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Regulatory and Washington

  • Generics cos. turn to biosimilars as patent cliff approaches

    With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


  • FTC, drug cos. clash over patent settlements

    It has become a perennial issue, and one that is likely to crop up at least once this year: patent settlements.


  • GDUFA reduces wait time for generics

    For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


  • Gilead receives FDA approval for lower-dose HIV drug in children

    FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

    Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

  • NCPA seeks special enrollment period for Part D patients from CMS

    ALEXANDRIA, Va. — The National Community Pharmacists Association is calling for the Centers for Medicare and Medicaid Services to allow senior patients to enroll in a new Medicare Part D prescription drug plan via a special enrollment period, particularly if patients believe that "material misrepresentations" led them to sign up for a "preferred network" plan with inadequate pharmacy access.

  • NACDS Foundation announces grant opportunity to study impact of medication management services

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores Foundation has announced a $750,000 grant opportunity to conduct research examining the impact of medication management services on patient health outcomes within existing medical homes or accountable care organization delivery models, and released a corresponding request for proposal.

  • New executives named to NRF board

    NEW YORK — The National Retail Federation has announced the newest executives elected to serve on its board of directors. The announcement was made during NRF's 101st Annual Convention in New York. Each new board member will serve a three-year term. Macy chairman, president and CEO Terry Lundgren was re-elected to serve another full-year as chairman of the NRF board. 

    The new executives elected to serve on NRF board of directors include:

    • Thomas Belk, Belk chairman and CEO;

  • Bristol-Myers Squibb, AstraZeneca diabetes drug hits speed bump at FDA

    PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

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