FDA approves Sanofi and Regeneron’s new eczema drug
The US Food and Drug Administration (FDA) approved Sanofi and Regeneron's Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).
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The US Food and Drug Administration (FDA) approved Sanofi and Regeneron's Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis).
9 February 2017 | By Niamh Marriott, Digital Editor
"It is our longstanding position that Amgen's asserted patent claims are invalid and we look forward to moving forward with the appeal process."
13 December 2016 | By Niamh Louise Marriott, Digital Editor
The European Medicines Agency (EMA) has accepted for review the marketing authorisation application for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
5 October 2016 | By Niamh Louise Marriott, Digital Content Producer
Regeneron Pharmaceuticals and Sanofi’s two placebo-controlled Phase 3 trials, evaluating dupixent (dupilumab) in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), met their primary endpoints evaluating the extent and severity of the disease.
30 August 2016 | By Niamh Louise Marriott, Digital Content Producer
The trial showed adding praluent to existing therapy reduced LDL cholesterol by approximately 50% from baseline, compared to 2% increase for placebo...
1 August 2016 | By Sanofi / Regeneron Pharmaceuticals, Inc.
Sanofi and Regeneron Pharmaceuticals, Inc. have announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for sarilumab, an investigational human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of adult patients with moderately to severely active rheumatoid arthritis...
6 June 2016 | By Victoria White, Digital Content Producer
Sanofi and Regeneron have announced that a one-year Phase III study evaluating investigational dupilumab met its primary and key secondary endpoints.
1 April 2016 | By Victoria White
Sanofi and Regeneron have announced positive topline results from two placebo-controlled Phase III studies evaluating investigational dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD).
24 March 2016 | By Victoria White
Regeneron and Bayer are to develop a combination therapy of the Ang2 antibody nesvacumab and the VEGF trap aflibercept for the treatment of eye diseases...
23 March 2016 | By Victoria White
Patients who added Praluent to their existing treatment regimen significantly reduced the frequency of their apheresis therapy by 75% compared to placebo....
17 March 2016 | By Victoria White
A jury has delivered a verdict in Amgen's favour in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to PCSK9...
11 March 2016 | By Victoria White
A Phase III study demonstrated that sarilumab was superior to adalimumab in improving signs and symptoms in patients with active RA...
8 February 2016 | By Victoria White
NICE was concerned that alirocumab had not been compared with the combination therapy of ezetimibe plus a statin and that trials of the drug were not able to provide robust information on cardiovascular outcomes...
30 October 2015 | By Victoria White
Bayer plans for an immediate introduction of Eylea to the market with Germany being one of the first launch countries in Europe...
28 September 2015 | By Victoria White
Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses, offering two levels of efficacy...