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
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
Long note alert— apologies! Get a cup of coffee and settle in… Dear All: My 22 Apr 2019 note entitled Scary, Scarier, Scariest: Achaogen / FT editorial / CBS “60 Minutes” on AMR (link) caused a number of you to write expressing your related concerns and frustrations. Many thanks for those thoughts! A core theme in those
Dear All (and with thanks to Kevin Outterson for substantial help with this newsletter), On August 2, 2019, the US government agency that administrates Medicare & Medicaid (CMS) announced several significant changes to hospital antibiotic reimbursement in US hospitals, effective October 1, 2019 (link to the very detailed Federal Register notice; go here for user-friendly summaries in Health
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
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 (wonkish alert: coffee up, settle in, and read the reports!), As you will recall, WHO’s most current pipeline review found that globally we do not have sufficient innovation as yet to address current or future needs (Butler et al. AAC 2022; see also this newsletter as well as the amr.solutions webpage summarizing pipeline reviews
Dear All (and with thanks to Kevin for co-authoring), The UK NHS England Pilot is known to us all as the first real attempt at an antibiotic subscription model and now it will be undergoing a major overhaul. In case you are a new reader or would like a refresher on the pilot, here are the links
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!) 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: Blog: “The World Needs New Antibiotics.
Dear All (wonkish alert … get your coffee!), EFPIA have recently released a report estimating the value of a Transferable Exclusivity Extension (TEE, report, press release) that provides new generalized insights into ways to think about the value of new antibiotics and the appropriate size of the Pull rewards needed to bring that new antibiotic
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