Intravenous immunoglobulins (IVIGs) offer a versatile treatment modality for a variety of immune-mediated disorders. Originally used for antibody replacement therapy, their unexpected anti-inflammatory and immunomodulatory effects have allowed them to extend their use to other conditions. Derived from the pooled plasma of thousands of healthy donors, IVIGs contain a broad spectrum of antibodies, which contribute to their effectiveness in modulating immune responses, such as helping to neutralize autoantibodies, suppress inflammatory pathways, and restore immune homeostasis. The many mechanisms of IVIGs, including Fc receptor blockade, modulation of B cell function, and the enhancement of regulatory T cell activity, improve their therapeutic potential across a broad spectrum of clinical scenarios.
This Monday, the FDA gave approval of Biotest’s Yimmugo, an innovative therapeutic to treat primary immunodeficiencies (PID). Yimmugo is a polyvalent IVIG approved in the US for substitution therapy in primary antibody deficiency syndromes. PIDs are a group of over 450 rare, chronic conditions where a part of the body's immune system is absent or malfunctioning. Although each PID is unique, they all affect the immune system's ability to function properly.
Last week, a case study about a patient with autoimmune cerebellar ataxia (ACA) showed significant improvement in health after nine plasmapheresis sessions and six doses of IVIG, despite negative cancer screenings. Ongoing management included biannual rituximab treatments. This news gives hope to the potential of using plasmapheresis and IVIG for treatment of non-tumor anti-Tr/DNER antibody-associated ataxia.
Another recent paper describes a trial for the use of IVIG for COVID-19 patients. The results found an improvement in the National Early Warning Score 2 at the end of treatment in the IVIG arm and a statistically significant reduction in mortality. Therefore, IVIG was deemed to be a safe and effective adjunctive therapy to standard-of-care treatment in moderate-to-severe COVID-19 patients needing ventilatory support.
This report aims to explore the events and trends of the biopharmaceutical industry in Q2 (April, May, June). Besides crovalimab and Vyloy, two more novel antibody drugs have been approved this year
The start of 2024 has seen leaps in deals for antibody therapeutics, especially ADCs (antibody-drug conjugates). This report aims to explore the events and trends of the biopharmaceutical industry in Q1. As of now, only two novel antibody drugs have been approved this year, but many more in regulatory review are expected to be fully approved.
Alzheimer’s research has undergone transformative changes in recent years, characterized by breakthroughs, controversies, and a reevaluation of long-held theories. Recently, BioArctic announced a global license agreement with Bristol Myers Squibb for BioArctic’s PyroGlutamate-
The FDA has revoked Emergency Use Authorizations (EUAs) for multiple COVID-19 monoclonal antibody (mAb) therapies, including those developed by Eli Lilly, AstraZeneca, Vir Biotechnology, and Regeneron. This decision reflects the challenges of targeting rapidly mutating viruses like SARS-CoV-2, which