A new, worldwide coalition of plasma companies seeking to develop and deliver a hyperimmune immunoglobulin therapy for fighting COVID-19 takes the view that many hands make light work.
The Korea Export Import Bank (KEXIM) took a step toward fulfilling its mandate to finance Korean companies’ overseas expansion by seeking managers for a new ₩400 billion (US$328 million) fund.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Algernon, Arcturus, Ascentage, Ascletis, Astellas, Athersys, Beigene, Bellerophon, Biohaven, Calcimedica, Can-Fite, Hope, Predictive, Ridgeback.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Aslan, Bausch Health, Biocryst, Bridge, Eli Lilly, Firstwave, Fujifilm, Kazia, Laurent, Mesoblast, Neuclone, Viriom.
The latest global regulatory news, changes and updates affecting biopharma, including: Drug Enforcement Administration, Department of Health and Human Services, FDA, International Coalition of Medicines Regulatory Authorities, EMA, European Commission, National Institute for Health and Care Excellence, NIH, Office for Human Research Protections, Pharmaceuticals and Medical Devices Agency, Therapeutic Goods Administration.
PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
Indian scientists have discovered a previously unknown mechanism underlying life-threatening sepsis and proposed a new treatment strategy centered upon cell-free chromatin (cfCh), they reported in the March 4, 2020, edition of PLOS ONE.
HONG KONG – China’s I-Mab Biopharma Co. Ltd. has entered a strategic partnership with Indonesia’s PT Kalbe Genexine Biologics (KG Bio). Through the deal, KG Bio will receive the right of first negotiation to commercialize two I-Mab-discovered candidates in the ASEAN and MENA regions as well as Sri Lanka.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19). “We’re going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesn’t destroy your lungs at the same time,” Mesoblast CEO Silviu Itescu told BioWorld.
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