FDA Grants Review Extension for New Diabetes Drug
A review of the proposed diabetes drug saxagliptin has been extended from April 30 until July 30 by the U.S. Food and Drug Administration. The companies developing the drug, Bristol Myers Squibb and AstraZeneca, requested the extension.
Earlier this month, an FDA panel of outside medical experts determined that the drug doesn't carry an excess cardiovascular risk, the Wall Street Journal reported.
Saxagliptin is a type of drug called a DPP-4 inhibitor that's designed to increase levels of so-called incretin hormones in order to help lower blood glucose levels. The only DPP-4 drug currently on the market in the United States is Merck and Co.'s Januvia.
Late last year, the FDA said drug makers would have to conduct more stringent clinical trials for type 2 diabetes drugs in order to better assess the drugs' heart attack and stroke risks, the Journal reported.
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Smoking, Secondhand Smoke Increase Breast Cancer Risk: Experts
Smoking or exposure to secondhand smoke increase a young woman's risk of breast cancer, say Canadian experts who reviewed data presented at a two-day conference in Toronto last November. The review was published by the Ontario Tobacco Research Unit.
"Even moderate exposure to passive smoking such as living or working with a smoker early in life increases a woman's risk of breast cancer when she's in her 30s, 40s or 50s," said panelist Anthony Miller, a professor and associate director of research at the Dalla Lana School of Public Health at the University of Toronto, CBC News reported.
Panel Chair Neil Collishaw said an estimated 80 percent to 90 percent of women have been exposed to tobacco smoke in adolescence and adulthood, which means they face an increased risk of breast cancer.
There's a cause-and-effect relationship between active smoking and increased risk of breast cancer for women of all ages, the panel concluded. But they said there's not enough evidence to link secondhand smoke exposure and breast cancer in older, postmenopausal women, CBC News reported.
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Morning Sickness Linked to Smarter Babies: Study
Children born to mothers who have morning sickness may be smarter than those whose moms don't have nausea and vomiting during pregnancy, suggests a new study.
Researchers found that the children of mothers with morning sickness scored higher on tests designed to assess children's IQ and mental acuity, the Canadian Press reported.
But while this difference was statistically significant, it doesn't mean that children born to mothers who didn't have nausea during pregnancy are developmentally slow, said senior author Dr. Gideon Koren, director of the Motherisk Program at the Hospital for Sick Children in Toronto. It's just that the other children scored higher on the tests.
The study appears in the Journal of Pediatrics.
Nausea has long been recognized as a sign of a healthy pregnancy, according to the CP. Pregnant women who have morning sickness are less likely to have a miscarriage and less likely to have babies with congenital cardiovascular problems.
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Missing Lab Samples Destroyed: U.S. Army
Three disease samples reported missing from a U.S. Army lab were likely destroyed, according to officials.
The samples of Venezuelan Equine Encephalitis were noted as missing last year during an inventory of samples left by a departing researcher, said Caree Vander Linden, a spokeswoman for the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., the Associated Press reported.
An investigation determined that the three samples were likely among those destroyed when a freezer malfunctioned, Vander Linden said Wednesday.
A thorough investigation found no evidence of criminal activity, said U.S. Army Criminal Investigation Command spokesman Chris Grey, the AP reported.
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