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Latest From Mesoblast Limited
Around 100 executives highlight the hot areas to watch on the R&D front in 2021. From cancer to CNS and from regenerative medicine to real world data, expectations are high on many fronts.
Although its 300-patient, Phase III trial is not likely to reduce mortality, Australian firm says the full dataset may show potential for off-the-shelf cell therapy in acute respiratory distress syndrome.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
The Australian company's off-the-shelf cell therapy fell foul of the US FDA for graft-versus-host disease recently but Novartis is backing remestemcel-L as a potential treatment for acute respiratory distress syndrome.
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- Angioblast Systems Inc.