Pharmaceuticals, Biotechnology and Life Sciences
Regeneron Pharmaceuticals and Sanofi have received U.S. Food and Drug Administration (FDA) acceptance for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE).
ViGeneron GmbH, a next-generation gene therapy company, has announced a target-specific strategic collaboration and option agreement with Regeneron Pharmaceuticals Inc. (Regeneron) to develop and commercialize a gene therapy product based on ViGeneron’s novel engineered recombinant adeno-associated virus vectors (vgAAVs) to treat an inherited retinal disease (IRD).
Sanofi and Regeneron posted positive results with an overall survival (OS) benefit from the Phase 3 trial investigating its PD-1 inhibitor Libtayo (cemiplimab) monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic.
Regeneron Pharmaceuticals and Sanofi today announced that the European Commission (EC) has extended the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent is the only systemic medicine approved in the EU to treat these patients.
Sanofi and Regeneron’s phase 3 clinical trial results announced Friday show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life.
European Commission has approved a third indication for Dupixent® (dupilumab) for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. It is also approved for moderate-to-severe atopic dermatitis and severe asthma.
Regeneron Pharmaceuticals on Wednesday said it got positive pivotal Phase 3 results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholesterolemia (HoFH).
The European Commission (EC) has licensed Dupixent (dupilumab), developed by Regeneron and Sanofi, for older than 12 patients as an add-on maintenance treatment for severe asthma with type 2 inflammation.
Sanofi’s pivotal Phase 3 test of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents met its primary and key secondary…
Sanofi and Regeneron Pharmaceuticals said they will accelerate and expand investment for the clinical development of the PD-1 (programmed cell…