Cell Therapy – Talk Bio

FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy

5 days ago talkbio0Tagged Capricor Therapeutics, Cardiomyopathies, Cell Therapy, Clinical Data, Complete, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3, Rejection, Response process, United States Food and Drug Administration

FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter

Bayer’s BlueRock Lays Off 50 Employees, Shuts Cambridge Labs in Streamlining Move

3 weeks ago talkbio0Tagged Bayer, bemdaneprocel, BlueRock Therapeutics, Cambridge research labs, Cell Therapy, Drug Industry, layoffs

BlueRock Therapeutics; Bayer; layoffs; biotech; Cambridge research labs; cell therapy; streamlining; bemdaneprocel; OpCT-001; pharmaceutical industry

Vertex’s Islet Cell Therapy Shows Dramatic Reduction in Dangerous Low Blood Sugar Levels in Type 1 Diabetes Trial

4 weeks ago talkbio0Tagged Cell Therapy, Diabetes Mellitus, Insulin-Dependent, Endogenous, Hypoglycemia, Insulin, islet, Stem Cell Therapy, zimislecel

Vertex; islet cell therapy; zimislecel; Type 1 diabetes; hypoglycemia; phase 1/2 trial; endogenous insulin; stem cell therapy

FDA’s Top Cell and Gene Therapy Leaders Exit Amid CBER Upheaval

4 weeks ago talkbio0Tagged Anatol, biopharma regulation, CBER, Cell Therapy, Changing, gene therapy, Leadership, Nicole Verdun, Peter Marks, Rachael, United States Food and Drug Administration

FDA; cell therapy; gene therapy; CBER; Nicole Verdun; Rachael Anatol; Peter Marks; leadership changes; biopharma regulation

BioNTech Halts Cell Therapy Manufacturing at Maryland Site, Lays Off Dozens

4 weeks ago talkbio0Tagged BioNTech, BNT211, Cancer Therapeutic Procedure, CAR-T, Cell Therapy, Clinical Trials, Gaithersburg, layoffs, Manufacturing Facilities, Maryland (geographic location)

BioNTech; cell therapy; Maryland; layoffs; CAR-T; BNT211; Gaithersburg; manufacturing facility; cancer therapy; clinical trial

Illuminating the CKD Patient Journey: Clinicogenomic Data Reshapes Research & Drug Discovery

1 month ago talkbio0Tagged Cell Therapy, Chronic Kidney Diseases, Clinical Trials, clinicogenomics, Drug Discovery, gene therapy, Precision Medicine

chronic kidney disease; CKD; clinicogenomics; drug discovery; cell therapy; gene therapy; clinical trials; personalized medicine

Forging the Future of Cell Therapy: Bayer and BlueRock’s Unique Journey

1 month ago talkbio0Tagged Bayer, bemdaneprocel, biotech partnerships, BlueRock Therapeutics, Cell Therapy, Identifier, Parkinson 's disease, Phase 3 trials, Regenerative Medicine, RMAT

cell therapy; Bayer; BlueRock Therapeutics; Parkinson’s disease; bemdaneprocel; biotech partnerships; RMAT designation; Phase 3 trials; regenerative medicine