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Pneumonia Caused By Community-Acquired MRSA: An Emerging And Deadly Threat, Usually Preceded By Flu
As community-acquired infections due to meticillin-resistant Staphylococcus aureus (CA-MRSA) increase, so lethal cases of CA-MRSA pneumonia are also on the rise. A paper in the June edition of looks at the emerging and deadly threat of community-acquired necrotising pneumonia due to CA-MRSA. CA-MRSA pneumonia appears to occur most commonly following an influenza-like illness and may have special relevance given the emergence of H1N1 influenza.
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Survey Reveals Women Aren't Doing All They Can To Support Breast Health
A recent Yankelovich survey unveiled that although a large majority of women know there are simple steps they can take to support breast health, few women are taking the necessary actions. What"s more, 80 percent of the women surveyed have been personally affected by breast cancer or know someone who has been. To address this issue, One A Day Women"s Multivitamins is encouraging women to join a virtual march against breast cancer through the One A Day Women"s Take A Stand Campaign.
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WorldCare Clinical Implements MCC's Imaging Performance Metrics In Support Of Standardized Peformance For Imaging Trials
45th DIA Annual Meeting -- Booth # 1501 -- WorldCare Clinical, LLC (WCC), a leading imaging CRO for clinical trials in the pharmaceutical, biotechnology and medical device industries, announced that it is offering version 1.0 of the Metrics Champion Consortium (MCC) Imaging Performance Metrics to all sponsors" imaging trials beginning July 1, 2009, through its WorldPro™ technology solution.
Diagnostics

FDA Accepts CyDex Pharmaceuticals' IND Application For Oncology Drug

CyDex Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company"s Investigational New Drug (IND) application for a clinical study of Captisol-Enabled® melphalan HCL (CDX-353). Melphalan is an FDA-approved low dose chemotherapy for multiple myeloma marketed under the brand name Alkeran® by GlaxoSmithKline. In December 2008, CyDex received orphan-drug designation from the FDA for melphalan "as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation." This designation provides an important economic incentive, granting CyDex seven years of exclusive marketing rights. "IND acceptance for Captisol-enabled melphalan is an important milestone for CyDex as we work to develop a portfolio of new drugs for the hospital acute care market," said Theron E. Odlaug, CyDex"s president and chief executive officer. "We look forward to establishing a relationship with a strategic out-licensing partner to advance CDX-353 into the clinic and, longer-term, develop and commercialize this promising oncology product." Upcoming clinical studies are expected to begin with a phase 2(a) trial that compares the pharmacokinetics of CyDex"s CDX-353: Propylene Glycol-Free Melphalan HCL with Alkeran, and evaluate safety parameters. Alkeran is packaged as two separate vials that must be combined prior to injection and, due to its limited stability, administered immediately thereafter. CyDex"s version of melphalan is enabled by Captisol®, the company"s proprietary and patented sulfobutylether í²-cyclodextrin. Captisol-Enabled® melphalan is a one-vial formulation that does not contain harsh co-solvents and remains stable at room temperature for an extended period of time. "CDX-353 is a novel form of melphalan that is more stable and could potentially allow for longer administration durations and slower infusion rates compared to current pre-transplant treatments for multiple myeloma," said Parameswaran Hari, M.D., Clinical Director of the Adult Bone Marrow Transplant Program and Associate Professor of Medicine at the Medical College of Wisconsin. "These advantages have the potential to enable doctors to safely achieve a higher dose intensity of pre-transplant chemotherapy, which could lead to better therapeutic outcomes." CyDex Pharmaceuticals, Inc.


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