R&D Insight

BARDA seeks information: Are you creating an antibiotic for Yersinia or other biothreat Gram-negatives?

Dear All, BARDA is interested in hearing from antibiotic developers about antibiotics which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP (post-exposure prophylaxis) of a biothreat indication, specifically: Y. pestis, F. tularensis, and/or B. pseudomallei. Here’s the core message from the pre-solicitation notice: Topline: “The U.S. Government

Read More »

Health Security underpins Economic Security: Fabulous webinar chaired by Dame Sally

Dear All, I want to call your attention to the replay available on YouTube of the excellent 24 Sep 2020 webinar entitled “The global movement of microorganisms:Tracking the spread of difficult-to-treat infections.” Chair by Dame Sally, this 90-minute webinar (link) had 4 global speakers: (Geneva) Hanan Balkhy, Assistant Director-General, World Health Organization (Addis Ababa) John Nkengasong,

Read More »

PASTEUR Act (re)introduced: A delinked Pull award advances in the US!

Dear All (with thanks to Kevin Outterson for leading this note), HUGE news today: Senator Michael F. Bennet and Senator Todd Young have introduced an updated PASTEUR Act that (if enacted) would create a predictable path to rewarding new #FireExtinguishersOfMedicine for their value to society via a subscription contract (valued at $750m to $3b) that prepays

Read More »

Help Alan Carr with a point survey on COVID-19 vaccines!

Dear All, Once again, we’re going to have a brief change from our usual programming with this newsletter. I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries:

Read More »

In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to

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 »

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). 8 Apr 2021 update: IDSA have published an updated version of this document. It excellent to see IDSA working steadily to provide up-to-the-minute advice! 24 Nov 2021 update: IDSA

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 »

EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges

Read More »
Scroll to Top