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BioWorld - Saturday, February 21, 2026
Home » Topics » Neurology/psychiatric, BioWorld

Neurology/psychiatric, BioWorld
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Stem cells

Japan endorses two iPSC drugs for approval under CEA pathway

Feb. 20, 2026
By Marian (YoonJee) Chu
No Comments
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
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AI medical illustration

AI transforming med tech in 2026; clinical need drives investments

Feb. 18, 2026
By Shani Alexander
No Comments
Med-tech companies with an AI component in their solutions will certainly find investors willing to back them. AI after all, is being used to develop more effective, smarter technologies. However, investors will only deploy capital into innovations that address genuine clinical needs. The aging population is driving interest in devices targeting cardiovascular and musculoskeletal disorders, and other solutions geared toward neurological conditions, women’s health and diagnostics are also attracting investor attention.
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Illustration of SCAN in Parkinson’s vs healthy subcortex

SCAN is core circuit affected in Parkinson’s disease

Feb. 18, 2026
By Mar de Miguel
No Comments
Parkinson’s disease is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder, and patients experience problems with cognitive and emotional processes as well. SCAN, the somato-cognitive action network identified in 2023, could reshape the definition of PD. Treating this circuit can improve outcomes.
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Neural network
Newco news

Vesalic targeting toxic muscle exosomes in motor neuron diseases

Feb. 17, 2026
By Nuala Moran
No Comments
Newco Vesalic Ltd. has formed to take forward research indicating extracellular vesicles secreted by skeletal muscle cells carry toxic payloads that are key drivers of motor neuron diseases, including amyotrophic lateral sclerosis. The discovery of this process, which is largely external to the brain and the central nervous system, has opened up new targeting possibilities, and Vesalic is now working on in vivo studies to demonstrate preclinical proof of concept.
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Woman taking medication for mental illness

Compass nears NDA; psilocybin scores again in resistant depression

Feb. 17, 2026
By Karen Carey
No Comments
Positive results from the second of two phase III trials set Compass Pathways plc’s synthetic psilocybin treatment, COMP-360, on track for a potential U.S. FDA approval within a year as the first classic psychedelic cleared for treatment-resistant depression.
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3D illustration of organoid models in a petri dish
Drug design, drug delivery & technologies

Human organoid mimics cancer-induced cachexia

Feb. 17, 2026
By Mar de Miguel
No Comments
The variety of organoids that can be developed in vitro is enabling major advances. Depending on the type of tissues and the research goals, these small 3D cell-based structures that mimic real tissue offer certain advantages over animal models. Scientists at the University of Padova in Italy have created human neuromuscular organoids to reproduce cancer-induced muscle cachexia, a condition that murine models do not accurately replicate.
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Illustration of normal muscle compared to muscle atrophy in cancer cachexia or anorexia

Tumor, immune and neural cells are involved in cancer cachexia

Feb. 13, 2026
By Mar de Miguel
No Comments
A circuit formed by tumor, immune and nervous systems triggers cancer cachexia and anorexia, the excessive loss of weight, muscle and fat experienced in some cancer types. A new study is the first showing these three actors of a triangle interaction that initiates and feeds the process.
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Abbvie claims CMS’ selection of Botox violates the IRA

Feb. 12, 2026
By Mari Serebrov
No Comments
Undeterred by all the unsuccessful biopharma suits challenging the U.S. Medicare price negotiations, Abbvie Inc. filed its own complaint Feb. 11 in the U.S. District Court for the District of Columbia, seeking to undo CMS’ selection of Botox in the third round of the negotiations.
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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 11, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


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Regenxbio’s MPS II gene therapy gets CRL

Feb. 10, 2026
No Comments
As many had predicted following news of a clinical hold on the gene therapy last month, Regenxbio Inc. disclosed receipt of a complete response letter (CRL) regarding its BLA for RGX-121 (clemidsogene lanparvovec) in mucopolysaccharidosis II, an ultrarare neurodegenerative disease in dire need of new therapies.
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