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

Gliadel Wafer advisory committee

Executive Summary

Guilford's Gliadel Wafer will be reviewed by the Oncologic Drugs Advisory Committee on Dec. 4 for treatment of first-line malignant glioma. The ODAC panel was originally scheduled for the afternoon of Sept. 11, but was cancelled due to the terrorist attacks. The meeting will begin at 8 a.m. at the Holiday Inn in Bethesda, Md

You may also be interested in...



Anthra Bonefos advisory committee

Anthra's Bonefos (clodronate sodium) will be reviewed by FDA's Oncologic Drugs Advisory Committee on the afternoon of Dec. 4. Anthra is seeking approval for the bisphosphonate (NDA 21-326) in the reduction of skeletal complications of bone metastases in patients with breast cancer. The meeting will be held at the Holiday Inn in Silver Spring, Md. The oncology committee will consider Guilford's NDA (20-637/S-016) for Gliadel Wafer (polifeprosan 20/carmustine implant) for first-line malignant glioma in the morning (1"The Pink Sheet" Oct. 15, In Brief)

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Latest Headlines
See All
UsernamePublicRestriction

Register

PS038665

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