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  • Head of Lilly's oncology biz resigns

    INDIANAPOLIS — John Johnson is bidding Eli Lilly adieu.

    Johnson, who served as SVP and president of the drug maker's oncology business — whose portfolio includes Alimta (pemetrexed) and Gemzar (gemcitabine hydrochloride) — resigned, effective Jan. 28. Johnson is taking on the chief executive role at specialty biopharmaceutical company Savient, effective Jan. 31. Savient is best known for its chronic gout treatment Krystexxa (pegloticase), which received regulatory approval in September 2010.

  • J&J posts losses for Q4, full-year earnings

    NEW BRUNSWICK, N.J. — Johnson & Johnson posted decreases in sales for fourth quarter 2010 and for the year, according to an earnings statement released Tuesday.

    Sales for the quarter were $15.6 billion, a 5.5% decrease from fourth quarter 2009’s $16.5 billion. Sales for the year were $61.6 billion, down by 0.5% from $61.9 billion in 2009.

    Meanwhile, profits for the quarter were $1.9 billion, a 12% decrease from $2.2 billion in fourth quarter 2009. Profits for the year were $13.3 billion, an 8.7% increase over $12.3 billion in 2009.

  • FDA accepts filing for CDI treatment

    SAN DIEGO — The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

    Optimer announced Monday the FDA’s acceptance of its approval application for fidaxomicin for treating clostridium difficile infection, or CDI. CDI is a colon infection that is a particular problem in hospitals, long-term care centers and in the broader community. It is estimated to affect more than 700,000 people per year. The agency has granted the application priority review and expects to finish its review by May 30.

  • Viibryd gets FDA approval

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating major depressive disorder, the agency said Friday.

    The FDA announced the approval of Viibryd (vilazodone hydrochloride), made by New Haven, Conn.-based PGxHealth.

  • In study, Alexza's schizophrenia treatment significantly improves symptoms

    MOUNTAIN VIEW, Calif. — An investigational schizophrenia drug appears effective in reducing agitation in patients with the disease, according to results of a late-stage clinical trial published in the British Journal of Psychiatry.

    Alexza Pharmaceuticals announced results of a phase-3 trial of the inhaled drug AZ-004 (loxapine), which showed statistically significant improvement in symptoms of agitation in patients compared with the placebo.

  • Forest Labs announces phase-3 trial results for depression drug

    NEW YORK — A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

    U.S. drug maker Forest Labs and French drug maker Pierre Fabre Medicament said that while the overall difference between patients treated with levomilnacipran and those treated with the placebo was not statistically significant, the drug consistently demonstrated improvement relative to the placebo over the course of the phase-3 trial.

  • Report: Genzyme CEO calls acquisition by Sanofi-Aventis a long process

    BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

    The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

  • Vertex's hepatitis C drug granted priority review by FDA, Health Canada

    CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.

    Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.

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