Mesoblast Limited
Level 1, 843A Glenhuntly Road
Caulfield South
VIC
3162
Tel: 03-9618-7000
211 articles with Mesoblast Limited
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Clinical Catch-Up: October 12-16
10/19/2020
It was another busy week for both COVID-19-related clinical trial news as well as trial updates for other indications. Here’s a look. -
Randomized Controlled Phase 3 Trial of Remestemcel-L for Reduced Mortality in COVID-19 Acute Respiratory Distress Syndrome Surpasses 50% Enrollment
10/13/2020
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that the randomized controlled Phase 3 trial of remestemcel-L on top of maximal care in ventilator-dependent patients with acute respiratory distress syndrome due to COVID-19 infection has surpassed 50% enrollment.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.
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In mid-August, the FDA’s Oncologic Drugs Advisory Committee voted 9 to 1 to recommend the drug for that indication. Although the agency isn’t required to follow an advisory committee’s recommendation, it usually does.
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The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
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Mesoblast Wins 2020 Fierce Biotech Innovation of the Year Award for remestemcel-L
9/15/2020
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that its lead product candidate remestemcel-L has been selected as the winner of the Fierce Innovation Awards - Life Sciences Edition 2020 for Biotech Innovation.
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Data Safety Monitoring Board Recommends Continuation of Remestemcel-L Phase 3 Trial in COVID-19 Patients With Acute Respiratory Distress Syndrome
9/4/2020
Mesoblast Limited announced that the independent Data Safety Monitoring Board recommended continuation of the Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome due to COVID-19 infection, following completion of trial’s first interim analysis.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
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Mesoblast Receives Ethics Approval to Treat COVID-19 Patients in Australia
9/2/2020
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that it has received ethics approval to include Australian hospitals in the Phase 3 randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome.
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Mesoblast Reports Substantial Operational Progress and Financial Results for the Year Ended June 30, 2020Mesoblast Well Prepared Ahead of First Potential US Product Launch
8/26/2020
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today reported operational highlights and financial results for the fourth quarter and full-year ended June 30, 2020 (FY2020). Mesoblast Chief Executive Dr Silviu Itescu stated: “We are very pleased to report the significant corporate progress made by the Company over the last financial year. The most notable achievement was the successful FDA Advisory Committee meeting held this month which resulted in an
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U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil™) for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease
8/14/2020
Mesoblast Limited announced that the Oncologic Drugs Advisory Committee of the United States Food and Drug Administration voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L in pediatric patients with steroid-refractory acute graft versus host disease.
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Update on Scheduled FDA Advisory Committee Meeting - Aug 11, 2020
8/11/2020
Mesoblast Limited provided an update on the scheduled meeting of the Oncologic Drugs Advisory Committee of the United States Food and Drug Administration which will review data supporting the Company’s Biologics License Application for approval of RYONCIL™ in the treatment of steroid-refractory acute graft versus host disease in children.
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Mesoblast Provides Remestemcel-L Update and Quarterly Activity Report
7/30/2020
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an update on upcoming milestones for its lead product candidate remestemcel-L, and an activity report for the fourth quarter ended June 30, 2020.
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Executive Leadership Expanded Ahead of First Potential U.S. Product Launch
7/24/2020
Mesoblast Limited, global leader in cellular medicines for inflammatory diseases, announced the appointment of Dagmar Rosa-Bjorkeson to the role of Chief Operating Officer, based in New York.
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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19
7/6/2020
Mesoblast Limited announced that an expanded access protocol has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 6, 2020.
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Remestemcel-L Improves Respiratory and Functional Outcomes in Patients With Inflammatory Lung Disease Phase 2 Trial Results Presented At 2020 International Society for Cell & Gene Therapy Annual Meeting
6/1/2020
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, announced that treatment with its lead mesenchymal stem cell product candidate remestemcel-L in patients with chronic obstructive pulmonary disease and an elevated state of inflammation resulted in improved respiratory and functional outcomes.
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Clinical Catch-Up: May 25-29
6/1/2020
In the lead-up to the ASCO Annual Meeting, companies were presenting some of their trial data, while other companies were presenting news related to COVID-19 studies. Here’s a look. -
Mesoblast Reports Strong Financial Position and Substantial Operational Progress For the Period Ended March 31, 2020
5/27/2020
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, reported financial, corporate and operational highlights for the nine months ended March 31, 2020.
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Mesoblast to Host Analyst Call on Financial Results for Period Ended March 31, 2020
5/26/2020
Mesoblast Limited, global leader in cellular medicines for inflammatory diseases, will host an analyst call to discuss the financial results for the period ended March 31, 2020.