Posted in:News Two New Applications for Trastuzumab (Herceptin®) Biosimilars Pending at FDA By C. Nichole Gifford August 11, 2017 Comments are off Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to... Read more Tagged with: Allergan, Amgen, Biocon, Celltrion, FDA, Genentech, Herceptin®, Hospira, Mylan, News, Pfizer, Regulatory, Teva, trastuzumab http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
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 FDA Advisory Committee Meeting Announced for Amgen’s and Allergan’s Proposed Biosimilar to Avastin® (Bevacizumab) By C. Nichole Gifford June 8, 2017 Comments are off The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215,... Read more Tagged with: Allergan, Amgen, Avastin®, bevacizumab, FDA, Genentech, News, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus