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

Antibiotic Development: Where Wall Street Guidance Is Watching FDA Guidances

This article was originally published in RPM Report

Executive Summary

FDA’s effort to create a clearer path for antibiotic development has produced a series of new guidance documents. Those guidances are making some products in development look well-positioned for regulatory review, and rekindling the interest on Wall Street in specialty antibiotic firms.

You may also be interested in...



GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D

In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?

Fair is Fair; But Science is Science

Theravance’s proposed new indication for Vibativ is not the first drug to fail because of evolving regulatory standards. It may, however, have provoked the clearest and most formal articulation of FDA’s views on the limits of “fairness” regarding drug development commitments when it comes to approval decisions.

FDA Continues To Clarify Antibiotic Requirements With New Guidance On Complicated UTI

A non-inferiority trial with a pre-specified non-inferiority margin is the most likely design for investigational antibacterial drugs targeted at cUTI, according to FDA draft guidance. Primary efficacy endpoint needs to include resolution of symptoms, on top of microbiological success.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080804

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