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  • FDA committee to discuss anti-NGF drug class at meeting

    WASHINGTON — A Food and Drug Administration panel will meet Monday to discuss a class of drugs designed to treat chronic painful conditions that currently are under development and the safety issues possibly related to the drugs.

  • FDA mulls over making some prescription drugs available over the counter

    SILVER SPRING, Md. — The Food and Drug Administration is looking at the possibility of selling certain prescription drugs over the counter under specific circumstances, the agency said.

  • Bydureon takes on diabetes

    The market for drugs to treat diabetes — especially Type 2 diabetes — has shown quite a bit of activity lately. At the end of January, the Food and Drug Administration approved Bydureon (exenatide), a once-weekly version of the drug Byetta, which was originally developed by Alkermes and subsequently developed further under an alliance between Amylin Pharmaceuticals and Eli Lilly that the two companies formed in 2002. In November 2011, however, Amylin and Lilly terminated their alliance in the wake of an announced diabetes drug partnership between Lilly and Boehringer Ingelheim.

  • Shire to compare Vyvanse with competing drug in phase-4 trial program

    PHILADELPHIA — Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

    Shire announced that it would start two phase-4 trials comparing its drug, Vyvanse (lisdexamfetamine dimesylate), with Alza's Concerta (methylphenidate hydrochloride).

  • Forest, Pierre Fabre drug 'significantly' reduced depression symptoms

    NEW YORK — A drug under development by Forest Labs and Pierre Fabre "significantly" reduced symptoms of major depressive disorder, the companies said Wednesday.

    New York-based Forest and Paris-based Pierre Fabre announced results of a phase-3 trial of levomilnacipran, saying the drug showed reductions in symptoms as early as one week after treatment was started. The companies expect results of another phase-3 trial of the drug this spring.

  • Diabetes drug from Lilly, BI hits shelves

    INDIANAPOLIS — A new drug for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim is available in pharmacies, the companies said Wednesday.

    The two companies announced the availability of Jentadueto (linagliptin and metformin hydrochloride). The Food and Drug Administration approved the drug on Jan. 30.

  • FDA turns down Eisai drug application

    WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

    Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

  • Drug price inflation outpaces general inflation, AARP study finds

    WASHINGTON — Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

    The study, conducted by AARP's Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.

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