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Obama Highlights Health Care Reform Progress In Weekly Address
In his weekly radio and Internet address, President Obama discussed efforts by congressional leaders and health care industry groups on health care reform legislation, The Hill reports. He said that "while there remains a great deal of difficult work ahead, I am heartened by what we have seen these past few days: a willingness of those with different points of view and disparate interests to come together around common goals -- to embrace a shared sense of responsibility and make historic progress" (Youngman, The Hill, 5/16). He said, "I have always believed that it is better to talk than not to talk, that it is far more productive to reach over a divide than to shake your fist across it," which has "been an alien notion in Washington for far too long, but we are seeing that the ways of Washington are beginning to change."In the Republican radio and Internet address. Rep. Charles Boustany (R-La.), a cardiovascular surgeon, said that a "government takeover of health care will put bureaucrats in charge of health care decisions that should be made by families and doctors." He added, "It will limit treatment options and lead to rationed care," and "to pay for government health care, your taxes will be raised." Boustany, a member of the House Republican Health Care Solutions Group, said, "That is something we cannot support, and frankly, it would clearly violate some of the principles the president himself has endorsed" (Superville, AP/Washington Post, 5/16). In related news, Office of Management and Budget Director Peter Orszag on Sunday said on CNN"s "State of the Union" that the administration might support taxing health care benefits to health pay for health care reform (Barr, Politico, 5/17). Timeline
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The NHS wants your views on an online personal health information service called HealthSpace.
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Families Of Sudden Unexplained Death Victims Should Receive Comprehensive Cardiogenetic Testing
Relatives of a young person who dies suddenly should always be referred for cardiological and genetic examination in order to identify if they too are at risk of sudden death, a scientist told the annual conference of the European Society of Human Genetics. Dr. Christian van der Werf, a research fellow at the Department of Cardiogenetics, Academic Medical Centre, Amsterdam, The Netherlands said that, although his team"s research showed that inherited heart disease was present in over 30% of the families of sudden unexplained death (SUD) victims, the majority of such relatives were currently not being referred for examination.
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D-Pharm Receives FDA Clearance To Commence A Phase III Trial Of DP-b99 In Acute Stroke Patients

D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel. The forthcoming Phase III trial is a randomized, double blind, placebo-controlled study (study acronym MACSI: Membrane Activated Chelator Stroke Intervention). It is designed to compare the effect on ischemic stroke outcome between a placebo group and a group of patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. D-Pharm plans to enroll 770 moderate to severely affected ischemic stroke patients worldwide, with first patients expected to be recruited in Israel and South Africa. Dr. Gilad Rosenberg, D-Pharm"s VP Clinical Development commented, "The FDA"s IND procedure involved review of the entire DP-b99 data set. Following 30 days for review of our IND application, the FDA has no further questions relating to DP-b99"s CMC, preclinical and clinical data package. I"m very pleased that the Agency is satisfied with our data and we can move forward with this important study without delay." Prior to the IND submission D-Pharm successfully completed the program outlined at the pre-IND meeting held with the FDA in January 2008. The program included additional toxicity studies, a drug interaction study with rtPA, and an interaction study with warfarin in healthy volunteers, as well as scale-up and optimization of the DP-b99 manufacturing process. About DP-b99 DP-b99 is a unique neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients and emerged from D-Pharm"s proprietary Membrane Activated Chelator (MAC) platform technology. D-Pharm successfully completed extensive testing of DP-b99 in pre-clinical and then in Phase I and Phase II clinical studies. Both preclinical and clinical studies indicate a favorable efficacy and safety profile for DP-b99. In the recently completed Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window. About Stroke Every year approximately 780,000 Americans have a new or recurrent stroke. The second most common cause of death worldwide, stroke is also the leading cause of serious long-term disability; 15% to 30% of stroke survivors experience permanent disability. According to the American Heart Association, the estimated direct and indirect cost in 2009 of stroke in the US is $68.9 billion. Only about 2 to 5% of acute stroke patients are eligible for treatment with tissue plasminogen activator (tPA), the only FDA approved drug treatment for acute stroke. $68.9 billion. Only about 2 to 5% of acute stroke patients are eligible for treatment with tissue plasminogen activator (tPA), the only FDA approved drug treatment for acute stroke. About D-Pharm Ltd. D-Pharm is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics and has generated a rich pipeline of patent protected proprietary products. D-Pharm"s pipeline includes advanced clinical stage products DP-b99 for treatment of acute ischemic stroke patients and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer"s disease. Other mimics of bioactive lipids, LipidoMimetix, are at an earlier developmental stage, for cancer. D-Pharm Ltd


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