Agitation

BioXcel Therapeutics Announces Plan for Evaluating BXCL501 in the At-Home Setting to Expand Its Market Potential

Retrieved on: 
Lunedì, Aprile 22, 2024
FDA, Patient, Dexmedetomidine, Safety, Agitation, Food, Bipolar disorder, Intermittent explosive disorder, Intelligence, Schizophrenia, Medicine, New product development, DSM-IV codes, Therapy, Type, Pharmaceutical industry

NEW HAVEN, Conn., April 22, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced additional details regarding the planned design of its SERENITY At-Home Phase 3 trial*to evaluate BXCL501, the Company’s investigational, proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with bipolar disorders or schizophrenia in the home setting. The Company’s plan to conduct this trial using a 120 mcg dose is based on feedback received from the U.S. Food and Drug Administration (FDA) following the recent receipt of agency minutes from the Type C meeting held on March 6, 2024.

Key Points: 
  • The outpatient trial is expected to enroll a total of approximately 200 patients with agitation associated with bipolar disorder or schizophrenia.
  • Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.
  • The primary objective is safety with efficacy measures as exploratory endpoints to evaluate use in the outpatient setting.
  • A corporate presentation, including information on the SERENITY program, is available on the Investors section of the Company’s website: bioxceltherapeutics.com.

Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting

Retrieved on: 
Lunedì, Aprile 15, 2024
Agitation, School, American Academy, University, Safety, Harm, Clinical trial, Dentistry, Cognition, CNS, Somnolence, Psychiatry, AAN, Central nervous system, Migraine, Therapy, Sleep

NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations highlighting its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado. The presentations include an oral presentation during the Clinical Trials Plenary Session of data from the ACCORD Phase 3 trial of AXS-05 in Alzheimer’s disease agitation (ADA). Presentations related to the AXS-07 clinical program in migraine include new pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3 trials. Additionally, there will be data presentations on cognition and sleep from the solriamfetol clinical program.

Key Points: 
  • NEW YORK, April 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced presentations highlighting its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado.
  • The presentations include an oral presentation during the Clinical Trials Plenary Session of data from the ACCORD Phase 3 trial of AXS-05 in Alzheimer’s disease agitation (ADA).
  • Presentations related to the AXS-07 clinical program in migraine include new pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3 trials.
  • Additionally, there will be data presentations on cognition and sleep from the solriamfetol clinical program.

Neumora Therapeutics Announces Clinical Hold of Phase 1 NMRA-266 Study

Retrieved on: 
Lunedì, Aprile 15, 2024
Rabbit, FDA, PAM, Safety, Convulsion, Agitation, Food, DSM-IV codes, Agency, IND, Toxicology, Therapy, Myenteric plexus, Pharmaceutical industry

The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits.

Key Points: 
  • The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits.
  • Following this action, the Phase 1 single ascending dose / multiple ascending dose study with NMRA-266 has been paused.
  • Approximately 30 participants have been dosed in the Phase 1 study, with no evidence of convulsions observed in any participant.
  • Neumora is working with the FDA to evaluate the potential to resolve the clinical hold.

UbiSim Virtual Reality EdTech Platform Enhanced with New Therapeutic Communication Scenarios for Nurse Learners

Retrieved on: 
Martedì, Aprile 30, 2024
Hardware, Technology, Education, Training, Managed Care, Professional Services, Neurology, LGBTQ+, Science, DEI (Diversity, Equity and Inclusion), Software, Consumer, Nursing, Health, Research, Alzheimer's disease, Respect, Learning, MSN, Virtual reality, Hospital, Agitation, Nose, Stomach, LGBT, Kaiser Family Foundation, Male, Communication, Conference, KFF, Catalog, Life, Obstetrics, STEM, Black, Environment, VR, Family, Mental health, Patient, Realism, RN, Next Generation, Pediatrics, Multimedia, Student, Knowledge

Learners practice administering medications and providing therapeutic communication to assist Morgan in this scenario that aligns with Nursing Fundamentals.

