CRP

Clinical Data Supports Novel Continuous Calprotectin Monitoring Wearable for IBD Management by EnLiSense

Retrieved on: 
월요일, 4월 8, 2024
Technology, Medical Devices, Health Technology, Nanotechnology, Other Health, Biotechnology, Hardware, Managed Care, Health, Data Management, Moses Austin, Conditional sentence, University, Professor, IL-6, Perspiration, Patient, Inflammation, Biomarker, Research, AI, Doctor of Philosophy, Senior, IBD, Translation, Management, C-reactive protein, Inflammatory bowel disease, Inflammatory Bowel Diseases, Trial of the century, CRP, Pharmaceutical industry

The study showcases the IBD Aware device's ability to non-invasively monitor calprotectin levels in both active and remission phases of IBD.

Key Points: 
  • The study showcases the IBD Aware device's ability to non-invasively monitor calprotectin levels in both active and remission phases of IBD.
  • These results not only affirm the accuracy of the IBD Aware device, but demonstrate its utility in the shifting paradigm of proactive IBD management that emphasizes continuous, data-driven decision-making.
  • “The IBD Aware device exemplifies our dedication to empowering healthcare professionals and enhancing patient outcomes through remote and continuous monitoring."
  • EnLiSense is pioneering work to build a future where proactive, personalized, and precision remote patient monitoring becomes the standard in chronic disease management.

Zone & Co Strengthens Leadership Team with Two Key Executive Appointments to Drive the Next Stage of Growth

Retrieved on: 
수요일, 4월 3, 2024
Cloud, GTM, Venture round, HR, AP, Garret, Organization, Growth, CFO, Payroll, ERP, History, Acquisition, IPO, TSX, Treasury, CAC, Vista Equity Partners, LTV, CRP, Rubicon Technologies, Renewable energy

Wonderling joins Zone with a history of leadership roles at pre- and post-IPO high-growth companies, most recently from Salesloft where he served as its Chief Accounting Officer.

Key Points: 
  • Wonderling joins Zone with a history of leadership roles at pre- and post-IPO high-growth companies, most recently from Salesloft where he served as its Chief Accounting Officer.
  • Garrett is an award-winning technology-marketing leader, who brings deep experience building out and leading revenue-driving global marketing organizations for both high-growth scale-ups and enterprise-level brands.
  • "Our company's trajectory is unmistakable, and I am eager to leverage our unique value proposition to captivate audiences and drive dominating growth.
  • We've only scratched the surface of its market potential and I look forward to helping unlock marketing-led growth."

Zone & Co Strengthens Leadership Team with Two Key Executive Appointments to Drive the Next Stage of Growth

Retrieved on: 
수요일, 4월 3, 2024
Cloud, GTM, Venture round, HR, AP, Garret, Organization, Growth, CFO, Payroll, ERP, History, Acquisition, IPO, TSX, Treasury, CAC, Vista Equity Partners, LTV, CRP, Rubicon Technologies, Renewable energy

Wonderling joins Zone with a history of leadership roles at pre- and post-IPO high-growth companies, most recently from Salesloft where he served as its Chief Accounting Officer.

Key Points: 
  • Wonderling joins Zone with a history of leadership roles at pre- and post-IPO high-growth companies, most recently from Salesloft where he served as its Chief Accounting Officer.
  • Garrett is an award-winning technology-marketing leader, who brings deep experience building out and leading revenue-driving global marketing organizations for both high-growth scale-ups and enterprise-level brands.
  • "Our company's trajectory is unmistakable, and I am eager to leverage our unique value proposition to captivate audiences and drive dominating growth.
  • We've only scratched the surface of its market potential and I look forward to helping unlock marketing-led growth."

ACORD's 2023 Annual Member Report Details Achievements in Industry-Wide Digitalization Efforts

Retrieved on: 
수요일, 3월 20, 2024
Organization, TSR, Transcriber, Reference architecture, Digital, CDR, Business, Total shareholder return, NGDS, Information model, Insurance, ADEPT, Architecture, LIP, Ecosystem, Metropolitan Cattle Market, Standard, Data, Representational state transfer, Risk, CRP

NEW YORK, March 20, 2024 /PRNewswire/ -- ACORD, the standards-setting body for the global insurance industry, today released its 2023 Member Report, detailing its efforts on behalf of its members over the past year. ACORD welcomed more than 100 new members across various stakeholder types, from carriers to brokers to solution providers. The report notes several key achievements, including:

Key Points: 
  • NEW YORK, March 20, 2024 /PRNewswire/ -- ACORD, the standards-setting body for the global insurance industry, today released its 2023 Member Report, detailing its efforts on behalf of its members over the past year.
  • "ACORD is in a unique position to help shape the future of insurance," said Bill Pieroni, President & CEO of ACORD, in his annual message to the ACORD member community.
  • "We have witnessed great change in the industry, and ACORD has grown and changed alongside our members.
  • From the first standardized forms to AI-based solutions, ACORD has worked with our members to enable transformation and drive impact across our ecosystem."

