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Merck’s Juvisync approved for Type 2 diabetes, high cholesterol

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

The FDA approved Merck’s Juvisync (sitagliptin and simvastatin), manufactured by Merck subsidiary MSD International GmbH Clonmel Co., based in Tipperary, Ireland. Merck operates under the name MSD outside the United States and Canada in order to avoid confusion with Germany-based Merck KGaA.

"This is the first product to combine a Type 2 diabetes drug with a cholesterol-lowering drug in one tablet," FDA Division of Metabolism and Endocrinology Products director Mary Parks said. "However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients."

Of the 26 million Americans with diabetes, about 20 million have Type 2 diabetes and often have high cholesterol levels as well.


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Kroger raises $1.5 million to support USO

BY Allison Cerra

CINCINNATI — Kroger announced that its annual Honoring Our Heroes fundraising campaign to support the United Service Organizations garnered $1.5 million.

The funds were raised in partnership with customers and associates through a variety of in-store activities at Kroger stores nationwide, as well as online at HonoringOurHeroes.com. Procter & Gamble and Anheuser Busch also participated in the program and contributed $250,000 each in conjunction with special sales programs in Kroger stores.

All of the funds raised will support the broad range of programs and services the USO provides to service members, their families and our veterans, Kroger said.

"We are forever grateful to our military men and women and their families for their service and sacrifice," Kroger group VP corporate affairs Lynn Marmer said. "The spirit of giving displayed by Kroger’s customers and associates in this year’s Honoring Our Heroes campaign exceeded our expectations. Their generosity will support the USO’s work to lift the spirits of America’s troops and their families."

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Merck KGaA, Ono sign agreement for oral MS, cancer drugs

BY Alaric DeArment

DARMSTADT, Germany — German drug maker Merck KGaA will collaborate with Japanese drug maker Ono Pharmaceutical to develop oral therapies for cancer and multiple sclerosis, Merck KGaA said.

The Merck Serono division of Merck KGaA, a separate company from U.S.-based Merck that operates as EMD in the United States and Canada, signed an agreement with Ono that gives it worldwide exclusive rights for development and commercialization of the MS drug ONO-4641 outside of Japan, Korea and Taiwan. Another license agreement gives Ono  Japanese co-development and marketing rights to Stimuvax, an investigative cancer immunotherapy that stimulates the body’s immune system to target cancer cells.

"Merck Serono is committed to building on our leadership franchise in multiple sclerosis, and we are excited about adding a potential oral treatment, ONO-4641, to our pipeline," Merck KGaA executive board member and Merck Serono division head Stefan Oschmann said. "We also believe that Ono will bring a wealth of experience in developing innovative therapies and understanding regulatory requirements in Japan."


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