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  • Pfizer receives complete response letter for Remoxy

    NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

    The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.

  • Chris Noth tapped as ambassador for Ask.Screen.Know.

    PRINCETON, N.J. — Novo Nordisk has teamed up with actor Chris Noth to underscore the importance of early diabetes screening and detection.

    Noth will serve as an ambassador for the national education program Ask.Screen.Know., Novo Nordisk said. As an ambassador, Noth will encourage Americans ages 45 years or older to get tested for diabetes and talk to a healthcare professional about the risk factors through a public service announcement and online at AskScreenKnow.com.

  • Watson to expand Salt Lake City manufacturing, R&D plant

    SALT LAKE CITY — Watson Pharmaceuticals plans to expand its manufacturing and research and development plant in Salt Lake City, the drug maker said.

    The $44 million expansion of the plant will include retrofitting about 20,000 sq. ft. of space and the construction of about 17,000 additional sq. ft. The expansion of the plant, which makes transdermal patches and topical gels, is expected to include the addition of about 300 new employees over the next three to five years.

  • AstraZeneca sells off Astra Tech to Dentsply

    WILMINGTON, Del. — AstraZeneca announced that it is selling its Astra Tech business to a professional dental products company in a cash transaction valued at about $1.8 billion.

    Dentsply will acquire Mölndal, Sweden-based Astra Tech, which focuses on dental and healthcare products, services and support. In 2010, Astra Tech recorded worldwide revenue of $535 million.

    AstraZeneca noted that the transaction is anticipated to be completed during the second half of 2011.

  • Endo completes acquisition of American Medical Systems

    CHADDS FORD, Pa. — Endo Pharmaceuticals has acquired a provider of devices and therapies for male and female pelvic health.

    Endo said its acquisition of American Medical Systems has boosted the drug maker's devices and services business segment, and the combination of AMS with Endo's existing platform will provide additional cost-effective solutions across the entire urology spectrum.

    The company announced its definitive agreement to acquire AMS in a cash transaction valued for approximately $2.9 billion.

  • Pfizer, Acura get FDA OK for Oxecta

    NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

    Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.

  • J&J subsidiary recalls one lot of Risperdal, risperidone tablets

    TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

    J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

  • FDA panel unanimously recommends approval of Eylea

    TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

    Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

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