On September 27, 2018, Cellular Biomedicine Group Inc. (NASDAQ: CBMG) announced it entered into a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah® in China. [Read more…]
Fate Therapeutics and ONO Pharmaceutical to Develop Off-the-Shelf, iPSC-derived CAR-T Cell Cancer Immunotherapies
Option-based Collaboration to Develop Two CAR T-Cell Product Candidates Using Fate’s Proprietary iPSC Product Platform
SAN DIEGO, Sept. 17, 2018 — Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that it has entered into a collaboration with ONO Pharmaceutical Co., Ltd. for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates. Using Fate Therapeutics’ proprietary induced pluripotent stem cell (iPSC) product platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. [Read more…]
Novartis Receives Health Canada Approval of its CAR-T cell therapy, Kymriah™
- Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy approved in Canada, is manufactured individually for each patient
- Novartis is working with qualified treatment centres to prepare for the delivery of this treatment for relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL indications
DORVAL, QC, Sept. 6, 2018 – Novartis is pleased to announce that following a Priority Review, Health Canada has approved Kymriah™ (tisagenlecleucel/ CTL019) the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in Canada.
Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, demonstrating the critical need for new therapies for these patients. [Read more…]
CAR-T Manufacturing | Novartis Selects French CDMO CELLforCURE
CELLforCURE is a French pharmaceutical group that is authorized to do CAR-T manufacturing at its bioproduction site in Les Ulis (Essonne). CELLforCURE holds two Good Manufacturing Practice (GMP) certificates that allows it to manufacture experimental and commercial cell and gene therapies.
On July 10, 2018, CELLforCURE signed an agreement to manufacture CAR-T products for Novartis. Under the terms of the agreement, CELLforCURE will produce cancer CAR-T therapies (“chimeric antigen receptor T-cells”).
Production is scheduled to begin in 2019 following transfer of Novartis’ CAR-T manufacturing technology to CELLforCURE. [Read more…]
RegMed Innovative Spikes on Heels of CAR-T, Gene Therapy, & Digital Pill Approvals
The regenerative medicine industry is a high-value, fast-growth market. With two CAR-T approvals, as well as the first gene therapy and digital pill approvals in the United States, we have had a lot of FDA “firsts.” The market gathered momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta), further “snowballing” the effect. [Read more…]
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