R&D Insight

Novo REPAIR Impact Fund: Global call is open through 31 July 2020

Dear All, Sharpen your pencils! The Novo REPAIR Impact Fund has just opened its 2020 call for proposals. The focus is on: Pathogens: from the high-priority list of the World Health Organization and the United States Centers for Disease Control and Prevention Therapies: first-in-class therapies have priority Modalities: small molecules, biologics and new modalities Phases: from the

Read More »

COVID-19 and bacterial infections / New webinars and meeting updates

Dear All: Three brief items for you today.  First up: Perhaps like many of you, I’ve been wondering whether or not COVID-19 and bacterial resistance would begin to cross paths in some fashion. I can’t think of a reason why COVID-19 would directly cause resistance, but use of antibiotics becomes pretty common after you’ve been

Read More »

Melinta goes bankrupt / Never let a good crisis go to waste

Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just before the end of 2019 (link). Formerly known as Rib-X (link), Melinta went public in 2017 through a reverse merger with Cempra (link); and via a series of deals had four

Read More »

Vaccines for AMR / A major review of R&D opportunities

Dear All: Just released is a substantial report commissioned by Wellcome Trust entitled “Vaccines to tackle drug-resistant infections: An evaluation of R&D opportunities.” The full .pdf is here. The associated website is worth exploring. In particular, there is an interactive tool that allows you to explore the parameters used to calculate relative priorities. As you probably already know, vaccines are an important

Read More »

Help update the WHO clinical antibacterial pipeline analysis

Dear All: As you know, WHO produced a pipeline update with a cut-off date of 1 July 2018. It’s now published both as a manuscript (Theuretzbacher et al. Lancet ID 2018, link) and a set of summary tables (link). Team WHO would like to update this analysis with a cut-off date of 1 Aug 2019. They

Read More »

WHO Pipeline review / Roadmap for susceptibility testing developers

Dear All: Two useful papers have just been released — see titles and abstracts below my signature. Both are Open Access so please do download & read! And just for full disclosure, know that I’m a co-author on both. First, a working group organized by WHO has produced a comprehensive review of the clinical antimicrobial pipeline for both

Read More »

Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance

Dear All: Along with our co-authors (Mark Goldberger, Barry Eisenstein, Roger Echols, John Tomayko, Mike Dudley, and Aaron Dane), George Talbot and I delighted to be able to share the attached manuscript which was released online yesterday at Clinical Infectious Diseases (link for online access & the abstract are below my signature). We are also sharing this brief slide set summarizing the

Read More »

Summary of funding initiatives (Simpkin et al.) + E9(R1) Statistical methods update (FDA)

Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As

Read More »

REVAMP, a pull incentive in the US: Time to make it happen!

Dear All: I previously wrote about the nascent REVAMP legislation that would create a Pull incentive in the US market. With everybody back from the July 4th holiday, the goal for this week is to get REVAMP into position to be offered as an amendment at the House Energy & Commerce Committee’s PAHPA mark-up (expected next week).

Read More »

Heads-up on REVAMP, a credible Pull incentive for the US!

Dear All: Incredibly exciting news! Due to the bipartisan efforts of Representatives John Shimkus (R-IL) and Tony Cardenas (D-CA), the Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 is now being introduced. This is the Pull incentive that we’ve been looking for in the US! The very short summary is that REVAMP (a) creates a new “priority antimicrobial product” category, (b) grants

Read More »
Scroll to Top