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Regulatory and Washington

  • Federal court upholds validity of Crestor patent

    WILMINGTON, Del. — A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

    AstraZeneca said the Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the District of Delaware ruling that a patent covering the drug Crestor (rosuvastatin calcium) was valid and enforceable. The patent, which expires in 2016, covers the active ingredient of Crestor.

  • Natural Products Association suspends 2013 MarketPlace show

    WASHINGTON — The Natural Products Association MarketPlace trade show will be suspended, the organization said, citing "new opportunities more strategically aligned with today's market needs."

    The convention had originally been scheduled for June 2013 in Las Vegas. The Natural Products Association and New Hope Natural Media have collaborated to produce the convention since 2008.

  • NRF reports boost in November sales with start to holiday shopping season

    WASHINGTON — According to the National Retail Federation, eager holiday shoppers helped November retail sales — excluding automobiles, gas stations and restaurants — increase 0.8% seasonally adjusted from October and increase 4.4% unadjusted year-over-year. The NRF also expects holiday sales to grow 4.1% over the last holiday season.

  • Specialty patients in Los Angeles could be forced to use mail-order, advocates say

    NEW YORK — Thousands of patients in Los Angeles with serious, chronic diseases could soon find themselves unable to get their drugs from community pharmacies, advocates for the pharmacies said.

  • ATA partners with minority caucuses to advance telemedicine legislation at the state level

    WASHINGTON — The American Telemedicine Association, the leading nonprofit membership organization for remote medical services, is working with three minority legislative caucuses to educate lawmakers and introduce model legislation for telehealth in statehouses around the country. ATA has formed partnerships with the National Organization of Black Elected Legislative Women (NOBEL), the National Black Caucus of State Legislators (NBCSL) and the National Hispanic Caucus of State Legislators (NHCSL) with the goal of maximizing state-government support of telemedicine.

  • J&J subsidiary seeks approval for Type 2 diabetes drug

    RARITAN, N.J. — A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

    J&J division Janssen Research & Development announced Wednesday that it had filed with the Food and Drug Administration for a drug combining the experimental drug canagliflozin and immediate-release metformin, a common generic drug for diabetes.

    The company also submitted a regulatory approval application to the FDA for canagliflozin in May 2012.

  • NABP implements nationwide effort to oversee compounding pharmacies

    MOUNT PROSPECT, Ill. — A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

    The National Association of Boards of Pharmacy said Wednesday that it would implement a four-part action plan centered around inspection of compounding pharmacies and sharing data from the inspections among boards of pharmacies around the country.

  • FDA accepts application for Takeda, Lundbeck antidepressant

    DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

    The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

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