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August 2014

Recent Stories of Interest

From Specialty Pharmacy News - Almost four-and-a-half years after the Biologics Price Competition and Innovation Act of 2009 was passed as part of the Affordable Care Act, the FDA finally has accepted an application for a drug seeking approval through the 351(k) biosimilar pathway established in the BPCIA. Sandoz said July 24 that the FDA had accepted its application for biosimilar filgrastim, making it the first company to disclose such information. Industry expectations are that approval could come next year, ushering in a new era of potential cost savings through greater competition in the U.S. Read more

A closely watched pilot program in oncology conducted by UnitedHealthcare has not… Read more

The country’s largest independent specialty pharmacy is going public. Diplomat Pharmacy, Inc.,… Read more

Consumer advocacy groups in California and Florida have taken various actions against… Read more

From the Editor

Welcome to your Specialty Pharmacy News subscriber-only Web page

Be sure to visit often, for PDFs of issues, archives of articles and data, and more!

Please e-mail me with your comments on the last issue of Specialty Pharmacy News, story ideas for future issues, or any other suggestions you have that can make the newsletter more useful for you.

August 21, 2014
Were WAG Execs Ousted for Major Forecasting Error

Were two Walgreens execs ousted for major forecasting error? http://tinyurl.com/k7dmjqv

August 19, 2014
FDA Approves Oral Drug for Gaucher Disease

FDA approves Genzyme’s Cerdelga (eliglustat) for certain adults with Gaucher disease type 1; drug is only first-line oral therapy for indication http://tinyurl.com/onfafmt

August 18, 2014
FDA Approves Next-Generation Avonex for MS

FDA approves Biogen Idec’s Plegridy, a pegylated interferon to treat MS that’s dosed every two weeks; drug is next-generation version of Avonex, which has weekly dosing http://tinyurl.com/jwmckv2

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