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The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.
Regeneron announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).
Bio-Thera provided an update on its pipeline at the BioPharmaSynergy conference in Amsterdam, reporting that its dupilumab, secukinumab, mepolizumab and vedolizumab biosimilars are in preclinical development.
Sanofi announced that the EC has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent was approved by the FDA in March 2017.
Sanofi and Regeneron announced that the FDA has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Sanofi and Regeneron filed a petition against Immunex, requesting an inter partes review (IPR) of patent 8,679,487. The petitioners argue that the ‘487 patent is invalid on novelty grounds. Earlier this month Sanofi and Regeneron filed a complaint in the District Court of Massachusetts, seeking a declaration of non-infringement.
Sanofi-Aventis, Genzyme Corporation and Regeneron filed a complaint in the District Court of Massachusetts seeking a declaration judgement that its development, manufacturing, sale, promotion and related activities for Dupixent® (dupilumab) do/will not directly or indirectly infringe Amgen’s US patent 8,679,487.
The results of two Regeneron ph III studies published in the New England Journal of Medicine report that dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, improved the signs and symptoms of atopic dermatitis, symptoms of anxiety and depression, and quality of life, compared with placebo.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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