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Regulatory and Washington

  • Pharmacies extend ACO movement

    With new payment models beginning to change the way hospitals and health providers are reimbursed for their services, health plan payers scrambling to control unsustainable medical costs and health information technology linking up the patient care silos, a more integrated and patient-centric care model is emerging out of the chaos of a health system in transformation. 


  • FDA panel backs J&J tuberculosis drug

    RARITAN, N.J. — A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

  • Industry divided over patent settlements

    Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


  • User fee re-authorization 
fuels generics’ outlook

    Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


  • FDA approves Mylan overactive bladder drug

    PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

    Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

    Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

  • NACDS Foundation collects nearly $1.8 million at New York dinner

    ALEXANDRIA, Va. — The 14th annual National Association of Chain Drug Stores Foundation dinner raised nearly $1.8 million to fund research, charity and scholarships, the foundation said Wednesday.

  • New York Gov. Cuomo visits PharmaSmart

    NEW YORK — Kiosk manufacturer PharmaSmart got a visit from New York Gov. Andrew Cuomo Tuesday as he visited companies that his administration sees as leading the way in the state's economic development.

    PharmaSmart was one of two companies in the Rochester, N.Y., area and one of 20 in the state overall to become part of Cuomo's Empire State Development Program.

  • Durbin, Blumenthal ask FDA to review energy drinks quickly

    Some legislators are concerned with the way energy drinks can affect young consumers, especially in light of news reports linking several deaths with energy drink use.

    Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., are urging the Food and Drug Administration to move quickly to review the safety of these drinks.

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