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    • News

    FDA Unexpectedly Rejects Pfizer’s Application for an Epoetin Alfa Biosimilar (Again)

    By C. Nichole Gifford June 28, 2017 Comments are off

    We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...

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    Tagged with: Amgen, epoetin alfa, Epogen®, FDA, Hospira, News, Pfizer, Regulatory

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    • News

    FDA Advisory Committee Meeting Announced for Amgen’s and Allergan’s Proposed Biosimilar to Avastin® (Bevacizumab)

    By C. Nichole Gifford June 8, 2017 Comments are off

    The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215,...

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    Tagged with: Allergan, Amgen, Avastin®, bevacizumab, FDA, Genentech, News, Regulatory

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  • Posted in:

    • Legal

    Litigation Spotlight: The Epoetin alfa (Epogen®) Litigation

    By Spencer Johnson June 5, 2017 Comments are off

    Introduction The Amgen, Inc. and Amgen Manufacturing, Limited (“Amgen”) litigation against Hospira, Inc. (“Hospira”), filed in...

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    Tagged with: Amgen, Amgen v. Hospira, BPCIA, District Court, epoetin alfa, Epogen®, Erythropoietin, Featured, Federal Circuit, Hospira, Janssen, Legal, Litigation, Notice Requirement, Patent Dance, Pfizer, Procrit®, Retacrit®, Supreme Court

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  • Posted in:

    • News

    FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Amgen’s Epogen®/Procrit® (epoetin alfa)

    By C. Nichole Gifford May 31, 2017 Comments are off

    Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s...

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    Tagged with: Amgen, Amgen v. Hospira, BPCIA, epoetin alfa, Epogen®, FDA, Hospira, Janssen, News, Pfizer, Procrit®, Regulatory, Retacrit®

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  • Posted in:

    • Legal

    Litigation Spotlight: The Apotex Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) Litigation

    By Rachel M. Echols May 10, 2017 Comments are off

    Introduction and Background The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the...

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    Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Featured, Federal Circuit, filgrastim, Legal, Litigation, Litigation Spotlight, Neulasta®, Neupogen®, Notice, Notice Requirement, Patent Dance, pegfilgrastim

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  • Posted in:

    • Legal

    Sanofi, Genzyme, and Regeneron Voluntarily Dismiss Dupixent® (Dupilumab) Declaratory Judgment Suit in Massachusetts

    By Seth Cockrum and C. Nichole Gifford May 8, 2017 Comments are off

    The battle over the proper forum for patent infringement litigation regarding Dupixent® (Dupilumab) appears to have been resolved.  Last...

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    Tagged with: Amgen, District Court, dupilumab, Dupixent®, Genzyme, Immunex, IPR, Legal, Litigation, PTAB, Regeneron, Sanofi, USPTO

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  • Posted in:

    • Legal

    The Patent Dance Goes on for Genentech and Amgen Over Bevacizumab (Avastin®)

    By C. Nichole Gifford and Daniel McCallum April 20, 2017 Comments are off

    Genentech filed suit against Amgen this past February when a dispute arose between the parties during the first step of the “patent...

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    Tagged with: Amgen, Avastin®, bevacizumab, BPCIA, District Court, Genentech, Genentech v. Amgen, Legal, Litigation, Patent Dance

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  • Posted in:

    • Legal

    Immunex Files Patent Infringement Suit Over Dupixent® (Dupilumab) and Seeks to Dismiss or Transfer Sanofi and Regeneron’s Prior DJ Complaint

    By C. Nichole Gifford and Seth Cockrum April 12, 2017 Comments are off

    As we previously reported, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. filed a Declaratory Judgment...

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    Tagged with: Amgen, District Court, dupilumab, Dupixent®, Immunex, Legal, Litigation, Regeneron, Sanofi

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  • Posted in:

    • News

    Sanofi and Regeneron Follow Declaratory Judgment Complaint with an IPR Petition as FDA Approves Dupixent® (dupilumab)

    By C. Nichole Gifford and Seth Cockrum March 30, 2017 Comments are off

    We reported last week that Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. had filed suit in...

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    Tagged with: Amgen, dupilumab, Dupixent®, Immunex, IPR, Legal, PTAB, Regeneron, Sanofi, USPTO

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