Genzyme Therapeutics

Genzyme Therapeutics
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Genzyme Therapeutics

 •  January 8

• Companies also announce submission of dupilumab supplemental BLA for uncontrolled, persistent asthma Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) 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....

Genzyme Therapeutics

 •  December 15, 2017

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension (OLE) study and the ATLAS...

Genzyme Therapeutics

 •  December 13, 2017

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), the second deadliest skin cancer after melanoma.[i],[ii] Cemiplimab, an investigational human antibody targeting PD-1...

Genzyme Therapeutics

 •  November 9, 2017

• Clinical-stage oral drug candidate (PRN2246) with the potential to treat multiple sclerosis • Principia to receive $40 million upfront payment, future milestone payments could total $765 million Sanofi will develop Principia Biopharma Inc.’s experimental oral treatment that shows promise in multiple sclerosis (MS) and, potentially, other central...

Genzyme Therapeutics

 •  October 16, 2017

Sanofi and Regeneron Pharmaceuticals, Inc. today announced positive results from a Phase 2 investigational study of dupilumab in adults with active moderate-to-severe eosinophilic esophagitis. The study showed that patients who received dupilumab weekly reported a significant improvement in the ability to swallow versus placebo. The results of this...

Genzyme Therapeutics

 •  July 21, 2017

- 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, 2017

– 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, 2017

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, 2017

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, 2017

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...