AUC

Quolet announces completion of Phase 1 healthy volunteer study evaluating the safety and bioavailability of Cannabidiol in a novel formulation intended for treatment of various neurological and psychiatric diseases

Retrieved on: 
Thursday, February 22, 2024
Start-Up, Biotechnology, Alternative Medicine, Professional Services, Health, Cannabis, Pharmaceutical, Neurology, Mental Health, Natural Resources, Clinical Trials, Therapy, Anxiety, Capsule, Multimedia, KCL, Absorption, Blood, Schizophrenia, GRAS, AUC, Lung, Cmax, Risk, Hepatotoxicity, University, Innovation, SME, University of Oxford, THC, Disorder, Lymphatic system, DMF, Adipose tissue, Brain, Pharmaceutical industry

Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).

Key Points: 
  • Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).
  • Researchers at King’s College London partnered with the SEEK group to test whether its bioavailability could be improved by administering CBD in a novel patented lipid formulation.
  • This lipid formulation allows high doses of CBD (200mg) to be administered in capsules including only GRAS and/or pharmaceutical approved ingredients.
  • In one visit they were given the lipid-CBD, and in the other visit they were given standard CBD-only formulation.

Neurocode Launches Groundbreaking pTau217 Blood Test for Alzheimer's Disease Clinical Diagnosis

Retrieved on: 
Monday, March 4, 2024
Collection, Doctor of Philosophy, Research, MD, Blood, Pathology, Cerebrospinal fluid, Neurology, AUC, LDT, Laboratory developed test, Diagnosis, Simoa, Autopsy, Biomarker, Gold, Health, Patient, Radiation exposure, CSF, DSM-IV codes, Disease, PET, JAMA Neurology, Brain, Medical imaging

Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.

Key Points: 
  • Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes.
  • Neurocode's new blood test is as accurate as brain imaging or CSF testing for diagnosing Alzheimer's, but is faster, more accessible, less expensive, and less invasive.
  • Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility.
  • Sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site.

Lunit Presents Seven Study Results at ECR 2024: Showcasing AI's Robust Performance in Diverse Clinical Settings

Retrieved on: 
Wednesday, February 28, 2024
Therapy, Workload, Breast cancer, Area, Odense University Hospital, Algorithm, Woman, Radiology, Pneumothorax, Artificial intelligence, AI, Research, Triage, Pathology, Deep learning, Use, AUC, Workflow, King's College London, NHS, ACV, ECR, Mammography, Radboud University Medical Center, Report, Patient, Poster, Human, Medical device

SEOUL, South Korea, Feb. 28, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the presentation of seven studies at the European Congress of Radiology (ECR) 2024, to be held in Vienna, Austria, from February 28 to March 3. Four will be presented through oral presentations and three as E-posters.

Key Points: 
  • Four out of seven AI products, including Lunit INSIGHT CXR, showed superior performance compared to human readers.
  • Lunit invites booth visitors at ECR 2024 to explore detailed information on the project and discuss potential future collaborations.
  • "We are proud to present our latest research findings at this year's ECR, demonstrating the robust performance and versatility of our Lunit INSIGHT suite in various clinical settings and scenarios.
  • Join Lunit at booth AI-15 in the EXPO X1 hall to witness how the Lunit INSIGHT suite is shaping the future of radiology across the globe.

Robinhood Markets, Inc. Reports January 2024 Operating Data

Retrieved on: 
Thursday, February 15, 2024
Crypto, Net, Robinhood Markets, AUC, Cryptocurrency

MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Robinhood Markets, Inc. (“Robinhood”) (NASDAQ: HOOD) today reported selected monthly operating data for January 2024:

Key Points: 
  • MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Robinhood Markets, Inc. (“Robinhood”) (NASDAQ: HOOD) today reported selected monthly operating data for January 2024:
    Funded Customers at the end of January were 23.5 million, up approximately 120 thousand from December 2023(1).
  • Assets Under Custody (AUC) at the end of January were $102.4 billion, roughly flat to December 2023.
  • Net Deposits were $3.8 billion in January, translating to a 44% annualized growth rate relative to December 2023 AUC.
  • Over the last twelve months, Net Deposits were $19.5 billion, translating to an annual growth rate of 26% relative to January 2023 AUC.

Pacira Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy

Retrieved on: 
Thursday, February 15, 2024
FDA, Foot, Bupivacaine, AUC, Hydrogen chloride, Safety, Numerical, Patient, Journal

TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy. The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl. The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.

Key Points: 
  • TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its pivotal Phase 3 study supporting the efficacy and safety of EXPAREL® (bupivacaine liposome injectable suspension) as a single-dose sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy.
  • The results demonstrate that EXPAREL significantly improved pain control and reduced opioid consumption through 96 hours versus bupivacaine HCl.
  • The data, which provided the basis for FDA approval for this indication was published in the Journal of Clinical Anesthesia.
  • “The role of EXPAREL as a sciatic nerve block in the popliteal fossa, particularly for pain control following foot and ankle procedures, is pivotal as clinical goals toward outpatient migration continue to grow,” said Gary Schwartz, MD, FASA, Vice Chair of Pain and Anesthesiology at Maimonides Medical Center and lead author on the publication.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Robinhood Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Tuesday, February 13, 2024
Bitcoin, Acquisition, Customer, Total, Net, Investment, Growth, Fraud, Retirement, AUC, SBC, FDIC, Gold, Entrepreneurship, Adjustment, MAU, ARPU, GAAP, Cryptocurrency, Robinhood Markets, Active users, IRA, EPS, Movement

MENLO PARK, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Robinhood Markets, Inc. (“Robinhood”) (NASDAQ: HOOD) today announced financial results for the fourth quarter and full year 2023, which ended December 31, 2023.

