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Entasis Therapeutics Holdings Inc.

https://www.entasistx.com/

Latest From Entasis Therapeutics Holdings Inc.

Antibiotics With Bacteria-Specific, Rather Than Site-Specific, Indication Headed To US FDA

Entasis is seeking a pathogen-specific approval for its antibiotic/beta lactamase inhibitor candidate rather than an indication specific the site of an infection. Achaogen’s earlier failure to do the same may have helped set a path.

Infectious Diseases Review Pathway

Entasis Anticipates First FDA Approval Of Pathogen-Specific Antibacterial

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

Clinical Trials Drug Approval Standards

US FDA Revisits Gonorrhea Drug Development As Fast-Emerging Resistance, Preclinical Challenges Hold Back New Products

From animal models to non-inferiority margins, US FDA is seeking new perspectives on gonorrhea R&D, including how to incorporate extragenital infections into clinical programs.

Research & Development Clinical Trials

Public/Private Partnerships Keep Gonorrhea Drug Development Alive

Only two new antibiotics are in Phase III trials for gonorrhea: Entasis’ zoliflodacin, in collaboration with the Global Antibiotic R&D Partnership, and GlaxoSmithKline’s gepotidacin in partnership with the US Biomedical Advanced R&D Authority.

Drug Approval Standards Research & Development
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