Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature), FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here.
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
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
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
Addendum: This is the third in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the 4th and final newsletter. Aside: I can’t comment on it in detail today, but do note that IACG (Interagency Coordination Group on AMR) have just released their final report to the UN Secretary
Addendum: This is the second in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the next newsletter. Dear All: Two somewhat overlapping ideas at the start of the week: First, FDA today announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations
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
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
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
Heads-up … numerous changes in the meeting calendar: Lots of new events as well as rescheduling of previously announced events. Dear All, A busy start to the week! First, I’ve received notes expressing concern regarding news that Glaxo is trying to find a buyer for (some of) its antibiotics. With all the angst about the