ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
Latest Newsletters
Dear All (wonkish ... but worth it ... get ready to follow the links!),Greetings in the new year! As a marvelous way to end the last year, the US FDA announced on 12 Dec 2025 its approval of two new oral therapies for gonorrhea, thus addressing the priority pathogen lists of both WHO (High priority) and CDC (Urgent) due to the rise in resistant infections. Achieving this has been a huge lift for reasons we'll discuss below. To get you started, here are the main links you need:The US labels for the two new drugsGepotidacin (Blujepa, developed by GSK)The pivotal Phase 3 study supporting approval is now published as Ross et al., The Lancet, https://doi.org/10.1016/S0140-6736(25)00628-2.Zoliflodacin (Nuzolvence, developed by Innoviva Specialty Therapeutics and GARDP)The pivotal Phase 3 study supporting approval is now published as Luckey et al., The Lancet, https://doi.org/10.1016/S0140-6736(25)01953-1Background materialsHook EW et al. Development of New Antimicrobials for Urogenital Gonorrhea Therapy: Clinical Trial Design Considerations. Clinical Infectious Diseases. 2020;70(7):1495–500, https://doi.org/10.1093/cid/ciz899. This is an excellent review of the challenges of developing new therapies for gonorrhea.23 April 2021 FDA workshop on developing drugs for gonorrhea. The superb materials from this workshop are readily available online at that link. You would find value in reviewing them all,...
Dear All, Regular readers will...
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...
Dear All (and with thanks...
R&D Insight
Dear All,Once again, we’re going to...
Dear All:Among various paradoxes that...
Dear All:I have learned that...
Dear All,Sharpen your pencils! The...
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...
Dear All (and with thanks to...
Dear All, Two items for...
Dear All, Three things today......
Dear All, Greetings from ECCMID...
Dear All,A key theme of...
Dear All,Following hard on the...
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
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 ...
Read More →
NIAID workshop: What is a robust PK-PD package?
Dear All: The ~150 of us who gathered in Washington yesterday and today for the NIAID’s PK-PD workshop enjoyed a very rich conversation. It’s really ...
Read More →
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 newsletters, most recently ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 ...
Read More →
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 2020 BEAM Alliance-sponsored AMR Conference ...
Read More →
What does an antibiotic cost to develop? What is it worth? How to afford it?
Dear All (long, wonkish note alert!): Today we have a 3-part discussion of cost and value with this summary 3-part message: Developing antibiotics is expensive, ...
Read More →
Assessing antibiotic value: DTR, fire extinguishers, and a view from Australia
Dear All (wonkish note alert — refresh your coffee before proceeding — with thanks to Kevin Outterson for co-authoring this note!), The intertwined questions of ...
Read More →
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 & ...
Read More →
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 ...
Read More →
FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about ...
Read More →
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...