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Patient Has Speedy Recovery From New Heart Valve Procedure
For years, George Forschler knew the mitral valve in his heart was failing and would eventually need repair or replacement. Concerned about the risks associated with open heart surgery the traditional way to access a mitral valve he did his best to postpone the inevitable. Forschler, a retired U.S. Air Force Brigadier General who now heads a consulting firm, kept his heart healthy by exercising at the gym and doing weekend chores on his farm near here.
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National Public Health Organizations Brief Capitol Hill On H1N1
The recent H1N1 flu outbreak served as a genuine test of our national public health system"s ability to respond to an emerging public health threat and experts are cautioning that a more severe outbreak could occur in the fall of 2009. Leaders from some of the nation"s foremost public health and medical associations will conduct a briefing for staff members from House and Senate offices on Thursday, May 21, 2009. Speakers will focus on the status of the current public health workforce and efforts needed to sustain workforce capacity to respond to emerging infectious diseases.
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Survey: 40 Percent Of Senior Citizens Not Taking Prescribed Medicines Due To Budget Concerns
A new survey, released today by The Senior Citizens League (TSCL), found that senior citizens are being forced to make drastic cuts to their medical and food budgets due to the recession.
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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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