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

Targanta’s Oritavancin Gets FDA “Complete Response”; Additional Phase III Needed

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency requests Phase III study with MRSA subgroup: cost of additional study could lead company to seek development partner.

You may also be interested in...



Mirror, Mirror: Long-acting Antibiotics Dalbavancin, Oritavancin Emerging With Similar Profiles

Full results for Durata’s dalbavancin and The Medicine’s Co.’s oritavancin – both lipoglycopeptides – suggest the mode of administration is likely to become a key differentiating factor if the drugs are approved.

Oritavancin Phase III Results Support FDA’s New Endpoint, Sponsor Says

FDA’s new early endpoint for efficacy in ABSSSI had been criticized at the time it was released. But reporting positive results for a second Phase III study of oritavancin, The Medicines Co. CEO says the agency’s ABSSSI endpoints are “appropriate” for industry.

Oritavancin Phase III Results Support FDA’s New Endpoint, Sponsor Says

FDA’s new early endpoint for efficacy in ABSSSI had been criticized at the time it was released. But reporting positive results for a second Phase III study of oritavancin, The Medicines Co CEO says the agency’s ABSSSI endpoints are “appropriate” for industry.

Related Content

Topics

UsernamePublicRestriction

Register

PS067206

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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