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    Lupin’s Generic Version of Tamiflu® Joins the Band of Flu Fighters

    By Caitlin M. Wilmot February 20, 2018 Comments are off

    Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir...

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    Tagged with: FDA, Lupin, oseltamivir phosphate, Roche, Tamiflu®

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    Celltrion and Teva File Declaratory Judgment Action Against Thirty-Seven Rituxan®-related Patents

    By Seth Cockrum January 16, 2018 Comments are off

    We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva...

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    Tagged with: Biogen, Celltrion, Genentech, Herceptin®, IPR, News, PTAB, Rituxan®, Rituximab, Roche, Teva, trastuzumab

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    Celltrion and Teva File Declaratory Judgment Action Against Thirty–Eight Herceptin®-related Patents

    By Seth Cockrum January 15, 2018 Comments are off

    On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International...

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    Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, IPR, News, Patent Dance, Roche, Teva, trastuzumab

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    FDA Advisory Committee Recommends Approval of CAR-T Cell Therapy and Two New Biosimilars

    By C. Nichole Gifford July 18, 2017 Comments are off

    Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...

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    Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab

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    Pfizer Challenges Another Herceptin® Patent With Two New IPR Petitions

    By C. Nichole Gifford July 11, 2017 Comments are off

    On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897...

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    Tagged with: Genentech, Herceptin®, Hospira, IPR, Legal, News, Pfizer, PTAB, Roche, trastuzumab, USPTO

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    Pfizer Challenges Genentech’s Carter ’213 Antibody Patent With Two New IPR Petitions

    By C. Nichole Gifford June 2, 2017 Comments are off

    On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213...

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    Tagged with: Celltrion, Genentech, Herceptin®, Hospira, IPR, Legal, Mylan, News, Pfizer, PTAB, Roche, Teva, trastuzumab, USPTO

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    Celltrion Challenges Another Herceptin® Patent With Two New IPR Petitions

    By C. Nichole Gifford May 18, 2017 Comments are off

    Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213...

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    Tagged with: Celltrion, Genentech, Herceptin®, IPR, Legal, News, PTAB, Roche, Teva, trastuzumab, USPTO

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    Pfizer Files IPR Petitions on Three More Rituximab® Patents

    By C. Nichole Gifford May 3, 2017 Comments are off

    Over the last two weeks, Pfizer, Inc. (“Pfizer”) has filed petitions for inter partes review (“IPR”) of three additional patents...

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    Tagged with: Biogen, Celltrion, Genentech, IPR, Legal, Mabthera, News, Pfizer, PTAB, Rituxan®, Rituximab, Roche, USPTO

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    Celltrion Submits Application for Herzuma (trastuzumab) in Japan and Launches Truxima (rituximab) in Europe

    By C. Nichole Gifford May 2, 2017 Comments are off

    Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in...

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    Tagged with: Celltrion, EMA, FDA, Genentech, Mabthera, News, Regulatory, Rituxan®, Rituximab, Roche

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