Key Points: 
  • Learners practice administering medications and providing therapeutic communication to assist Morgan in this scenario that aligns with Nursing Fundamentals.
  • Learners practice administering medications and providing therapeutic communication to assist Morgan in this scenario that aligns with Nursing Fundamentals.
  • In addition to the two new scenarios, updates to the UbiSim platform include a major new functionality related to the UbiSim intuitive editor.
  • Nurse educators can now customize their UbiSim nursing scenarios by adding an NG tube, while nurse learners are able to install an NG tube on any patient within the simulations.

BioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer’s Dementia

Retrieved on: 
Mercoledì, Aprile 10, 2024
FDA, Dexmedetomidine, Safety, Agitation, Food, Dementia, Intelligence, Live, Patient, AAD, Medicine, New product development, Database, Positive, Therapy, Type, Pharmaceutical industry

NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company’s investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with Alzheimer’s dementia (AAD) in the care setting. The Company’s plan to conduct this trial is based on feedback received from the U.S. Food and Drug Administration (FDA), following the recent receipt of minutes from the Type B/Breakthrough Therapy designation meeting held with the agency on February 20, 2024.

Key Points: 
  • “The design of our upcoming TRANQUILITY In-Care trial largely mirrors TRANQUILITY II, which demonstrated positive efficacy and safety results with a 60 mcg dose of BXCL501,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics.
  • “We have completed two recent meetings with the FDA on our TRANQUILITY program, and are pleased to have obtained clarity on the next steps for our AAD development path.
  • The trial is expected to enroll patients with episodic agitation, with patients self-administering 60 mcg of BXCL501 or placebo when agitation episodes occur over the trial period.
  • A slide presentation on the TRANQUILITY program is available on the Investors section of the Company’s website: bioxceltherapeutics.com.

 Zep® Introduces Pro Wash N Wick Innovative Vehicle Wash

Retrieved on: 
Martedì, Aprile 23, 2024
Trucking, Aftermarket, Automotive, General Automotive, Transport, Chemicals, Plastics, Specialty, Manufacturing, Retail, Fleet Management, Zep, Multimedia, Marketing, Wash, Agitation

Zep ®, the go-to cleaning brand for professionals, announces the launch of Pro Wash N Wick, a superior vehicle wash engineered for excellence.

Key Points: 
  • Zep ®, the go-to cleaning brand for professionals, announces the launch of Pro Wash N Wick, a superior vehicle wash engineered for excellence.
  • View the full release here: https://www.businesswire.com/news/home/20240423531123/en/
    Zep Pro Wash N Wick is a premium-grade solution that introduces a breakthrough in vehicle washing technology, combining unparalleled cleaning with fast sheeting to create an exceptionally quick drying and spot-free shine.
  • (Photo: Business Wire)
    Pro Wash N Wick is distinguished by its high-foaming formula, which effortlessly cuts through road film, diesel exhaust and bugs.
  • “Pro Wash N Wick represents Zep's commitment to innovation and our understanding of the needs within the vehicle wash industry,” said Lauren Houser, Zep Vice President of Marketing.

Agitated Solutions Receives Health Canada License for Orbis Microbubble Generator to Streamline Cardiac Bubble Studies

Retrieved on: 
Giovedì, Aprile 18, 2024
Health, Medical Devices, General Health, Clinical Trials, Research, Science, Cardiology, Brain, Stroke, Hearing, Agitation, University Health Network, Travel, Heart, MD, Health Canada, Life, ASI, Newsweek, Patent, PFO, Autopsy, UHN, Northwestern Medicine, Organic acid, Multimedia, Diagnosis, Standard of care, Atmosphere, Toronto General Hospital, Longevity, Medical device, Incidence

Agitated Solutions, Incorporated (ASI) announced today that it has been issued a Medical Device Establishment License (MDEL) from Health Canada for its innovative Orbis™ Microbubble Generator that simplifies and streamlines the process of saline agitation and delivery for cardiac bubble studies.

Key Points: 
  • Agitated Solutions, Incorporated (ASI) announced today that it has been issued a Medical Device Establishment License (MDEL) from Health Canada for its innovative Orbis™ Microbubble Generator that simplifies and streamlines the process of saline agitation and delivery for cardiac bubble studies.
  • View the full release here: https://www.businesswire.com/news/home/20240418247093/en/
    The Orbis™ Microbubble Generator is the first tool to automatically agitate the saline with uniform, small bubbles that endure longer for visibility.
  • The standard of care for cardiac bubble studies requires one clinician to conduct the imaging while a second clinician agitates and injects the saline.
  • Immediately following receipt of the Health Canada license, the first clinical use of Orbis was conducted at University Health Network (UHN) Toronto General Hospital in Toronto, Canada.

