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

Dalbavancin Delay: Pfizer Pulls NDA To Conduct Extra Phase III Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

Antibiotic study will take 18 months to complete, Pfizer says.

You may also be interested in...



Dalvance Protocol Accord With FDA + Actavis Marketing = Home Run?

With a Special Protocol Agreement and an experienced sales team lined up, all the firm has to do now is get hospitals excited about an expensive antibiotic in a highly-genericized market.

Dalvance Approval Is Durata’s GAIN: First Test Of FDA’s Antibiotics Incentives

Durata has honor of having first drug approved under Qualified Infectious Disease Product designation and gains the benefits of an added five years of market exclusivity.

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS142970

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