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Comment 27 of 67, added on May 25th, 2013 at 3:45 PM.
Why do planets farthest from sun have highest winds? Team closes in on answer
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223
dichloride) to treat men with symptomatic late-stage (metastatic)
castration-resistant prostate cancer that has spread to bones but not to
other organs. It is intended for men whose cancer has spread after
receiving medical or surgical therapy to lower testosterone.
Prostate cancer forms in a gland in the male reproductive system found
below the bladder and in front of the rectum. The male sex hormone
testosterone stimulates the prostate tumors to grow. According to the
National Cancer Institute, an estimated 238,590 men will be diagnosed with
prostate cancer and 29,720 will die from the disease in 2013.
Xofigo is being approved more than three months ahead of the product¡¯s
prescription drug user fee goal date of Aug. 14, 2013, the date the agency
was scheduled to complete review of the drug application. The FDA reviewed
Xofigo under the agency¡¯s priority review program, which provides for an
expedited review of drugs that appear to provide safe and effective therapy
when no satisfactory alternative therapy exists, or offer significant
improvement compared to marketed products.
¡°Xofigo binds with minerals in the bone to deliver radiation directly to
bone tumors, limiting the damage to the surrounding normal tissues,¡± said
Richard Pazdur, M.D., director of the Office of Hematology and Oncology
Products in the FDA¡¯s Center for Drug Evaluation and Research. ¡°Xofigo is
the second prostate cancer drug approved by the FDA in the past year that
demonstrates an ability to extend the survival of men with metastatic
In August 2012, the FDA approved Xtandi to treat men with metastatic
castration-resistant prostate cancer that has spread or recurred, even with
medical or surgical therapy to minimize testosterone. Xtandi is approved
for patients who have previously been treated the chemotherapy drug
Xofigo¡¯s safety and effectiveness were evaluated in a single clinical
trial of 809 men with symptomatic castration-resistant prostate cancer that
spread to bones but not to other organs. Patients were randomly assigned to
receive Xofigo or a placebo plus best standard of care.
The study was designed to measure overall survival. Results from a
pre-planned interim analysis showed men receiving Xofigo lived a median of
14 months compared to a median of 11.2 months for men receiving placebo. An
exploratory updated analysis conducted later in the trial confirmed
Xofigo¡¯s ability to extend overall survival.
The most common side effects reported during clinical trials in men
receiving Xofigo were nausea, diarrhea, vomiting and swelling of the leg,
ankle or foot. The most common abnormalities detected during blood testing
included low levels of red blood cells (anemia), lymphocytes
(lymphocytopenia), white blood cells (leukopenia), platelets
(thrombocytopenia) and infection-fighting white blood cells (neutropenia).
from New Zealand
Comment 26 of 67, added on May 25th, 2013 at 7:14 AM.
Georgia: Angry Mob Scuttles Anti-Homophobia Rally
STOCKHOLM, Sweden, May 17 (UPI) -- In utero exposure to depression
medications may increase the risk of autism spectrum disorders in less than
1 percent of cases, researchers in Sweden say.
First author Dheeraj Rai, a clinical lecturer at the Department of Public
Health Sciences at Karolinska Institutet in Stockholm, and colleagues at
the University of Bristol; Avon and Wiltshire Partnership Mental Health NHS
Trust in Bristol, England; and Drexel University School of Public Health on
Philadelphia said the study involved 4,429 cases of autism spectrum
disorder -- 1,828 with and 2,601 without intellectual disability and 43,277
age and sex matched controls.
The study involved 1,679 cases of autism spectrum disorder and 16,845
controls with data on maternal anti-depressant use.
The study, published in the British Medical Journal, said parental
depression and other characteristics were recorded in administrative
registers before the birth of the child. Maternal anti-depressant use,
recorded at the first antenatal interview, was available for children born
from 1995 onwards.
A history of maternal -- but not paternal -- depression was associated with
an increased risk of autism spectrum disorders in offspring, the study
said. In the subsample with available data on drugs, this association was
confined to women reporting anti-depressant use during pregnancy
irrespective of whether selective serotonin reuptake inhibitors or
non-selective monoamine reuptake inhibitors were reported, the study said.
"Whether this association is causal or reflects the risk of autism with
severe depression during pregnancy requires further research," the study
authors wrote in the study. "However, assuming causality, anti-depressant
use during pregnancy is unlikely to have contributed significantly towards
the dramatic increase in observed prevalence of autism spectrum disorders
as it explained less than 1 percent of cases."
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