Monday, January 5, 2009

Posts Tagged ‘Food And Drug Administration’

Scientists Puzzled By Severe Allergic Reaction To Cancer Drug In The Middle Southern US

Saturday, December 6, 2008 17:02

A recent study from the Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill, the Vanderbilt-Ingram Comprehensive Cancer Center and the Sarah Canon Cancer Center in Nashville have identified an unusually high rate of allergic reaction in cancer patients living in the middle South who received ...

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Prescription Labels Geared Toward Pharmacies, Not Patients

Friday, December 5, 2008 14:00

The Institute of Medicine estimates that 1.5 million medication errors occur each year in the United States and poor labeling is one cause of the mistakes. While the Food and Drug Administration has some standards on what prescription labels must include, few regulations guide the format of the information, said ...

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Manic Phase Of Bipolar Disorder Benefits From Breast Cancer Medication

Friday, December 5, 2008 13:24

Researchers at the National Institutes of Health’s National Institute of Mental Health (NIMH) who conducted the study also explained how: Tamoxifen blocks an enzyme called protein kinase C (PKC) that regulates activities in brain cells. The enzyme is thought to be over-active during the manic phase of bipolar ...

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Drug That Reduces Prostate Size And Cancer Risk Also Improves Early Detection

Friday, December 5, 2008 12:11

A new study from the Southwest Oncology Group strongly suggests that for men at risk of the disease -- which strikes one in six men -- finasteride also raises the odds that physicians will find fast-growing prostate cancers early, when they are most easily treatable. "It appears that a man concerned ...

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Women Prescribed Drugs Linked To Birth Defects Not Often Advised To Use Birth Control

Friday, December 5, 2008 10:59

"We found that over the course of a year, one in six women of reproductive age filled a prescription for a medication labeled by the Food and Drug Administration as increasing the risk of fetal abnormalities," said Eleanor Bimla Schwarz, M.D., assistant professor in the departments of medicine and obstetrics, ...

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Cervical Cancer Vaccine To Be Evaluated

Friday, December 5, 2008 3:56

Two new HPV vaccines are currently being brought to market. Merck’s vaccine -- Gardasil -- was approved federal Food and Drug Administration earlier this year and GlaxoSmithKline’s Cervarix is expected to be endorsed by the agency later this year. The CDC recommends that the ...

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Cause Of Debilitating Skin Condition Suggested

Friday, December 5, 2008 1:59

Reporting in the October issue of the American Journal of Dermatopathology, the authors suggest a possible explanation for why some patients on kidney dialysis who are injected with a "contrast agent" during a magnetic resonance imaging (MRI) develop nephrogenic systemic fibrosis (NSF). The U.S. Food and Drug Administration now requires ...

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Radiation Oncologists Use Real-time System To Plant ’Seeds’ Against Cancer

Friday, December 5, 2008 1:29

While the system, which is made by Nucletron, a technology company based in The Netherlands, is only being used for imaging and planning purposes so far, it ultimately will help with the actual placement of the seeds. To date, Jefferson is the first medical center in the Delaware Valley to ...

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New Synthetic Version Of Clot Preventing Drug Heparin Created

Thursday, December 4, 2008 7:16

Led by Jian Liu, Ph.D., scientists in the UNC School of Pharmacy discovered that they could remove a complex element from the heparin molecule without altering the drug’s function. The component, a single sugar called iduronic acid, is difficult to replicate and was long thought to be an important contributor ...

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’Jumping Genes’ Could Make For Safer Gene Delivery System

Thursday, December 4, 2008 3:14

The catch is that viruses can be infectious and some types of viruses occasionally land in a target genome near an oncogene and raise the risk of cancer. Plasmids don’t carry that risk, but they are not nearly as efficient at reproducing in cells, which is important when the goal ...

