Pink Sheet is part of the Business Intelligence Division 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

R&D IN BRIEF

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Barr's adenovirus vaccines constitute its first biologics BLA: Barr's adenovirus types 4 and 7 live oral vaccines carry an FDA user fee date of July 31, 2009, making it the company's first in-house biologics to reach FDA review. Barr, through its Duramed subsidiary, entered into a multi-year agreement in 2001 to develop the vaccines for the U.S. Department of Defense. The vaccine product is administered as an oral enteric-coated tablet with an inner tablet core containing live adenovirus - type 4 or type 7 - surrounded by an outer tablet coat and a final enteric coat. The type 4 and type 7 vaccine tablets are taken together to prevent wild type 4 adenovirus-associated acute respiratory disease and to induce neutralizing antibody to type 7 adenovirus. The BLA is supported by a Phase III placebo-controlled study in more than 4,000 male and female Navy and Army recruits
Advertisement

Related Content

In Brief
Vivus’ Qnexa Works “Surprisingly” Well In Diabetes
R&D In Brief
Arena Will Move 5-HT2A Antagonist Into Phase III For Insomnia In 2008

Topics

Advertisement
UsernamePublicRestriction

Register

PS004012

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