Sanofi reported overall net sales increased by 5.5 percent for second-quarter 2019, driven by Sanofi Genzyme, Sanofi Pasteur and emerging markets.
FDA approves expanded label for Regeneron/Sanofi’s Dupixent
Analysts, Approvals, Asthma, Atopic Dermatitis (Eczema), Biologics, Blockbusters, Chronic Obstructive Pulmonary Disease (COPD), Chronic Rhinosinusitis, Corticosteroids, Environmental Allergies, Eosinophilic Esophagitis, Expanded Label, FDA, FDA/Regulatory, Food Allergies, Nasal PolypsThe U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
Novartis’ QMF149 met primary and key secondary endpoints in the Phase III QUARTZ clinical trial for asthma.
Verily announced a strategic collaboration deal with Novartis, Otsuka, Pfizer, Sanofi, and six major health systems.
The European Commission approved Dupixent (dupilumab) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide, who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.
GlaxoSmithKline Plc said the company’s three-in-one drug Trelegy Ellipta met the main goal of a late-stage asthma study, signaling a possible boost to the British drugmaker’s lung medicines division.
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending approval in the European Union for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.
The FDA approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes for Genentech’s Xolair as an additional formulation for allergic asthma and chronic idiopathic urticaria.
Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.
