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  • FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

  • Pfizer to sell Lipitor directly by mail

    NEW YORK — Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.

    The Wall Street Journal reported that Pfizer would partner with health plans to sell Lipitor (atorvastatin) directly to consumers through the mail when the drug's patent expires at the end of the month, opening the drug to generic competition.

  • Shire seeks approval to make Gaucher disease drug at new plant

    LEXINGTON, Mass. — British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.

    The company said Tuesday that it had filed with the Food and Drug Administration and the European Medicines Agency for approval to produce the Gaucher disease drug Vpriv (velaglucerase alfa) at its Lexington, Mass., plant. The company expects to win approval to make the drug there early next year.

  • Pfizer acquiring Excaliard Pharmaceuticals

    NEW YORK — Pfizer will acquire a San Diego-based drug maker focused on treatments for skin scarring, the company said Tuesday.

    Pfizer said it would buy privately owned Excaliard Pharmaceuticals, whose lead product, EXC 001, is in phase-2 trials for skin scarring, also known as skin fibrosis, a result of surgical procedures. There currently are no Food and Drug Administration-approved treatments to reduce scar severity. Financial terms of the deal were not disclosed.

  • FDA approves Eylea

    SILVER SPRING, Md. — After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

  • Amgen drug reduces risk of prostate cancer spreading to bones, study finds

    THOUSAND OAKS, Calif. — A drug made by Amgen delayed the spread of prostate cancer to the bones in men with the disease and prolonged the survival of men with the condition, according to results of a late-stage clinical trial.

  • Perrigo names M&A vet to corporate development post

    ALLEGAN, Mich. — Perrigo on Monday named Christopher Roop to the post of VP corporate development. In this role, Roop will be responsible for identifying, evaluating and pursuing acquisition targets that complement the company’s strategic growth objectives.

  • Gilead Sciences acquires Pharmasset for $11 billion

    FOSTER CITY, Calif. — Drug maker Gilead Sciences will acquire Pharmasset for $11 billion, or $137 per share, Gilead said Monday.

    Pharmasset, based in Princeton, N.J., is a drug maker that currently has three treatments for hepatitis C undergoing clinical trials, including PSI-7977, which is in late-stage development.

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