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

Inex/Enzon Marqibo to ODAC

Executive Summary

FDA's Oncologic Drug Products Advisory Committee will review Inex/Enzon's liposomal vincristine formulation Marqibo (formerly Onco TCS) Dec. 1, firms announce. Sponsors seek third-line monotherapy indication for treatment of relapsed aggressive non-Hodgkin's lymphoma. FDA lists Dec. 1 and 2 as tentative ODAC meeting dates. [Editor's Note: For more information, visit 1FDAAdvisoryCommittee.com]...

You may also be interested in...



Berlex Bonefos review

FDA's Oncologic Drugs Advisory Committee will discuss Berlex' NDA (21-776) for Bonefos (clodronate) as an adjuvant treatment for the reduction of occurrence of bone metastases in Stage II/III breast cancer patients on Dec. 2. Bonefos has an estimated user fee deadline of March 9, 2005. The committee will also review Ilex/Enzon's liposomal vincristine formulation Marqibo NDA (21-600) for relapsed aggressive non-Hodgkin's lymphoma and Ilex' Clolar (clofarabine) NDA (21-673) for pediatric patients (1-21 years) with refractory or relapsed acute leukemias on Dec. 1 (1"The Pink Sheet" Oct. 4, 2004, In Brief). The meeting will be held at the Holiday Inn in Silver Spring, Md. beginning at 8 a.m. on Dec. 1 and 8:30 a.m. on Dec. 2. [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...

Metsera Launches As New Obesity Contender Flush With $290m

Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture. 

Deal Watch: AbbVie Teams With MedinCell On Long-Acting Injectables

Collaboration Edition: Including deals involving Evotec/Variant, Sanofi/IGM/Nurix, ABVC/OncoX and Harmony/Bioprojet, along with tech transfer agreements and deals in brief.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS044765

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