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Specialty Pharmacy

  • Natco Pharma gets FDA approval for generic Vidaza
    SILVER SPRING, Md. — The Food and Drug Administration has approved Natco Pharma’s generic of Celgene and Breckenridge’s Vidaza (azacitidine for injection). The drug is indicated to treat myelodysplastic syndrome.
     
    Natco’s generic will be available in a dosage strength of 100 mg per vial. The drug had combined sales of $188 million for the 12 months ended April 2017, the company said.
     

  • FDA outlines efforts to reduce orphan drug designation backlog

    SILVER SPRING, Md. — The Food and Drug Administration is committing to eliminate its orphan drug designation request backlog within 90 days and respond to all orphan drug requests within 90 days of receipt. The agency on Thursday outlined its Orphan Drug Modernization plan, which it said is part of a larger effort called the Medical Innovation Development plan modernize and make efficient the FDA’s regulatory tools and policies.

  • FDA approves Genentech’s Rituxan Hycela
    SILVER SPRING, Md. — The Food and Drug Administration recently approved a new treatment option for patients with three of the most common types of blood cancer. Genentech’s Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection was approved Thursday to treat adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma and previously untreated and previously treated chronic lymphocytic leukemia. 
     

  • AmerisourceBergen’s US Bioservices gets CPPA accreditation

    WASHINGTON — The Center for Pharmacy Practice Accreditation has awarded specialty pharmacy US Bioservices, a part of AmerisourceBergen, its specialty pharmacy practice accreditation, the organization announced Friday.

  • Walgreens and Greater Than AIDS teams on free testing for 7th straight year

    DEERFIELD, Ill. — Walgreens and Greater Than AIDS, a leading national public information response to the domestic HIV/AIDS epidemic, are teaming up for the seventh straight year with health departments and local AIDS service organizations to offer free HIV testing and counseling about prevention strategies, including Pre-Exposure Prophylaxis, as part of a National HIV Testing Day effort.

  • Supreme Court ruling offers some clarity on biosimilar ‘patent dance’

    WASHINGTON — In a decision that will have a big impact on the burgeoning biosimilars market, the Supreme Court on Monday overturned an appeals court decision which said Sandoz had to wait 180 days under federal law after receiving Food and Drug Administration approval to launch its biosimilar of Amgen’s Neupogen (filgrastim), Zarxio (filgrastim-sndz). The court did not rule out the possibility of state law allowing such an injunction, sending that question to a lower court.

  • AAM: Generics saved $253B in 2016, $1.7T in past decade

    WASHINGTON — Generics continue to play a key role in the healthcare system, according to the the Association for Accessible Medicines’ recently released ninth annual Generic Access and Savings in the U.S. report, compiled by the QuintilesIMS Institute for the AAM (formerly the Generic Pharmaceutical Association). The report highlights that generic drugs saved the healthcare system $253 billion in 201, bringing 10-year savings to $1.67 trillion.

  • Diplomat adds former OptumRx exec to board
    Jeff Park was OptumRx’s COO from July 2015 to July 2016 following the company’s merger with Catamaran, where Park had been EVP operations since March 2014.
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