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.
The whistleblower claim was brought by former employee Michael Bawduniak, who accused the company of paying off doctors to favor its multiple sclerosis drugs over those of its competitors. The trial for this case was scheduled to begin July 26.
Biogen Inc. on Wednesday tried to assuage investor worries by laying out a plan for its Alzheimer’s disease drug being developed with Eisai Co. Ltd. and promising to draw lessons from the setbacks to its treatment Aduhelm.
The agency will expedite its review of Eisai Co Ltd’s (4523.T) and Biogen Inc’s (BIIB.O) experimental Alzheimer’s drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.
Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm (aducanumab-avwa) following its post on ClinicalTrials.gov.
Biogen has terminated the company’s asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being tested in Phase I as a treatment for amyotrophic lateral sclerosis (ALS).
Roche’s experimental Alzheimer’s drug crenezumab failed to meaningfully slow or prevent cognitive decline in people at risk of a rare, inherited form of the disease, the Swiss drugmaker said on Thursday.
Even with the COVID-19 emergency measures, payers still had an eye on the potential flood of gene therapies for rare diseases brewing in the pipeline, and were pondering new ways to pay for them.
Biogen and Ionis Pharmaceuticals have announced results from the Phase III VALOR trial and an open-label extension trial of the amyotrophic lateral sclerosis (ALS) hopeful tofersen. This data suggests that earlier initiation of the drug compared to delayed initiation decreased declines in clinical function, respiratory function, muscle strength and quality of life.
Sage Therapeutics and partner Biogen shared news that their Phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).