Pathologic Function

Novartis and Relation Therapeutics form AI-driven, multi-program atopic disease collaboration

3 days ago talkbio0Tagged * * atopic diseases * *, * * functional cell, AI-powered, Asthma, atlases, Billion, Drug Discovery, Eczema, Hypersensitivity, IL13 gene, immuno-dermatology, Lab-in-the-Loop, milestones, multi-program collaboration, Novartis

Novartis; Relation Therapeutics; AI-powered drug discovery; Lab-in-the-Loop; atopic diseases; immuno-dermatology; multi-program collaboration; asthma; allergies; eczema; allergic rhinitis; $55 million upfront; $1.7 billion milestones; functional cell atlases

Japan Approves Anti-CD19 Monoclonal Antibody UPLIZNA for Suppression of Relapse in Immunoglobulin G4-Related Disease (IgG4-RD)

3 weeks ago talkbio0Tagged Anti-CD19 Monoclonal Antibody, Approved, IgG4-RD, IgG4-Related Disease, Immunoglobulin IgG4, inebilizumab, Japan, Ministry of Health, MITIGATE trial, Mitsubishi Tanabe Pharma, Relapse, Uplizna, Visual Suppression, Welfare

UPLIZNA; Inebilizumab; Anti-CD19 monoclonal antibody; IgG4-related disease (IgG4-RD); Immunoglobulin G4; Japan approval; Relapse suppression; MITIGATE trial; Mitsubishi Tanabe Pharma; Ministry of Health, Labour and Welfare

Zag Bio Launches with $80M to Teach the Immune System to Make Better Tregs

1 month ago talkbio0Tagged AbbVie, Autoimmune Diseases, Diabetes Mellitus, Insulin-Dependent, Funding, Immune Tolerance, Regeneron, Regulatory T-Lymphocytes, sanofi, Series A, thymus-targeted therapy, Tregs, Zag Bio

Zag Bio; Tregs; regulatory T cells; autoimmune diseases; thymus-targeted therapy; Series A funding; immune tolerance; Type 1 diabetes; AbbVie; Regeneron; Sanofi

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

2 months 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 months 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 months 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

2 months 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

3 months 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

3 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

3 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