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Got Calcium? Food Labels Confuse Consumers, Study Shows

Wednesday, December 3, 2008 18:38

A woman at risk for osteoporosis is told by her doctor to get 1,200-1,500 milligrams of calcium every day. But when she looks at the Nutrition Facts panel on a carton of yogurt or a jug of milk, she finds that calcium is only listed by "Percent Daily Value" (%DV). ...

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Genes That Affect Responses Of Multiple Sclerosis Patients To Copaxone Identified

Wednesday, December 3, 2008 13:27

Copaxone® was the first original Israeli drug to be approved by the U.S. Food and Drug Administration (FDA), and is today marketed in over 40 countries worldwide, including the U.S.A., Europe, Australia, Latin America and Israel. The drug molecule was the fruit of research by Prof. Michael Sela, Prof. Ruth Arnon ...

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Tiny Radioactive Spheres Effectively Treat Cancer That Has Spread To The Liver

Wednesday, December 3, 2008 6:31

They say that the technique appears to offer a treatment option for patients who develop multiple tumors in their liver from cancer metastasis. "Most of these patients don’t have other effective treatment options, because surgery is not possible if there are multiple tumors in their liver," says the study’s lead ...

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More Children On Chronic Medications For Blood Pressure, Cholesterol, Asthma, Depression And Diabetes

Tuesday, December 2, 2008 13:46

The finding is included in a study of chronic medication use in children 5 to 19 reported Wednesday, Nov. 7 at the annual meeting of the American Public Health Association by researchers from the Saint Louis University School of Medicine and School of Public Health and pharmacy benefit manager Express ...

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Biopharmaceutical Infrastructure Key To Lower Drug Development Costs

Tuesday, December 2, 2008 8:54

A new NIST-sponsored study found that the biopharmaceutical industry spend a total of $1,219 million on infrastructure technology?884 million on the R&D technology infrastructure including bioimaging, biomarkers, informatics, and gene expression and $335 million on infrastructure for commercial manufacturing and postmarket surveillance. (Credit: NIST) Prepared ...

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Smaller Heart Pump Bridges Time To Transplant For More Women

Tuesday, December 2, 2008 7:11

"The fact that we have a technology where the outcomes in women are equal to men is important," said Roberta C. Bogaev, M.D., lead author of the study and medical director of heart failure and cardiac transplantation at the Texas Heart Institute in Houston. "Historically, because of their size, ...

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How Can We Regulate Medicines Better?

Tuesday, December 2, 2008 7:02

Licensing of new drugs in Europe is increasingly controlled by the European Medicines Agency (EMEA), yet new drugs have only to show they are equivalent to current treatments rather than show superiority. This favours the interests of drug companies, say Silvio Garattini and Vittorio Bertele from the Mario Negri Institute ...

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Drug May Limit Radiation Kidney Damage In Bone Marrow Transplantation Patients

Tuesday, December 2, 2008 2:48

It suggests that long-term administration of the drug captopril, starting at three weeks after patients receive total body irradiation in preparation for bone marrow transplantation (BMT), showed a favorable trend for better long-term kidney function and better long-term patient survival. Chronic kidney failure continues to be a major complication in ...

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Promising New TB Drug Given Special Status By US And European Regulators

Tuesday, December 2, 2008 2:30

Currently, TB patients must adhere to a complex treatment regimen over a six- to nine-month period. This demanding schedule often results in patients skipping treatment doses, which has given rise to drug-resistant strains of M. tuberculosis, including multi-drug-resistant (MDR) and, more recently, extensively drug-resistant (XDR) TB. SQ109, an antimicrobial agent developed ...

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Exercise And Education Helps Women With Fibromyalgia

Tuesday, December 2, 2008 0:21

Fibromyalgia affects approximately 3.4 percent of women and 0.5 percent of men in the United States, according to background information in the article. Patients with fibromyalgia experience chronic pain throughout their bodies for at least three months, along with specific sites of tenderness. Causes and mechanisms are poorly understood. "Even ...

