FDA declines to approve Brilinta
WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.
The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.
A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.
Eileen Myers joins The Little Clinic
BRENTWOOD, Tenn. — The Little Clinic has appointed Eileen Myers as director of prevention and health management. She will be responsible for leading the health-and-wellness initiatives and for overseeing the rollout of an expanded scope of services for the clinic operator.
Myers most recently worked as a private practice dietitian, counseling patients with weight and eating disorder issues. She also has been a consultant, providing motivational interviewing and behavior change strategy expertise for business and industry organizations. She has worked closely with The Little Clinic for three years as a consultant on scope of services and SmartPath Prevention programs.
"We are pleased to officially welcome Eileen Myers to our team," stated Ford Brewer, chief medical officer for The Little Clinic. "Her work with The Little Clinic over the past three years has been an asset as we continue to provide quality, affordable health care to our customers."
The Little Clinic currently operates healthcare clinics inside select Kroger stores in Kentucky, Tennessee and Ohio; King Sooper in Colorado; Fry’s Food Stores in Arizona; and Publix supermarkets in Georgia and Florida.
More than 6% of American women developed gestational diabetes in 2008
WASHINGTON — More than 6% of women who gave birth in hospitals in the United States in 2008 had diabetes or developed gestational diabetes during pregnancy, according to a new analysis by the federal government’s Agency for Healthcare Research and Quality.
The agency found that more than a quarter million women, or 6.4%, who gave birth had the conditions that can produce risks for the mother and the baby, including risk of preterm birth and miscarriage and risk of the baby having low blood sugar, jaundice or overly large body size. Gestational diabetes usually disappears after delivery.
The analysis was based on data in the report “Hospitalizations Related to Diabetes in Pregnancy, 2008,” which uses data from the 2008 Nationwide Inpatient Sample, a database of hospital inpatient stays in all short-term, nonfederal hospitals.