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Merrimack gets orphan drug designation for pancreatic cancer treatment

BY Alaric DeArment

CAMBRIDGE, Mass. — The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

Merrimack announced that it received the designation for MM-398, described as a novel, stable, nanotherapeutic encapsulation of the chemotherapy drug irinotecan.

The FDA gives orphan drug designation to treatments for diseases that affect fewer than 200,000 people in the United States. Once approved, an orphan drug gets extended market exclusivity, regulatory fee reductions and support for research and development initiatives.

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FDA gives new approval to Novartis MS drug

BY Alaric DeArment

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker’s U.S. subsidiary said Monday.

Novartis Pharmaceuticals announced the FDA’s approval of Gilenya (fingolimod) for the reduction of T1 gadolinium-enhancing lesions, areas of inflammation in the central nervous system that mark disease activity in people with MS.

"Neurologists commonly use gadolinium contrast MRI activity to assess for active inflammation in people living with MS," MS Center for Innovations in Care at the Missouri Baptist Medical Center director Barry Singer said. "These data show that treatment with Gilenya helped to significantly reduce contrast MRI activity in people with relapsing-remitting MS."

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Safeway commences 10th annual MDA campaign

BY Allison Cerra

PLEASANTON, Calif. — Safeway announced its 10th annual campaign to benefit the Muscular Dystrophy Association’s efforts to develop treatments and assist people coping with neuromuscular diseases.

Through Labor Day, Safeway banners — including Safeway, Vons, Pavilions, Dominick’s, Randalls, Tom Thumb, Genuardi’s, Carrs and Pak ‘N Save stores in the United States and Canada — will collect donations that will be distributed to MDA and Muscular Dystrophy Canada. Additionally, the company’s U.S. retail stores also will participate in the "Make a Muscle, Make a Difference" program, which provides MDA with a portion of the proceeds of specially marked products purchased by Safeway customers.

Over the years, Safeway has raised more than $58 million for muscular dystrophy charities.

"We are honored and pleased to continue our association with one of the most highly regarded charitable causes in the world," said Larree Renda, EVP and chair of the Safeway Foundation. "MDA is a remarkable organization funding more than 300 leading-edge research projects worldwide annually that are changing lives."

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