News|Articles|November 1, 2024

A Guide for Running Statistically Powered Clone-Screening Experiments

This whitepaper explores how power analysis can help determine the optimal sample size for statistically powered clone screening experiments in bioreactors. Learn how to improve key performance indicators such as titer, rate, and yield while accounting for bioprocess variability.

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Immunovant's FcRn Antibody IMVT-1402 Misses Primary Endpoint in Cutaneous Lupus

IMVT-1402 (imeroprubart) failed to reach statistical significance on CLASI-A at Week 12 in a 57-patient proof-of-concept study, and Immunovant will stop development in cutaneous lupus erythematosus. The anti-FcRn antibody continues in five other autoimmune indications.

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FDA Grants SOTIO's SOT106 ADC Orphan Drug and Fast Track Designations for Sarcoma

SOTIO Biotech's LRRC15-targeted antibody-drug conjugate SOT106 now holds both Orphan Drug and Fast Track Designations in soft tissue sarcoma and osteosarcoma. The company expects to start first-in-human testing later in 2026.

September 24th, 2026

BIIE Aims to Be a Global Immune Engineering Embassy

Dr Stephen Wilson, CEO of the Botnar Institute of Immune Engineering, describes Basel's collaborative ecosystem and a 3-year roadmap linking research to global clinical partners.

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Tecvayli-Darzalex Combo Shows Near-Normal Myeloma Survival

Johnson & Johnson's modeling projects 18.5-year life expectancy with Tecvayli-Darzalex versus 4.9 years for standard care.

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September 24th, 2026

InnoCare Signs Research Deal With Lilly Worth Up to $3.35 Billion

InnoCare will discover compounds against up to 5 targets for Lilly, backing a deal worth up to $3.35 billion in milestones.

September 23rd, 2026

The BioPharm Brief: Earlier Treatment, New Testing, and Sjögren’s Data

FDA expands Winrevair’s label with HYPERION data, formalizes the use of non-animal testing methods, and Amgen reports positive Phase 3 results for dazodalibep in Sjögren disease.

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FDA Expands Winrevair Label With HYPERION Data in Recently Diagnosed PAH

The FDA has approved a label update for Merck's Winrevair (sotatercept-csrk) incorporating Phase 3 HYPERION data, showing a 76% reduction in clinical worsening events when added to background therapy in adults diagnosed with pulmonary arterial hypertension within the past year.

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How BIIE's Technology Stack Integrates Immune Engineering Disciplines

BIIE CEO Dr Stephen Wilson outlines rapid growth plans and a multidisciplinary technology stack targeting global clinical translation.