Brain

Ceribell Receives FDA Breakthrough Device Designation for Delirium Indication

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Thursday, September 8, 2022
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SUNNYVALE, Calif., Sept. 8, 2022 /PRNewswire/ -- Ceribell, Inc. announced today that it has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA). A first-of-its-kind technology, the Ceribell® system utilizes machine learning to analyze electroencephalography (EEG) signals to detect delirium. The Ceribell point-of-care EEG system first received FDA 510(k) clearance in 2017 for indicating suspected seizure activity and is currently utilized in intensive care units (ICUs) and Emergency Rooms across the United States.  

Key Points: 
  • Breakthrough Device Designation recognizes Ceribell's point-of-care EEG as a first-of-its-kind technology for the detection of delirium.
  • SUNNYVALE, Calif., Sept. 8, 2022 /PRNewswire/ -- Ceribell, Inc. announced today that it has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA).
  • A first-of-its-kind technology, the Ceribell system utilizes machine learning to analyze EEG signals to detect delirium.
  • The Ceribell system's Breakthrough Device Designation was grounded in early clinical studies that have provided clear evidence that the system is likely to improve the current standard of care.

Small Pharma to Participate in Upcoming September Investor Conferences

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Thursday, September 8, 2022
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LONDON, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the Company or Small Pharma), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, announces that George Tziras, Chief Executive Officer and Dr. Carol Routledge, Chief Medical and Scientific Officer, will participate in upcoming investor conferences this September.

Key Points: 
  • LONDON, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the Company or Small Pharma), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, announces that George Tziras, Chief Executive Officer and Dr. Carol Routledge, Chief Medical and Scientific Officer, will participate in upcoming investor conferences this September.
  • Details of the sessions are as follows:
    Jefferies Innovation in Mental Health Summit, New York City
    To schedule a one-on-one meeting with Small Pharmas management team, please contact your respective assigned conference representative or [email protected] .
  • Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression.
  • Small Pharma initiated a clinical program into N, N-dimethyltryptamine (DMT) assisted psychotherapy in February 2021.

Xinteza Introduces Novel Key Enzyme to Solve Major Bottlenecks in Cannabinoid Biosynthesis

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Thursday, September 8, 2022
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TEL AVIV, Israel, Sept. 8, 2022 /PRNewswire/ -- Xinteza API Ltd., an innovative biosynthesis technology company, announced today the discovery of a new catalytic enzyme, capable of solving one of the major bottlenecks that has so far limited the design of sustainable and cost-efficient cannabinoid biosynthesis production systems, in breakthrough research led by Prof. Asaph Aharoni at the Weizmann Institute of Science.

Key Points: 
  • As reported previously , Xinteza has recently unveiled discoveries for a patent-pending whole new non-cannabis source of cannabinoid biosynthesis related genes and enzymes.
  • This newly discovered gene pool includes a novel prenyl-transferase enzyme, featuring superior kinetics and improved flexibility in introduction into micro-organism-based expression systems.
  • "As we expand our IP's commercialization and collaboration activity, we are highly motivated by this pivotal discovery of such a key novel enzyme.
  • "We continue to optimize commercial-scale processes of cannabinoid biosynthesis with the most sophisticated proprietary cannabinoid producing genes and enzymes from our growing portfolio", Gal added.

Propanc Biopharma Reports Significant Effects of PRP Against the Tumor Microenvironment

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Thursday, September 8, 2022
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It was concluded that PRP could have a significant impact on the tumor microenvironment as a potential clinical application.

Key Points: 
  • It was concluded that PRP could have a significant impact on the tumor microenvironment as a potential clinical application.
  • Despite recent advances in understanding its molecular and genetic basis, more than one third of those affected die each year from cancer.
  • She explains that tumor formation is influenced by two factors, genetic changes in tumor cells and the rearrangement of components of the tumor microenvironment.
  • In recent years, cancer research has focused on the tumor microenvironment.

