R&D Insight

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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WHO 2020 preclinical antibacterial pipeline data call

Dear All:  As you will hopefully recall from November 2019, Theuretzbacher et al. published a review of the preclinical pipeline that summarized data on 407 companies active in the preclinical R&D space during the window Sep 2016 through 1 May 2019. Go here for the newsletter about that paper and go here for my master summary

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4-7 Sep 2018: ESCMID-ASM Conference #3 on AMR (initial flyer)

Dear All: Now available is the initial flyer for next year’s ESCMID-ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This third meeting will be 4-7 Sep 2018 in Lisbon and will follow the prior (and excellent!) meetings #1 (Vienna, 2016) and #2 (Boston, 2017). Although you can’t register for it yet (and I’ll let you know as soon

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Lessons in Discovery from Lynn Silver + Pro-con on alternatives to antibiotics

Dear All: “Good decisions come from experience, and experience comes from bad decisions … and paying attention.” You’ve probably heard the first part of that before, but the “… and paying attention” is my addition and reflection upon reading Lynn Silver’s most recent commentary in the Springer Series Topics in Medicinal Chemistry, edited by Jed Fisher, Marvin

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International Course on Antibiotics and Resistance ICARe, 11-19 Nov 2017

Dear All: FYI, see below an announcement of an 8-day intensive course in Paris in November 2017: “ICARe is designed for early career scientists – assistant professors, new industry scientists, MDs, and postdoctoral research associates – as well as members from developing areas contending with the practical challenge of managing the antibiotic resistance problem with

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Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,

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Workshop on TB drugs: Lessons for the antibacterial community

Dear All: ​I listened with interest to the 19 July 2017 FDA Workshop entitled “Development of New Tuberculosis Treatment Regimens– Scientific and Clinical Trial Design Considerations.” Most of the materials from the meeting are available online (see link below my signature).  I was interested in this workshop both because I want to see new TB

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Final FDA Unmet Need Guidance!

Dear All:  Just out in the last 24h is the announcement that FDA’s 2013 Unmet Need Guidance has now been released in final form. The associated FR guidance is also worth reading as it provides a summary of what has been updated: “This guidance finalizes the draft guidance of the same name issued July 2, 2013 (78 FR

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