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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By C. Nichole Gifford
On June 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”)...
Tagged with: AbbVie, adalimumab, Biogen, EMA, FDA, Humira®, Imraldi®, News, Regulatory, Samsung Bioepsis
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By C. Nichole Gifford
Fujifilm Kyowa Kirin Biologics announced that its Medical Marketing Application (“MMA”) for FKB327, a biosimilar to AbbVie’s Humira®...
Tagged with: AbbVie, adalimumab, AstraZeneca, Avastin®, bevacizumab, EMA, FDA, Fujifilm Kyowa Kirin, Humira®, News, Regulatory
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By C. Nichole Gifford
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
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
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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Janssen Files BPCIA Patent Infringement Suit Against Samsung Bioepis’s Renflexis® (infliximab-abda)
By C. Nichole Gifford
Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson, (“Janssen” or “Plaintiff”) filed a Complaint in...
Tagged with: BPCIA, District Court, Inflectra®, Infliximab, Janssen, Legal, Litigation, Patent Dance, Remicade®, Renflexis®, Samsung Bioepsis
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By C. Nichole Gifford
Partner Nikki Gifford gave a presentation entitled “Intellectual Property – Recent Developments and Implications,” at the World...
Tagged with: BPCIA, IPR, Litigation, Patent Dance, Sandoz v. Amgen, Supreme Court
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By C. Nichole Gifford
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
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