BrainStorm Cell Therapeutics Inc.
http://www.brainstorm-cell.com
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Latest From BrainStorm Cell Therapeutics Inc.
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.
Pink Sheet Podcast: BrainStorm Withdraws NurOwn, NIH Nominee On Drug Pricing, Gene Therapy Long-Term Follow-Up
Pink Sheet reporters and editor discuss BrainStorm’s next steps after withdrawing the NurOwn BLA, NIH director nominee Monica Bertagnolli’s thoughts on drug affordability, and the US FDA’s effort to ensure long-term follow-up of gene therapy patients.
Company Information
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Biotechnology
- Gene Therapy, Cell Therapy
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Drug Discovery Tools
- ADMET
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