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BrainStorm, Catalent Complete Tech Transfer for NurOwn
contractpharma
December 08, 2021
Autologous cell therapy for the treatment of ALS and PMS will be manufactured at Catalent’s 32,000 sq.-ft. cell therapy manufacturing facility in Houston.
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BrainStorm Announces Positive Topline Data in NurOwn Study for Progressive MS
americanpharmaceuticalreview
March 30, 2021
BrainStorm Cell Therapeutics announced topline data from the Company's Phase 2 trial evaluating three repeated administrations of NurOwn® (MSC-NTF cells), each given 2 months apart, as a treatment for progressive multiple sclerosis (MS).
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BrainStorm Receives FDA Feedback on ALS Clinical Development Program
americanpharmaceuticalreview
February 25, 2021
BrainStorm Cell Therapeutics recently met with senior leadership from the U.S. Food and Drug Administration (FDA) and received FDA feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) ALS Phase 3 clinical trial.
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BrainStorm Announces NurOwn Expanded Access Program
americanpharmaceuticalreview
January 05, 2021
BrainStorm Cell Therapeutics has announced the initiation of a NurOwn® (MSC-NTF cells) Expanded Access Program (EAP) for patients with amyotrophic lateral sclerosis (ALS) who completed the Company's recently concluded pivotal Phase 3 clinical trial ...
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Catalent, BrainStorm Enter ALS Drug Manufacturing Pact
contractpharma
October 23, 2020
Catalent will undertake the transfer of the manufacturing process to, and provide future cGMP clinical supply of NurOwn from its Houston facility.
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BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update
prnewswire
October 16, 2020
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced financial results for the third quarter ended September 30, 2020, and provided a corporate update.
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BrainStorm Expands Clinical Pipeline to Evaluate NurOwn for Alzheimer's Disease
americanpharmaceuticalreview
July 03, 2020
BrainStorm Cell Therapeutics announced a new clinical program focused on the development of NurOwn® as a treatment for Alzheimer's disease.
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FDA Accepts BrainStorm’s NurOwn IND Application for Progressive Multiple Sclerosis
americanpharmaceuticalreview
December 19, 2018
BrainStorm Cell Therapeutics announced the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application to.....
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BrainStorm Announces NurOwn Phase 3 Trial Agreements
pharmaceutical-technology
July 20, 2017
BrainStorm Cell Therapeutics has signed definitive agreements with Massachusetts General Hospital and California Pacific Medical Center (CPMC) to enroll patients in the planned Phase 3 clinical trial of NurOwn in amyotrophic lateral sclerosis (ALS),