BrainStorm Cell Therapeutics
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Brainstorm’s ALS Data Fail to Persuade FDA Advisors, Who Vote Down the Stem Cell Therapy
NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.
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FDA Again Spurns BrainStorm’s ALS Data, This Time With Official Refusal
BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.
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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 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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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
