but some had concerns about the drug’s ability to replicate positive results from earlier trials in larger Phase III trials, ...
The drug targets a rare form of ALS caused by a genetic mutation that leads to the accumulation of toxic levels of the SOD1 protein. Through the Biogen early access program, about 330 ALS patients ...
Ionis and Biogen scrap development of ALS drug Carlsbad-based Ionis Pharmaceuticals and Biogen announced last month that they were terminating the development of an ALS drug. Patients diagnosed ...
Biogen (NASDAQ:BIIB) has received EU regulatory approval for its drug Qalsody, also known as tofersen, for the treatment of ALS associated with a mutation in the superoxide dismutase 1 gene ...
The win with Qalsody aside, Biogen like other companies has weathered its share of ALS drug failures, most recently with an Ionis-partnered candidate called BIIB105. That drug wasn’t as far ...
The drug, an antisense oligonucleotide (ASO ... viewing it as a significant development for the ALS community. Through Biogen's early access program, approximately 330 people with SOD1-ALS ...
Through the Biogen early access program, about 330 people with SOD1-ALS have received QALSODY across ... and risks and uncertainties associated with drug development and commercialization.
(Reuters) -Biogen said on Thursday that the European Commission has granted marketing authorization under exceptional circumstances for its amyotrophic lateral sclerosis (ALS) drug Qalsody.
emphasized the company's commitment to bringing QALSODY to SOD1-ALS patients throughout Europe as quickly as possible. QALSODY has also been approved in the United States, and Biogen is in discussions ...