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  • GSK, Impax ink licensing deal for Parkinson's drug

    LONDON and HAYWARD, Calif. — GlaxoSmithKline will pay Impax Pharmaceuticals $11.5 million upfront to exclusively sell Impax's investigational Parkinson’s disease treatment.

    In addition to the $11.5 million upfront payment, Impax Pharmaceuticals, the branded drug division of Impax Labs, is eligible to receive potential payments of up to $175 million upon the successful achievement of development and commercialization milestones.

  • Biodel's Steiner to retire, remains board member

    DANBURY, Conn. — A drug maker specializing in the treatment of diabetes announced the retirement of its chief scientific officer.

    Biodel this week said Solomon Steiner, who is a company co-founder, will remain on the company's board of directors. Prior to holding his chief scientific officer position, Steiner was chairman, president and CEO of Biodel from its inception in late 2003 through March of this year, at which point Errol De Souza was appointed to be the company's president and chief executive, and Charles Sanders was named board chairman.

  • 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.

  • Watson, Richter enter licensing agreement for Esmya

    MORRISTOWN, N.J. — A subsidiary of Watson Pharmaceuticals has entered a licensing agreement with a subsidiary of Hungarian drug maker Richter to develop and market a drug for uterine fibroids, the two companies said Thursday.

    Watson Labs and PregLem said European studies had shown Esmya (ulipristal acetate) to be a safe and effective treatment for the disease, a benign tumor condition that affects between one-fifth and one-fourth of women of reproductive age worldwide. Watson expected to start phase-3 studies of the drug in the United States in 2011.

  • FDA: Tessalon should be packaged in childproof containers

    SILVER SPRING, Md. — A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

    Tessalon (benzonatate) is made by Forest Labs and comes in the form of a round, liquid-filled gelatin capsule. The drug is used to relieve cough in patients older than 10 years of age.

  • Citing safety concerns, Lilly suspends cancer drug trial

    INDIANAPOLIS — Eli Lilly is suspending a late-stage clinical trial of a cancer drug amid safety concerns, the drug maker said Monday.

    The company had been conducting a phase-3 trial of the pharmaceutical drug tasisulam as a second-line treatment for patients with melanoma whose cancer could not be removed or had spread to other parts of the body. Melanoma, the deadliest form of skin cancer, is diagnosed in 68,000 people in the Untied States every year, according to the American Cancer Society.

  • 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.

  • 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.

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