Key Points: 
  • 2023 Record Revenues of $1.9 billion, up 37% year-over-year, including $471 million in Q4
    Q4 GAAP net income of $30 million, or $0.03 per share, and Adjusted EBITDA of $133 million
    MENLO PARK, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Robinhood Markets, Inc. (“Robinhood”) (NASDAQ: HOOD) today announced financial results for the fourth quarter and full year 2023, which ended December 31, 2023.
  • “2023 was a strong year as our product velocity continued to accelerate, our trading market share increased, and we started to expand globally,” said Vlad Tenev, CEO and Co-Founder of Robinhood.
  • The most for retirement with Robinhood Gold - Through April 30, Robinhood is offering customers subscribed to Robinhood Gold up to 3% extra on every dollar contributed to their Robinhood Retirement accounts, including IRA transfers and 401(k) rollovers.
  • Robinhood will host a conference call to discuss its results at 2 p.m. PT / 5 p.m.

Adtalem Global Education Names Scott Liles as the New Medical and Veterinary President

Retrieved on: 
Tuesday, February 13, 2024
Veterinary, Pets, Health Insurance, Other Education, Continuing, General Health, University, Consumer, Health, Education, U.N, Financial services, Doctor of Philosophy, Medicine, Nationwide, Growth, Adtalem Global Education, AUC, Veterinary medicine, MBA, RUSM, Accenture, London Business School, American University, McKinsey & Company, ACAMS, Economics, Texas A&M University, ATGE, Management

Adtalem Global Education Inc. (NYSE: ATGE), a national leader in post-secondary education and the nation’s largest healthcare educator1, has appointed Scott Liles as president, Adtalem medical and veterinary, effective April 1.

Key Points: 
  • Adtalem Global Education Inc. (NYSE: ATGE), a national leader in post-secondary education and the nation’s largest healthcare educator1, has appointed Scott Liles as president, Adtalem medical and veterinary, effective April 1.
  • In his new role, Liles will have principal responsibility for the academic, operational and financial outcomes of the Medical and Veterinary reporting segment.
  • His strong business acumen and expertise in leading global organizations make him a fantastic addition to the Adtalem leadership team,” said Steve Beard, president and CEO, Adtalem Global Education.
  • “It’s an honor to rejoin the Adtalem family and be part of the solution to fulfilling the needs of the healthcare workforce while impacting local and global communities,” said Scott Liles, president, Adtalem medical and veterinary.

Prevencio and Emory Winship Cancer Institute AI-driven HART CVE Test Data Predicts Risk of Adverse Cardiovascular Effects Associated with Prostate Cancer Therapy

Retrieved on: 
Wednesday, February 7, 2024
Software, Research, Radiology, Oncology, Technology, Artificial Intelligence, Health Technology, Clinical Trials, Science, Cardiology, Other Science, Health, Skin cancer, Prostate cancer, ADT, American Cancer Society, Arrest, AUC, Patient, Diagnosis, Radiation, CVE, Control, Risk, Radiation therapy, Assistant professor, Stroke, Artificial intelligence

Researchers and clinicians from Emory Winship Cancer Institute collaborated to test their prostate cancer population.

Key Points: 
  • Researchers and clinicians from Emory Winship Cancer Institute collaborated to test their prostate cancer population.
  • “With cancer patients living longer, understanding the adverse cardiac effects due to cancer treatments, such as androgen deprivation therapy (ADT), is critical,” said Sagar Anil Patel, M.D., Assistant Professor, Department of Radiation Oncology and member of the Cancer and Control Research Program at Emory Winship Cancer Institute.
  • “It is rewarding to work with Dr. Patel and his team at Emory Winship Cancer Institute to demonstrate HART CVE’s usefulness in monitoring their prostate cancer patients.”
    This data adds to Prevencio’s previous HART CVE risk scoring collaboration with Memorial Sloan Kettering on lung radiation cancer patients.
  • Prostate cancer is the second most common cancer in men in the U.S., after skin cancer.

NYU Langone Health Awarded $13 Million to Create National Center to Promote Diabetes Equity Research

Retrieved on: 
Tuesday, February 6, 2024
Olive, Partnership, NYU Langone Health, Digestive, Family, Kidney failure, Public, Prediabetes, Nerve, Research, Health equity, MD, Caregiver, Patient, UCLA, Kidney, Paratriathlon, Olive View–UCLA Medical Center, School, Organization, American Diabetes Association, Social medicine, MPH, Diabetes, Education, AUC, Trust, Bangladesh Technical Education Board, Community, Type 2 diabetes, Workforce, African Americans, Pharmaceutical industry

To generate more community-engaged diabetes research, the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health, has pledged $13 million to NYU Langone Health, Albert Einstein School of Medicine/Montefiore Health System, and UCLA School of Medicine to create the National Center for Engagement in Diabetes Equity Research (CEDER), the first of its kind.

Key Points: 
  • To generate more community-engaged diabetes research, the National Institute of Diabetes and Digestive and Kidney Diseases, a division of the National Institutes of Health, has pledged $13 million to NYU Langone Health, Albert Einstein School of Medicine/Montefiore Health System, and UCLA School of Medicine to create the National Center for Engagement in Diabetes Equity Research (CEDER), the first of its kind.
  • Co-led by Nadia Islam, PhD, associate professor in the Institute for Excellence in Health Equity at NYU Langone, CEDER will create a centralized national infrastructure designed to foster community engagement and participation of diverse populations in Type 2 diabetes research.
  • "It is our hope that everyone committed to advancing equity in diabetes research and care can access the support and mentorship they need."
  • CEDER is funded by the National Institute of Diabetes and Digestive and Kidney Diseases.