Pharmafile Logo

FDA Breakthrough Therapy Designation

- PMLiVE

Biogen agrees $850m felzartamab rights deal with TJ Biopharma

The agreement gives Biogen full global rights to the investigational antibody across immune-mediated diseases

- PMLiVE

MHRA authorises Biogen’s higher-dose Spinraza for SMA treatment

SMA is a rare genetic neuromuscular condition affecting around 1,600 people in the UK

- PMLiVE

Biogen to acquire Apellis in $5.6bn deal

The deal will enhance Biogen’s growth portfolio in immunology and rare disease

- PMLiVE

Eisai and Biogen’s new data shows Alzheimer’s patients choose to stay on Leqembi long-term

The findings were presented at the 20th International Conference on Alzheimer’s and Parkinson’s Diseases in Denmark

- PMLiVE

J&J’s nipocalimab gets FDA Fast Track designation for lupus

The autoimmune disease affects approximately three to five million people globally

- 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

AstraZeneca’s Saphnelo demonstrates positive results in systemic lupus erythematosus

Over 3.4 million people globally are affected by SLE, and it is one of the leading causes of death in young women in the US

- 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

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links