Tag Archives: biotechnology news

Sandoz Launches First Biosimilar Drug in U.S.

A new chapter in the generics/innovator wars began Thursday as Sandoz, Novartis’ generics division launched its Neupogen biosimilar, Zarxio, in the U.S. at about a 15-30% discount from the price of Neupogen. While biosimilars have been marketed in Europe since 2006, Congress … Continue reading

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Fed. Cir. Rules Requirements for Direct Infringement by Multiple Parties

CAFC Decides Akamai v Limelight–Holds For Infringement By Limelight–Defines Criteria For Directing And Controlling Customers’ Performance In Akami Technologies v. Limelight Networks, App. No. 2009-1372, -1380, -1416, -1417 (Fed. Cir., August 13, 2015), the court, sitting en banc after a … Continue reading

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FDA Finalizes Biosimilar Guidance

The Regulatory Affairs Professional Society (RAPS) has posted an informative article “After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity.”  The article includes links to the final guidance documents. You can find the article here.

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“Precision Medicine” Initiative Leaves Patents “Lost in Space”

On January 30th, the White House released a press release expanding upon President Obama’s mention of “precision medicine” in his State of the Union Address. Not surprisingly, the details are pretty much what we who are involved in various aspects … Continue reading

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