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  • FDA reaccepts approval application for Remoxy

    CUPERTINO, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

    Durect announced Thursday that the FDA had accepted a resubmitted application by King Pharmaceuticals for Remoxy (oxycodone), a controlled-release painkiller designed to reduce the risks of misuse. King and Pain Therapeutics are developing the drug using Durect’s drug-delivery technology.

  • Q4, full-year earnings up for Novartis

    BASEL, Switzerland — Swiss drug maker Novartis posted sales of $14.2 billion for fourth quarter 2010 and $50.6 billion for the year as a whole, according to an earnings report released Thursday.

    That compared with sales of $12.9 billion and $44.3 billion during fourth quarter 2009 and 2009 as a whole, respectively. Profits for the year were nearly $10 billion, an 18% increase from $8.4 billion in 2009, though profits for the quarter decreased by 2%, from fourth quarter 2009’s $2.32 billion to $2.27 billion in fourth quarter 2010.

  • Amylin trims losses in Q4, full-year results

    SAN DIEGO — Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

  • Eisai's severe sepsis drug fails in trial

    WOODCLIFF LAKE, N.J. — Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

    Eisai said a phase-3 trial of the drug eritoran found the drug did not significantly reduce mortality in patients with the condition compared with placebo.

    Severe sepsis causes about 215,000 deaths in the United States every year, with a mortality rate of about 30%.

  • 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.

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