Posted in:News FDA Advisory Committee Recommends Approval of CAR-T Cell Therapy and Two New Biosimilars By C. Nichole Gifford July 18, 2017 Comments are off Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public... Read more Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Pfizer Challenges Genentech’s Carter ’213 Antibody Patent With Two New IPR Petitions By C. Nichole Gifford June 2, 2017 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... Read more Tagged with: Celltrion, Genentech, Herceptin®, Hospira, IPR, Legal, Mylan, News, Pfizer, PTAB, Roche, Teva, trastuzumab, USPTO http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News PTAB Institutes Hospira’s IPR on Herceptin® Patent By C. Nichole Gifford March 16, 2017 Comments are off Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 16, 2016 for inter partes... Read more Tagged with: Biocon, Genentech, Herceptin®, Hospira, IPR, Legal, Mylan, News, PTAB, Roche, trastuzumab, USPTO http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Genentech and Mylan Settle IPRs on Carter ‘213 Antibody Patent for Herceptin® By C. Nichole Gifford March 10, 2017 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... Read more Tagged with: Biocon, Genentech, Herceptin®, IPR, Legal, Mylan, News, PTAB, Roche, trastuzumab, USPTO http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Accepts BLA from Mylan and Biocon for Pegfilgrastim Biosimilar By C. Nichole Gifford February 16, 2017 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)... Read more Tagged with: Biocon, FDA, Mylan, Neulasta®, News, pegfilgrastim, Regulatory, Roche http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus