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  • Kombiglyze XR now available

    PRINCETON, N.J. — A new oral treatment for Type 2 diabetes hit the shelves Friday.

    Bristol-Myers Squibb and AstraZeneca announced the availability of Kombiglyze XR (saxagliptin and metformin hydrochloride), which the companies called the only once-daily treatment for diabetes that combined metformin with a DPP-4 inhibitor, the drug class to which saxagliptin belongs.

    The drug is designed for use alongside diet and exercise to improve glycemic control in adults with Type 2 diabetes.

  • Pfizer forms licensing agreement with Seattle Genetics

    BOTHELL, Wash. — Pfizer has paid Seattle Genetics $8 million to license its antibody technology, Seattle Genetics said Thursday.

    Seattle Genetics, based in Bothell, Wash., said Pfizer would pursue antibodies for treating an unspecified form of cancer using its antibody-drug conjugate technology. ADCs are monoclonal antibodies that selectively deliver anti-cancer agents to tumor cells. Seattle Genetics has developed anti-tumor drugs called auristatins, which are attached to antibodies and then used to kill the cancer cells while sparing noncancer cells.

  • Genentech granted supplemental approval for Actemra

    SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.

    The FDA approved Actemra (tocilizumab) for the inhibition and slowing of structural joint damage, improvement of physical function and achievement of clinical response in patients with moderate to severe rheumatoid arthritis. The drug originally was approved as a treatment for RA last year.

  • Spectrum, Viropro to develop biosimilar

    IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

    Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.

  • Merck's hepatitis C drug granted priority review by FDA

    WHITEHOUSE STATION, N.J. — The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

    Merck said the FDA would seek to complete its review of the application for the drug boceprevir within six months. Authorities in the European Union have granted expedited review as well.

  • AdventRx's application for Exelbine accepted by FDA

    SAN DIEGO — The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

    The FDA accepted AdventRx’s application for Exelbine (vinorelbine). The drug is a branded generic, being formulated with the same active ingredient as Navelbine, originally marketed by French drug maker Pierre Fabre and now available as a generic from seven companies.

  • Pfizer seeks to stop generic versions of Lipitor

    NEW YORK — A generic version of the world’s top-selling cholesterol treatment is expected to hit the market this year, but the branded version’s manufacturer is trying to put the brakes on the launch, according to media reports.

    Gurgaon, India-based Ranbaxy Labs plans to launch its version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin) in the United States in November and will receive six months’ market exclusivity in which to compete directly against Pfizer’s version, under the terms of the Hatch-Waxman Act of 1984.

  • Pfizer inks deal with Santaris

    SAN DIEGO — Pfizer will pay Danish biotech company Santaris Pharma $14 million for access to its development platform for RNA-based therapies, Pfizer said Tuesday.

    The drug maker said the deal would expand on an existing one between Hoersholm, Denmark-based Santaris and Wyeth, which Pfizer acquired in 2009. Santaris could take in up to $600 million in milestone payments, as well as royalties on products developed under the collaboration.

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