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…]
Celularity Acquires CariCord, Adds Biosourcing Assets, Establishes Relationship with ClinImmune Labs
WARREN, N.J., Aug. 31, 2018 — Celularity, an allogeneic immuno-oncology and placental cell therapeutics company, today announced it entered into a definitive agreement to acquire CariCord, the family cord blood bank established by the University of Colorado and ClinImmune Labs. Through its exclusive ClinImmune Labs relationship, CariCord is the first, and so far the only family cord blood bank to operate inside a FDA Licensed Laboratory. ClinImmune Labs is an academic component of the School of Medicine at the University of Colorado at Denver and Health Sciences Center. Financial details of the transaction were not disclosed. [Read more…]
StemTek and Biopredic International partner to deliver assay ready liver models
Both companies plan to combine their respective technologies to deliver storable assay-ready 3D liver models for toxicology testing to reduce time and cost in new drug development.
August 21, 2018, Bilbao, Spain and Saint Grégoire, France — StemTek and Biopredic International are joining forces to design convenient, ready to use storable systems for toxicology screening on 3D liver cell models. 3D cell culture technology recapitulates the natural architecture of the tissue in a convenient laboratory format, producing more predictive data for in vivo tests. This technology allows a better understanding of the interaction of candidate compounds in areal physiological model, thus reducing drug failures. [Read more…]
Preliminary Results From BioCardia’s Phase III Pivotal CardiAMP Heart Failure Trial Reported In Circulation Research Journal
SAN CARLOS, Calif., Aug. 22, 2018 — In a Viewpoint paper published online today in Circulation Research, the Phase III CardiAMP Heart Failure Trial (CardiAMP-HF Trial) studying the investigational CardiAMP stem cell therapy from BioCardia®, Inc. (OTC: BCDA) was highlighted as an example of personalized medicine, with promising results from the first 10 patients in the roll-in cohort reported. The company believes this to be the first outcomes data published from any pivotal trial of a stem cell therapy for heart failure. The paper is authored by Peter Johnston, M.D., Eric Duckers, M.D., Ph.D., Amish Raval, M.D., Thomas Cook, Ph.D. and Carl Pepine, M.D. [Read more…]
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