Genzyme Therapeutics

Genzyme Therapeutics
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Genzyme Therapeutics

 •  July 21

- First investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Dupixent®...

Genzyme Therapeutics

 •  July 10

– With up to 20 Months of Dosing, Fitusiran Safety and Tolerability Profile Remains Encouraging – – Once Monthly, Subcutaneous Fitusiran Achieves Median Annualized Bleeding Rate (ABR) of One for All Patients and Zero for Patients with Inhibitors in Exploratory Post-hoc Analysis – – New England Journal of Medicine Publishes Phase 1 Clinical Results...

Genzyme Therapeutics

 •  June 4

Sanofi and Regeneron Pharmaceuticals, Inc. today announced positive preliminary results with investigational REGN2810, a checkpoint inhibitor targeting PD-1 (programmed death 1), in patients with advanced cutaneous squamous cell carcinoma (CSCC). The data, pooled from two expansion cohorts of the REGN2810 Phase 1 trial, will be presented today at...

Genzyme Therapeutics

 •  April 25

Results observed in these patients through six years were similar to those in patients who did not relapse between courses "Relapses are not uncommon following the initiation of disease-modifying therapies for relapsing MS. Approximately 25% to 45% of RMS patients treated with DMTs experience relapses in the first year or two of treatment,...

Genzyme Therapeutics

 •  April 24

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Kevzara® (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid...

Genzyme Therapeutics

 •  April 24

Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved Thymoglobulin® [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. Kidney disease is the ninth leading cause of death in the US;...

Genzyme Therapeutics

 •  March 28

Dupixent will be available later this week to U.S. patients suffering from this chronic and debilitating form of eczema
Sanofi and Regeneron Pharmaceuticals, Inc.announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with...

Genzyme Therapeutics

 •  March 4

Late-breaking oral abstract to be presented today at the Annual Meeting of the American Academy of Dermatology
Sanofi and Regeneron Pharmaceuticals, Inc. today presented detailed results from the one-year Phase 3 CHRONOS study, which showed that patients receiving the investigational drug Dupixent® (dupilumab) with topical corticosteroids (TCS)...

Genzyme Therapeutics

 •  November 4, 2016

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the first patient has been enrolled and received an infusion in a pivotal Phase 3 clinical trial named COMET for the investigational therapy neoGAA. NeoGAA is a second-generation enzyme replacement therapy being studied for the...

Genzyme Therapeutics

 •  October 28, 2016

Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Applications (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid...