Biogen
NEWS
For people with, or at risk for, SOD1-ALS, the FDA’s approval of Qalsody is an important step toward advancing gene-specific research for this uniformly fatal disease.
During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
Between new formulations of traditional drugs nearing the market and completely novel approaches in mid-stage trials, 2023 is poised to be a pivotal year in Parkinson’s disease treatment.
The Boston Business Journal reported the layoffs would affect the multiple sclerosis team, but Biogen declined to confirm the details.
The Centers for Medicare and Medicaid Services released details about the patient registry it will require physicians to use to prescribe Leqembi, should it be approved by the FDA.
BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain (NfL) could be a reasonable predictor of clinical benefit.
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.
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