NICO and Elite Medical "Dream Team" Form Oncology Tissue Advisory Board

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Thursday, September 8, 2022
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INDIANAPOLIS, Sept. 8, 2022 /PRNewswire/ -- Surgeons, oncologists, and researchers all agree: When it comes to understanding complex and deadly brain tumors, tissue is the issue. Backed by dozens of published papers, the need for obtaining better quality tissue is identified as a key element in the scientific understanding of aggressive brain tumors like Glioblastoma Multiforme (GBM).

Key Points: 
  • Published data also suggests that NICO Corporation 's advanced tissue collection and biological preservation system slows the degradation of critical molecular information within resected tumor tissue.
  • This biological preservation process mimics the tissue microenvironment and may impact the understanding of tumor biology for GBM and other complex, aggressive brain cancers.
  • NICO's newly formed Oncology Tissue Advisory Board (OTAB) is tasked with pushing forward the standardization of tissue collection and preservation, with the goal of enabling more effective precision medicine therapies.
  • NICO technologies provide neurosurgeons with a systems approach to automating the biological preservation of GBM tissue in the operating room using the NICO Myriadand Automated Preservation System.

Cassava Sciences to Present at the H.C. Wainwright Global Investment Conference

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Thursday, September 8, 2022
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A live webcast will be available on the Investors page of Cassava Sciences website, www.CassavaSciences.com .

Key Points: 
  • A live webcast will be available on the Investors page of Cassava Sciences website, www.CassavaSciences.com .
  • An archived replay will be available for 90 days following the event.
  • Cassava Sciences Inc. is a clinical stage biotechnology company based in Austin, Texas.
  • Our novel science is based on stabilizing but not removing a critical protein in the brain.

Vistagen to Proceed with PALISADE-2 Phase 3 Clinical Trial of PH94B in Social Anxiety Disorder following Interim Analysis

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Thursday, September 8, 2022
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We are encouraged by the recommendation to continue PALISADE-2 to full enrollment as originally planned, said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • We are encouraged by the recommendation to continue PALISADE-2 to full enrollment as originally planned, said Shawn Singh, Chief Executive Officer of Vistagen.
  • We believe that the recommendation resulting from the interim analysis to resume PALISADE-2 is the best course of action.
  • No severe or serious adverse events were reported for PH94B in PALISADE-1 or PALISADE-2 or in other clinical trials.
  • VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression.

Autobahn Therapeutics Announces Successful Financing to Support Strategic Advancement of ABX-002 for Treatment Resistant Depression

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Thursday, September 8, 2022
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TRD is a subsegment of major depressive disorder (MDD) and is characterized by an inadequate response to treatment after using two or more approved medications.

Key Points: 
  • TRD is a subsegment of major depressive disorder (MDD) and is characterized by an inadequate response to treatment after using two or more approved medications.
  • Extensive clinical precedent provides strong evidence of thyroid hormones role in depression, suggesting that its augmentation could lead to jump-starting responses in people taking antidepressants.
  • ABX-002 is expected to augment antidepressant treatments by potentiating the beneficial effects of these drugs on monoaminergic signaling.
  • Autobahn plans to initiate a Phase 1 single- and multiple-ascending dose trial with ABX-002 in healthy volunteers in the second half of 2022.

Moleculin Selected to Present at the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care

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Thursday, September 8, 2022
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Details of the presentations are as follows:

Key Points: 
  • Details of the presentations are as follows:
    Title: The Value of Collaboration in Clinical Development: Experience from Poland
    For more information about the conference, visit: www.roswellpark.org/msc-symposium .
  • is a clinical stage pharmaceutical company focused on the development of a broad portfolio of drug candidates for the treatment of highly resistant tumors and viruses.
  • The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

KAZIA TO PRESENT FINAL DATA FROM PAXALISIB PHASE II STUDY IN GLIOBLASTOMA AT ESMO

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Thursday, September 8, 2022
Brain, Glioblastoma, VEGFR3, GBM, DIPG, NASDAQ, US, Orphan, AT/RT, KZIA, PI3K, Twitter, ASX, Pharmaceutical industry, Genentech

Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021.

Key Points: 
  • Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021.
  • Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020.
  • Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021.
  • This document was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.