Summary of opinion: Bimzelx, 21/03/2024 Positive

Retrieved on: 
수요일, 4월 3, 2024
Civil service commission, Psoriatic arthritis, Hidradenitis suppurativa, Methotrexate, Psoriasis, MRI, Magnetic resonance imaging, Inflammation, Committee, Nonsteroidal anti-inflammatory drug, Disease-modifying antirheumatic drug, HS, Medication package insert, C-reactive protein, Ankylosing spondylitis, European Commission, Marketing, CHMP, CRP, Axial spondyloarthritis

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.
  • The marketing authorisation holder for this medicinal product is UCB Pharma S.A.
  • The CHMP adopted a new indication for the treatment of hidradenitis suppurativa.
  • Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
    Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

NodThera’s NLRP3 Inhibitor NT-0796 Reverses Neuroinflammation in Parkinson’s Disease Phase Ib/IIa Trial

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목요일, 3월 7, 2024
Queen Square, Doctor of Philosophy, Aes, TREM, CXCL8, CXCL1, Blood, IL-6, Cerebrospinal fluid, Inflammation, Neuroinflammation, NLRP3, Șaeș, Fibrinogen, Volunteering, Risk, Human, Biomarker, AFL, CRP, Patient, Pharmacokinetics, Disease, DSM-IV codes, MRCP, MBBS, Brain, CCL2, Mouse, Face, Pharmaceutical industry

IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.

Key Points: 
  • IL-1β, IL-6, CCL2, CXCL1 and CXCL8) over 28 days compared to baseline to levels approximating those of healthy elderly controls, demonstrating reversal of NLRP3-mediated neuroinflammation.
  • In addition, reductions in neurodegenerative markers were also observed following oral dosing of NT-0796, including NfL and soluble TREM (sTREM2).
  • The correlation between Parkinson’s disease and neuroinflammation is well-documented, with alpha-synuclein fibrils triggering microglial NLRP3 activation, leading to neuroinflammation and subsequent neurodegeneration.
  • This is the inaugural demonstration of an NLRP3 inhibitor’s potential to not only address Parkinson’s disease but also offer a broader impact on neurodegenerative diseases.

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
목요일, 2월 22, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Week, Regulation, Research, Investment, University, Regulation Fair Disclosure, Webcast, CRP, Intellectual property, Progressive supranuclear palsy, Medication, Plasma, ALS, Marketing, Disclosure, AMX0035, Neurosurgery, Publication, Psychiatry, C-reactive protein, Safety, Biomarker, Amylyx Pharmaceuticals, Clinical trial, Survival, Journal of Neurology, Mutation, IND, Wolfram syndrome, PSP, Otsuka Pharmaceutical, Brain cell, Pharmaceutical industry

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Net product revenue for the three months ended December 31, 2023 was $108.4 million, compared to net product revenue of $102.7 million for the three months ended September 30, 2023.
  • Amylyx announced the first patient dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP).
  • The first participant was dosed in December 2023, and topline results are anticipated in 2025 or 2026.

Rebamipide May Combat Low-Grade Inflammation in Post-COVID-19 Syndrome Patients

Retrieved on: 
월요일, 2월 19, 2024
Group 1, Coronavirus, AAAAI, Research, SARS-CoV-2, Doctor of Philosophy, Multimedia, Inflammation, Nonsteroidal anti-inflammatory drug, Enterocyte, Asthma, ELISA, Radical, Arthralgia, Group 2, COVID-19, CRP, COVID, Patient, Journal, Rehabilitation, Plasma, Ageing, Rebamipide, American Academy, Pharmaceutical industry

MILWAUKEE, Feb. 19, 2024 /PRNewswire-PRWeb/ -- Rebamipide may be useful for rehabilitation of patients with SARS-CoV-2 post-COVID syndrome according to new research being presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Washington, DC, this month.

Key Points: 
  • "This study revealed higher levels of lipopolysaccharide-binding protein, and lower levels of bacterial permeability protein in patients with post COVID syndrome.
  • Rebamipide, by reducing intestinal permeability, reduces endotoxin load, lowering the level of low-grade inflammation.
  • To explore Rebamipide's usefulness for rehabilitating SARS-CoV-2 post-COVID syndrome patients, researchers examined 62 patients, aged 42-55 years with post-COVID-19 syndrome using nonsteroidal anti-inflammatory drugs for joint pain.
  • Given the effects of SARS-CoV-2 on enterocytes, the results suggest that Rebamipide may be useful for rehabilitation of patients with SARS-CoV-2 post-COVID syndrome.

EnLiSense CCM Advances Validation of Real-Time IBD Inflammatory Biomarker Monitoring with Two Recent Peer-Reviewed Longitudinal Studies

Retrieved on: 
목요일, 2월 15, 2024
Hardware, Health Technology, Data Management, Other Health, Technology, Professional Services, Biometrics, Medical Devices, Genetics, Artificial Intelligence, Wearables, Mobile Technology, Biotechnology, Science, Data Analytics, Research, Health, Biosensor, Digital health, Ulcerative colitis, Senior, Doctor of Philosophy, Translation, Hasso Plattner Institute, Moses Austin, MD, Professor, Inflammation, Blood, IL-6, Quality of life, Bioelectronics, Gastrointestinal tract, Trial of the century, Scientific Reports, Management, University, Perspiration, CRP, Clinical, Inflammatory bowel disease, Patient, Biological engineering, Optimism, IBD, Conditional sentence, TNF, Endoscopy, National Institutes of Health, Medical imaging

Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.

Key Points: 
  • Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.
  • EnLiSense's journey reaches a significant milestone with over half a million human biomarker readings, underscoring the extensive validation of our technology.
  • These readings provide crucial data points, enhancing the precision and trustworthiness of inflammatory biomarker monitoring.
  • The studies involved measuring inflammation markers CRP, TNF-α, and IL-6 in subjects' blood and sweat continuously in subjects with and without IBD.

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

Retrieved on: 
수요일, 2월 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