R&D Insight

7 Nov 2017 FDA VRBPAC: Clinical development plan for a S. aureus vaccine (Part 1 of 3)

Addendum: This is the first in a 3-newsletters series on this topic. Go here and here for the next two newsletters. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All:  I just learned that FDA’s Vaccines and Related Biological Products Committee (VRBPAC) will meet at

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7 Nov 2017 FDA VRBPAC: Pfizer’s S. aureus vaccine — do results in one population generalize? (Part 2 of 3)

Addendum: This is the second in a 3-newsletters series on this topic. Go here for the first newsletter and here for the final newsletter. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All:  I wrote on 19 Oct 2017 about the meeting on 7 Nov 2017

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Ouch! Pfizer terminates S. aureus vaccine trial due futility (Part 3 of 3)

Addendum: This is the third in a 3-newsletters series on this topic. I need to do a specific newsletter on the challenges of vaccines but for now this is the place where I am accumulating relevant papers. Go here and here for the prior newsletters.  5 Feb 2023 addendum: A GSK Staphylococcus aureus vaccine candidate (GSK3878858A) was reported

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FDA Antimicrobial Drugs Advisory Committee (AMDAC) on 26 Apr 2019: IM Bacitracin for staphylococcal pneumonia and empyema in infants?!

Addendum: This is the first of a series of newsletters on IM bacitracin. Go here for the next newsletter. Dear All: FDA has announced that on 26 April (8:30a-1:00p) it will have an Antimicrobial Drugs Advisory Committee to “… discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and

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