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May 2016

Recent Stories

From Specialty Pharmacy News - A dispute between the New York attorney general and various health insurers over their restrictive coverage of hepatitis C drugs could produce ripples that reach beyond that state. The situation is not the first such instance of pushback against payers’ coverage policies, and it’s certainly not the first example of resistance to policies specific to hepatitis C therapies. But it could very well serve as a catalyst for other groups that are fighting back on ever-tightening specialty drug coverage policies. Read more

As genetic tests continue to flood the market, Cigna Corp. is preparing… Read more

In a little more than a year after the FDA approved the… Read more

CMS’s recently proposed rule that would test different reimbursement tactics in Medicare… 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.

May 18, 2016
Genentech Bladder Cancer Drug Gets Accelerated Approval

FDA gives accelerated approval to Genentech’s Tecentriq (atezolizumab) to treat common type of bladder cancer; drug is first and only anti-PDL1 cancer immunotherapy with FDA approval http://www.gene.com/media/press-releases/14626/2016-05-18/fda-grants-gen...

April 6, 2016
FDA Approves Second Biosimilar

The FDA approves Celltrion’s Inflectra for all indications of the reference product, Janssen Biotech’s Remicade; drug is second FDA-approved biosimilar, first monoclonal antibody www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm

March 31, 2016
FDA Issues More Biosimilars Draft Guidance

FDA releases draft guidance on biosimilar products’ labeling, gives 60-day comment period http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

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