Roche (company) – Talk Bio

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

5 days 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

1 month 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

1 month 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

1 month 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

1 month 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

1 month 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

2 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

Roche and AbbVie Announce Phase 3 Venclexta Trial Fails to Meet Primary Endpoint in High-Risk MDS

3 months ago talkbio0Tagged AbbVie, Antineoplastic Agents, azacitidine, Clinical Research, Clinical Trials, Miller Dieker syndrome, MYELODYSPLASTIC SYNDROME, Phase 3 trial, Roche (company), Venclexta, venetoclax, Verona

Roche; AbbVie; Venclexta; venetoclax; azacitidine; myelodysplastic syndromes; MDS; Phase 3 trial; VERONA study; clinical trial results; cancer drug

Roche Advances Prasinezumab Into Phase III Trials for Parkinson’s Despite Mixed Phase II Results

3 months ago talkbio0Tagged alpha-synuclein antibody, Biological Markers, Clinical Trials, disease-modifying treatment, PADOVA study, Parkinson 's disease, Pasadena, Phase 3 Clinical Trials, Prasinezumab, Prothena, Roche (company)

Roche; prasinezumab; Parkinson’s disease; Phase III trial; clinical trials; alpha-synuclein antibody; Prothena; PADOVA study; PASADENA study; biomarker; disease-modifying treatment

Genentech Lays Off 143 Employees as Part of Ongoing Cuts by Roche in Bay Area

3 months ago talkbio0Tagged Aortic Valve Insufficiency, Bay Area, biotech industry, Dosage Forms, genentech, layoffs, Roche (company), South San Francisco, WARN filing

Genentech; Roche; layoffs; South San Francisco; biotech job cuts; Bay Area; AI strategy; WARN filing; pharmaceutical; biotech industry