Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Theravance telavancin NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Theravance submits telavancin for treatment of complicated skin and skin structure infections. The South San Francisco biopharmaceutical company is requesting a priority review for the injectable lipoglycopeptide antibiotic, giving it an estimated user fee date of June 7. The NDA is based on the firm's ATLAS I and ATLAS II trials, which Theravance says were "the largest clinical program ever" in CSSSIs. The company is collaborating with Astellas on development and commercialization of telavancin...

You may also be interested in...



Astellas’ Potential Zelnorm Competitor Ramosetron Poised For Phase III Trials

Astellas Pharmaceuticals could enter U.S. Phase III studies with its diarrhea-predominant irritable bowel syndrome agent YM060 (ramosetron) as soon as the first half of 2008, Executive VP Toshinari Tamura told analysts during a third quarter earnings call Feb. 1

Teva And Hikma Plan Long-Term Environmental Commitments

Teva has disclosed plans to focus on climate action and resilience, responsible use of natural resources and emissions, effluents and waste, as part of a long-term environmental sustainability commitment. Meanwhile, Hikma has at the same time committed “to further reducing our climate impact and improving the resilience of our business in the face of future climate change.”

Kite Strikes CAR-T Access & Discount Deal For Tecartus In England

Health technology assessment body NICE wants Kite to collect more evidence to prove that Tecartus can cure relapsed or refractory mantle cell lymphoma. But in the meantime, it says the CAR-T therapy should be made available on the National Health Service, making UK patients among the first in the world to be offered access to the treatment.

Topics

UsernamePublicRestriction

Register

OM017175

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