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Shelf life of Privigen extended

BY Alaric DeArment

KING OF PRUSSIA, Pa. A drug used to treat genetic immune deficiency disorders will have a longer shelf life under a decision by the Food and Drug Administration.

CSL Behring announced Monday that the FDA had approved its supplemental approval application to extend the shelf life of the IV drug Privigen (immune globulin intravenous [human]) from two to two and a half years, making it the first IV immunoglobin that can be stored at room temperature throughout its shelf life. The drug also is used to treat chronic immune thrombocytopenic purpura, a disease in which the immune system destroys platelets in the bloodstream, leaving patients susceptible to bleeding.

“CSL Behring has a history of developing innovative immonuglobin therapies, and we continually strive to enhance the quality of the life-saving products our patients depend on,” CSL Behring VP and general manager for U.S. commercial operations Robert Lefebvre said.

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Schnucks’ O’Brien to serve on Department of Agriculture advisory committee

BY Alaric DeArment

ST. LOUIS An executive from Schnuck Markets will serve on an advisory committee of the Department of Agriculture, Schnucks said this week.

Agriculture secretary Tom Vilsack announced that Schnucks VP produce and floral Mike O’Brien would be one of 25 people appointed to a two-year term on the USDA’s Fruit and Vegetable Industry Advisory Committee. O’Brien is also vice chairman of the Produce Marketing Association.

 

“I am honred to represent Schnuck Markets and the retail produce industry as a member of this committee,” O’Brien said. “I am looking forward to the opportunity to contribute and to make a difference for families across the nation.”

The committee, originally chartered in 2001, advises the secretary of agriculture on industry issues related to fruits and vegetables.

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Gilead commences phase 3 trial for single-tablet HIV treatment

BY Alaric DeArment

FOSTER CITY, Calif. Gilead Sciences has started a late-stage clinical trial of an investigational 4-in-1 treatment for HIV, the drug maker said.

Gilead announced the initiation of a phase 3 trial of its “Quad” HIV drug, a single-tablet treatment that combines elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. The study will compare the Quad regimen with the standard of care among adults with HIV-1 who have not taken antiretroviral treatments. The company is also investigating cobicistat as a standalone boosting agent for antiretroviral drugs.

“We are pleased to announce that the Quad phase 3 clinical program is underway,” Gilead EVP research and development and chief scientific officer Norbert Bischofberger said. “Efficacy and safety results from the phase 2 study suggest that the Quad may represent an important new option for patients with HIV.”

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