R&D Insight

Final FDA LPAD guidance: Same substance, useful clarifications

Dear All, FDA have released the final version of their LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs, really should be LPPAAAD) guidance. You can get it here. I have generated a comparison with the Jul 2018 draft version that you can get here. As a reminder, the central concept of the LPPAAAD pathway

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Help Alan Carr with a point survey on COVID-19 vaccines!

Dear All, Once again, we’re going to have a brief change from our usual programming with this newsletter. I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries:

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Beyond the AMR Action Fund: PBS NewsHour and Things for us all to do!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), While we’re all thrilled with the announcement of the AMR Action Fund (newsletter), we’ve also had in parallel a demonstration of why the fund alone is insufficient to solve the antibiotic innovation crisis (newsletter on withdrawal of plazomicin’s marketing application in Europe). Thus, it’s

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CC4CARB solicitation is out (16 Mar 2020 deadline) / Superb WSJ podcast on antibiotic economics

Dear All, I wrote on 3 Jan 2020 (link) about the NIAID contract intended to establish an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). The formal solicitation has now gone live and can be found here. The deadline for applications is 16 Mar 2020. Get to it! In parallel, there is a superb Wall Street Journal podcast dated 13 Jan 2020 about

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Lancet series video tour / Japan’s 2021 PPL (Priority Pathogen List)

Dear All, As a follow-up to yesterday’s relatively wonkish newsletter, I thought I’d quickly point out two things that may not have been obvious and one fun sidenote. First, those Lancet papers on Sustainable Access to Antibiotics are exciting but also a lot to absorb! As an introduction, I’d encourage you to start with this

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48,015 → 0: Antibacterial discovery is hard. Really, really hard.

Dear All (and with thanks to Patricia Bradford for co-authoring this newsletter), When you are seeking novelty, antibacterial discovery is hard … really, really, REALLY hard. And it gets even harder if you want activity vs. Gram-negative bacteria. As the latest proof of this, a paper from GARDP’s Blasco et al. describing use of an

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