C-reactive protein

Kiniksa Pharmaceuticals Announces Development Indication for Abiprubart

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화요일, 4월 2, 2024
Janus, Week, CD154, Rheumatoid arthritis, Jaki, Patient, Cohort, KNSA, Joint, Clinical trial, C-reactive protein, CD40, Least squares, Pharmacokinetics, Safety, FDA, Rheumatoid factor, Pharmaceutical industry

HAMILTON, Bermuda, April 02, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced plans to initiate a Phase 2b trial with abiprubart in Sjogren’s Disease. Additionally, the company announced data from Cohort 4 of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.

Key Points: 
  • HAMILTON, Bermuda, April 02, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced plans to initiate a Phase 2b trial with abiprubart in Sjogren’s Disease.
  • Additionally, the company announced data from Cohort 4 of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis.
  • Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.
  • “We believe abiprubart has the potential to provide meaningful benefit to patients suffering from Sjogren’s Disease, a debilitating disorder with no current FDA-approved therapies.

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

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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.

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

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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.

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

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수요일, 2월 21, 2024
Freedom, Recurrence, Scar, Inflammation, FDA, Quality of life, TSX, C-reactive protein, Pericardial fluid, Pericarditis, Viral, CRDL, Safety, Pericardium, Therapy, Chronic pain, Fatigue, Length of stay, Patient, News, Heart, Hospital, Research, NRS

Topline Results Expected in Q2 2024

Key Points: 
  • "Having achieved full patient enrollment, we are now positioned to announce high-level MAvERIC-Pilot clinical trial data in the second quarter of this year.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

Kiniksa Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Portfolio Execution

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수요일, 2월 28, 2024
Real-World Evidence, Cohort, KNSA, C-reactive protein, Rheumatoid factor, Recurrence, Investment, Telephone, Partnership, Growth, ID, Joint, Genentech, Roche, Rheumatoid arthritis, American College, Webcast, Patient, Pericarditis, Paradigm, Prescription, CD40, Pharmaceutical industry

HAMILTON, Bermuda, Feb. 28, 2024 (GLOBE NEWSWIRE) --  Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today reported fourth quarter and full-year 2023 financial results and recent portfolio execution.

Key Points: 
  • Total revenue for the fourth quarter of 2023 was $83.4 million, compared to $61.9 million for the fourth quarter of 2022.
  • Total operating expenses for the fourth quarter of 2023 were $83.3 million, compared to $55.8 million for the fourth quarter of 2022.
  • Net income for the fourth quarter of 2023 was $25.2 million, compared to net income of $4.5 million for the fourth quarter of 2022.
  • Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Wednesday, February 28, 2024, to discuss fourth quarter and full-year 2023 financial results and recent portfolio execution.

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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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.

New Research: Eating Almonds Can Aid in Post-Exercise Recovery

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수요일, 2월 21, 2024
Woman, Magnesium, Body composition, Senior lecturer, Overweight, Inflammation, Exercise, Muscle soreness, Potassium, Vitamin E, Frontiers, King's College London, Triglyceride, Nutrient, Fats, Creatine kinase, Athlete, C-reactive protein, Myopathy, Appetite, DV, Research, Public, Dietary supplement

MODESTO, Calif., Feb. 21, 2024 /PRNewswire/ -- A new study found that eating almonds reduced some feelings of muscle soreness during exercise recovery which translated to improved muscle performance during a vertical jump challenge. These results expand on prior research1 which looked at how almonds affect muscle recovery after exercise.

Key Points: 
  • These results expand on prior research1 which looked at how almonds affect muscle recovery after exercise.
  • The treadmill test was designed to cause muscle damage to see how almonds affected muscle recovery.
  • Study Conclusion: Snacking on almonds for eight weeks reduced perceived feelings of muscle soreness during recovery from muscle-damaging exercise, resulting in better maintenance of muscle functional capacity.
  • This study suggests that almonds are a functional food snack to improve exercise tolerance in mildly overweight, middle-aged adults.

Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

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목요일, 2월 15, 2024
Fast Track, Recurrence, Scar, Inflammation, FDA, Quality of life, TSX, C-reactive protein, Myocarditis, Pericardial fluid, Pericarditis, Viral, CRDL, ODD, Safety, Pericardium, Therapy, Chronic pain, Fatigue, Length of stay, Patient, News, Disease, Heart, Hospital, Research, NRS, Priority review, Pharmaceutical industry

Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

electroCore Expands Intellectual Property Portfolio

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화요일, 2월 6, 2024
C-reactive protein, Patent, Virus, COVID, Disorder, Vagus nerve, Patient, Blood, United States patent law, Coronaviridae, ElectroCore

ROCKAWAY, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the United States Patent and Trademark Office has issued a patent related to systems and methods for treating disorders associated with viruses in the Coronaviridae family (COVID).

Key Points: 
  • ROCKAWAY, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced the United States Patent and Trademark Office has issued a patent related to systems and methods for treating disorders associated with viruses in the Coronaviridae family (COVID).
  • U.S. Patent No.
  • 11,894,148 entitled “Systems and Methods for Treating Patients With Diseases Associated With Viruses” generally relates to methods for treating disorders with viruses in the COVID family using electrical impulses transcutaneously to the vagus nerve for about 30 seconds to about 5 minutes, from 2 to 5 times per day, to reduce a level of C-reactive protein in the blood of the patient.

Tourmaline Bio Announces Expected Upcoming Key Milestones for the Clinical Development of TOUR006, a Long-Acting Subcutaneous Inhibitor of IL-6 with Best-in-Class Potential, in Thyroid Eye Disease (TED) and Atherosclerotic Cardiovascular Disease (ASCVD)

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월요일, 1월 8, 2024
TED, Quality of life, Entrepreneurship, TRML, C-reactive protein, Diplopia, Membrane protein, Moyamoya disease, FDA, Alignment, Inflammation, Injection, Spirited, Half-life, MD, Pharmacokinetics, IL-6, Biomarker, Patient, Safety, Cardiovascular disease, CRP, CAS, Exophthalmos, Pharmaceutical industry

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, announced today that:

Key Points: 
  • This second pivotal trial will replace the previously planned TED basket trial and does not impact Tourmaline’s expected cash runway through 2026.
  • This trial is targeted to commence in the first half of 2024, with topline data expected in the first half of 2025.
  • Pending success, the results from the Phase 2 trial are expected to position Tourmaline to be ready in 2025 to commence a pivotal Phase 3 trial in cardiovascular disease.
  • To date, TOUR006 has been studied in 448 participants, including patients with autoimmune disorders, across six clinical trials.