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Antibiotic Pipeline Profile: Narrowing The Spectrum Of Drug Activity

 
• By Bridget Silverman

Development is most advanced in C. difficile infection, but US FDA's exploration of pathways to expedite single pathogen treatments could spur earlier-stage QIDP projects targeting Staphylococcus and Pseudomonas species.

3D illustration of Clostridium difficile bacteria. Bacteria which cause pseudomembraneous colitis and are associated with nosocomial antibiotic resistance

FDA's push to define a regulatory pathway that will encourage development of drugs for single pathogens could be good news for the handful of companies betting on the approach.

The agency is considering a flexible approach to single-species antibiotic development, in line with the agency's flexible position on orphan...

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More from Anti-infective

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.

Gilead Ready To Go After Hepatitis D Again

 
• By Joseph Haas

Following an FDA complete response in 2022, Gilead is getting ready to refile bulevirtide for hepatitis D. The drug already is approved in the EU, UK and elsewhere.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By Joseph Haas

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Chinese Vaccine Makers Turn To Emerging Markets

 
• By Dexter Jie Yan

Chinese producers of novel vaccines are increasingly pivoting to developing markets overseas in the face of a collapse in their domestic sales.

More from Therapy Areas

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 
• By Sushmita Panda

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 
• By Sushmita Panda

Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.

New Regenxbio DMD Data Support Gene Therapy Accelerated Approval

 
• By Joseph Haas

Regenxbio reported functional and biomarker data from an ongoing study of RGX-202, which it hopes to file for approval in Duchenne muscular dystrophy in 2026.