PHARMACY

Sanofi-Aventis to close manufacturing plant

BY Alaric DeArment

KANSAS CITY, Mo. A decline in demand in North American markets has prompted a drug maker to close a plant in the United States.

Sanofi-Aventis U.S. announced last week that it would close its Kansas City, Mo., manufacturing plant. The plant mostly makes pill-based medications.

“The site has an excellent performance record, and the Kansas City community has been extremely supportive through the years,” Sanofi head of manufacturing for solid pharmaceuticals Alain Peychaud said in a statement. “Ultimately, however, the decision was made based on a strong decline in demand.”

The closing of the plant will take place in phases and is expected to be complete by mid-2012.

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Japanese drug maker permitted to start clinical trials of diabetes drug

BY Alaric DeArment

OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.

Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.

The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.

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FDA rejects application for new epilepsy drug

BY Alaric DeArment

TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.

Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.

J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.

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