PHARMACY

Actos cuts Type 2 diabetes risk among majority of patients, study finds

BY Alaric DeArment

SAN ANTONIO — A drug for Type 2 diabetes made by Takeda Pharmaceutical taken in the morning prevented the disease from developing in nearly three-quarters of patients who were at risk, according to a new study in the New England Journal of Medicine.

Researchers enrolled 602 patients through the University of Texas Health Science Center San Antonio and seven other centers and administered Actos (pioglitazone) to them, finding that it prevented Type 2 diabetes in 72% of those whose obesity, ethnicity and other factors put them at risk for the disease.

“It’s a blockbuster study,” lead author and UT School of Medicine professor Ralph DeFronzo said. “The 72% reduction is the largest decrease in the conversion rate of prediabetes to diabetes that has ever been demonstrated by any intervention, be it diet, exercise or medication.”

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FDA approves Bristol’s cancer drug

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” FDA Office of Oncology Drug Products director Richard Pazdur said. “Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”

The news comes after the company reported that the drug boosted survival rates among patients in a late-stage clinical trial.

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Court: Watson’s generic Fentora infringes on branded counterpart

BY Alaric DeArment

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.

Cephalon sued Watson over the generic version of Fentora in 2008, though the Delaware court ruled that Watson’s version of the drug did not infringe U.S. Patent Nos. 6,200,604 and 6,974,590, and that those two patents are invalid.

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