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

Theravance Could Face Prospect Of Another Trial For Vibativ In HAP

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Theravance could potentially have to conduct a new clinical trial to gain FDA approval for a nosocomial pneumonia indication for the firm's antibiotic Vibativ

You may also be interested in...



FDA's Pending HAP/VAP Guidance Could Further Dampen Antibiotic Drug Development

FDA's pending guidance on clinical trials for antibiotics to treat hospital- and ventilator-acquired pneumonia can't help but add a measure of stability to the uncertain regulatory environment in the field, but stakeholders fear that when the clouds part, the view will be of a very high bar.

FDA's Pending HAP/VAP Guidance Could Further Dampen Antibiotic Drug Development

FDA's pending guidance on clinical trials for antibiotics to treat hospital- and ventilator-acquired pneumonia can't help but add a measure of stability to the uncertain regulatory environment in the field, but stakeholders fear that when the clouds part, the view will be of a very high bar.

FDA Found Answer To Vibativ Dilemma Of Teratogenicity Vs. Microbial Resistance In REMS

A Risk Evaluation and Mitigation Strategy that addresses the teratogenicity of Theravance’s Vibativ enabled FDA to manage an internal disagreement that pitted the drug’s risk to the unborn against the public health need for new antibiotics.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS004386

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