For Media Queries Contact Joan Lawson at 720-726-7604
Our New Site is Coming Soon!
Our entire site is coming soon but in the interim here’s some brief information about who we are and what we do.
We're Your Pharma, Biotech and Device Partner - Experts in Regulatory Strategy,
Clinical, CMC and Strategic Program Development
CBR is committed to providing clients with both strategic
and technical consulting in the areas of FDA representation,
strategic program development, clinical program development,
process development and quality assurance oversight. We have been responsible
for the approval of numerous drugs and biologics in the US since 2002.
07-Jan 15, 4:00 PM EST - The ODAC advisory committee unanimously recommended approval
for the first biosimilar in the U.S., filgrastim (Zarxio), by Sandoz. The vote was 14-0 on the following question: Question 3 – Does the committee agree
that based on the totality of the evidence, EP2006 should receive licensure
for each of the 5 indications for which US-licensed Neupogen is currently
CBR was able to listen to the entire committee proceedings and would be
delighted to share information for those who were not able to log-in.