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Biogen Idec - Articles and news items

sb5

Samsung Bioepis seeks EU approval for its biosimilar adalimumab candidate, SB5

Industry news / 18 July 2016 / Victoria White, Digital Content Producer

At an estimated $4billion a year, the reference product, Humira, is among the European Union’s largest single drug expenditures…

zinbryta

EC grants marketing authorisation for Zinbryta in multiple sclerosis

Industry news / 5 July 2016 / Victoria White, Digital Content Producer

The approval of Zinbryta is supported by results from two studies, including DECIDE, the largest and longest head-to-head Phase III study ever conducted in MS…

biosimilars

Efficacy and safety of Biogen’s anti-TNF biosimilars presented at EULAR

Industry news / 9 June 2016 / Victoria White, Digital Content Producer

Data demonstrating long-term comparable efficacy, safety and immunogenicity of Benepali (etanercept) and Flixabi (infliximab) have been presented at EULAR…

opicinumab

Phase II study of opicinumab in MS misses primary endpoint

Industry news / 7 June 2016 / Victoria White, Digital Content Producer

The primary endpoint primary endpoint was a multicomponent measure evaluating improvement of physical function, cognitive function, and disability…

Aducanumab

Investigational Alzheimer’s treatment Aducanumab accepted into EMA’s PRIME programme

Industry news / 2 June 2016 / Victoria White, Digital Content Producer

PRIME aims to bring treatments to patients faster by enhancing the EMA’s support for the development of investigational medicines…

flixabi

Infliximab biosimilar Flixabi approved in the EU

Industry news / 31 May 2016 / Victoria White, Digital Content Producer

The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade…

haemophilia B

EC approves Alprolix for the treatment of haemophilia B

Industry news / 13 May 2016 / Victoria White, Digital Content Producer

The European Commission has approved Alprolix (rFIXFc) for the treatment of haemophilia B and maintained its orphan designation…

haemophilia

Biogen announces plans to spin off its haemophilia business

Industry news / 3 May 2016 / Victoria White, Digital Content Producer

The new company, to be named at a later date, will focus on the discovery and development of therapies for the treatment of haemophilia…

Daclizumab

Daclizumab demonstrates significant improvements in cognition in RRMS

Industry news / 22 April 2016 / Victoria White, Digital Content Producer

New data demonstrates daclizumab’s positive cognitive outcomes and safety profile in patients with relapsing-remitting multiple sclerosis (RRMS)…

Tecfidera

Tecfidera demonstrates sustained efficacy in RRMS studies

Industry news / 18 April 2016 / Victoria White, Digital Content Producer

Biogen has unveiled new Tecfidera research that reinforces its sustained efficacy in newly diagnosed relapsing-remitting multiple sclerosis patients…

haemophilia B

CHMP adopts positive opinion of haemophilia B treatment, Alprolix

Industry news / 26 February 2016 / Victoria White

Alprolix is a recombinant clotting factor therapy developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1…

enbrel

EC approves Benepali – the first biosimilar of Enbrel

Industry news / 18 January 2016 / Victoria White

Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there…

 

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