BrainStorm Cell Therapeutics Inc.
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Latest From BrainStorm Cell Therapeutics Inc.
Relyvrio’s Failure Sparks NeuroSense ALS Development Changes
NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.
Finance Watch: Though Flush With Cash, Theseus Seeks Alternatives, Gets Two Quick Offers
Restructuring Edition: OrbiMed/Foresite and Concentra responded quickly after Theseus implemented a 72% workforce reduction and began a search for strategic alternatives despite having $225.4m in cash. REGENXBIO, Novavax and Lyell also revealed job cuts despite large cash stockpiles.
Promising Pathway Act Would Fill Gap For Rare Disease Treatments That Don’t Fit Accelerated Approval, Advocates Say
Bill would enable two-year provisional approval of drugs to treat life-threatening illnesses, such as ALS, based on substantial evidence of safety and early evidence of efficacy. At a Senate committee hearing, rare disease advocates said it would remedy the FDA’s inconsistent application of regulatory flexibility, but a bioethicist cautions it would lower the bar for approval.
Intarcia’s Fight To Win ITCA 650 Approval: Former Employees Object To FDA AdComm Presentations
In another case of criticism after an adcomm, three former Intarcia employees, including the key developer of the ITCA 650 device, contend agency made ‘erroneous statements’ about performance and manufacturing to the advisory committee that voted unanimously against the type 2 diabetes treatment.
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