Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Genentech Asks A Lot From Avastin Hearing

This article was originally published in The Pink Sheet Daily

Executive Summary

The Avastin sponsor and FDA each submit their understandings of the central questions to be resolved at the June hearing on CDER's proposal to withdraw the breast cancer indication for bevacizumab.

You may also be interested in...



Roche Succeeds In Changing EMA Ruling On Avastin

The Committee for Medicinal Products for Human Use has reversed its previous rejection and is granting an indication for treatment of first-line breast cancer in combination with capecitabine.

Roche Succeeds In Changing EMA Ruling On Avastin

The Committee for Medicinal Products for Human Use has reversed its previous rejection and is granting an indication for treatment of first-line breast cancer in combination with capecitabine.

Genentech, CDER Tussle Over Avastin Hearing Panel And Format

In a sign of the uphill battle Genentech faces in retaining Avastin’s breast cancer claim, the company’s efforts to shape the panel and format for a June 28-29 hearing on the indication’s withdrawal are encountering strong opposition from FDA’s Center for Drug Evaluation & Research.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS072091

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