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

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.

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

 

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.

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Brazil Pilots Digital Drug Pack Inserts

 

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

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CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 

One CDRH employee said the cuts already are having a major effect on morale.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.