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  • FDA to allow dispensing of GSK's Type 2 diabetes drug Avandia in retail pharmacies again

    SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

  • Diplomat added to limited-distribution network for Cornerstone Therapeutics' Bethkis

    FLINT, Mich. — Cornerstone Therapeutics has added specialty pharmacy Diplomat to its limited-distribution network for a newly approved treatment for cystic fibrosis, Diplomat said Friday.

    Diplomat will distribute Bethkis (tobramycin inhalation solution), which received Food and Drug Administration approval in October for treating chronic bacterial lung infections caused by P. aeruginosa in cystic fibrosis patients.

  • Sandoz launches authorized generic version of PharmaDerm's Solaraze

    PRINCETON, N.J. — Sandoz has launched an authorized generic version of a topical drug for treating actinic keratosis, the company said.

    Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of authorized generic diclofenac gel in the 3% strength. The drug is a version of PharmaDerm's Solaraze.

  • FDA approves Bayer's Nexavar for thyroid cancer

    SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

    The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

  • FDA gives regular approval to Pfizer's Xalkori

    NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

  • Greatest phase-2, phase-3 drug R&D activity seen in oncology, report finds

    BURLINGTON, Mass. — While drug companies are developing treatments for a wide variety of diseases, the greatest amount of mid- to late-stage research and development activity is in cancer treatments, according to a new report.

    According to healthcare market research company Decision Resources, among the top 25 drug companies, oncology is the focus for 30% of phase-2 drugs and 22% of phase-3 drugs. Other areas seeing strong activity include drugs for obesity, diabetes, infections and central nervous system disorders.

  • Engaging patients: Health care’s new ‘holy grail’

    It has been called “the blockbuster drug of the century,” the holy grail of health care and the next great frontier in the search for a more responsive and cost-effective healthcare system. But is it a truly achievable goal, and will it really transform the way health care is delivered in the United States?

  • FDA wants more clinical trial data before approving Forest, Gedeon Richter psychiatric drug

    NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

    The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug's efficacy, but wanted more clinical trial data.

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