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

 
• By Joseph Haas

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.

PS2110_Acinetobacter Baumannii_1200-BDGNT6 (Alamy)
Up close, Acinetobacter Baumannii may not look it much, but developing treatments has taken a lot of industry-regulator collaboration. • Source: Alamy

Entasis Therapeutics Holdings Inc. hopes to be the first company to obtain a pathogen-specific indication from the US Food and Drug Administration with a broad claim for its antibacterial combination product SUL-DUR to treat carbapenem-resistant Acinetobacterbaumannii infections, and it is relying on the agency’s flexibility regarding challenging disease areas with unmet medical need to get that done.

For its combination of the generic polymyxin antibiotic sulbactam with its novel beta-lactamase inhibitor durlobactam (SUL-DUR), the AstraZeneca PLC...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

House Gives US FDA More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.