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

Panel Gives Mixed Reviews To Using Single Trial For Community-Acquired Pneumonia

Executive Summary

The Anti-Infective Drugs Advisory Committee's failure to agree on a preferred approval pathway for antibiotics to treat community-acquired bacterial pneumonia opens the door for FDA to offer several options to industry.

You may also be interested in...



Solithromycin Proves Safe, Makes Cempra A Deal Target

The antibiotic showed promising results in a late-stage study of the oral formulation, setting the company up as a potential target for acquirers and partnering opportunities – though for now it is signaling its intent to go it alone.

Mortality Vs. Clinical Cure: Telavancin Review Expected To Renew Debate On Nosocomial Pneumonia Endpoints

FDA’s Anti-Infective Drugs Advisory Committee will take up Theravance’s Vibativ NDA on Nov. 29 following two “complete response” letters and the sponsor’s rejected requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.

View From ICAAC: How Higher Prices Can Help Save Antibiotic R&D

At the annual anti-infectives meeting, experts consider revamping the business model to spur development of novel antibiotics, with cooperation of regulators in Europe and U.S.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053940

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