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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
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
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
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
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
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...
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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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
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
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...
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