Article: Questions and answers on the withdrawal of the marketing authorisation for Ixempra (ixabepilone).

Article: CHMP denies B-MS and Santhera drugs.
Pharma Marketletter;  December 1, 2008 ;     576 words ... ... Medicinal Products for Human Use (CHMP) adopted a negative opinion for Bristol-Myers Squibb's Ixempra (ixapebilone) and confirmed its previous ... capecitabine or as monotherapy. The CHMP said it is concerned that the "very ...

Article: B-MS withdraws Ixempra MAA.
Pharma Marketletter;  March 30, 2009 ;     434 words ... ... marketing authorization for Ixempra (ixabepilone), 2mg/ml powder ... Medicinal Products for Human Use (CHMP) adopted a negative opinion ... which was under review by the CHMP at the time of the withdrawal ... information about the withdrawal of Ixempra will be made available in a ...

Article: FDA Approves Ixempra for Advanced Breast Cancer Patients.
M2 Presswire;  October 23, 2007 ;     700+ words ... ... and Drug Administration: FDA Approves Ixempra for Advanced Breast Cancer Patients ... Food and Drug Administration has approved Ixempra (ixabepilone), a new anti-cancer ... other cancer drugs. The FDA evaluated Ixempra under priority review, completing its ...

Article: FDA APPROVES IXEMPRA FOR ADVANCED BREAST CANCER PATIENTS
US Fed News Service, Including US State News;  October 22, 2007 ;     700+ words ... ... Food and Drug Administration has approved Ixempra (ixabepilone), a new anti-cancer ... other cancer drugs. The FDA evaluated Ixempra under priority review, completing its ... therapies that benefit patients in need." Ixempra was approved for use in combination with ...

Article: FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic ...
PR Newswire;  October 16, 2007 ;     700+ words ... ... Administration (FDA) has granted approval of IXEMPRA(TM) (ixabepilone) as monotherapy ... The FDA has also granted approval of IXEMPRA in combination with capecitabine for the ... anthracycline therapy is contraindicated. IXEMPRA is a microtubule inhibitor belonging to ...

Article: FDA OKs Ixempra for breast cancer.
Pharma Marketletter;  October 22, 2007 ;     661 words ... ... Drug Administration has approved its drug Ixempra (ixabepilone) as a monotherapy for patients ... based treatment. The FDA, which accepted Ixempra for priority review earlier this year ... patients. The second trial, which compared Ixempra plus capecitabine with capecitabine alone ...

Article: B-MS' Ixempra increases PFS in triple negative ...
Pharma Marketletter;  December 22, 2008 ;     692 words ... ... Myers Squibb says new study data show that Ixempra (ixabepilone) plus capecitabine resulted ... enrolled in two Phase III clinical trials of Ixempra (046 and 048), were presented at the ... negative breast cancer, data show that Ixempra plus capecitabine (191 patients) is ...