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Specialty Pharmacy

  • Sanofi, Genzyme get closer to deal

    CAMBRIDGE, Mass. — It appears that French drug maker Sanofi-Aventis’ efforts to acquire U.S. biotech company Genzyme are getting somewhere, according to company and media reports.

  • PakSense introduces BIOmed Label

    BOISE, Idaho — PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.

    PakSense said its BIOmed Label is about the size of a sugar packet and can be used to digitally monitor the temperatures of pharmaceuticals, biologics and vaccines during storage and distribution.

  • 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.

  • 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.

  • 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.

  • Senator to float bill to address drug shortages

    EDINA, Minn. — Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem. The senator said she also is pressing the Food and Drug Administration and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.

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