Regulatory and Washington

LISLE, Ill. — Pharmacy benefit manager Catamaran Corp. has opened a new "Center of Excellence" in downtown Indianapolis, the company said Thursday.

Catamaran announced the opening of the 13,000-square-foot center, which it said will support the services it will provide under the $60 million, six-year Medicaid contract with the Indiana state government, signed in October.

DANBURY, Conn. — The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

Biodel announced that it had received orphan drug designation for glucagon to prevent hypoglycemia, or abnormally low blood sugar, in patients with CHI.

PHILADELPHIA — Patients once considered "aspirin resistant" may not be resistant to aspirin after all, according to a study published online by Circulation, the journal of the American Heart Association. Rather, the protective coating around the aspirin to prevent stomach issues may be delaying the absorption of aspirin, leading clinicians to believe that patients are aspirin resistant. 

ATLANTA — The influenza season is officially underway as flu incidence is already above the national threshold, Thomas Frieden, director of the Centers for Disease Control and Prevention, told reporters during a teleconference Monday. "This is the earliest regular flu season we've had in nearly a decade, since the 2003-2004 flu season," he said. "That was an early and severe flu year, and while flu is always unpredictable, the early nature of the cases as well as the specific strains we're seeing suggest that this could be a bad flu year."

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

The FDA announced the approval of Cometriq (cabozatinib) to treat medullary thyroid cancer — a cancer that develops in cells in the thyroid gland that make calcitonin, a hormone that helps maintain a healthy level of calcium in the blood — that has spread to other parts of the body. Another drug to treat medullary thyroid cancer, AstraZeneca's Caprelsa (vandetanib), was approved last year.

WASHINGTON — Increasing the prescriptions filled by Medicare beneficiaries by 1% would reduce the program's spending on medical services by about 0.2% by reducing costs in such areas as hospitalizations, according to a new report by the Congressional Budget Office.

RARITAN, N.J. — A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.