Reuters Health News Summary
Following is a summary of current health news briefs.
Bowing to pressure, FDA approves Sarepta's Duchenne drug
Bowing to pressure from patient advocates, the U.S. Food and Drug Administration on Monday approved a treatment for Duchenne muscular dystrophy even though an outside panel of experts and the agency's own reviewers questioned the drug's efficacy. The FDA's lead reviewer, Dr. Ronald Farkas, recently quit the agency after issuing a scathing report criticizing the quality of the data presented by Sarepta Therapeutics Inc, developer of the drug Exondys 51, known also as eteplirsen.
Florida declares neighborhood Zika-free, but CDC remains cautious
U.S. health officials on Monday urged pregnant women to consider putting off nonessential travel to Miami due to the Zika virus even as they lifted a travel warning for one neighborhood. Earlier in the day, Florida's governor declared the neighborhood of Wynwood Zika-free and invited visitors to return. The Centers for Disease Control and Prevention left in place a travel warning issued on Aug. 19 for nearby Miami Beach even as it discontinued one issued on Aug. 1 for Wynwood due to local transmission of the mosquito-borne virus that can cause serious birth defects.
Wearable device helps reduce low blood sugar episodes
A new "flash" blood sugar monitoring system cuts down on episodes of low blood sugar in people with type 1 diabetes, researchers say. Low-blood sugar, or hypoglycemia, can be dangerous in diabetics. Sometimes called an insulin reaction, or insulin shock, severe cases of hypoglycemia can lead to unconsciousness and seizures.
Novartis intensifies Entresto push with new analysis
Novartis on Monday intensified its bid to convince doctors to prescribe its heart failure drug Entresto, releasing an analysis that concluded the medicine contributed to higher quality of life scores compared with an older drug. The decline in health-related quality of life scores among patients hospitalized with reduced ejection fraction heart failure was less steep among Entresto patients compared to those taking the drug enalapril, Switzerland's Novartis said in a statement.
GSK cuts vaccine price for refugees, bowing to pressure
GlaxoSmithKline is cutting the price charged for its pneumococcal vaccine when given to refugees, following complaints about the product's "exorbitant" cost by medical charity Medecins Sans Frontieres. The British drugmaker said on Monday it would provide Synflorix, which protects children against pneumonia and other diseases, at a discounted price of $3.05 per dose to recognized civil society organizations.
In youngest suicide victims, ADD is more common than depression
(Reuters Health) - When children under 12 commit suicide, they are more likely to have a diagnosis of attention deficit disorder than depression, a U.S. study suggests. "Although suicide is extremely rare in elementary school-aged children, a child can and sometimes will think about and even attempt suicide," said senior study author Dr. Jeffrey Bridge of Nationwide Children's Hospital in Columbus, Ohio.
U.S. FDA approves Bayer contraceptive device Kyleena
The U.S. Food and Drug Administration approved Bayer AG's hormonal contraceptive device, Kyleena, to prevent pregnancy for up to five years, the German company said on Monday. The small, flexible plastic T-shaped intrauterine device (IUD) releases the hormone levonorgestrel that stops the womb lining from thickening, which in turn prevents pregnancy.
Too little sleep, or too much, linked to risk of heart disease
(Reuters Health) - Sleep irregularities may be tied to a variety of health problems, such as diabetes and obesity, that can increase the risk of cardiovascular disease, a leading U.S. doctors group says. The risk may go up when people get too little sleep, or too much, according to a statement from the American Heart Association (AHA).
Astellas, Vical herpes vaccine fails mid-stage study
Japan's Astellas Pharma Inc and San Diego-based Vical Inc said their experimental herpes vaccine failed a mid-stage study involving certain kidney transplant patients. Vical's shares was down about 18 percent in light premarket trading on Monday.
Codeine not safe for kids, doctors warn
(Reuters Health) - Codeine isn't safe for children and shouldn't be used to ease pain or relieve coughs, a leading U.S. pediatricians group warns. Codeine has been prescribed for decades for both purposes, despite mounting evidence that it doesn't always work and sometimes causes serious or potentially fatal side effects, doctors argue in a statement from the American Academy of Pediatrics.
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