FDA asks diabetes drug makers to prove treatments won’t increase risks to heart health
ROCKVILLE, Md. Manufacturers of drugs and biologics for treating Type 2 diabetes should include evidence that the treatments will not increase the risk of heart attacks and other cardiovascular disease, the Food and Drug Administration announced Wednesday.
More than 23 million people in the United States have diagnosed Type 2, or adult-onset, diabetes. Patients with diabetes have twice to four times the risk of heart disease, compared to those without it, and no approved therapies for diabetes have been proven to reduce the risk, the FDA said.
“We need to better understand the safety of new anti-diabetic drugs,” director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research Mary Parks said in a statement. “Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.”
Gilead sues Teva over approval application for generic Truvada
NEW YORK Gilead Sciences has filed a lawsuit against Israeli generic drug maker Teva Pharmaceutical Industries and a subsidiary.
Gilead, which filed the suit Friday in a United States District Court in New York, alleged that Teva committed patent infringement when it filed an approval application with the Food and Drug Administration for a generic version of Truvada (emtricitabine), a drug for treating HIV.
Gilead has a license to manufacture and sell the drug from Emory University in Atlanta.
Take Care adds another clinic to its network in Miami/Fort Lauderdale area
CONSHOHOCKEN, Pa. Take Care Health Systems, which is owned by Walgreens, has opened one new clinic in the Miami/South Fort Lauderdale area. The opening marks the 10th Take Care Clinic in the market.
The company currently operates 313 clinics in 18 states.