Phase 2"12 Nov 2023 newsletter: "Fireside Chat with BARDA’s Branch Chief for Antimicrobials".The video from this newsletter (see also below my signature) is highly recommended as a primer on that way that Team BARDA think about medical countermeasures!26 Sep 2023 newsletter: "BARDA Medical Countermeasures BAA: Substantial updates"BARDA's BAA-23-100-SOL-00004 is open through Sep 2028!As to the 1-day symposium, it runs 9a-5p ET on 20 Nov 2025 in Washington DC. Let me quote from the announcement (highlights added by me):"Join us in person for an engaging showcase of early-stage health security innovations supported by BARDA through our Division of Research, Innovation, and Ventures (DRIVe), the BARDA Accelerator Network, BARDA Ventures, BLUE KNIGHT, and CARB-X. "The symposium will bring together BARDA-supported innovators, U.S. government partners, investors, strategic partners, and other key stakeholders to highlight technologies and foster collaborations to advance the development of medical...
Dear All,Referring back to the...
Dear All,Attention phage developers --...
Dear All,D-Day and the momentous Normandy...
Dear All,If you represent a...
Dear All, Sadly, I must...
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R&D Insight
Dear All, Just released, the...
Dear All, Committing serial email...
Dear All: OK, I’ll say that...
Dear All,Today we have two...
Dear All: FDA today posted...
Dear All (wonkish alert ......
Dear All: Today we have...
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...
Dear All,Along with more than...
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Dear All, Greetings from ECCMID...
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Dear All, A short one...
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
1/19 videos
1
Episode 18 w/Robin Hiley- Fireside Chat
19:48
2
Episode 17 w/ Ella Balasa and Rob Purdie of WHO Task Force of AMR Survivors - AMR Fireside Chat
38:24
3
Episode 16 w/ Ramanan Laxminarayan, PhD - AMR Fireside Chat
32:59
4
Episode 15 w/ Mark Albrecht, PhD - AMR Fireside Chat
43:55
5
Episode 14 w/ Lynn Silver - AMR Fireside Chat
56:23
6
Episode 13 w/ Kevin Outterson - AMR Fireside Chat
30:01
7
Episode 12 w/ Tina Joshi, PhD - AMR Fireside Chat
34:22
8
Episode 11 w/ Martin Heidecker - AMR Fireside Chat
32:31
9
Episode 10 w/ Anna Govett - AMR Fireside Chat
14:54
10
Episode 9 w/ Fatema Rafiqi, PhD - AMR Fireside Chat
34:10
11
Episode 8 w/ Ghada Zoubiane, PhD - AMR Fireside Chat
35:04
12
Episode 7 w/ Trevor Lithgow, PhD - AMR Fireside Chat
35:41
13
AMR Snapshots: Episode 2 - John Rex (Editor-In-Chief, AMR.Solutions)
26:25
14
Episode 6 w/ Maryn McKenna - AMR Fireside Chat
45:50
15
Episode 5 w/ Christine Årdal - AMR Fireside Chat
43:44
16
Episode 4 w/ Peter Beyer - AMR Fireside Chat
39:21
17
Episode 3 w/ Kevin Outterson - AMR Fireside Chat
11:45
18
Episode 2 w/ Henry Skinner, PhD - AMR Fireside Chat
15:44
19
Episode 1 w/ Kevin Outterson - AMR Fireside Chat
52:56
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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Developing antibiotics for children: There are no easy answers
Aside: If you’ve enjoyed the prior discussions of movies to inspire antibiotic R&D and very apropos given the theme of today’s newsletter, please check out the ...
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New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
Dear All (and with thanks to Kevin Outterson for substantial help with this newsletter), On August 2, 2019, the US government agency that administrates Medicare & ...
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Push! Pull! Push! Pull! / Highlights from Davos 2018
Dear All: Three important documents were released at / during / around the World Economic Forum meeting that occurred this week in Davos. First and foremost, ...
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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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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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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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FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
Dear All (and with apologies … long note alert!): Yesterday’s AMDAC was very productive. For reference, all the materials are here and a reasonably detailed set of ...
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Mirror Bacteria: An AMR threat of unprecedented magnitude
Dear All (wonkish but stick with it … I’m going to try very hard to de-wonk it; addendum: see also the follow-up newsletter mentioned below), ...
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FDA workshop: Insights on inhaled antifungals and antibacterials
Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus ...
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Developing systemic & inhaled antibiotics for lung infections
Dear All: I missed it personally, but by all reports the session on 3 June 2017 at ASM Microbe entitled “Development of New Drugs and ...
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Scary, Scarier, Scariest (Part 2): What can YOU do about it?
Long note alert— apologies! Get a cup of coffee and settle in… Dear All: My 22 Apr 2019 note entitled Scary, Scarier, Scariest: Achaogen / FT ...
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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...