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Licensing

  • FDA approves first-ever drug for rare blood disorder

    SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment made by Alexion Pharmaceuticals for a rare blood disorder that affects children.

    The FDA announced the approval of Soliris (eculizumab) for atypical hemolytic uremic syndrome, a rare and chronic disease that can lead to kidney failure, stroke and death. According to the FDA, aHUS accounts for 5% to 10% of all cases of hemolytic uremic syndrome.

  • Compounding pharmacies not under FDA jurisdictional authority, federal judge rules

    HOUSTON — A recent federal court ruling could have big implications for compounding pharmacies.

  • Q&A: Eyeing managed care in 'HD' — Mark deBruin, H. D. Smith

    Longtime industry veteran Mark de Bruin in July signed on with wholesaler H. D. Smith as corporate VP managed care. Drug Store News sat down with de Bruin recently to discuss the managed care climate for the independent pharmacy operator and how the business of pharmacy continues to evolve. 


    DSN: What are the challenges facing managed care networks today? 


  • Eddie Li to join Novo Nordisk as VP regulatory affairs

    PRINCETON, N.J. — Novo Nordisk has appointed a new VP regulatory affairs.

    Effective Sept. 12, Eddie Li will lead the drug maker's U.S. regulatory team and maintain relationships with individuals and agencies outside of Novo Nordisk that play a role in the Food and Drug Administration's review and approval process, the company said.

    Li will report to Anne Philips, corporate VP clinical development, medical and regulatory affairs for North America.

  • PTCB executive director, CEO steps down

    WASHINGTON — Melissa Murer Corrigan, executive director and CEO of the Pharmacy Technician Certification Board, is leaving the organization in late November, PTCB's board of governors announced Thursday.

  • Impax confirms patent challenge for generic Nuedexta

    HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempts to market a generic pseudobulbar affect treatment.

    Impax said that Avanir Pharmaceuticals, Avanir Holding Co. and the Center for Neurologic Study filed a patent infringement suit in the U.S. District Court of Delaware in connection with Impax's attempt to market a generic version of Nuedexta capsules (dextromethorphan hydrobromide and quinidine sulfate) in the 20-mg/10-mg strength.

  • BioPlus Specialty Pharmacy awarded VIPPS accreditation

    ALTAMONTE SPRINGS, Fla. — Less than one month after joining the specialty pharmacy network of health insurer Blue Cross and Blue Shield of North Carolina, BioPlus Specialty Pharmacy has received an accreditation from the National Association of Boards of Pharmacy, the company said.

  • BestNursingDegree.com awards $7,500 in scholarships to promote nursing education

    CAMBRIDGE, Mass. — BestNursingDegree.com, an education and career resource for current and aspiring nurses, has announced the winners of this year’s “Back to School” nursing scholarships.

    The scholarships, in the amount of $2,500 each, were created to support nursing education at various levels. Winners were chosen from a pool of more than 500 applicants on the strength of their academic and extracurricular records. The winners are as follows:

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