John Rex

Transferable exclusivity vouchers (TEV) in EU: Coming soon!

Dear All: EMA today hosted an exciting stakeholder webinar in which they gave a heads-up on the work they have done to create concrete requirements for the upcoming TEVs (TDEVs, Transferrable Data Exclusivity Vouchers) for novel antibacterial agents. The recording and slides from the webinar will be released soon (within a few days, we were

Read More »

Standardized panels of highly resistant bacteria: New resource from PACE and UKHSA

Dear All: As a way to pressure test your candidate compounds, PACE (Pathways to Antimicrobial Clinical Efficacy) and UKHSA (the UK Health Security Agency) have collaborated to release five new contemporary antimicrobial resistance (AMR) strain panels: The five panels contain 145 bacterial strains isolated within the last five years. Available organisms cover the priority Gram-negative

Read More »

Global Review of Pull Incentives / PASTEUR Sign-On Letter

Dear All: We need to make Pull incentives work! On this theme, our first topic for today is an opportunity for organizations to sign a letter of support for PASTEUR. This letter is co-led by the AMR Action Fund, BIO, Cystic Fibrosis Foundation, Infectious Diseases Society of America and Partnership to Fight Infectious Diseases. Here

Read More »

CARB-X: 2nd 2026 application call; 5x impact of CARB-X funding!

Dear All: CARB-X have just announced their 2nd 2026 call for applications. There are 4 thematic areas for your proposals: Direct-acting therapeutics for infections caused by Gram-negative bacteria “Proposals must target the development of agents for the treatment of Gram-negative priority pathogens” (see our Bugs & Drugs page). Novel Chemistry for AMR Challenge: target-based therapeutics

Read More »

#AMRSOS! The (human) cost of AMR: Data from 19 countries in Asia

Dear All: Significantly strengthening our database documenting the human cost of AMR, we now have an impressive survey of mortality associated with severe infections in 19 Asian countries during the period Sep 2022 to Feb 2025. Here are the links you need: (the primary paper): Mo Y, Hao X, Ding Y et al. Severe health-care-associated

Read More »

Milken webinar: Innovative financing models for antimicrobials

Note: I’ve been away on holiday (see the newsletter’s postscript) and so there are multiple new items in both the meetings calendar and the list of funding opportunities: TB! PACCARB! Funding for antifungals! Funding for R&D in India! Look closely!  Dear All: The AMR Multi-Stakeholder Partnership Platform (AMR MSPP) collaborated with the Milken Institute on

Read More »

AWaRe antibiotic usage – Is 70% Access a good target?

Dear All: An important and instructive analysis of optimal global antibiotic usage targets has just been published in Lancet Public Health. To follow the plot, here are the links you need: The new paper: Cook et al.: “Benchmarking AWaRe: estimating optimal levels of AWaRe antibiotic use in 186 countries, territories and areas based on clinical

Read More »

WHO: Virtual discussion on challenges of evidence generation

Dear All: WHO have announced a very interesting 2-h virtual dialogue on optimal evidence generation across the antibiotic R&D lifecycle! Here are the details you need:  When: 31 Aug 2026 (virtual, 2-4p CET):  What: A dialogue on challenges such as fragmented regulatory requirements, trade-offs in clinical trial design, and gaps between evidence generated for regulatory

Read More »

FDA guidance on Substantial Effectiveness; EMA concept paper on Evaluation of Antifungal Agents): Comments sought!

Dear All: Both FDA and EMA have very recently released important documents for comment. See below the links and commentary on the two documents. == FDA: The Substantial Evidence guidance, further updated: Comments due 22 Sep 2026 ==FDA have released a further revision of their Dec 2019 draft guidance entitled “Demonstrating Substantial Evidence of Effectiveness

Read More »
Scroll to Top