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Specialty Pharmacy

  • FDA looks to pull the plug on Avastin's breast cancer indication

    SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

  • FDA approves revised dosage of HIV-combo drug

    TITUSVILLE, N.J. — The Food and Drug Administration has approved a revised dosage for a drug combination, which includes a Johnson & Johnson drug, in HIV patients who have received treatment but whose virus has not become immune to the J&J drug.

  • Axium receives ACHC accreditation

    LAKE MARY, Fla. — The Accreditation Commission for Health Care has accredited specialty pharmacy provider Axium Healthcare Pharmacy, Axium said Tuesday.

  • Regulatory approval application accepted for Exparel

    PARSIPPANY, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug made by Pacira Pharmaceuticals, Pacira said Tuesday.

    The drug maker submitted its application for the long-acting painkiller Exparel (bupivacaine) in September.

    The drug is a topical medication for managing pain following surgery. The FDA expects to finish reviewing the application in July 2011.

  • Genzyme (again) turns down Sanofi-Aventis

    CAMBRIDGE, Mass. — Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.

    The offer has been extended until Jan. 11, Genzyme said.

    Sanofi has sought to buy Genzyme since August. Genzyme, based in Cambridge, Mass., specializes in treatments for rare genetic disorders, such as Fabry disease and Gaucher disease.

  • Gout treatment market to be driven by biotech drugs, Decision Resources finds

    BURLINGTON, Mass. — Biotech drugs will help drive the markets for acute and chronic gout through 2019, according to a new report by market research firm Decision Resources.

    The report, titled “Acute and Chronic Gout — New Agents Target Refractory Patients and Tap Market Opportunity,” found that the acute gout drug market would triple in size to $117 million, while the chronic gout market would reach $1.83 billion.

  • Trial data of investigational lung cancer treatment said to extend survival by more than four months

    RIDGEFIELD, Conn. — An investigational treatment for lung cancer made by Boehringer Ingelheim Pharmaceuticals extended patients’ survival by more than four months, according to results of a late-stage clinical trial announced Thursday.

    BI said the phase 2b/3 “LUX-Lung 1” trial of BIBW 2992 (afatinib) showed a fourfold increase in survival among advanced non-small cell lung cancer patients taking the drug versus those taking placebo, whose survival was extended by one month.

  • Study shows 50% reduction of myeloma among patients

    ANN ARBOR, Mich. — A new three-drug combination may work as a front-line treatment for cancer of the plasma cells, according to an early-stage clinical study.

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