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Vidaza in Medical News

Video: The MDS Foundation Says Published Data Confirms VIDAZA(R) Significantly Extends Survival in Patients with the Malignant Condition MDS

... vidaza Restores Gene Function to Double Survival and Incr...wed medical journal The Lancet Oncology confirms vidaza extends survival for patients with higher-risk MDS... "The data from this large international study of vidaza is important news for the patients we represent, v...

Eisai Will Initiate First Head-to-Head Study Comparing Dacogen(R) (decitabine for injection) and Vidaza(R) (azacitidine) in Patients with Myelodysplastic Syndromes

...sponse rates, for Dacogen(R) versus Vidaza(R). "Findings from this trial could help clarify the fundamental differences between Dacogen and vidaza and ultimately help clinicians with treatment selection," said Dr. Anastasios Raptis, co-director, Myelodysplastic Syndrome Program, attending, Stem C...

Pharmion and MethylGene Present Favorable Clinical Data From Combination MGCD0103/Vidaza(R) Study in Myelodysplastic Syndromes and Acute Myelogenous Leukemia at The 49th American Society of Hematology (ASH) Meeting

...nd chief executive officer of Pharmion. "Together, vidaza and MGCD0103 showcase Pharmion's highly complement...planned three-arm randomized study of MGCD0103 and vidaza in AML and MDS patients." The study entitled, "P...ory AML, or untreated patients with AML were given vidaza at its approved dose/schedule (75 mg/m2 SC daily f...

Pharmion and Methylgene Report Favorable Results for Phase 2 MGCD0103 Single- Agent Studies in Relapsed or Refractory Lymphomas at the 49th American Society of Hematology (ASH) Meeting

... release contains forward-looking statements, including summary statements relating to the interim or preliminary results of clinical trials involving vidaza and MGCD0103. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the...

Pharmion to Present Clinical Data on Key Hematology Products at American Society of Hematology (ASH) Annual Meeting

...ocus on the detailed presentation of data from the vidaza overall survival study, which demonstrate an unpre... the meeting include alternate dosing schedules of vidaza and the use of vidaza as a maintenance therapy for patients with higher-...
Vidaza in Medical Technology

Clinical Data Reported on Vidaza in Hematologic Malignancies and Advanced Solid Tumors

HDAC Inhibitor MGCD0103 Demonstrates substantial Response Rate in Two Clinical Trials Clinical Data Presented on Pilot Pharmacokinetic Study of Oral Azacitidine Exelixis Reports Comprehensive XL880 Phase I Data At ASCO Exelixis Reports Integrated Data From Phase II Clinical Trials of XL999 a...

Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)

...ata from largest Phase 3 study conducted in MDS - vidaza therapy confers highly significant 9.4 month media...ens - Two year overall survival rate of 50.8% for vidaza compared to 26.2% for conven... to the EMEA, given the highly compelling data for vidaza in the treatment of MDS," said Patrick J. Mahaffy,...

Pharmion and MethylGene Start Phase 2 Combination Clinical Trial With MGCD0103 and Vidaza(R) in Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

...ymphoma (NHL). Patients will receive 75 mg/m2 of vidaza either intravenously or subcutaneously in combinat...are delighted to be participating in this trial of vidaza and MGCD0103," commented Dr. Anas Younes, Professo...of Hodgkin lymphoma. About Vidaza In May 2004, vidaza became the first drug approved by the FDA for the ...

MDS Patients on Five-Day Vidaza(R) Dosing Schedules Achieve Transfusion Independence Consistent with Seven-day Schedule

...ered subcutaneous every four weeks for six cycles: vidaza 5-2-2 (75 mg/m2/day x 5 days, two days off therapy...l days at same dose as the first five days; N=50); vidaza 5-2-5 (50 mg/m2/day x 5 days, followed by 2 days o...ys at the same dose as the first five days; N=51); vidaza 5 (75 mg/m2/day x 5 days; N=50). The majority of p...

Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)

... Two year survival rate of 50.8 percent for vidaza versus 26.2 for conventional...9.4 months median survival benefit for patients on vidaza compared to conventional car...syndromes (MDS). In the primary endpoint analysis, vidaza treatment was associated with a median survival of...

Pharmion to Present Clinical Data on Commercial and Pipeline Products at 2007 American Society of Clinical Oncology (ASCO) Meeting

...six of our products will be presented or published, including Phase III data for Satraplatin and Thalidomide, encouraging Phase II data for Amrubicin, vidaza and MGCD0103, and human bioavailability data for oral azacitidine. These data demonstrate the strength of the Pharmion business model; we are focused ...
Vidaza in Biological News

The MDS Foundation supports the FDA's decision to expand vidaza label to include survival data

Crosswicks, NJ (August 22, 2008) The Myelodysplastic Syndromes (MDS) Foundation supports the decision by the U.S. Food & Drug Administration (FDA) to extend the label for VIDAZA (azacitidine) to include data from the AZA-001 clinical trial. Results from the trial found that azacitidine is the o...

FDA approves Vidaza label expansion

Washington D.C. (August 21, 2008) The Aplastic Anemia & MDS International Foundation (AA&MDSIF) is pleased to inform patients that the U.S. Food & Drug Administration (FDA) has expanded the label for VIDAZA (azacitidine) to include data from the AZA-001 trial, which found that Vidaza is the only...

The MDS foundation supports vidaza's recommendation for European approval

...ucts for Human Use (CHMP) recommending approval of vidaza (azacitidine) for specific types of MDS patients, ...upon data from the AZA-001 trial, which found that vidaza nearly doubled the two-year survival rate for high... of life." The AZA-001 trial also showed that, vidaza delays the progression of MDS to acute myeloid leu...

Vidaza receives positve opinion from European CHMP

... European Committee for Medicinal Products for Human Use (CHMP) has awarded vidaza (azacitidine) a positive opinion for the treatment of myelodysplastic syndr...tients' lives, but also improves their quality of life. We are hopeful that vidaza will receive marketing approval shortly and quickly be available for patien...
Vidaza in Biological Technology

Pharmion Corporation Announces 2007 Operating Results

... to $142.2 million for 2006. In the U.S., sales of vidaza totaled $131.4 million in 2007, compared to $130.6...2006. Named patient and compassionate use sales of vidaza in Europe and other international markets totaled ... in the fourth quarter of 2006. Worldwide sales of vidaza totaled $44.8 million in the fourth quarter, compa...

EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes

...rated Assessment Procedure. Pharmion submitted the vidaza MAA to the EMEA earlier this month. The Accelera... to demonstrate superiority in overall survival of vidaza versus conventional care regimens, and these data ...y of Hematology annual meeting in December 2007. vidaza has been designated as an Orphan Medicinal Product...

Pharmion's Oral Azacitidine Granted Fast Track Status for Myelodysplastic Syndromes

...ted with Vidaza. In the primary endpoint analysis, vidaza treatment was associated with a median survival of...uation of long-term or maintenance therapy. About vidaza vidaza was the first drug approved for the treatment of a...

Pharmion and MethylGene Announce Collaboration to Develop Sirtuin Inhibitors as Anti-Cancer Agents

...ecutive Officer of Pharmion. "With the recent survival data demonstrated by vidaza in higher-risk MDS, epigenetic therapies are rapidly emerging as an importa...an be re-expressed in cancer cells when DNA hypermethylation is reversed by vidaza and/or inappropriate histone deacetylation is inhibited by MGCD0103. Rather...
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