Pathologic Function

Eye Disease Biotech Kala Bio Collapses After Failed Clinical Trial, Lender Takes Control

5 days ago talkbio0Tagged Clinical trial failure, Corneal epithelial defect, Experimental drug, foreclosure proceedings, Kala Bio, KPI-012, lender takeover, Oxford Finance, PCED, Persistent, Shock, Workforce reduction

Kala Bio; biotech collapse; failed drug trial; KPI-012; persistent corneal epithelial defect; PCED; lender takeover; Oxford Finance; foreclosure proceedings; workforce reduction; clinical trial failure

Sanofi Partners with EVOQ Therapeutics to Advance NanoDisc-Based Autoimmune Therapies

2 weeks ago talkbio0Tagged Autoimmune Diseases, Celiac Disease, Diabetes Mellitus, Insulin-Dependent, EVOQ, Immune Tolerance, License Agreement, Lupus Vulgaris, MOG antibody disease, NanoDisc, Rheumatoid Arthritis, sanofi

Sanofi; EVOQ Therapeutics; NanoDisc; autoimmune disease; license agreement; immune tolerance; celiac disease; type 1 diabetes; MOG antibody disease; rheumatoid arthritis; lupus

Johnson & Johnson to Separate Orthopaedics Business

2 weeks ago talkbio0Tagged DePuy Synthes, Diastasis, Johnson & Johnson, medtech, Orthopedics

Johnson & Johnson; Orthopaedics; DePuy Synthes; MedTech; Separation

AI is Transforming Drug Safety—But Governance Sets Essential Guardrails

3 weeks ago talkbio0Tagged Adverse reaction to drug, AI guardrails, Artificial Intelligence, Bias (Epidemiology), Data Integrity, drug safety, Jeavons syndrome, patient safety, Pharmacovigilance, regulatory governance, United States Food and Drug Administration

artificial intelligence; drug safety; pharmacovigilance; adverse drug events; regulatory governance; FDA; EMEA; AI guardrails; data integrity; bias; patient safety

uniQure’s Gene Therapy AMT-130 Significantly Slows Huntington’s Progression in Pivotal Trial

1 month ago talkbio0Tagged AMT-130, Approved, Clinical Trials, Disease Progression, gene therapy, huntingtin-lowering, Huntington 's disease, Nerve Degeneration, UniQure, United States Food and Drug Administration

Gene therapy; uniQure; AMT-130; Huntington’s disease; clinical trial; disease progression; FDA approval; huntingtin-lowering; neurodegeneration

Pfizer Veteran Suneet Varma Named CEO of Phase 3-Ready Biotech Startup Intent Biologics

2 months ago talkbio0Tagged Appointments, biotech startup, CEO, Clinical Trials, Immunology, Inflammation, Intent Biologics, Pfizer vet, Phase 3, Regenerative Medicine, Suneet Varma

Suneet Varma; Pfizer vet; Intent Biologics; CEO appointment; regenerative medicine; Phase 3 clinical trials; biotech startup; inflammation and immunology

FDA Pushes Back Agios’ Pyrukynd Thalassemia Decision to December

2 months ago talkbio0Tagged Agios, decision delay, Liver damage, PDUFA, Pyrukynd, REMS, Thalassemia, United States Food and Drug Administration

FDA; Agios; Pyrukynd; thalassemia; PDUFA; decision delay; REMS; hepatocellular injury

Prothena’s Alzheimer’s Trial Hit by High ARIA-E Rates, Resulting in ‘Non-Competitive’ Profile

2 months ago talkbio0Tagged Alzheimer 's disease, amyloid beta antibody, ARIA-E, ASCENT, Cerebral Edema, clinical program, non-competitive profile, Prothena, PRX012, subcutaneous administration

Prothena; PRX012; Alzheimer’s disease; ARIA-E; brain swelling; phase 1 trial; non-competitive profile; amyloid beta antibody; ASCENT clinical program; subcutaneous administration