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March 2015

Recent Stories of Interest

From Specialty Pharmacy News - Almost five years to the day that the 351(k) biosimilar pathway was established through the passage of the Biologics Price Competition and Innovation Act (BPCIA), the FDA on March 6 approved the first product to come onto the U.S. market through this route. The agency also granted Sandoz Inc.’s Zarxio (filgrastim-sndz) approval for all five indications that its reference drug, Amgen’s Neupogen, has, a move underscoring the FDA’s confidence in the biosimilar’s safety, purity and potency. Read more

After going literally decades without making an acquisition, Diplomat Pharmacy, Inc. has… Read more

Almost four months to the day from when a news report suggested… Read more

The drug industry focus on specialty pharmaceuticals will continue in 2015, spurred… Read more

From the Editor

Welcome to your Specialty Pharmacy News subscriber-only Web page

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March 30, 2015
UnitedHealth Agrees to Buy PBM Catamaran for $12.8B

UnitedHealth agreed to buy PBM Catamaran for $12.8 billion. http://tinyurl.com/qe3bea8

March 20, 2015
Judge Clears Way for First Biosimilar Launch

Judge declines to grant Amgen’s request for injunction to prevent Sandoz biosimilar Zarxio from launching; reference drug is Amgen’s Neupogen http://www.fdalawblog.net/NEUPOGEN%20-%20Opinion%20PI%20Denial.pdf

March 18, 2015
FDA OKs Expanded Use of Kalydeco

FDA approves Vertex’s Kalydeco for use in children ages 2 to 5 with certain mutations in CFTR gene; drug has had approval for use in people at least 6 years old http://tinyurl.com/l2ghrhz

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