Friday, July 20, 2012
Don't Be Afraid to Talk to Your Kids About Colorado Killings
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U.S. FDA OKs Onyx's Kyprolis for multiple myeloma
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Whoppers of 2012, Early Edition
So many false and misleading claims have already surfaced that, once again, we are moving up the clock on our annual wrap-up of the campaign season’s worst political whoppers, as we did four years ago. We’d like to think there would be no need for a
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FDA approves Novartis drug Afinitor for breast cancer
The drug is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.
Afinitor, also known as everolimus, is designed to be given in combination with another drug, Aromasin, to treat women whose cancer has recurred or progressed after treatment with two other therapies.
A late-stage trial showed that patients who received Afinitor plus Aromasin had a 4.6 month improvement in the median time to disease progression or death over those receiving Aromasin plus a placebo, the FDA said.
Afinitor is already approved to treat patients with certain other types of cancer.
(Reporting By Toni Clarke; editing by Carol Bishopric)
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FDA approves Onyx blood cancer drug Kyprolis
The injectable drug Kyprolis treats multiple myeloma, a form of cancer that causes tumors to grow in the bone marrow, preventing the production of normal blood cells. Patients with the disease have low red blood cell counts and are more likely to experience infections and excessive bleeding.
The FDA approved the drug for patients who have already tried at least two other drugs, including Velcade and various drugs that boost the immune system.
Shares of South San Francisco, Calif.-based Onyx Pharmaceuticals rose $6.34, or 9.3 percent, to $74.74.
The company studied the drug in 266 patients with advanced multiple myeloma who had already been treated with Velcade and thalidomide. About 23 percent of patients experienced a full or partial disappearance of their tumors, with the typical effect lasting about 7.8 months.
Thirty percent of patients experienced side effects from the drug, including fatigue, fever, shortness of breath and diarrhea.
About 21,700 people will be diagnosed with multiple myeloma this year and 10,710 will die from the disease, according to the American Cancer Society.
The drug was approved under the FDA's accelerated approval program, which allows the agency to clear drugs based on promising preliminary data. Drug companies have to submit follow-up studies showing that the drug performed as expected.
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European regulator: Gene therapy treatment OK
In a statement on Friday, the EMA said Glybera, made by Dutch company uniQure, should be approved across Europe for the treatment of an extremely rare disorder that leaves people unable to digest fat. The treatment consists of a gene that makes a protein to break down fat.
Gene therapy is an experimental technique that tries to cure diseases by replacing genes that don't work. It has never been approved in the U.S. and most trials over the past two decades have failed. China was the first country to approve a gene therapy treatment in 2003 for cancer.
Scientists have struggled to find ways to deliver the genes safely, often by using a harmless virus. There are also concerns that inserting a gene at the wrong spot could cause cancer or that the body's immune system might attack the new gene and the virus used to deliver it.
The EMA previously rejected Glybera three times but it was reconsidered at the request of the European Commission. The agency recommended approval under tough restrictions and will require the company to set up a registry to closely track patients. Previous trials of the treatment only tested it in 27 patients.
"It is only meant for patients with the greatest need," said Monika Benstetter, an EMA spokeswoman, explaining the gene therapy is intended for people with no other treatment options. She said only a handful of gene therapy treatments had been considered before
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How to protect kids from whooping cough outbreaks
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Bounty mutiny descendants have low rates of myopia: study
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In Washington, free HIV-AIDS testing while you wait
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Nobel laureate, discoverer of HIV, sees 'hope' for cure
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Thursday, July 19, 2012
Study Ties Infant Birth Weight to Mothers' Breast Cancer Risk
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Drug Widely Used to Treat MS May Not Slow Progression
However, prior studies have found that interferon beta does reduce MS flare ups, so patients should continue taking it, researchers said.
The new study is published in the July 18 issue of the Journal of the American Medical Association.
In multiple sclerosis, the body's immune system attacks myelin, or the substance that insulates nerve fibers of the central nervous system. The damage disrupts nerve signals traveling to and from the brain, which can lead to numbness, movement difficulties, blurred vision, fatigue and eventually, problems with thinking and memory.
About 85 percent of those with multiple sclerosis start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the National Multiple Sclerosis Society. More than half go on to develop a more progressive form of the disease, in which symptoms worsen over time and there are fewer, shorter periods without symptoms. Over time, the disease can lead to loss of vision and paralysis.
The study included data on nearly 2,700 multiple sclerosis patients from British Columbia, Canada, with relapsing-remitting MS who were followed for four to 11 years. About one-third of the patients were treated with interferon beta after it became available in the early 1990s and one-third were not treated with interferon beta. The researchers also examined data on a third group of MS patients who were diagnosed and followed before interferon beta was a treatment option.
The investigators found no statistically significant difference in how long it took for patients prescribed interferon beta to become disabled, defined as needing a cane to walk 330 feet.
"We were not able to find a significant association between interferon beta exposure and progression to disability," said Helen Tremlett, an associate professor of neurology at the University of British Columbia.
Most patients with multiple sclerosis, though not all, develop severe disability 10 to 20 years after diagnosis, according to background information in an accompanying editorial. Several studies have suggested that interferon beta, by reducing relapses, could also prolong progression to disability, Tremlett said. Still other research has found that brain scans of people taking interferon beta show less damage.
Though the exact mechanism of how interferon beta benefits multiple sclerosis patients isn't fully understood, the drug acts on the immune system and reduces inflammation.
"What the field pretty strongly believed is if you reduced relapse rate, surely that should translate into beneficial impact on disease progression," Tremlett said. "Subsequent studies seem to indicate there is disassociation between relapses and long-term irreversible disease progression."
Interferon beta is typically given by injection when people are first diagnosed.
That shouldn't change as a result of these findings, said Timothy Coetzee, chief research officer for the National MS Society. The new study doesn't negate prior studies that have found that the drugs reduce the frequency of relapses.
"If patients are taking the existing disease-modifying therapies
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