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Roche expands Herceptin franchise
Roches blockbuster breast cancer treatment Herceptin has been launched in the UK as a treatment for stomach cancer.It is a boost for the Herceptin franchise - already worth $4.8 billion to the manufacturer - demonstrating that targeting HER2-positive tumours...
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Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-040
Keryx Biopharmaceuticals, Inc.announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 ...
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FDA Expands Use of Approved Breast Cancer Drug
Provides oral regime for hormone positive and HER2-positive advanced breast cancer SILVER SPRING, Md., Jan.29 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat...
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Strong operating performance for Roche in 2009
The total Roche Group's sales grew by 10% in local currencies (8% in Swiss francs; 7% in US dollars) to 49.1 billion Swiss francs, with the Pharmaceuticals Division accounting for 80% of Group sales and the Diagnostics Division contributing 20%.Sales growth...
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FDA Okays Drug Combo for Advanced Breast Cancer
The U.S.Food and Drug Administration (FDA) has approved the combination of the targeted therapy Tykerb (chemical name: lapatinib) and the hormonal therapy Femara (chemical name: letrozole) to treat post-menopausal women diagnosed with hormone-receptor...
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AEterna Zentaris says Keryx reaches SPA agreement with FDA for Phase III study of perifosine
- Canadian biopharmaceutical company AEterna Zentaris Inc (TSE: AEZ) said yesterday that its US partner, Keryx Biopharmaceuticals (NASDAQ: KERX), has reached an agreement with the US Food and Drug Administration (FDA) regarding a Special Protocol Assessment ...
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AEterna Zentaris says Keryx reaches SPA agreement with FDA for Phase III study of perifosine
- Canadian biopharmaceutical company AEterna Zentaris Inc (TSE: AEZ) said yesterday that its US partner, Keryx Biopharmaceuticals (NASDAQ: KERX), has reached an agreement with the US Food and Drug Administration (FDA) regarding a Special Protocol Assessment ...
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Keryx Biopharmaceuticals Announces Protocol Assessment Agreement With FDA For Phase 3 Trial Of KRX-0401 (Perif
Keryx Biopharmaceuticals, Inc.(Nasdaq: KERX) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX...
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK (AP) -- Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine.The agreement makes it more likely the Food and Drug Administration will approve...
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Keryx, FDA Agree on Colon Cancer Drug Study Goals
Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve perifosine if...
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Keryx, FDA agree on colon cancer drug study goals
Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve perifosine if...
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve...
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK_Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve...
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK -- said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine.The agreement makes it more likely the Food and Drug Administration will approve perifosine if it meets its goals...
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Keryx, FDA Agree on Colon Cancer Drug Study Goals
NEW YORK (AP) -- said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine.The agreement makes it more likely the will approve perifosine if it meets its goals in the clinical trial.
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve...
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK (AP) - Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will...
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Keryx, FDA agree on colon cancer drug study goals
Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve perifosine if...
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Keryx, FDA agree on colon cancer drug study goals
Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will approve perifosine if...
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Keryx, FDA agree on colon cancer drug study goals
Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The Associated Press NEW YORK Keryx Biopharmaceuticals Inc. said Wednesday it reached an...
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Keryx, FDA agree on colon cancer drug study goals
NEW YORK (AP) - Keryx Biopharmaceuticals Inc.said Wednesday it reached an agreement with regulators on the design of a late-stage study of its cancer drug candidate perifosine. The agreement makes it more likely the Food and Drug Administration will...
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Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Patients with Refractory Metastatic Colorectal Cancer
NEW YORK, Feb.3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase...
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Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Patients with Refractory Metastatic Colorectal Cancer
Phase 3 X-PECT Trial (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) to be led by Dr.Johanna Bendell, Director, GI Oncology Research, Sarah Cannon Research Institute PR Newswire NEW YORK, Feb. 3 NEW YORK, Feb. 3 /PRNewswire-FirstCall/ ...
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Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-040
NEW YORK PHASE 3 TRIAL DESIGN: The Phase 3 X-PECT (Xeloda, + Perifosine Evaluation in Colorectal cancer Treatment) trial will be a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a...
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Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Patie
NEW YORK, Feb.3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase...
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