Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to...
Genentech
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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
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s...
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By Andrew Storaska Comments are off
On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s...
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By C. Nichole Gifford Comments are off
The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215,...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, FDA, Genentech, News, Regulatory
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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
Baxalta Incorporated and Baxalta GmbH (collectively “Baxalta” or “Plaintiffs”) filed a Complaint in the United States District...
Tagged with: Baxalta, Chugai, District Court, emicizumab, Genentech, Legal, Litigation, Shire
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