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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. 2 This progress has implications for diagnosis, therapeutic efficacy, and potentially establishing clinically relevant endpoints.

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Rilzabrutinib Cuts Flares in IgG4-Related Disease; Fast Track Granted in US

The Pharma Data

The results come from a open-label, proof-of-concept, Phase 2 study (NCT04520451) and highlight rilzabrutinib’s potential as a disease-changing treatment option for a condition that currently has limited and non-specific treatment options and involves substantial patient suffering due to its chronic and progressive course.

Disease 40
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Dapirolizumab Pegol Phase 3 Data Shows SLE Fatigue and Disease Activity Improvement at EULAR

The Pharma Data

Dapirolizumab Pegol Demonstrates Promise in Phase 3 SLE Trial, Showing Improvements in Fatigue and Disease Activity at EULAR 2025 UCB (Euronext Brussels: UCB) and Biogen Inc. The latest data from the PHOENYCS GO trial reinforce the potential of dapirolizumab pegol to improve disease outcomes in people with moderate-to-severe SLE.

Disease 40
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Good things come in 3s

SugarCone Biotech

Over 70% of new patients are diagnosed with stage IV disease, also called extensive stage disease (ES-SCLC). For these patients, clinical onset means severe symptoms and a rapid decline in overall health. The tarlatamab results have of course triggered a stampede of development of DLL3-targeted therapies.

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Amgen Unveils Phase 2 Obesity Trial Results for Monthly Maritide at ADA’s 85th Scientific Sessions

The Pharma Data

This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit. Both data sets now provide foundational insight into the design and direction of Amgen’s upcoming Phase 3 MARITIME clinical development program.

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Roche’s NXT007 Shows Early Promise for Normalising Clotting in Haemophilia A

The Pharma Data

Importantly, the therapy demonstrated a favorable safety profile, with no thromboembolic events reported so far. No thromboembolic events—an important safety consideration for all coagulation therapies—were reported. The Phase I/II data presented at the ISTH 2025 Congress mark a significant development in the journey of NXT007.

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J&J’s Dual-Target CAR T-Cell Therapy Shows Promise in Large B-Cell Lymphoma

The Pharma Data

Currently, treatment options for patients with relapsed or refractory disease remain limited, and prognosis is poor. Two cases of immune effector cell–associated neurotoxicity syndrome (ICANS) were observed — one Grade 1 and another Grade 3 , with the Grade 3 event occurring in a patient with central nervous system (CNS) lymphoma.