Dear All (wonkish note alert … top-up your coffee and settle in!), Today we have a tour of a recent paper in Clinical Infectious Diseases in which FDA presents a very instructive analysis of endpoints used in recent CABP (Community-Acquired Bacterial Pneumonia) trials and how data such as these might permit further convergence of global
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
Dear All (wonkish note alert — refresh your coffee before proceeding — with thanks to Kevin Outterson for co-authoring this note!), The intertwined questions of (i) the cost to develop a new antibiotic and (ii) how much we should pay for such a new antibiotic have been an increasingly frequent newsletter topic, with a real
Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about FDA’s planned workshop on animal models to support antibacterial development and I was able to listen to the workshop via webcast. As brief context (and please be sure to look
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, Not having antibiotics is even more expensive, and We have to solve this! First, what does it cost to bring a new antibiotic to market? To start us off, we
This newsletter is part of a series — here are the links to Part 1, (this one is Part 2), Part 3, Part 4, and Part 5. Also relevant is the 5 April 2024 newsletter entitled “48,015 → 0: Antibacterial Discovery Is Hard. Really, Really Hard.“ Dear All (wonkish note alert!), The recent newsletter on chemicals, drugs, and halicin (link, see
Note: See also these related newsletters: 13 Jan 2019 on DTR as part of the language of resistance, 7 Jun 2020 on using DTR to estimate antibiotic value, and 25 Apr 2025 on evolving the idea of DTR to include antibiotic access. There is also a 5-minute DTR explainer on YouTube that you might find useful.
Dear All (wonk-ish note alert and also with particular thanks as always to Kevin Outterson for helping to refine this newsletter): Sparked at least in part by the innovation metrics in recent pipeline analyses (specifically, the ideas of No Cross-Resistance, New Chemical Class, New Target, and New Mechanism of Action) used in the 2018 pipeline
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 / around the Davos 2020 World Economic Forum. A brief summary follows, with some supplemental details below my signature. Access to Medicine Foundation (ATMF) released their 2nd scorecard on industry
Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just before the end of 2019 (link). Formerly known as Rib-X (link), Melinta went public in 2017 through a reverse merger with Cempra (link); and via a series of deals had four