BioSpace News Archive

Fist Assist Devices, LLC, has received FDA 510(k) clearance for use of the Fist Assist FA-1 device in the United States as an arm massage and increased vein circulation device and has commenced marketing the Fist Assist FA-1 device for that indication for use.

Predictive Oncology (NASDAQ: POAI), an AI-driven oncology and drug discovery company, announced today that two of their wholly owned subsidiaries, Soluble Biotech Inc. and TumorGenesis Inc. are both expanding their unique services by completing the fabrication and qualification of GMP facilities.

Molecular Loop Biosciences, Inc. announced today that its SARS-CoV-2 Research Sequencing Panel has been deployed by Labcorp.

Cryoport, Inc., a global leader in temperature-controlled supply chain solutions for the life sciences industry, announced that Cellenkos®, Inc., a privately held, clinical-stage biotechnology company, has selected Cryoport to provide a staged, on-demand, logistics solution for COVID-19 therapy shipments for patients in need.

Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic “off-the-shelf” gene-edited Chimeric Antigen Receptor (CAR)-NK cells derived from induced pluripotent stem cells (iPSCs) and NK cell engager multifunctional antibodies, announced today that Olivier Gouédard, PharmD, MBA has been appointed as Chief Operating Officer, effective immediately

Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a specialty pharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue.

Aidoc, leading provider of AI solutions for medical imaging and icometrix, world leader in imaging AI solutions for patients with neurological conditions, announced a partnership that will provide an AI-based Stroke suite for rapid triage of patients with suspected stroke.

AbCellera (Nasdaq: ABCL) today announced it has secured a site in Vancouver for the construction of a Good Manufacturing Practices (GMP) manufacturing facility for the production of therapeutic antibodies, which will be the first of its kind in Canada.

Grace Science, LLC announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to GS-100, an investigational AAV9 gene replacement therapy for the treatment of NGLY1 deficiency.

Galecto, Inc., a publicly listed, clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced preliminary topline results from an investigator-initiated trial examining Galecto’s inhaled galectin-3 inhibitor.