The Phase 2 DAHLIAS study (NCT04968912), a multicenter, randomized, placebo-controlled, double-blind trial, evaluated nipocalimab—an investigational monoclonal antibody targeting the neonatal Fc receptor (FcRn)—in adults aged 18–75 with moderate-to-severe primary Sjögren’s disease (SjD) seropositive for anti-Ro60 and/or anti-Ro52 IgG autoantibodies. A total of 163 participants were randomized 1:1:1 to receive intravenous nipocalimab 5 mg/kg, 15 mg/kg, or placebo every 2 weeks through Week 22, alongside standard-of-care therapy. The primary endpoint was the change from baseline in the Clinical EULAR Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score at Week 24, a composite measure assessing 11 systemic domains including constitutional symptoms, lymphadenopathy, glandular swelling, articular, cutaneous, respiratory, renal, muscular, peripheral/central nervous system, and hematological involvement.
The extended follow-up of the DANISH trial, published in the Journal of the American College of Cardiology on October 22, 2025, provides critical long-term insights into the role of primary prevention implantable cardioverter-defibrillators (ICDs) in patients with nonischemic heart failure with reduced ejection fraction (HFrEF). Originally published in 2016 with a median follow-up of 5.6 years, the trial showed no significant reduction in all-cause mortality with ICDs. This new analysis extends median follow-up to 13.2 years (IQR 11.6–14.6 years), tracking 1,116 randomized patients until death or January 31, 2024.
On October 24, 2025, Eli Lilly and Company announced a strategic collaboration with Cipla Limited, a leading Indian pharmaceutical firm, to distribute and promote Yurpeak® (tirzepatide injection) in India. Tirzepatide, a dual GLP-1 and GIP receptor agonist, is approved for chronic weight management in adults with obesity or overweight accompanied by at least one weight-related comorbidity. Marketed as Yurpeak® in this partnership, it represents Lilly’s entry into India’s burgeoning market for anti-obesity therapies.
On October 23, 2025, the U.S. Food and Drug Administration (FDA) expanded the label for Novo Nordisk’s oral semaglutide (Rybelsus®) to include reduction of major adverse cardiovascular events (MACE)—cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke—in adults with type 2 diabetes mellitus (T2D) and either established cardiovascular disease or high cardiovascular risk, irrespective of prior CV event history. This approval establishes oral semaglutide as the first oral GLP-1 receptor agonist with a cardiovascular indication for both primary and secondary prevention.
On October 20, 2025, the U.S. Food and Drug Administration (FDA) granted approval to Roche’s Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis (LN), a severe complication of systemic lupus erythematosus (SLE) that affects the kidneys. Lupus nephritis is characterized by inflammation that can lead to kidney damage, impaired function, and, in severe cases, kidney failure.
