The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause.
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed.
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis (gMG) in China, marking the first positive phase III data for the candidate globally.
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
Abbisko Therapeutics Co. Ltd. and Allist Pharmaceuticals Co. Ltd. signed an exclusive licensing deal that gives Allist rights to develop, manufacture and commercialize Abbisko’s ABK-3376, an EGFR tyrosine kinase inhibitor for $188 million plus royalties.
Abbisko Therapeutics Co. Ltd. and Allist Pharmaceuticals Co. Ltd. signed an exclusive licensing deal that gives Allist rights to develop, manufacture and commercialize Abbisko’s ABK-3376, an EGFR tyrosine kinase inhibitor for $188 million plus royalties.
Even its name is a testament to how enigmatic the tingible macrophage has been. Tingible, which means stainable, certainly gives no clues to its functions – but was, at least, one thing that was known about the cells. Now, scientists at the Garvan Institute of Medical Research have tracked the lifecycle and function of tangible macrophages in the lymph nodes, with implications for understanding autoimmune disorders, which are still poorly understood. Published March 2, 2023, in the journal Cell, the study highlights intravital imaging techniques the scientists used to observe how macrophages formed within the lymph nodes and how they behaved in real time.
Junshi Biosciences Co. Ltd.’s ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, met the primary endpoints of reducing the levels of low-density lipoprotein cholesterol in two phase III trials in primary hypercholesterolemia and mixed hyperlipidemia.
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