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Novartis AG Says Biosimilar Shows Similar Efficacy As ...:  Novartis AG (ADR) (NYSE:NVS) released positive data for its experimental biosimilar of Amgen, Inc.'s (NASDAQ:AMGN) Neupogen today, which shows the biosimilar having similar efficacy against neutropenia in breast??...  Url: http://www.bidnessetc.com/

FDA plans review of Sandoz's Neupogen biosimilar ...:  FDA's Oncologic Drugs Advisory Committee will meet January 7 to discuss Sandoz's biologics license application for EP2006, a biosimilar version of Amgen's top-selling Neupogen (filgrastim) and the first ever biosimilar??...  Url: http://www.mmm-online.com/

Amgen-Sandoz squabble over Neupogen copy could ...:  In fact, as a lawsuit over Sandoz's knockoff version of the Amgen ($AMGN) therapy Neupogen shows, the two sides don't even agree on the rules. Here's the background. Sandoz, the Novartis ($NVS) generics unit, filed for??...  Url: http://www.fiercepharma.com/news

Neupogen (Filgrastim) Drug Information: Description, User ...:  Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)??? produced by recombinant DNA technology. NEUPOGEN?? is the Amgen Inc. trademark for Filgrastim??? which has been selected as the name for recombinant methionyl??...  Url: http://www.rxlist.com/script/main/hp.asp

Sandoz demonstrates safety and efficacy of Neupogen ...:  Sandoz, the generics subsidiary of Swiss pharma major Novartis (NOVN: VX), has today released Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference??...  Url: http://www.thepharmaletter.com/

FDA Law Blog: Feeling Dissed, Amgen Sues After Sandoz ...:  Feeling Dissed, Amgen Sues After Sandoz Abandons the BPCIA Patent Dance Procedures for NEUPOGEN Biosimilar; Alleges Unfair Competition, Patent Infringement, and Theft. By Kurt R. Karst ???. Ever since the July 2014??...  Url: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/

Amgen Fights To Protect Neupogen's Exclusivity - Seeking ...:  Sandoz, a unit of Novaratis, received notice from the FDA in July that its Biologic Licensing Application had been accepted and is currently under review. The.  Url: http://seekingalpha.com/

FDA Law Blog: Courtroom Drama Over NEUPOGEN ...:  Courtroom Drama Over NEUPOGEN Biosimilar Spills Over to FDA With the First Petition Accompanied by a 505(q) Certification. By Kurt R. Karst ???. Last week when this blogger reported on the lawsuit filed by Amgen, Inc.  Url: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/



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