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Regulatory and Washington

  • FDA approves generic hypertension pill made by Actavis

    DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

    Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.

  • FDA approves combination of two GSK drugs for skin cancer

    SILVER SPRING, Md. — The Food and Drug Administration has approved two drugs made by GlaxoSmithKline for use together in patients with advanced melanoma that can't be removed by surgery or has spread to other parts of the body, the agency said Friday.

    The FDA announced the new approval for Mekinist (trametinib) and Tafinlar (dabrafenib). The agency originally approved the two drugs for use as single agents for the same indication in May 2013.

  • NuVal, eastern Texas public health group partner on wellness initiatives

    QUINCY, Mass. — A company that ranks the nutritional value of foods sold in supermarkets is working with a public health organization in Texas to promote health and wellness.

  • APhA announces candidates for 2015-2016 president-elect; group awards grants for pharmacy-based projects to improve care

    WASHINGTON — A pharmacy professor and compounding pharmacy owner are candidates for president-elect of the American Pharmacists Association for 2015-2016, the group said.

    The APhA said the candidates for the position are Virginia Commonwealth University School of Pharmacy professor and community pharmacy residency program director Jean-Venable Goode and Newport Beach, Calif.-based Westcliff Compounding Pharmacy owner Michael Pavlovich. Members will have the opportunity to meet the candidates at the APhA Annual Meeting and Exposition in Orlando, Fla., in March.

  • NCPA survey: Drugs often don't make it to patients' hands due to efforts to combat prescription drug abuse

    ALEXANDRIA, Va. —Vulnerable patients, including seniors and cancer patients, suffer from lack of access to needed painkillers as efforts to combat diversion and misuse of controlled substances often result in drugs not getting into the hands of those who need them, according to a new pharmacist survey by the National Community Pharmacists Association. 

  • Good Fortune: 10 trends to watch in 2014

    Rather than take vacation for Christmas and New Year’s, the editors of DSN worked to compile a list of the top 10 trends that will shake up the business in 2014.

    Clinics explode onto scene

    Keep a close eye on retail-based health clinics come 2014.

    The convenient care industry has come far since hitting the scene in 2000 and today — with nearly 1,500 clinics nationwide — they are proving their importance within the changing healthcare landscape.

  • Takeda starts phase-3 trials of vedolizumab

    OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.

    Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn's disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.

  • Daiichi Sankyo hopes to get FDA nod for anti-clotting drug

    PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

    Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.

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