Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
Mylan
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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
Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 16, 2016 for inter partes...
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By C. Nichole Gifford Comments are off
On March 10, 2017, the PTAB published a decision terminating the proceedings in IPR2016-1693 and IPR2016-1694 because the parties have...
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By C. Nichole Gifford Comments are off
The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k)...
Tagged with: Biocon, FDA, Mylan, Neulasta®, News, pegfilgrastim, Regulatory, Roche
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