Pharmafile Logo

clinical development

- PMLiVE

Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for lupus

Therapies like topical steroids manage symptoms but there is currently no cure

- PMLiVE

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

- PMLiVE

Eisai submits new drug application for subcutaneous Leqembi in Japan

LEQEMBI is a treatment for early Alzheimer’s disease

- PMLiVE

Biogen and Eisai receive MHRA approval for updated dosing of early Alzheimer’s treatment

The MHRA approval for IV dosing comes following positive results from the global phase 3 trial

- PMLiVE

Biogen expands portfolio in deal with Alcyone Therapeutics

The agreement gives Biogen full rights to a potential therapy for patients with neurological disorders

Biogen Idec building

Biogen/Eisai’s Alzheimer’s drug Leqembi shows continued benefit over four years

An estimated 13 million people in the US will be living with Alzheimer’s disease by 2050

- PMLiVE

FDA unveils PreCheck programme to enhance US domestic pharma supply chain

The new initiative was developed in response to President Donald Trump's executive order

Biogen Idec building

Biogen’s Qalsody granted MHRA approval to treat rare form of motor neurone disease

Mutations in the SOD1 gene are responsible for approximately 2% of all cases of the disease

- PMLiVE

AstraZeneca unveils plans to boost US footprint with $50bn investment

The funds will go towards establishing a multi-billion dollar drug substance facility in Virginia

Biogen Idec building

Biogen to boost US manufacturing footprint with $2bn North Carolina investment

The commitment is aimed at advancing the company's late-stage clinical pipeline

Biogen Idec building

Biogen initiates phase 3 study of felzartamab in kidney disease patients

Approximately 36,000 people in the US are affected by primary membranous nephropathy

Biogen Idec building

Biogen and City Therapeutics to develop RNAi therapies in deal worth over $1bn

The partners will focus on a target that mediates key central nervous system diseases

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links