Pathologic Function

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

2 days ago talkbio0Tagged Blood - brain barrier anatomy, CorestemChemon, Drug Discovery, FDA/EMA regulatory pathways, Gene Expression Profiling, heart organoids, Lifetech, liver organoids, lymphocyte immune globulin, anti-thymocyte globulin, Organoids, preclinical CRO, Predictive analytics, Tumorigenicity

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models

EU Lifts Restriction on Valneva’s Chikungunya Vaccine for Older Adults, Recommends Caution

2 weeks ago talkbio0Tagged Adverse event, chikungunya vaccine, concerns, Elderly (population group), European Medicines Agency, Ixchiq, label extension, Safety, Valneva

Valneva; Chikungunya vaccine; IXCHIQ; European Medicines Agency; older adults; safety concerns; label extension; adverse events

FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk

2 weeks ago talkbio0Tagged Alzheimer 's disease, Cerebral Edema, dosing, eli lilly, Kisunla, label update, Neuregulins, Safety, Treatment Protocols, United States Food and Drug Administration

FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6

Altimmune’s Incretin Misses Fibrosis Improvement Endpoints in MASH Trial

4 weeks ago talkbio0Tagged Altimmune, Clinical Trials, Fibrosis, Glucagon-Like Peptide 1, Incretins, MASH, pemvidutide

Altimmune; incretin; pemvidutide; fibrosis; MASH; GLP-1; clinical trial

Amgen Adjusts Phase 3 Dosing for MariTide After Midstage Side Effects Concerns

1 month ago talkbio0Tagged Adverse event, amgen, Clinical Trials, Dosage, Escalation, gastric inhibitory polypeptide receptor, GLP-1 receptor, MariTide, Obesity, Phase 3, Vomiting

Amgen; MariTide; Phase 3; obesity treatment; dose escalation; vomiting; adverse events; clinical trial; GLP-1 receptor; GIP receptor

EMA Identifies Very Rare Eye Condition as Side Effect of Semaglutide

2 months ago talkbio0Tagged Adverse effects, Blindness, Infrequent, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, NAION, Ozempic, Rybelsus, semaglutide, Wegovy

EMA; semaglutide; rare side effect; NAION; vision loss; Ozempic; Wegovy; Rybelsus

AstraZeneca Details Its Oral SERD ‘Switching’ Regimen Amid Feasibility Questions

2 months ago talkbio0Tagged AstraZeneca, camizestrant, CDK4/6 inhibitor, Disease Progression, ESR1 gene, Malignant neoplasm of breast, Mutation, Oral SERD, SERENA-6 trial, treatment resistance

AstraZeneca; oral SERD; camizestrant; breast cancer; ESR1 mutation; SERENA-6 trial; CDK4/6 inhibitor; disease progression; ASCO 2025; treatment resistance

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

2 months 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

2 months 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

Patient Death in Rocket Pharmaceuticals Gene Therapy Trial Prompts FDA Clinical Hold

2 months ago talkbio0Tagged acute systemic infection, Adverse event, Capillary Leak Syndrome, gene therapy, Glycogen Storage Disease Type IIb, Patient Death, Rocket, RP-A501, Study on Hold, United States Food and Drug Administration

Rocket Pharmaceuticals; gene therapy; Danon disease; clinical hold; FDA; patient death; capillary leak syndrome; acute systemic infection; RP-A501; adverse event