Pathologic Function – Page 2

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

2 months ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Viking Therapeutics Shares Crash After Obesity Pill VK2735 Delivers 12% Weight Loss, But Side Effects and Discontinuations Raise Concerns

2 months ago talkbio0Tagged Adverse event, aspects of adverse effects, Clinical Trials, Contraceptives, Oral, drug efficacy, gastrointestinal, Obesity, Stock Crash, Viking, VK2735, Weight Loss

Viking Therapeutics; VK2735; obesity pill; weight loss; clinical trial; stock crash; side effects; adverse events; gastrointestinal; drug efficacy

HHS Revives ’90s-Era Task Force to Improve Childhood Vaccine Safety

2 months ago talkbio0Tagged Adverse reactions, Advisory Committees, Centers for Disease Control and Prevention (U.S.), CHARGE Syndrome, Childhood, Childhood Vaccines, Jay Bhattacharya, NIH Mouse, Robert F. Kennedy Jr., United States Food and Drug Administration, Vaccine Safety, Vaccines

HHS; childhood vaccines; vaccine safety; task force; Robert F. Kennedy Jr.; Jay Bhattacharya; NIH; FDA; CDC; vaccine oversight; adverse reactions; childhood immunization schedule

CorestemChemon Partners with ATG Lifetech to Expand Organoid and Transcriptomics Capabilities

3 months 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

4 months 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

4 months 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 months 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

4 months 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

5 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

5 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