FDA recommended generating additional clinical data to meet FDA’s BLA requirements NEW YORK – BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently met with senior leadership from the U.S. Food and Drug Administration (FDA) and received...
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NEW YORK and SOMERSET, N.J. – BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, and Catalent (NYSE: CTLT), a global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that...
NEW YORK, NY — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial...
NEW YORK, NY — Brainstorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today provided an update on the grant and allowance of three patent applications for NurOwn® and NurOwn-Exosomes. The European Patent office granted patent No. 3105587 titled ‘Method of Qualifying of Cells’...
NEW YORK, NY — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its investigational...
Biomarker data suggest that NurOwn drives significant changes on multiple biomarkers across ALS disease pathways which may be important in achieving clinical outcomes NEW YORK – BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that biomarker data on NurOwn® will be...
PHILADELPHIA, PA and VANCOUVER, British Columbia — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce the initiation of Good Manufacturing Practice (GMP) manufacturing of its lead candidate for treating prostate cancer, Bria-Pros+. GMP manufacturing of...
Scientists have found success in treating a ‘neglected’ inflammatory condition, polymyalgia rheumatica, with a drug that could provide an alternative to steroids for patients. The study, carried out by Anglia Ruskin University (ARU) and published in the New England Journal of Medicine, describes a successful trial of sarilumab. The drug,...
Amsterdam – After 40 years of treating metastatic bladder cancer with chemotherapy as a primary treatment, scientists now present a new approach using immunotherapy combinations. The results of not just one, but two studies have been presented at the European Society for Medical Oncology (ESMO) conference in Madrid. The outcomes...
London, UK – The phase 3 clinical trial, led by Professor Peter Szlosarek at Queen Mary and sponsored by Polaris Pharmaceuticals, has unveiled a breakthrough in the treatment of malignant pleural mesothelioma (MPM), a rare and often rapidly fatal form of cancer with limited therapeutic options. The ATOMIC-meso trial, a...