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February 2016

Recent Stories

From Specialty Pharmacy News - In 2015, the specialty pharmacy industry hit some noteworthy milestones. The FDA approved a record number of drugs, with more than half of them considered specialty therapies. Approvals for oncology drugs continued to lead the specialty category, with the immunotherapies Yervoy (ipilimumab), Opdivo (nivolumab) and Keytruda (pembrolizumab) in particular racking up indications. The agency also approved the first biosimilar product, Zarxio (filgrastim-sndz), in a decision that most payers hope is merely the first of many to come (see story, below). Read more

When the FDA approved the first drug to use the 351(k) approval… Read more

The rising costs of drugs continue to garner headlines as payers struggle… Read more

With the pharmaceutical pipeline heavy with specialty products, many of them infusible,… 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.

January 14, 2016
BioMarin Receives Complete Response Letter for Duchenne MD Therapy

FDA issues complete response letter to BioMarin for Kyndrisa (drisapersen) NDA for Duchenne muscular dystrophy amenable to exon 51 skipping http://investors.bmrn.com/releasedetail.cfm?ReleaseID=950309

November 23, 2015
Repatha Will Be Only PCSK9 Inhibitor Offered by CVS/caremark

Amgen scored an exclusive spot on CVS/caremark's commercial formularies for PCSK9 inhibitor Repatha. http://tinyurl.com/pgpzle2

November 11, 2015
Express Scripts Terminates Pharmacy Tied to Horizon

Express Scripts removed a pharmacy with ties to Horizon Pharma from its network. http://tinyurl.com/nwqrhp3

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