Roche (company) – Talk Bio

Ollin Biosciences Launches with $100M to Challenge Roche in Eye Disease Market

4 hours ago talkbio0Tagged Ang2, Biosciences, Clinical Trials, Disorder of eye, Macular edema due to diabetes mellitus, Ollin, OLN324, Roche (company), Vabysmo, Vascular Endothelial Growth Factor A, Wet AMD

Ollin Biosciences; Roche; eye disease; biotech; VEGF-A; Ang2; wet AMD; diabetic macular edema; clinical trial; OLN324; Vabysmo

Genentech (Roche) Signs $420 Million Deal With OMass Therapeutics for Preclinical IBD Program

2 weeks ago talkbio0Tagged Drug Discovery, genentech, Inflammatory Bowel Diseases, milestone payments, OdyssION platform, OMass, Partnership, preclinical program, Roche (company), small molecule therapy

Genentech; Roche; OMass Therapeutics; inflammatory bowel disease (IBD); preclinical program; biotech partnership; OdyssION platform; small molecule therapy; drug discovery; milestone payments

Roche and Alnylam Push Zilebesiran into Phase III Trial Despite Mixed Phase II Hypertension Data

2 weeks ago talkbio0Tagged Alnylam, Cardiovascular system, Hypertensive disease, KARDIA-3, outcomes, Phase 2 Clinical Trials, Phase 3 Clinical Trials, RNA Interference, Roche (company), ZENITH trial, Zilebesiran

Roche; Alnylam; zilebesiran; hypertension; RNAi therapeutics; KARDIA-3; Phase II trial; Phase III trial; cardiovascular outcomes; ZENITH trial

Genentech’s $700M North Carolina Plant and Telix’s FDA CRL Update

3 weeks ago talkbio0Tagged biomanufacturing, Complete Response Letter, CRL, genentech, Holly Springs, Manufacturing Facilities, Medicinal product acting as imaging agent (product), metabolic medicines, North Carolina, Obesity, Roche (company), Telix, United States Food and Drug Administration

Genentech; Roche; North Carolina; manufacturing facility; $700 million; Holly Springs; metabolic medicines; obesity treatments; biomanufacturing; Telix; FDA; Complete Response Letter (CRL); imaging agent

FDA Investigates Elevidys Death; Sarepta and Roche Deny Link to Gene Therapy

2 months ago talkbio0Tagged Brazil, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Patient Death, Roche (company), Safety, Suspensions, United States Food and Drug Administration

FDA; Elevidys; Sarepta Therapeutics; Roche; gene therapy; Duchenne muscular dystrophy; patient death; Brazil; market suspension; safety concerns

Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab

2 months ago talkbio0Tagged Alzheimer 's disease, amyloid-lowering drug, Biological Markers, Brainshuttle, Drug Development, Interventional procedure, Phase 3 Clinical Trials, Roche (company), TRONTIER, Trontinemab

Roche; Alzheimer’s disease; trontinemab; amyloid-lowering drug; Brainshuttle; Phase III trial; TRONTIER studies; drug development; biomarkers; early intervention

CHMP Recommends Against Approval of Elevidys Gene Therapy in Europe, Dealing Blow to Sarepta and Roche

2 months ago talkbio0Tagged CHMP, ELEVIDYS, EMBARK trial, Europe, gene therapy, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Muscular Dystrophy, Duchenne, negative opinion, Roche (company)

CHMP; Elevidys; Sarepta; Roche; gene therapy; Duchenne muscular dystrophy; EMA; negative opinion; Europe; EMBARK trial

Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns

2 months ago talkbio0Tagged concerns, ELEVIDYS, gene therapy, halt, Muscular Dystrophy, Duchenne, patient deaths, Roche (company), Safety, shipment, United States Food and Drug Administration

Roche; Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy; gene therapy; FDA; shipment halt; safety concerns; patient deaths

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

2 months ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

TIGIT Turmoil: How Pharma Burned Billions on Failed Immuno-Oncology Projects

3 months ago talkbio0Tagged Arcus Biosciences, Clinical Trials, Gilead, immuno-oncology, iTeos, Merck, Myers, Novartis, Pharma, Roche (company), SmithKline Beecham, squibb, TIGIT gene, Tiragolumab

TIGIT; immuno-oncology; failed clinical trials; pharma investment loss; Gilead; GSK; Bristol Myers Squibb; Novartis; Merck; Roche; iTeos; Arcus Biosciences; tiragolumab; belrestotug