Stem cell and other new biological therapies are target of major NIH contract to U of MN
...CT provide the technical expertise, as well as the regulatory structure, to ensure that all FDA requirements are satisfied. An example of the ongoing work, Wagner and his team are working on adult stem cells, which may be useful for treating a number of diseases, such as Parkinson's, stroke, diabetes, and heart...Fosrenol shows significant reduction in serum phosphate in Chinese end-stage kidney disease patients
...on (FDA). The company also submitted the drug for regulatory review in the European Union and Canada. Shire has an exclusive worldwide license to develop, manufacture, use and sell lanthanum carbonate under patents owned by AnorMED Inc. Lanthanum carbonate works by binding to dietary phosphate in the stomach....GlaxoSmithKline Drug Discovery and Development Research Grant Program 2003
...he HIV Vif Gene Viral infectivity factor (Vif), a regulatory protein expressed by HIV, plays a critical role in...hang said. A New Strategy to Inhibit Tat Tat is a regulatory protein of HIV which plays a role in shielding reservoirs of dormant HIV-infected cells from cytotox...PRAECIS PHARMACEUTICALS INC receives FDA approval for Plenaxis
... the United States, PRAECIS has also initiated the regulatory review process for Plenaxis TM in the European Un...2003. The Company expects an action by the German regulatory authorities during 2004 and will pursue expanded European Union approval under the Mutual Recognitio......s been to obtain enough freshly purified CD4+CD25+ regulatory T cells from a single donor patient to achieve thi... circumvent this difficulty. The authors performed regulatory T cell expansion ex vivo by stimulation with allogeneic antigen-presenting cells, which has the addi...Regulatory T cells keep graft-versus-host disease in check
...s been to obtain enough freshly purified CD4+CD25+ regulatory T cells from a single donor patient to achieve thi...circumvent this difficulty. The authors performed regulatory T cell expansion ex vivo by stimulation with allogeneic antigen-presenting cells, which has the addi...Roche files marketing application for Avastin with European health authorities
...ny types of cancers, and we will work closely with regulatory authorities to bring Avastin to patients as quickly as possible, particularly as this is the first treatment of its kind." An application for approval of Avastin in metastatic colorectal cancer was filed with the US FDA in September and has been desi...National vaccine advisory committee issues recommendations to strengthen supply of routine vaccines
...funds for vaccine stockpiles; increase support for regulatory agencies; maintain and strengthen liability protec...mulate development of new vaccines; and streamline regulatory process without compromising safety or efficacy(JAMA. 2003;290:3122-3128. Available post-embargo at...Malpractice reform must focus on reducing patient injury, not just limiting awards
...ve improvements in patient safety. Legislative or regulatory efforts to motivate this type of change could include: Licensure requirements such as the risk management training required by the Massachusetts Board of Registration. Insurance regulators could provide premium discounts on malpractice insurance ba...Family members say dying patients need better end-of-life emotional and medical support
...ith the role that governmental and nongovernmental regulatory structures should play in assuring that the health care system provides competent, coordinated, and compassionate care at life's end," the authors write. Joan M. Teno, M.D., M.S., from Brown Medical School, Providence, R.I., and colleagues review...UCSD Medical Center receives NIH contract to set up National Tuberculosis Educational Curriculum
...rnia Healthcare Association, responding to various regulatory effects by both the federal and California Occupational Safety and Health Administration related to TB. Dr. Jackson is a Fellow of the American Academy of Nursing (FAAN) and is Certified in Infection Control (CIC). As the administrator of the TCCC...New report presents options for oversight of genetic testing of human embryos
... intersection of two technologies with a confusing regulatory status: assisted reproduction and genetic testing. In the United States, oversight of assisted reproductive technologies (ART) has been left primarily in the hands of the individual physicians and there is no uniform and comprehensive system to assur...The BESST way to judge IVF success
...nd cognitive disabilities(see below). Doctors and regulatory agencies are now trying to reduce the soaring number of multiple births worldwide caused by IVF. "Multiple births are now at the highest level ever," says Suzy Leather of the UK's Human Fertilisation and Embryology Authority, which will soon restrict...New flu vaccine provides insight into immunity development
...n criteria can change. In the case of FluMist, the regulatory agencies increased the number of people it considered sufficient to demonstrate the product's safety after the vaccine was already in late stages of development, prolonging the process. Because of its genetics, Greenberg said, the flu virus has the a...Clinical trial of new TB vaccine begins
...accines, conducted the preclinical development and regulatory activities required to begin the study to test the vaccine in humans, in collaboration with Dr. Horwitz. "The development of the vaccine required a decade-long effort, and we are gratified to see the vaccine progress to clinical trials," said Dr. ...Breakthrough cancer treatment Avastin receives first approval in the US
...ustralia. We are dedicated to working closely with regulatory authorities to bring Avastin to patients as quickly as possible, particularly as this is the first treatment of its kind." Avastin is the first anti-angiogenic therapy a totally novel approach to the treatment of metastatic colorectal cancer. The dr...New data on the effect of Atacand(R) on NYHA class in a broad spectrum of heart failure patients
...the CHARM Programme, AstraZeneca expects to submit regulatory application for the use of Atacand in heart failure during the second quarter 2004. *Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity (CHARM) study programme...Study: National medical privacy law makes health research harder, more expensive
...t develop better ways of working with patients and regulatory agencies to define the proper balance." Kline-Rogers and her colleagues at the U-M Cardiovascular Outcomes Research and Reporting Program set out to obtain written consent from heart patients six months after they left the U-M hospital after being tr...How to sedate? That is the question!
...creased, training requirements have increased, and regulatory requirements limit therapeutic options for most dentists to use oral sedative drugs. In a Keynote Address during the 82nd General Session of the International Association for Dental Research, Dr. Raymond Dionne (National Institute of Dental Research,...Adaptive regulatory T cells suppress killing of persistently infected cells
...y could not destroy them. The key finding was that regulatory CD4+ T cells suppress the normal function of the C...mice. Importantly, suppressing the activity of the regulatory CD4+ cells could prevent dysfunction of CD8+ T cells. The researchers conclude that CD4+ T cells co...