
Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir...
By Caitlin M. Wilmot Comments are off
Mumbai-based pharmaceutical manufacturer Lupin recently received FDA approval for its generic version of Roche’s Tamiflu® (oseltamivir...
Tagged with: FDA, Lupin, oseltamivir phosphate, Roche, Tamiflu®
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By Seth Cockrum Comments are off
We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva...
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By Seth Cockrum Comments are off
On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International...
Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, IPR, News, Patent Dance, Roche, Teva, trastuzumab
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By C. Nichole Gifford Comments are off
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab
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By C. Nichole Gifford 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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By C. Nichole Gifford 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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By C. Nichole Gifford 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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By C. Nichole Gifford 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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By C. Nichole Gifford 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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