Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Antibacterial Drugs: FDA Panel To Explore Approval Path For Single-Species Agents

Executive Summary

US agency’s advisory committee will weigh the pros and cons of five possible development and regulatory pathways, with a specific focus on animal models.

You may also be interested in...



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.

Four Early-Stage Antibacterial Drugs To Watch: Highlights From IDWeek

Promising drugs from Tetraphase, ContraFect, Spero and Entasis get a platform at the Infectious Diseases Society of America’s IDWeek.

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120414

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel