The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain could be a reasonable predictor of clinical benefit.
Tag Archive for: tofersen
Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
uniQure inked a deal with Apic Bio Tuesday to gain development and commercialization rights for APB-102, a therapeutic intended to treat a rare, genetic form of ALS.
The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
Ionis Pharmaceuticals Inc. announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for review of tofersen, an investigational medicine for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). SOD1-ALS is a progressive and uniformly fatal disease that affects fewer than 1,000 people across Europe.
The U.S. Food and Drug Administration has extended the review of Biogen Inc.’s (BIIB.O) experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) by three months, the company said on Monday.
Biogen may have found its CEO in Mathai Mammen – former head of research and development in pharmaceuticals at Johnson & Johnson – following the pending departure of current company head Michel Vounatsos.
Longer-term use and early initiation of Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) was effective in slowing disease progression, according to a new analysis by the company published on Wednesday.
The U.S. Food and Drug Administration has agreed to review Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS), after the therapy failed a late-stage study but showed promise in some patients.