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Regulatory and Washington

  • FDA approves J&J diabetes drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

    The FDA announced the approval of J&J subsidiary Janssen Pharmaceuticals' Invokana (canagliflozin) tablets, designed for use with diet and exercise to improve blood-sugar control in adults with the disease.

  • GPhA hires 'influential' D.C. lobbyist

    WASHINGTON — The generic drug industry's main trade group in Washington has hired a prominent lobbyist to head its government affairs team.

    The Generic Pharmaceutical Association announced that it had hired Melissa Schulman as SVP government affairs, describing her as "one of the best known advocates" in Washington, noting her ranking as an influential lobbyist in publications such as Roll Call, The Hill and National Journal. Schulman previously worked as a Democratic lobbyist for the Bockorny Group.

  • CDC launches second series of impactful 'quit smoking' ads

    ATLANTA — Continuing with the success of last year’s national education ad campaign, "Tips from Former Smokers," a second series of ads was launched Thursday by the Centers for Disease Control and Prevention. 

  • Giant-Landover signs statement of support for National Guard, reserve

    WASHINGTON — The head of Ahold USA's Giant-Landover banner has pledged the supermarket chain's support for the Department of Defense's Employer Support of the Guard and Reserve.

    Giant-Landover, officially Giant Food of Landover, Md., said president Anthony Hucker signed a statement of support for National Guard and reserve employees at the Brentwood Giant Food in Washington, accompanied by ESGR District of Columbia chairman George Alexander. Established in 1972, the ESGR develops and maintains employer support for the Guard and Reserve service.

  • HHS updates HIPAA rules for electronic health records

    NEW YORK — The Department of Health and Human Services issued a new rule that it said was necessary to protect the security of health information stored online.

    As required by the Health Information Technology for Economic and Clinical Health Act, which was part of the 2009 economic stimulus bill, HHS said it would change patient privacy rules in the Health Insurance Portability and Accountability Act in order to provide for privacy and security protection for information stored in electronic health records.

  • FDA approves injectable antihistamine using BD Simplist

    FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

    BD announced the approval of diphenhydramine hydrochloride injection, an antihistamine, packaged in its recently launched Simplist pre-filled injectables, which are made by subsidiary BD Rx and designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors.

  • Homeopathy association honors Sen. Tom Harkin

    MILWAUKIE, Ore. — The American Association of Homeopathic Pharmacists on Wednesday honored Sen. Tom Harkin, D-Iowa, with an award of appreciation for introducing and supporting legislation that safeguards Americans' right to choose complementary health care. Chairman of the Senate Health, Education, Labor and Pensions Committee, Harkin has been a longtime supporter of patient access to homeopathic medicines, AAHP noted. 

  • FDA approves Aciphex Sprinkle capsules

    WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

    Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.

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