
We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...
By C. Nichole Gifford 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...
Tagged with: Amgen, epoetin alfa, Epogen®, FDA, Hospira, News, Pfizer, Regulatory
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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 Spencer Johnson Comments are off
Introduction The Amgen, Inc. and Amgen Manufacturing, Limited (“Amgen”) litigation against Hospira, Inc. (“Hospira”), filed in...
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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By C. Nichole Gifford Comments are off
Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s...
Tagged with: Amgen, Amgen v. Hospira, BPCIA, epoetin alfa, Epogen®, FDA, Hospira, Janssen, News, Pfizer, Procrit®, Regulatory, Retacrit®
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By Rachel M. Echols Comments are off
Introduction and Background The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the...
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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By Seth Cockrum and C. Nichole Gifford 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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By C. Nichole Gifford and Daniel McCallum 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...
Tagged with: Amgen, Avastin®, bevacizumab, BPCIA, District Court, Genentech, Genentech v. Amgen, Legal, Litigation, Patent Dance
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By C. Nichole Gifford and Seth Cockrum Comments are off
As we previously reported, Sanofi-Aventis U.S. LLC, Genzyme Corporation, and Regeneron Pharmaceuticals, Inc. filed a Declaratory Judgment...
Tagged with: Amgen, District Court, dupilumab, Dupixent®, Immunex, Legal, Litigation, Regeneron, Sanofi
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By C. Nichole Gifford and Seth Cockrum 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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