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AMR Roundtable: Optimism About CARB-X's Success And Prospects For The Future (Part 2)

 
• By Mandy Jackson

The Pink Sheet spoke with CEOs of Zavante and Amplyx as well as a BARDA official during a roundtable discussion at the recent BIO convention about incentives for antibiotic and antifungal drug development, including a lengthy discussion of the US BARDA's CARB-X accelerator, including ideas for expanding geographically and by product type.

Bacterias 3D rendering

The Biomedical Advanced Research and Development Authority (BARDA) is doing its part to combat the global problem of antimicrobial resistance (AMR) by incentivizing investments in new antibiotics, including funding through the drug development accelerator CARB-X.

Antimicrobial Incentives

The Pink Sheet spoke with BARDA's Acting Deputy Director Joe Larsen about CARB-X and other ways of providing incentives and...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges