Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)

Long and wonkish note alert — please refresh your coffee before you start reading!  Dear All: I was able to attend and speak at the 12 July 2019 Public Meeting organized by FDA on the LPAD (Limited Population Antibacterial and Antifungal Drug) pathway. The current draft guidance is here and the meeting agenda is found here. The meeting

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FDA workshop: Insights on inhaled antifungals and antibacterials

Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to

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Developing antibiotics for children: There are no easy answers

Aside: If you’ve enjoyed the prior discussions of movies to inspire antibiotic R&D and very apropos given the theme of today’s newsletter, please check out the newly released 4-minute YouTube discussion of a scene from Master and Commander in which antibiotics could have saved a young man’s arm! Dear All (Wonkish alert! There’s a lot of

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Impact of PASTEUR: 9.9m lives saved, ROI of 125:1

Dear All (and with thanks to Kevin Outterson for being lead author on this newsletter), (wonkish alert on this one … refresh your coffee and dig in!) The Center for Global Development have released a blog post and a paper estimating the potential impact of the PASTEUR Act. Here’s what you need: Blog: “The World Needs New Antibiotics.

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The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five

Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary:  The original

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