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  • FDA rejection of lower-dose Copaxone will likely ward off generic competition

    NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

  • FDA approves Merck's Gardasil for prevention of anal cancer

    WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

    According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, and the only one indicated  to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.

  • Cephalon appoints new CEO

    FRAZER, Pa. — Cephalon on Thursday appointed Kevin Buchi as CEO and a member of the company's board.

  • FDA approves Watson oral contraceptive

    MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

    Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

  • FDA approves Novartis drug for high blood pressure treatment

    EAST HANOVER, N.J. — The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company. 

    Amturnide combines the only approved direct rennin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

  • Takeda settles patent suits relating to Actos

    DEERFIELD, Ill., and OSAKA, Japan — Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

  • Lilly completes acquisition of Avid

    INDIANAPOLIS — One month after announcing it would acquire a leader in molecular imaging development, Eli Lilly announced it has completed its acquisition of Avid Radiopharmaceuticals.

  • AstraZeneca discontinues development of RSV drug

    LONDON — An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

    AstraZeneca has requested the withdrawal of its pending biological license application for motavizumab from the Food and Drug Administration. Motavizumab is an investigational monoclonal antibody that could prevent serious respiratory syncytial virus disease.

    AstraZeneca said it will incur a financial impairment charge of $445 million in fourth quarter 2010.

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