Y2020

In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): There’s been a lot of recent discussion about “lessons learned from COVID-19.” Indeed, there are many valuable points: global cooperation, preparedness, supply chains, and so forth. As an example, I note the 17 Sep 2020 communique from the G20 Health Ministers (link): it was heavily

Read More »

FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

Read More »

Timely guidelines, regularly updated: COVID-19, C. difficile, and beyond

Dear All, During the 18-19 Nov 2019 FDA-IDSA-NIAID-Pew workshop on ways to enhance antibacterial research (link), we spent some time discussing the slow pace of updates to most guidelines. With the notable exception of the rapid guidance updates used in the HCV community (link), most guidelines are updated infrequently and each update feels like a Herculean

Read More »

Treating resistant Gram-negatives: IDSA provides pragmatic expert advice

Dear All, IDSA (Infectious Diseases Society of America) have today released an eagerly awaited new guidance document on treating infections due to resistant Gram-negative bacteria (link). The thing that makes this document unusual is that it is an expert guidance rather than a formal guideline. Although there is value in formal guidelines that carefully review

Read More »

New antibiotics are not being registered or sold in Europe in a timely manner

Dear All (and with thanks to Kevin for leading the charge on this newsletter), While listening to last week’s BEAM-sponsored AMR Conference (really a wonderful conference, thank you Team BEAM, go here to listen to the sessions), we tumbled onto a really, really disturbing trend: New antibiotics are not being registered or sold in Europe in

Read More »
Scroll to Top