NAFLD

Inventiva reports its 2023 full-year results

Retrieved on: 
Wednesday, March 27, 2024
DSM-IV codes, NMPA, Acceleration, Partnership, Patient, Income tax, G&A, BofA Securities, MASH, Equity, SUSAR, IND, Marketing, Bank statement, IRB, Clinical trial, Investigational New Drug, European Investment Bank, Fatty liver disease, Type 2 diabetes, T2D, Euronext Paris, EIB, Phase, Optimism, NAFLD, Sino Biopharmaceutical Limited, Pharmaceutical industry

Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.

Key Points: 
  • Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.
  • R&D expenses for the fiscal year ended December 31, 2023, amounted to (€110.0) million compared to (€60.5) million in 2022.
  • Net financial income was (€5.1) million for the fiscal year ended December 31, 2023, compared to €2.8 million in 2022.
  • Income tax amounted to (€0.6) million for the 2023 fiscal year, compared to €0 million for 2022.

MediciNova Announces Two Abstracts regarding MN-001 (tipelukast) and MN-002 Accepted for Presentation at the 92nd EAS 2024 Congress, the Annual Meeting of the European Atherosclerosis Society

Retrieved on: 
Wednesday, March 20, 2024
Congress, Juntendo University, Dyslipidemia, Patient, SAFETY, Research, Code, MD, Abstract, Type 2 diabetes, HTG, Tokyo Stock Exchange, EAS, Lipid metabolism, NAFLD, T2DM, Pharmaceutical industry

Presentation details will be disseminated as they become available.

Key Points: 
  • Presentation details will be disseminated as they become available.
  • Ph.D., M.P.H., Chief Medical Officer, MediciNova, Inc., commented, “We are very pleased that the two presentations were accepted at the EAS 2024 Congress.
  • One presentation is regarding the objectives and design of the ongoing Phase 2 clinical trial enrolling patients with Type 2 diabetes, dyslipidemia, and NAFLD.
  • The other presentation is regarding the mechanism of action of MN-001/MN-002 in lipid metabolism, particularly the effects on cholesterol efflux capacity.

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Fatty liver disease, Cirrhosis, Exercise, Entrepreneurship, Liver disease, Physician, F2, Patient, Research, Diet, Fibrosis, Drug development, NASH, Therapy, NAFLD, FDA, THR, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy.
  • Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.

ENDRA Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Diagnosis, De novo, PIN, Obesity, MRI, Syndrome, Metabolism, KCH, Knowledge Organization (journal), International, National Health Service, NHS, Research, Radiology, MASH, Trial of the century, International Classification of Diseases, Hepatology, World Health Organization, Data collection, Prediabetes, NDRA, Liver, Type 2 diabetes, Liver disease, Marketing, NAFLD, Endocrinology, Video game

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three months and year ended December 31, 2023 and provides a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three months and year ended December 31, 2023 and provides a business update.
  • Highlights from the fourth quarter of 2023 and recent weeks include:
    Installed first TAEUS system in the UK at King’s College Hospital for clinical evaluation.
  • In the third quarter of 2023, ENDRA submitted a De Novo request for its TAEUS liver system to the FDA.
  • In the fourth quarter of 2023, the FDA issued an Additional Information (AI) request to ENDRA.

American Liver Foundation Statement on FDA Approval of Resmetirom

Retrieved on: 
Thursday, March 14, 2024
HCC, Liver failure, American Liver Foundation, Fatty liver disease, Liver disease, Disease, Caregiver, Risk, Cirrhosis, Inflammation, Chairperson, Patient, Life, Liver transplantation, Hope, Doctor of Philosophy, MASH, MD, ALF, Pharmacotherapy, Fibrosis, NASH, Hepatology, Hepatocellular carcinoma, NAFLD, FDA, Liver, Food, Pharmaceutical industry

FAIRFIELD, N.J., March 14, 2024 /PRNewswire/ -- Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease* (NAFLD) and causes inflammation in the liver and liver damage.

Key Points: 
  • NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease * (NAFLD) and causes inflammation in the liver and liver damage.
  • "American Liver Foundation applauds the FDA approval of the groundbreaking new drug therapy treatment, resmetirom, for patients with NASH who have progressed to fibrosis," said Lorraine Stiehl , Chief Executive Officer, American Liver Foundation.
  • American Liver Foundation offers many free resources to patients and families affected by liver disease.
  • *Note: The nomenclature for NAFLD and NASH recently changed to metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) respectively.

New ICD-10-CM Code by the World Health Organization Paves the Way for Improved NAFLD Diagnostics Including ENDRA Life Sciences’ TAEUS System

Retrieved on: 
Wednesday, February 21, 2024
FDA, Health, Diabetes, Surgery, Health Insurance, Pharmaceutical, Therapy, CE, American Diabetes Association, NAFLD, Endocrinology, T2D, Research, Medicine, Person, CMS, Non-alcoholic fatty liver disease, Liver disease, NDRA, Prediabetes, Obesity, Cardiovascular disease, Food, ALT, De novo, Global health, Weill Cornell Medicine, Risk, Hepatology, Cirrhosis, European, Prevalence, Ultrasound, World Health Organization, Medicare, Type 2 diabetes, Metabolic syndrome, Patient, Fibrosis, Primary care, Fatty liver disease, NASH, Diagnosis, Knowledge Organization (journal), WHO, International Classification of Diseases, Dietary supplement

The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.

Key Points: 
  • The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.
  • These codes are issued by the World Health Organization (WHO) and are used to show payers why a particular service was medically necessary.
  • The inclusion of NAFLD under the ICD-10 K76.0 code facilitates standardized billing for its diagnosis.
  • "This positive development is testament to the growing awareness of liver health and the intensifying need for effective diagnostic solutions.

