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Fungal Toxin Mystery Solved Using Biolog's Phenotype MicroArrayTM Technology
An important breakthrough in fungal toxin biology has been made possible through the use of Biolog"s Phenotype MicroArray technology. This major advance is described in two recent publications from a group at CSIRO in Queensland, Australia. The work by Donald Gardiner and his collaborators has recently been published in online editions of the journals Fungal Genetics and Biology and Microbiology.
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Abbott And AstraZeneca Submit New Drug Application To The FDA For CERTRIAD™, An Investigational Treatment For Mixed Dyslipidemia
Abbott Park, Illinois (NYSE: ABT) and London, UK - Abbott and AstraZeneca announced that the companies have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational compound for the treatment of mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL- cholesterol (the "bad" cholesterol), high triglycerides and low HDL-cholesterol (the "good" cholesterol). The NDA submission for this investigational compound, containing the active ingredients of CRESTOR® (rosuvastatin calcium) and TRILIPIX® (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD™.
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Complications Early In Pregnancy Or In Previous Pregnancies Adversely Affect Existing Or Subsequent Pregnancies
Complications in early pregnancy or in previous pregnancies can predict the likelihood of further problems in current or subsequent pregnancies, according to research carried out by an international group of experts.
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Journal Of Clinical Oncology Publishes Study Demonstrating Improvement In Overall Response And Progression-Free Survival-Chronic Lymphocytic Leukemia

Cephalon, Inc. (Nasdaq: CEPH) announced yesterday that the Journal of Clinical Oncology has published data from a pivotal phase 3 study demonstrating that TREANDA® (bendamustine HCl) for Injection improved clinical outcomes when compared to chlorambucil in patients with chronic lymphocytic leukemia (CLL). Results of this study were the basis of the March 2008 U.S. Food and Drug Administration (FDA) approval of TREANDA for CLL, the first agent approved by the FDA for this disease since 2001. According to the American Cancer Society, there will be more than 15,000 new cases of CLL diagnosed in 2009 alone. The study results were published online today and will also appear in the print edition later this year. This Phase 3, randomized, international, multicenter, open-label study evaluated the efficacy and safety of TREANDA compared to chlorambucil in previously untreated patients with advanced (Binet stage B-C) CLL. Patients received TREANDA (100 mg per square meter on days 1 and 2) (n=162) or chlorambucil (0.8 mg/kg on days 1 and 15) (n=157) for up to six treatment cycles. In this study, TREANDA demonstrated significantly better outcomes for both primary endpoints compared to chlorambucil: overall response rate and progression-free survival (PFS).The overall response rate was significantly higher in patients receiving TREANDA than chlorambucil (68% vs. 31%; pAbout TREANDA TREANDA, a novel chemotherapy, was approved by the FDA for the treatment of CLL in March 2008. Efficacy relative to other first line therapies other than chlorambucil has not been established. TREANDA received its second approval in October 2008 for the treatment of patients with indolent B-cell non-Hodgkin"s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The following serious adverse reactions have been associated with TREANDA in clinical trials: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions, and other malignancies. TREANDA has a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of TREANDA remains unknown, TREANDA may act in two distinct ways to kill cancer cells. Preclinical studies suggest that TREANDA may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway). Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Deutschland GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas" licensee, Mundipharma International Corporation Limited. In Germany, bendamustine is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and select Asia Pacific Rim countries. Cephalon, Inc.


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