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BrainStorm Cell Therapeutics Inc.

http://www.brainstorm-cell.com

Latest From BrainStorm Cell Therapeutics Inc.

ALS Drugs: A Long History Of Regulatory Twists At US FDA

The US FDA is set for two high-profile advisory committee meetings on potential ALS treatments before the end of 2022. Whatever the outcome, they will fit a pattern: when it comes to ALS treatments, there is very little about the regulatory process that feels routine.

BioPharmaceutical United States

AstraZeneca's Ultomiris Disappoints In ALS, Setting Back Rare Disease Ambitions

AstraZeneca is discontinuing a Phase III trial of the long-acting complement inhibitor it gained via its Alexion acquisition in amyotrophic lateral sclerosis because of lack of efficacy in an interim analysis. Interest is now turning to antisense and cell therapy candidates from other companies that are in late-stage development for the condition.

Clinical Trials Rare Diseases

US FDA Rebukes Another Sponsor For Touting Investigational Product Based On Subgroup Efficacy

CytoDyn’s COVID-19 candidate leronlimab joins BrainStorm’s ALS therapy in being taken to task as FDA has become more willing to publicly counter investigational drug data announcements it considers to be misleading.

Clinical Trials Coronavirus COVID-19

BrainStorm’s Phase III Data Do Not Support Clinical Benefit Of NurOwn In ALS, US FDA Says

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.

Drug Approval Standards Clinical Trials
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