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  • PhRMA: More than 400 rare disease treatments in development, pending approval

    WASHINGTON — More than 400 drugs are in late-stage clinical development or awaiting Food and Drug Administration approval as treatments for rare diseases, according to a report by the drug industry lobby.

  • Takeda seeks FDA approval for hypertension treatment

    OSAKA, Japan — Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.

    Takeda announced that it had submitted an application with the Food and Drug Administration for the fixed-dose drug azilsartan medoxomil and chlorthalidone. Azilsartan medoxomil is an angiotensin II receptor blocker, or ARB, that lowers blood pressure by blocking the angiotensin II hormone.

  • Par sees sales gains across all sectors

    WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

    Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.

  • Novo Nordisk develops treatment for rarest bleeding disorder, seeks FDA approval

    PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

    The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.

  • Onglyza gets label update

    PRINCETON, N.J., and WILMINGTON, Del. — The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

    Bristol-Myers Squibb and AstraZeneca said the Food and Drug Administration approved the labeling update for Onglyza (saxagliptin), which now includes efficacy and safety information about the drug's effects on patients with renal impairment or end-stage renal disease.

  • Forest to acquire Clinical Data

    NEW YORK — Drug maker Forest Labs plans to acquire the developer of a recently approved antidepressant.

    Forest announced that it would pay $1.2 billion, or $30 per share, to acquire Clinical Data, saying the acquisition would give it control of the drug Viibryd (vilazodone hydrochloride), a treatment for major depressive disorder in adults that won Food and Drug Administration approval last month. The agreement also includes up to $6 per share in addition for milestones related to Viibryd.

  • Study: Amphetamine use could pose Parkinson's disease risk

    ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

  • New cardiovascular risk calculator now available online

    NEW YORK — In line with American Heart Month, Boehringer Ingelheim's Micardis has introduced a cardiovascular risk-reduction calculator, designed to assess patients' cardiovascular risk.

    The calculator, which can be accessed at MicardisPro.com, is an interactive, useful tool for healthcare professionals to assist patients in reaching their cardiovascular risk-reduction goal, the company said.

    Micardis (telmisartan) is a drug designed to treat hypertension.

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