EC Approves Dupixent as the first biologic medicine for children (6-11) with severe atopic dermatitis 

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.

European Commission approves Dupixent for severe chronic rhinosinusitis with nasal polyposis

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 posts positive results from testing Evinacumab in patients with certain type of high cholesterol

One of the Regeneron Genetics Center's robotic employees hard at work preparing lab samples. Image: regeneron.com

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).

Sanofi, Regeneron explore Dupixent’s role in targeting Type 2 inflammation as an underlying cause of atopic dermatitis

Sanofi’s pivotal Phase 3 test of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents met its primary and key secondary endpoints. Sanofi said Wednesday that, in the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching, and certain health-related quality of life measures. Sanofi noted that Dupixent is… Continue reading Sanofi, Regeneron explore Dupixent’s role in targeting Type 2 inflammation as an underlying cause of atopic dermatitis

Sanofi and Regeneron to boost investment for two development programs

A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. REUTERS/Christian Hartmann/File Photo

Sanofi and Regeneron Pharmaceuticals said they will accelerate and expand investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases.

Sanofi, Regeneron’s asthma study meets two primary endpoints

A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. REUTERS/Christian Hartmann/File Photo

The pivotal Phase 3 Libery ASthma Quest study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints, Sanofi and Regeneron Pharmaceuticals said Monday.

Cemiplimab gets FDA breakthrough therapy designation for certain cell carcinoma

French multinational pharmaceutical company SANOFI logo is seen at the headquarters in Paris, France, March 8, 2016. REUTERS/Philippe Wojazer

Sanofi and Regeneron Pharmaceuticals, said on Friday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma.