R&D Insight

WHO wants your input on its draft TPPs for needed antibacterial agents

Dear All, WHO has developed a set of draft TPPs (target product profiles) for needed new antibiotics. As part of the process, they are now opening a public consultation. Here is the essential text from their announcement: “The World Health organization (WHO) is developing target products profiles (TPPs) for needed antibacterial agents, providing the public

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Looking forward: The global pre-clinical antibacterial pipeline / How will we care for these precious jewels?

​Dear All, Long note alert! There are two deep and deeply connected topics to share today. Refresh your coffee and settle in… Today’s first topic: Adding to the recent reviews of the clinical stage pipeline for both traditional products (link to the Sep 2019 Pew Charitable Trusts summary), and non-traditional products (link to an Aug 2019 newsletter summarizing

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Two things: WHO’s looking GLASS + FDA’s advances with PDUFA VI

Dear All: Two things today. Unrelated, but both relevant! WHO’s GLASS: WHO’s Global Antimicrobial Resistance Surveillance System (GLASS) was created during October 2015 and seeks to obtain coordinated and consistent global estimates on resistance rates. In a major report released on 29 Jan 2018, GLASS now provides provides official national AMR data for the period 2016-17 from 40 countries

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WHO 2019 Review of the Preclinical and Clinical Antibacterial Pipeline

(15 Apr 2021 update: WHO have today released a 2020 update to the report discussed in this newsletter.) Dear All, WHO has today released two exhaustive reviews of the antibacterial R&D universe (and by way of full disclosure, let me say upfront that I participated in the clinical pipeline discussion). Based on a cut-off date

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Young people and AMR: A global summit! A video game!

Dear All, Today we have two hopeful signs from our younger colleagues about the future of AMR! First Global AMR Youth SummitThe World Health Students’ Alliance (WHSA) has announced a 3-day virtual event (20-22 Nov 2020, see details below) where “youth around the world come together to discuss, learn, and get empowered about various AMR-related

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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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Chemicals vs. drugs (Part 1): The end of bacitracin / the buzz around halicin

This newsletter has a follow-up here. Dear All, Today’s theme is a 2-part journey that could be subtitled “Many are called, but few are chosen,” or “It’s easy to kill bacteria — steam, fire, and bleach are consistently effective — but those aren’t drugs!” Our first stop is with a very old compound, bacitracin. Approved in 1948

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21st Century Cures v2.0 — PASTEUR Act is embedded!

Dear All, Building on the success of the 21st Century Cures Act passed in 2016 and springboarding from a concept paper published in Science, U.S. Reps. Diana DeGette, D-Colorado, and Fred Upton, R-Michigan, have today introduced the 21st Century Cures Act v2.0! Here are the links you need: Discussion draft of the Cures 2.0 bill Cures 2.0

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