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BioWorld - Thursday, September 28, 2023
Home » Topics » Disease categories and therapies » Neurology/Psychiatric

Neurology/Psychiatric
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Adcom: Evidence not there yet for Nurown

Sep. 27, 2023
By Mari Serebrov
No Comments
Brainstorm Cell Therapeutics Inc.’s Nurown got a thumbs down from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Sept. 27, as the committee voted 1-17, with one abstention, that the data presented demonstrated substantial evidence of effectiveness for treatment of mild to moderate amyotrophic lateral sclerosis.
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AI generated illustration of a brain on fire
Neurology/Psychiatric

Newco news: Arialys has autoimmune solution to psychosis problem

Sep. 27, 2023
By Anette Breindl
No Comments
Arialys Therapeutics Inc. launched this month with $58 million in seed funding, an experimental compound it is developing for autoimmune encephalitis and autoimmune psychosis, and high aspirations for its field. “Yes, I want to treat these patients, I want these patients to have a better life. But I also want drug discovery and development folks to think differently about discovering new drugs for the CNS,” Jay Lichter told BioWorld.
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Brain with handshake and cityscape

Acurastem, Takeda strike $580M licensing deal for ALS, neurodegenerative drugs

Sep. 26, 2023
By Marian (YoonJee) Chu
No Comments
Acurastem Inc. said on Sept. 25 that it struck an out-licensing deal potentially worth $580 million with Takeda Pharmaceutical Co. Ltd. to develop drugs for amyotrophic lateral sclerosis (ALS) and other PIKfyve gene-targeting therapeutics. Under the terms, Tokyo-headquartered Takeda obtains exclusive worldwide rights to Acurastem’s PIKfyve-targeting therapeutics, including Acurastem’s lead AS-202 asset, an antisense oligonucleotide therapy to treat ALS.
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Japan’s MHLW approves slew of new drugs, including Eisai/Biogen’s Leqembi for Alzheimer’s

Sep. 26, 2023
By Tamra Sami
No Comments
Thanks to a raft of new approvals by Japan’s Ministry of Health, Labor and Welfare (MHLW), patients in Japan will soon have access to Biogen Inc./Eisai Co. Ltd.’s Leqembi (lecanemab), an amyloid-beta binder, for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease.
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Brain and DNA
Neurology/Psychiatric

Acurastem and Takeda sign license agreement for Acurastem’s PIKFYVE-targeted therapeutics

Sep. 26, 2023
No Comments
Acurastem Inc. has entered into a license agreement with Takeda Pharmaceutical Company Ltd. to develop and commercialize Acurastem’s PIKFYVE-targeted therapeutics, including AS-202, an innovative antisense oligonucleotide (ASO) for the treatment of amyotrophic lateral sclerosis (ALS).
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Neurology/Psychiatric

Orexia Therapeutics describes new orexin OX2 receptor agonists

Sep. 26, 2023
No Comments
Orexia Therapeutics Ltd. has identified bicyclic-heterocycle derivatives acting as orexin OX2 receptor agonists. As such, they are reported to be useful for the treatment of narcolepsy, circadian rhythm disorder, genetic disorders, coma, metabolic syndrome, neurodegeneration, osteoporosis and sleep apnea, among others.
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Cells and DNA helix

US FDA flexibility the question as Nurown goes before adcom

Sep. 25, 2023
By Mari Serebrov
No Comments
How flexible should the U.S. FDA evidentiary standards be for a therapy addressing a significant unmet need in a disease such as amyotrophic lateral sclerosis (ALS)? That’s the question the agency’s Cellular, Tissue and Gene Therapies Advisory Committee will ponder Sept. 27 as it looks at the data for Brainstorm Cell Therapuetics Inc.’s Nurown (debamestrocel), a mesenchymal stromal cell therapy targeting ALS. Nurown is going into the adcom with a bit of a checkered history that includes a refuse-to-file letter and a single phase III trial that failed to demonstrate efficacy for the primary endpoint and all key secondary efficacy endpoints, according to the FDA briefing document.
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Annalise Enterprise CTB

Annalise.ai software improves radiologists’ diagnostic accuracy and speed

Sep. 22, 2023
By Shani Alexander
No Comments
An artificial intelligence (AI) tool developed by Annalise.ai Pty Ltd. was able to improve radiologists’ accuracy in detecting abnormalities on non-contrast computed tomography brain (CTB) scans. According to a study published in European Radiology, the Annalise Enterprise CTB module improved radiologists' accuracy by 32% and reduced their overall reading time by 11%.
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Regenlife

Photobiomodulation study sheds light on potential Alzheimer’s treatment

Sep. 22, 2023
By Annette Boyle
No Comments

Light therapy during sleep helps increase resistance to Alzheimer’s disease (AD) progression, a study in Frontiers of Optoelectronics suggests. The researchers found that photobiomodulation (PBM) during deep sleep improved the ability of the lymphatic system to flush beta-amyloid from the brains of mice, demonstrating the importance of sleep in fending off the neurodegenerative disease and opening a possible new therapy for prevention and treatment of Alzheimer’s.


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Brain maze
Neurology/Psychiatric

Brain path could relieve pain as an alternative to opioids without producing dependence

Sep. 22, 2023
By Mar de Miguel
No Comments
Scientists at the University of Chicago have discovered a signaling pathway guided by nicotinic acetylcholine receptors (nAChRs) that could relieve pain even when tolerance to opioids was present. This mechanism did not produce dependence after treatment and could be explored to develop new drugs.
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