Safety – Talk Bio

Merck Advances Middle Dose of ROR1 ADC in Relapsed/Refractory DLBCL After Safety Review

1 week ago talkbio0Tagged Adverse event, Clinical Trials, Diffuse Large B-Cell Lymphoma, Merck, middle dose, Relapsing course, ROR1 protein, human, Safety, therapeutic autologous dendritic cells, Unresponsive to Treatment, vedotin, waveLINE-003, Zilovertamab

Merck; ROR1; ADC; zilovertamab vedotin; middle dose; 1.75 mg/kg; relapsed DLBCL; refractory DLBCL; WaveLINE-003; safety; adverse events; clinical trial; ASCO 2025

Analysts Downplay Intellia Adverse Event, but Gene Therapy Safety Remains Under Scrutiny

1 week ago talkbio0Tagged Adverse event, ATTR-CM, Event, Gene Modification, gene therapy, Intellia, liver transaminase, MAGNITUDE trial, Response process, Safety, Stock Decline

Intellia Therapeutics; gene therapy; safety event; adverse event; MAGNITUDE trial; liver transaminase; stock decline; ATTR-CM; gene editing; analyst response

Neurogene Details New Safety Measures After Young Patient’s Death in Rett Syndrome AAV Gene Therapy Trial

3 weeks ago talkbio0Tagged AAVS1 gene, ASGCT, Clinical Trials, Dosage, gene therapy, Individual Adjustment, Lymphohistiocytosis, Hemophagocytic, Measures, MECP2 gene, Neurogene, NGN-401, Rett Syndrome, Safety, United States Food and Drug Administration

Neurogene; AAV gene therapy; Rett syndrome; NGN-401; ASGCT; safety measures; HLH; clinical trial; MECP2 gene; FDA; dose adjustment

FDA, CDC call for pause of chikungunya shot rollout in older adults

4 weeks ago talkbio0Tagged Adverse event, Centers for Disease Control and Prevention (U.S.), Chikungunya Fever, concerns, Elderly (population group), Ixchiq vaccine, pause recommendation, Safety, United States Food and Drug Administration

Ixchiq vaccine, chikungunya, safety concerns, older adults, FDA, CDC, pause recommendation, adverse events

Exclusive: Vertex drops AAV gene therapy research, tRNA therapy partnership

1 month ago talkbio0Tagged Dependovirus, gene therapy, Industry, Partnership, research, Safety, Transfer RNA

gene therapy, Dependovirus, Transfer RNA, Partnership, Industry, research, Safety

Akeso, Summit’s PD-1/VEGF bispecific records another pivotal study win in NSCLC

2 months ago talkbio0Tagged Akeso, Combined, Ivonescimab, Keytruda, Non-Small Cell Lung Carcinoma, PD-1/VEGF, Pharmacotherapy, Safety, summit

Ivonescimab, Non-Small Cell Lung Carcinoma, Akeso, PD-1/VEGF, Keytruda, summit, Pharmacotherapy, Combined, Safety

Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss

2 months ago talkbio0Tagged Diabetes Mellitus, Non-Insulin-Dependent, Glucagon-Like Peptide 1, Hemoglobin A1c measurement, Injectables, Oral cavity, orforglipron, Phase 3 Clinical Trials, Safety, Weight Loss

orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables