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Mesoblast is completing Phase 3 trials for its rexlemestrocel product candidates for advanced heart failure and chronic low back pain. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvcnlvbmNpbC1yZW1lc3RlbWNlbC1sLTQwMDAwOTg= According to CEO Silviu Itescu, “if approved, the launch for this product [Ryoncil] is planned in 2020.“We have a PDUFA date for September 30, and we have industrial scale manufacturing in place to meet the commercial demand as we expect to move forward.”Itescu added: “We have sufficient capacity to meet our Ryoncil GVHD launch plans, and we have the ability to increase and plans underway to increase our capacity requirements.”The deal grants Mesoblast access to the Swiss CDMO’s cell therapy manufacturing facility in Singapore.The firm also has the option of asking Lonza to build a dedicated facility to meet its long-term commercial objectives.Ryoncil is made from mesenchymal stem cells from healthy donors.According to Mesoblast, it counteracts the inflammatory processes responsible for steroid-refractory aGVHD in people who have received prior stem cell transplants.The product’s mechanisms of action include “down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.”Ryoncil is also being tested as a therapy for children infected with COVID-19 who have acute respiratory distress syndrome, cardiovascular problems or other complications.Itescu said: “For acute respiratory distress syndrome, recruitment of Phase III trial of remestemcel is ongoing. encoded search term (remestemcel-L (Ryoncil)) and remestemcel-L (Ryoncil) Hematology-Oncology Guidelines: 2017 Midyear ReviewAmerican Cancer Society Update: 'It Is Best Not to Drink Alcohol'Time to Stop Pressuring Women on Screening Mammography?Mid-Career Oncologist Cites Harassment, Leaves Top Center Ruxolitinib Beats Standard Therapy at Tamping Down Resistant Graft-Versus-Host DiseaseShare cases and questions with Physicians on Medscape consult.

The trial completion is expected during the fourth quarter.“And we assume that we will be establishing a strategic partnership for manufacturing commercialization for this indication.”Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.Many technologies are used to characterize biological products, manufacturing processes, and raw materials.

Diseases & Conditions An FDA advisory committee voted 9-1 in favor of approval of the cell therapy remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease. It is an investigational therapy comprising culture-expanded mesenchymal stem cells. 989518-overview Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Article Scant evidence for Mesoblast’s stem cell candidate in treating pain, say experts. If approved, RYONCIL is expected to be launched in the US in 2020.Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate Ryoncil™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD).

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Ryoncil is already marketed in Japan for the treatment of children and adults with acute Graft Versus Host Disease, under the brand name Temcell, by Mesoblast's licensee JCR Pharmaceuticals Co., Ltd.

886758-overview If approved, RYONCIL has the potential to be an effective and safe therapy to improve survival outcomes in the most vulnerable population of children with severe forms of this disease who can have mortality rates as high as 90 percent.”In January, Mesoblast filed a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for RYONCIL for the treatment of children with steroid-refractory aGVHD. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. More on this story. Ryoncil (remestemcel-L) is a candidate cell therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD).

17-10-2019.

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