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If the company gets approval from the FDA, the third-party manufacturing facility will offer increased production capacity for the drug. The FDA approved Orencia, the first selective modulator

The new designation comes after the company presented positive results from a phase I/II study of the drug in May 2005. This fast track designation gives Genmab the

The alliance will utilize Trubion’s small modular immunopharmaceuticals (SMIPs), a novel class of immunotherapeutics with enhanced drug properties over monoclonal and recombinant antibodies. SMIPs are smaller than antibodies

Aspreva is currently conducting a global phase III study evaluating the efficacy and safety of CellCept in maintaining or improving symptom control with reduced doses of corticosteroids in

The trial is expected to enroll 49 patients with metastatic breast cancer who have relapsed following prior treatment with an anthracycline and taxane regimen. The primary objective of

The new drug application is primarily based on one-year data from the GLOBE study, an ongoing two-year phase III clinical trial comparing telbivudine with a standard therapy, lamivudine,

The payment was in connection with the closing of the deal that was first announced in November 2005. The value of this alliance could eventually exceed $400 million,

Review of the application is coordinated by the European medicines authority (EMEA). The procedure affords for a centralized authorization that is valid in all 25 member states of

Multicell will rename the compound to MCT-125, and will further evaluate it in a pivotal phase IIb/III clinical trial, which is expected to begin before the end of