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New HPV Vaccine Under Study

Monday, December 1, 2008 16:26

The vaccine, called nine-valent, is being compared with Gardasil, a quadrivalent vaccine already on the market that works against the two most deadly HPV types. “We’re testing Gardasil against three different doses of the investigational vaccine,” says Dr. Daron Ferris, family medicine physician and director of the MCG Gynecologic Cancer Prevention ...

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Re-engineered Gleevec Reduces Heart Risks, Study Suggests

Monday, December 1, 2008 13:46

The new study reports pre-clinical evidence that the newly re-engineered drug is just as effective as imatinib against gastrointestinal stromal tumor (GIST) and carries significantly less risk of heart failure. Developed by Novartis Pharmaceuticals, Gleevec is approved by the U.S. Food and Drug Administration for the treatment of chronic myeloid leukemia ...

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UT Southwestern Urologist Uses Botox To Treat Debilitating Condition

Monday, December 1, 2008 2:33

Dr. Gary Lemack talks with Lynette Kunz about a procedure to regain bladder control using Botox. Researchers are recruiting study participants for a Botox clinical trial investigating urological conditions. (Credit: Image courtesy of UT Southwestern Medical Center) “I can somewhat detect when my bladder is ...

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Use Of Diabetes Medication By Older Adults Linked With Increased Risk Of Heart Problems, Death

Sunday, November 30, 2008 22:26

The thiazolidinediones (TZDs) rosiglitazone and pioglitazone are oral hypoglycemic agents used to treat type 2 diabetes and have been shown to improve glycemic control. "While improved glycemic control has been linked to better clinical outcomes in diabetes and TZDs have been suggested as having potential cardiovascular benefits, recent concerns have ...

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Dasatinib, Nilotinib Show Strong Early Results As Frontline Therapy For Chronic Myelogenous Leukemia

Sunday, November 30, 2008 20:19

All patients in both trials have a complete cytogenetic response - absence of the aberrant chromosome that causes the disease - after one year on either drug. Approximately 90 percent reach complete cytogenetic response as early as 6 months. "These are early results but certainly encouraging so far in both cases," ...

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Memantine And Alzheimer’s Disease

Sunday, November 30, 2008 13:56

Dementia is an ever-increasing problem in today’s aging societies, with millions of patients and their carers affected worldwide. About one in five people over the age of 80 suffers from Alzheimer’s disease, the most common type of dementia. There is no cure and little hope is available for treatment, thus ...

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Participants In Studies Used As Basis For Medicare Decisions Differ From Beneficiaries

Sunday, November 30, 2008 2:37

Cardiovascular disease is the leading cause of death and disability among Medicare beneficiaries, according to background information in the article; expenses for this condition exceed those for any other. "Because Medicare expenditures continue to increase rapidly, it is necessary that coverage decisions be based on data most likely to maximize ...

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iPods Do Not Interfere With Cardiac Pacemakers, Study Shows

Saturday, November 29, 2008 22:09

Howard Bassen, a researcher with the U.S. Food and Drug Administration in Rockville, Md., led a research team that measured the magnetic fields produced by four different iPod models: a fourth-generation iPod and an iPod with video, and an iPod nano and iPod shuffle. They also measured the voltages ...

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Selective Reporting Of Antidepressant Trials Exaggerates Drug Effectiveness, Report Finds

Saturday, November 29, 2008 21:02

Turner and his colleagues examined reviews from the Food and Drug Administration (FDA) for trials of 12 widely prescribed antidepressant drugs approved between 1981 and 2004, involving 12,564 patients. They also conducted a systematic literature search to identify whether results of these studies had been published in medical journals. ...

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New Trial To Test Radiation-emitting Beads Against Advanced Liver Cancer

Saturday, November 29, 2008 14:36

The technique, called radioembolization, has been approved by the federal Food and Drug Administration for use in inoperable liver cancer. This is the first time that the particular technology, called SIR-Spheres microspheres, which is FDA-approved for treating colon cancer that has spread to the liver, is being studied in patients ...

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