Tagged as: Dupilumab

FDA Accepts Regeneron and Sanofi’s DUPIXENT (Dupilumab) sBLA for Priority Review

Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients aged 12 years and older with eosinophilic esophagitis (EoE).  EoE is a chronic, immune-mediated, atopic inflammatory condition of…

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Litigation Update:  Sanofi’s Summary Judgment Motion Denied, Immunex Renews Its Motion to Stay Pending IPR in DUPIXENT Patent Litigation

Following up on our previous coverage of Immunex’s patent infringement suit against Sanofi related to Immunex’s Dupixent® (dupilumab) biologic, Judge Otero recently denied Sanofi’s motion for summary judgement of invalidity based on indefiniteness of the claim terms “competes” and “binding affinity (Ka).” Sanofi criticized Immunex’s ’487 patent for failing to…

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