Immunological and Autoimmune Disorders

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Vaxcyte Announces Positive Phase 3 Topline Data for VAX-31 from OPUS-1 Trial; CSL and Alentis Partner to Advance Lixudebart for Rare Renal and Hepatic Diseases; Pfizer Announces Positive Repigmentation Results for LITFULO in Nonsegmental Vitiligo; AstraZeneca Completes Equity Investment in Summit Therapeutics; Lilly’s Jaypirca Receives FDA Approval Expansion for Certain Patients with Untreated CLL/SLL; Merck’s Tulisokibart Delivers Positive Phase 2b Results in Moderate-to-Severe Hidradenitis Suppurativa

Vaxcyte Reports Successful Topline Outcomes from Pivotal Phase 3 OPUS-1 Study of VAX-31 Vaxcyte, Inc. reported positive topline findings from OPUS-1, its pivotal Phase 3 trial in adults evaluating the safety, tolerability, and immunogenicity of VAX-31, the company’s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate being developed to prevent invasive pneumococcal disease (IPD) and pneumococcal pneumonia. Data from OPUS-1 are expected to form the clinical foundation for Vaxcyte’s planned Biologics License Application (BLA), which will be submitted for review by the U.S. Food and Drug Administration (FDA). Among adults aged 50 years and olde...

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FDA Approves Genentech’s GAZYVA for Lupus Nephritis; Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment; FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma; Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN; Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps

Peanut Allergy Treatment Space: Expanding Horizons Beyond Traditional Immunotherapy

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Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder

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Insights

Immunological and Autoimmune Disorders

TYK2 Inhibitors: The Competitive Race Fueling the Next Generation of Autoimmune Therapies

Lupus Nephritis: A SILENT but SEVERE Systemic Lupus Erythematosus Manifestation

Systemic Lupus Erythematosus: Mapping the Burden of a Complex Autoimmune Disease

Systemic Lupus Erythematosus Treatment Market: How Are the Leading Companies Countering the Rising Prevalence?

7 Promising Late-Stage SLE Drugs & New SLE Treatments Expected to Enter Therapeutic Domain

The gMG Treatment Gold Rush: Key Companies Racing Toward Breakthrough Launches by 2036

J&J and Protagonist’s ICOTYDE Ushers in First-in-Class Oral IL-23 Therapy

SOTYKTU Expands Its Reach as Bristol Myers Squibb Lands Key Approval in Psoriatic Arthritis

More Views & Analysis

CAR-T Beyond Cancer: Resetting Immunity in Autoimmune Diseases

TSLP Inhibitors: The New Frontier in Treating Type 2 Inflammatory Diseases

Roche’s GAZYVA Extends Indications Into Lupus, Strengthening Immunology Pipeline

Peanut Allergy Treatment Space: Expanding Horizons Beyond Traditional Immunotherapy

Sanofi’s WAYRILZ Approval Ushers in New Era for Immune Thrombocytopenia Treatment

The Rise of AI-Powered Point-of-Care Diagnostics: Transforming Real-Time Patient Care

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