Scrip is part 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

U.S. FDA Says Australian ChemGenex Needs Companion Diagnostic For Omapro

This article was originally published in PharmAsia News

Executive Summary

Australian-headquartered ChemGenex has agreed to meet with U.S. FDA in April to begin developing a validated assay test for determining which patients might benefit from its experimental chronic myeloid leukemia treatment Omapro.

You may also be interested in...



Australia's ChemGenex Reaches Agreement With U.S. FDA To Re-file Omapro NDA For Third-Line CML Treatment

PERTH, Australia - The chief executive officer of Melbourne-headquartered ChemGenex told investors and analysts July 14 that the company has reached agreement with U.S. FDA for a regulatory pathway forward of its Omapro (omacetaxine) new drug application for third-line treatment of chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors

Australia's ChemGenex Reaches Agreement With U.S. FDA To Re-file Omapro NDA For Third-Line CML Treatment

PERTH, Australia - The chief executive officer of Melbourne-headquartered ChemGenex told investors and analysts July 14 that the company has reached agreement with U.S. FDA for a regulatory pathway forward of its Omapro (omacetaxine) new drug application for third-line treatment of chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors

Australian ChemGenex Readies Omapro For Second NDA Despite U.S. FDA Setbacks

PERTH, Australia - Australian-headquartered ChemGenex has completed pivotal trials for Omapro for third-line treatment for chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors; the company expects to file its application with U.S. FDA while its NDA for second-line treatment for CML in patients with the Brc-Abl T315I is still under review

Related Content

UsernamePublicRestriction

Register

SC074368

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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