The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five
Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s
8 October 2018 No Comments
Wonkish
Push! Pull! Push! Pull! / Highlights from Davos 2018
Dear All: Three important documents were released at / during / around the World Economic Forum meeting that occurred this week in Davos. First and foremost,
23 January 2018 No Comments
Scary, Scarier, Scariest (Part 2): What can YOU do about it?
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
5 May 2019 No Comments
Modeling the value of an effective antibiotic — Megiddo et al.
Dear All: I have previously written about the challenge of applying health technology assessment (HTA) to estimate the monetary value of an effective antibiotic: To my knowledge,
17 February 2019 No Comments
Draft EMA antibacterial guidance: Analysis
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft
25 January 2019 No Comments
New mechanisms for antibiotic reimbursement in the United States: CMS’s IPPS FY2020 Final Rule
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 &
4 August 2019 No Comments
FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa
Dear All: FDA today hosted their eagerly awaited workshop on animal models in support of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae). It was a really
1 March 2017 No Comments
IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano
Dear All (long note alert … there’s a lot of material below my signature): Just published today is an IDSA White Paper entitled “Developing Antimicrobial
5 May 2017 No Comments
FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
Dear All (and with apologies … long note alert!): Yesterday’s AMDAC was very productive. For reference, all the materials are here and a reasonably detailed set of
13 April 2017 No Comments