R&D Insight

Non-traditional antibiotics: A pipeline review and an analysis of key development challenges

Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently

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Two new oral drugs for gonorrhea!

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

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Natural product-inspired antibiotics: 1943-2025

Dear All, In a paper that is clearly a labor of love (1,032 references!), Mark Butler and Robert Capon have summarized the history of 217 natural product-inspired antibiotics across 16 classes from penicillin to fidaxomicin! Here are the links you need: Butler MS, Capon RJ. Natural product inspired antibiotics approved for human use – 1943

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Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat

Dear All, Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.” Hence, CARB-X has

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FDA AdComm #2 on inhaled ciprofloxacin (11 Jan 2018); IMI Call for AMR diagnostics (28 Feb 2018 deadline)

Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018  (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3

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CARB-X Novel Chemistry for AMR Challenge

Dear All, Happy New Year! As a great start for January, Team CARB-X have announced (i) that they will have two funding calls during 2026 (April and then Q4) and (ii) that a theme focused on finding new chemical scaffolds will be part of both calls. Applications to these target-based therapeutics funding calls will require defined chemistry

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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 dig in!) Bonnifield and Towse of the Center for Global Development have released a blog post and a paper estimating the potential impact of the PASTEUR Act. Here’s what you need:

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Extending STEDI to diagnostics: STRIDES

Dear All (and with thanks to Betsy Trainor for co-authoring), The idea of the STEDI values of an antibiotic (its fire extinguisher-like values) comes up often. As a reminder, the STEDI values are Spectrum, Transmission, Enablement, Diversity, and Insurance. As a good example, consider Enablement: knowing that an antibiotic exists as a backup makes safe

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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 which FDA analyzes trends in antibacterial development from 1980-2019. To fully appreciate this paper, you need to look both at it and three other papers: FDA’s paper (https://doi.org/10.1093/cid/ciaa859): Dheman N, Mahoney N, Cox EM, Farley

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Antibacterial R&D is very hard! Two great pipeline reviews + an Industry-level view

Dear All (and with thanks to Stephan Harbarth for co-authoring this newsletter), A new review by Ursula Theuretzbacher and colleagues from GARDP provides an opportunity to (i) discuss the preclinical antibacterial pipeline (the new paper), (ii) remind you of a recent review of the Gram-negative clinical pipeline, and (iii) share an excellent Industry-level perspective on

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