Immunologic Factor – Page 2 – Talk Bio

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Sanofi Phase 3 Eczema Win Falls Short of Analyst Expectations

1 week ago talkbio0Tagged Amlitelimab, Dermatitis, Atopic, Dupixent, EASI-75, Eczema, Expectations, Market, Reaction, sanofi

Sanofi; amlitelimab; phase 3 trial; eczema; atopic dermatitis; analyst expectations; Dupixent; EASI-75; market reaction

Paul Offit, RFK Jr. Critic, Removed from Key FDA Vaccine Panel

1 week ago talkbio0Tagged Advisory Committees, CHARGE Syndrome, Paul Offit, Policy, removal technique, RFK Jr., United States Food and Drug Administration, vaccine panel, Vaccines, VRBPAC

Paul Offit; FDA; vaccine panel; RFK Jr.; removal; vaccine policy; VRBPAC; advisory committee; HHS

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

1 week ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Servier Pays $210M Upfront for Ex-US Rights to Ideaya’s PKC Inhibitor Darovasertib

1 week ago talkbio0Tagged Clinical Trials, Darovasertib, Ideaya Biosciences, Inhibitor, milestone payments, oncology licensing deal, Protein Kinase C, Protein Kinase C Inhibitor, royalties, Servier, uveal melanoma

Servier; Ideaya Biosciences; darovasertib; protein kinase C inhibitor; PKC inhibitor; uveal melanoma; oncology licensing deal; clinical trials; milestone payments; royalties

Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos

1 week ago talkbio0Tagged Child, COVID19 (disease), Evidence, Prasad, regulatory decisions, risk-benefit analysis, Spikevax, United States Food and Drug Administration, vaccine approval, Vaccine Safety, Vaccines, Vinay

Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis

Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile

1 week ago talkbio0Tagged benefit-risk profile, Clinical Trials, Dose-Limiting, Drug Development, Malignant Neoplasms, mesothelin, T-Cell engager, Toxicity aspects, ZW171, Zymeworks

Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity

Zenas BioPharma Secures $300M Royalty Deal for Obexelimab FDA Approvals

1 week ago talkbio0Tagged Approved, Autoimmune Diseases, IgG4-Related Disease, Lupus Erythematosus, Systemic, Obexelimab, Phase 3 INDIGO trial, Royalty, Royalty Pharma, United States Food and Drug Administration, Zenas BioPharma

Zenas BioPharma; Royalty Pharma; Obexelimab; autoimmune diseases; IgG4-Related Disease; Systemic Lupus Erythematosus; FDA approval; royalty agreement; Phase 3 INDIGO trial; funding

J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results

2 weeks ago talkbio0Tagged Autoimmune Diseases, Clinical Research, Clinical trial failure, daisy, Imaavy, Johnson and Johnson, Nipocalimab, Phase 2a Trial, Rheumatoid Arthritis

Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases

FDA Approves Updated COVID-19 Shots from Pfizer, Moderna, Novavax with New Restrictions

2 weeks ago talkbio0Tagged COVID19 (disease), high-risk groups, LP.8.1 sublineage, Moderna, Novavax, Pfizer, restrictions, United States Food and Drug Administration, Vaccines

FDA; COVID-19 vaccine; Pfizer; Moderna; Novavax; vaccine restrictions; high-risk groups; 2025-2026 booster; LP.8.1 sublineage

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

2 weeks ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial