Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Brainstorm Cell Therapeutics Inc. said it’s exploring all its options in the wake of a Sept. 27 U.S. FDA advisory committee vote, in which the committee overwhelmingly disagreed with the company that the data it presented supported the effectiveness of Nurown (debamestrocel) for the treatment of mild to moderate amyotrophic lateral sclerosis.
Brainstorm Cell Therapeutics Inc.’s Nurown got a thumbs down from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Sept. 27, as the committee voted 1-17, with one abstention, that the data presented demonstrated substantial evidence of effectiveness for treatment of mild to moderate amyotrophic lateral sclerosis.
Long bones, vertebrae and skull bones have distinct types of stem cells, and new insights into those stem cells could lead to new ways to treat both rare developmental disorders of skull formation and the all-too-common phenomenon of bone metastases. Scientifically, the work, which was published in two papers by Matthew Greenblatt and colleagues in Nature, adds to the increasing understanding of bone’s complexities. “Bone may serve as an endocrine organ that is secreting factors throughout the body,” Greenblatt said.
Lipids are “very diverse, but also vastly understudied,” Anne Brunet told the audience at the recent meeting on Aging Research and Drug Discovery. Advances in the ability to predict protein structures have fueled a much better understanding of the human proteome and its estimated 20,000 members. The lipidome is much larger, numbering maybe 100,000 total. And what those lipids do remains much more fuzzy. “Very little is known about their function, and especially their function during aging,” Brunet said. Slowly, however, technological advances are enabling researchers to understand the roles of lipids as well.
With the U.S. FDA’s approval of Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients, the company is prepping for a launch in the next two or three weeks.
IPSirius SAS, an early stage French immuno-oncology firm, hopes to obtain a clinical trial authorization from the U.K.’s Medicines and Healthcare Regulatory Products Agency next year, to enable it to move its novel therapeutic cancer vaccine into a first-in-human trial in patients with non-small-cell lung cancer.
IPSirius SAS, an early stage French immuno-oncology firm, hopes to obtain a clinical trial authorization from the U.K.’s Medicines and Healthcare Regulatory Products Agency next year, to enable it to move its novel therapeutic cancer vaccine into a first-in-human trial in patients with non-small-cell lung cancer.