IGC-AD1’s Interim Phase 2 Data Show a Reduction in Alzheimer’s Agitation at Week Two

Retrieved on: 
Martedì, Aprile 16, 2024
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Neurology, Mental Health, Other Science, Research, Science, Clinical Trials, Dementia, Safety, Agitation, THC, Pharma, Neuroinflammation, Cognition, Verbal aggression, Caregiver, Hospital, CB1, Behavior, IGC, Pharmaceutical industry

IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents.

Key Points: 
  • IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents.
  • IGC-AD1 is a first-of-its-kind THC-based-formulation undergoing a formal Phase 2 clinical trial in Alzheimer’s disease ( clinicaltrials.gov , Identifier: CT05543681).
  • “The interim data indicate early signs of potential clinical benefit with IGC-AD1 with infrequent treatment limiting side effects.
  • To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.

GE Appliances Introduces the First-Ever Spanish-Language Washer for U.S. Customers

Retrieved on: 
Venerdì, Aprile 12, 2024
Other Manufacturing, Environment, Other Retail, Specialty, Hispanic, Home Goods, Manufacturing, Green Technology, Consumer, Retail, Agitation, 1,000,000, Language, MSRP, Water, Multimedia, GE Appliances, Consumer electronics

GE Appliances’ all-new washer designed for Hispanic consumers in the U.S. is available today, ahead of National Laundry Day on April 15.

Key Points: 
  • GE Appliances’ all-new washer designed for Hispanic consumers in the U.S. is available today, ahead of National Laundry Day on April 15.
  • ft. Capacity Washer with Spanish-Language Panel with Soaking and Agitation Wash Modes is the first washer of its kind in the U.S., reinforcing GE Appliances’ commitment to creating laundry solutions for all.
  • "GE Appliances has long delivered meaningful household solutions and our first Spanish-language washer furthers that goal,” said David Wilson, senior commercial director of clothes care at GE Appliances.
  • GE Appliances laundry products are also backed by a 10-year limited warranty on the motor, offering long-lasting performance and peace of mind.

Does Compostable Packaging Actually Break Down? Composting Consortium Reveals Groundbreaking Findings from Largest Field Test in North America

Retrieved on: 
Martedì, Aprile 16, 2024
Education, Methane, University College London, PepsiCo, Agitation, Atlas, Compost, Growth, Colgate-Palmolive, Food, UCL, CMA, Overalls, ASTM International, RRS, Kraft Heinz, Sustainability, PLA, Circular economy, BPI, WWF, Research, SPC, CREF, Target Corporation, Western Michigan University, WMU, Recycling, CFTP, University, FPI, Consortium, Environment, Oxygen, Foodservice

NEW YORK, April 16, 2024 /PRNewswire/ -- Today, the Composting Consortium, an industry collaboration led by the Center for the Circular Economy at Closed Loop Partners, released a groundbreaking report that fills a critical data gap for the U.S. composting industry: how well does certified, food-contact compostable packaging actually break down in real-world composting facilities? The report, Breaking It Down: The Realities of Compostable Packaging Disintegration in Composting Systems, shares findings from an 18-month study––the largest known field test of certified, food-contact compostable packaging conducted in North America––revealing the realities of compostable plastic and fiber disintegration in diverse in-field composting conditions.

Key Points: 
  • The report, Breaking It Down: The Realities of Compostable Packaging Disintegration in Composting Systems , shares findings from an 18-month study––the largest known field test of certified, food-contact compostable packaging conducted in North America––revealing the realities of compostable plastic and fiber disintegration in diverse in-field composting conditions.
  • In total, the study tested over 23,000 units of certified food-contact compostable packaging within large-scale industrial composting environments.
  • This encompassed 31 types of fiber packaging & products and compostable plastic packaging & products––such as PLA and PHA––across 10 diverse composting facilities across the U.S.
  • The findings point to the viability of certified food-contact compostable packaging as an alternative packaging solution to single-use conventional plastic packaging.