R&D Insight

Non-traditional antibiotics: A pipeline review and an analysis of key development challenges

Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently

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Clever pipeline visualization from Pew + New guidance documents from FDA

Dear All, Two very brief notes today… First, Pew Trusts continues to work to provide ways to understand the antibiotic pipeline. Building on their ongoing surveys (link), their latest contribution is a clever visualization tool that shows how antibiotics have moved forwards, backwards, and/or stopped during the period 2014-2018. Go here to see it in action and prepare to

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18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

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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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Melinta goes bankrupt / Never let a good crisis go to waste

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

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WHO Collaborating Centres for AMR: A rapidly growing group!

Dear All, I recently learned about the designation of Stanford as a WHO Collaborating Centre (WHOCC) for AMR and Stewardship. This caused me to dig a bit more into the way that WHO has created a global network of Collaborating Centres. WHOCC designation represents a sustained and productive collaboration with WHO (link). As an example, Stanford’s

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Colistin is nephrotoxic / Antibiotic stewardship knowledge gaps / Fire extinguisher video

Dear All, To start your week, we have three tidbits for consideration. First, results from a trial entitled “Colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia (Magic Bullet study): an investigator-driven, open-label, randomized, noninferiority controlled trial” have been published (Critical Care 23:383, 2019, link). Cisneros et al. sought to enroll 496 subjects into this trial but

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Ouch! Pfizer terminates S. aureus vaccine trial due futility

Addendum: This is the third in a 3-newsletters series on this topic. Go here and here for the prior newsletters. Dear All: Per a press release today: Pfizer Inc. (NYSE:PFE) announced today that the Phase 2b trial STRIVE (STaphylococcus aureus SuRgical Inpatient Vaccine Efficacy) evaluating the company’s investigational Staphylococcus aureus (S. aureus) multi-antigen vaccine (PF-06290510) is being discontinued due to futility.

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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 antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the

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