PHARMACY

Johnson Foundation convenes committee to improve health of Americans

BY Drew Buono

WASHINGTON The Robert Wood Johnson Foundation has announced the formation of a new group called the Commission to Build a Healthier America. The commission will focus on factors outside the health care system and identify non-medical, evidence-based strategies—short- and long-term—to improve the health of Americans.

The group will investigate how factors, such as education, environment, income and housing, shape and affect personal behavioral choices through an extensive inquiry that will include regional field hearings.

Mark McClellan, the director of the Engelberg Center for Health Care Reform at The Brookings Institution and former FDA commissioner and administrator of the Centers for Medicare and Medicaid Services, and Alice Rivlin, senior economist at the Brookings Institution and former director of the Office of Management and Budget, will chair the two-year commission.

“For reasons that don’t appear to have much to do with health care, there is a big gap between how healthy we are and how healthy we could be,” said McClellan. “In fact, in some respects, wealthy Americans appear to be less healthy than middle income citizens of England. The commission will investigate practical strategies being developed and implemented around the country, in the public and private sectors, to strengthen our health and close the gap.”

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Possible new FDA diabetes drug guidelines could delay approvals

BY Drew Buono

SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.

The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.

That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.

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FDA approves Ranbaxy’s generic version of Risperdal

BY Drew Buono

NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.

Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.

Risperdal had sales of $924 million in 2007.

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