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Regulatory and Washington

  • CDC study reports drop in lower-limb amputations among diabetes patients

    ATLANTA — Leg and foot amputations among patients diagnosed with diabetes saw a dramatic decline between 1996 and 2008, thanks to improvements in blood-sugar control, foot care and diabetes management, along with declines in cardiovascular disease, according to a new study conducted by the Centers for Disease Control and Prevention.

  • NRF welcomes President Obama's emphasis on job creation

    WASHINGTON — After President Barack Obama delivered his State of the Union address on Tuesday night, the National Retail Federation issued a response regarding his remarks on job creation.

    NRF said it welcomed the President's emphasis on job creation, saying that it will help restore the nation's economic state.

  • FDA approves new administration method for Takeda cancer drug

    CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.

    The FDA approved injection under the skin of Velcade (bortezomib) for multiple myeloma and mantle-cell lymphoma, also known as subcutaneous injection.

    Takeda said the approval was based on results of a phase-3 trial conducted on 222 patients who had not received the drug before that showed subcutaneous injection worked as well as intravenous injection.

  • FDA OKs Genzyme plant in Massachusetts

    CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.

    Genzyme said the plant, located in Framingham, Mass., will help the company continue the production of Fabrazyme (agalsidase beta), a Fabry disease treatment, so that patients can be return to the full dosing levels (1 mg/kg).

  • Watson acquires Ascent Pharmahealth

    PARSIPPANY, N.J. — Watson Pharmaceuticals has acquired the Australia and Southeast Asia generic pharmaceutical business of Strides Arcolab for $392.4 million in cash.

  • Weis Markets joins SmartWay Transport Partnership

    SUNBURY, Pa. — Weis Markets on Monday announced it has joined the SmartWay Transport Partnership, a U.S. Environmental Protection Agency program that will help the grocer assess the environmental impact and energy efficiency of the trucks supplying its 161 stores.

  • Perrigo files for approval of generic nasal allergy drug

    ALLEGAN, Mich. — Perrigo is seeking approval from the Food and Drug Administration for a drug used to treat allergies in adolescents and adults, the company said Monday.

  • FDA panel gives thumbs down to Columbia Labs reproductive drug

    PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

    Columbia Labs and Watson Pharmaceuticals announced that the FDA's Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.

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