Omapro News and Research

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Lessons on the journey to commercialisation

One of the Asia Pacific region’s best known biotech leaders, Dr Greg Collier, says successful commercialisation of a new drug or therapy takes, “discipline, a strong set of nerves and a stroke of luck.”

28 Sep 2012

Cephalon intends to make takeover bid for ChemGenex

Cephalon, Inc. and ChemGenex Pharmaceuticals Limited today jointly announced that Cephalon's wholly-owned subsidiary, Cephalon CXS Holdings Pty Ltd, intends to make a takeover bid for ChemGenex.

29 Mar 2011

ChemGenex agrees with FDA on potential regulatory path to progress OMAPRO for CML

ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress OMAPRO™ (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).

14 Jul 2010

ChemGenex reports positive safety findings from two OMAPRO clinical trials at ASCO 2010

ChemGenex Pharmaceuticals Limited announced that positive safety findings from a combined analysis of two clinical trials for its lead product candidate, OMAPRO™ (omacetaxine mepesuccinate), were presented today during a poster discussion session at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

7 Jun 2010

FDA issues complete response letter regarding the NDA for OMAPRO

ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration's Office of Oncology Drug Products has issued a complete response letter regarding the new drug application for OMAPRO for the treatment of adults with chronic myeloid leukemia who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.

12 Apr 2010

ChemGenex shares falter as FDA requests more data on new leukemia drug

ChemGenex Pharmaceuticals Ltd. Shares fell most in the last 16 years to AUD$0.44 following a concern raised by the US drug regulators – US FDA. The FDA requested on Monday for more uniform clinical test data before they review and consider approval of the company’s new leukemia drug.

23 Mar 2010

FDA's ODAC voted to review T315I mutation prior to approval of OMAPRO

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee voted 7-1 that a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of OMAPRO™ (omacetaxine mepesuccinate).

23 Mar 2010

ChemGenex Pharmaceuticals' OMAPRO review: FDA reschedules ODAC meeting to 22 March, 2010

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting to 22 March 2010.

1 Mar 2010

ODAC to conduct public advisory meeting to review ChemGenex Pharmaceuticals’ NDA for Omapro

ChemGenex Pharmaceuticals Limited announced today the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) will conduct a public advisory meeting on 10 February 2010 to review the Company’s NDA for Omapro™ (omacetaxine mepesuccinate) for injection.

17 Dec 2009

ChemGenex Pharmaceuticals presents clinical results of Omapro drug at ASH meeting

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today updated clinical data showing that Omapro™ (omacetaxine mepesuccinate) produced durable hematologic and cytogenetic responses in chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

7 Dec 2009

ChemGenex Pharmaceuticals to present updated clinical data from its clinical trials with Omapro

ChemGenex Pharmaceuticals Limited announced today that updated clinical data from several of its clinical trials with Omapro™ (omacetaxine mepesuccinate) will be presented at the upcoming 51st American Society of Hematology Annual Meeting in New Orleans, Louisiana.

1 Dec 2009

EMEA determines MAA for omacetaxine mepesuccinate for treatment of CML patients

ChemGenex Pharmaceuticals Limited announced today that the European Medicines Agency ("EMEA") has determined that the Marketing Authorization Application ("MAA") for omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia (CML) patients who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation is valid.

28 Nov 2009

FDA accepts ChemGenex Pharmaceuticals' NDA for Omapro

ChemGenex Pharmaceuticals Limited announced today that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Omapro™ (omacetaxine mepesuccinate) for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

10 Nov 2009

Chemgenex completes NDA submission for its omacetaxine mepesuccinate to the FDA

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for OMAPRO™ (omacetaxine mepesuccinate). OMAPRO™ is being developed for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation.

9 Sep 2009