amyotrophic lateral sclerosis
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Amylyx Pharma’s ALS drug needs a Phase 3 study to support FDA submission
Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring data from a larger Phase 3 clinical trial and that study is slated to begin later this year.
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FDA calls out Brainstorm’s ALS stem cell therapy, says data don’t show benefit
A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA took the unusual step of publicly stating that study’s results do not show the stem cell therapy helps patients.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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FDA issues industry guidance for developing amyotrophic lateral sclerosis drugs
A market research report issued at the beginning of the year forecast that the market for ALS drugs in several key countries would exceed $1 billion over a 10-year period.
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Cytokinetics remains positive on negative Phase II reldesemtiv study in ALS
Despite the trial not showing statistical significance on the primary or secondary efficacy endpoints, the company views the data as supportive of reldesemtiv’s Phase III development
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Verge Genomics raises $32 million in Series A for AI-discovered drugs
San Francisco-based firm, focusing on Parkinson’s disease and amyotrophic lateral sclerosis, has raised $36 million to date.
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Medical Megatrends Stem Cells — Part III
A cure for spinal cord injury? Diabetes? Macular degeneration? Hope or just hype? There are […]