Nanox Receives FDA Clearance for HealthFLD, an Advanced AI-Based Software Empowering Clinicians in Assessment of Fatty Liver

Retrieved on: 
Tuesday, February 13, 2024
DSM-IV codes, Non-alcoholic fatty liver disease, Coronary artery disease, NAFLD, CT scan, Spine, Artificial intelligence, AI, MD, Osteoporosis, American Journal, Obesity, FDA, Cardiovascular disease, Food, Abdomen, Risk, Cirrhosis, Hepatology, Liver disease, Prevalence, University, MASH, Type 2 diabetes, AJR, Death, The Company, Patient, Diagnosis, Software, CAC, Medicine, Medical imaging

PETACH TIKVA, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) -- ("Nanox" or the "Company," Nasdaq: NNOX), an innovative medical imaging technology company, today announced that its deep-learning medical imaging analytics subsidiary, Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for HealthFLD, an artificial intelligence (AI) software that provides automated qualitative and quantitative analysis of liver attenuation from routine contrast and non-contrast chest and abdomen CT scans in patients between the ages of 18 to 75. HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).

Key Points: 
  • HealthFLD is intended to support clinicians in the detection of fatty liver, correlated with hepatic steatosis, an early sign of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
  • MASLD is commonly asymptomatic until it progresses to advanced liver fibrosis, and the current gold standard for diagnosis is a liver biopsy, which is invasive and costly.
  • HealthFLD was designed to help clinicians in the assessment and analysis of fatty liver in the general population from routine CT scans.
  • It’s promising to have a liver solution available that may help evaluate early signs of illness from routine imaging.”
    The HealthFLD clearance is the third product across the Nanox AI suite of population health solutions to receive FDA clearance.

Madrigal Pharmaceuticals Announces Publication of the Phase 3 MAESTRO-NASH Trial of Resmetirom in the New England Journal of Medicine

Retrieved on: 
Thursday, February 8, 2024
Principal, ALT, Liver failure, Fatty liver disease, Cirrhosis, Hepatotoxicity, Nausea, GGT, Death, Therapy, Biomarker, Patient, Breakthrough therapy, Safety, Incidence, FDA, NAFLD, Lipoprotein, Priority review, Diarrhea, NAS, Woman, University of Oxford, Disease, Drug development, Fibrosis, Biopsy, Risk, Week, Heart rate, PDUFA, CAP, NASH, Medicine, Liver cancer, Liver, Pharmaceutical industry

NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.

Key Points: 
  • NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally.
  • Resmetirom received Breakthrough Therapy designation from the FDA and is under review to become the first medicine approved to treat patients with NASH with liver fibrosis.
  • Approximately 50% of patients treated with resmetirom 100 mg with biopsies at Week 52 showed either NASH resolution or fibrosis improvement.
  • More than 80% of patients with biopsies at Week 52 had either fibrosis reversal or no progression of fibrosis.

Three Journal of Pharmaceutical Analysis Studies Explore the Use of Traditional Chinese Medicine for Various Diseases

Retrieved on: 
Friday, January 26, 2024
DMY, Microangiopathy, Neoplasm, VEGF, NAFLD, Radiation, Fe, ATGL, Disease, Lung cancer, TCM, DR, Risk, Quality of life, Diabetic retinopathy, Journal, Nano, Traditional Chinese medicine, Liver, Noetics, Protein, HSP90, CDC37, Non-alcoholic fatty liver disease, Iron

XI'AN, China, Jan. 26, 2024 /PRNewswire/ -- Despite demonstrating significant clinical efficacy against various diseases, the widespread use of Traditional Chinese Medicine (TCM) is still limited.

Key Points: 
  • XI'AN, China, Jan. 26, 2024 /PRNewswire/ -- Despite demonstrating significant clinical efficacy against various diseases, the widespread use of Traditional Chinese Medicine (TCM) is still limited.
  • To address this gap, a new issue of the Journal of Pharmaceutical Analysis presents three independent studies which assessed the potency of TCM-based compounds for various human diseases, along with their molecular mechanisms of action.
  • Oridonin (ORI), a TCM derived from the Chinese herb Rabdosia rubescens, exhibits anti-inflammatory effects.
  • These studies provide a scientific basis for the development of TCM-based compounds into effective targeted therapies for various diseases.

New Clinical Trial Shows That While The Mediterranean Diet is Good, Pure C15:0 Supplementation Makes It Better

Retrieved on: 
Thursday, January 18, 2024
Fruit, NAFLD, Vegetable, EPA, Health, American Journal, SAN, Diet, Global health, Science, Nut, Fatty liver disease, Insulin, Calorie, LDL, Glucose, Grain boundary strengthening, Liver, Triglyceride, Longevity, Bifidobacterium, Clinical trial, Shellfish, Trial of the century, Blood pressure, Dietary supplement

SAN DIEGO, Jan. 18, 2024 /PRNewswire/ -- A game-changing clinical trial has revealed that enhancing the already renowned Mediterranean diet with pure C15:0 supplementation can elevate health outcomes even further.

Key Points: 
  • In a randomized, double-blinded and controlled clinical trial, supplementation with the same pure C15:0 ingredient in fatty15 improved the health outcomes of the Mediterranean diet.
  • SAN DIEGO, Jan. 18, 2024 /PRNewswire/ -- A game-changing clinical trial has revealed that enhancing the already renowned Mediterranean diet with pure C15:0 supplementation can elevate health outcomes even further.
  • The recent randomized, double-blinded, and controlled clinical trial , published in the American Journal of Clinical Research, has the scientific nutrition community buzzing.
  • Participants were divided into three groups: a caloric-restricted diet, a caloric-restricted diet following Mediterranean diet guidelines, and a caloric-restricted Mediterranean diet with C15:0 supplementation.