NAFLD

October is National Liver Awareness Month, Are You at Risk?

Retrieved on: 
Friday, September 29, 2023
Learning, AstraZeneca, Fatty liver disease, Partnership, Obesity, ALF, Diet, NASH, Genetics, Liver disease, Liver cancer, Non-alcoholic fatty liver disease, American Liver Foundation, Research, Inflammation, Education, Federally Qualified Health Center, Patient, Cooking, Risk, Liver, Knowledge, NAFLD, BMI, Hispanic, Liver failure, Conference, Caregiver, Dietary supplement

FAIRFIELD, N.J., Sept. 29, 2023 /PRNewswire/ -- October is National Liver Awareness Month and the American Liver Foundation is encouraging everyone to find out if they are at risk for fatty liver disease through its public awareness campaign, Think Liver Think Life™. Fatty liver disease affects an estimated 80-100 million Americans and is present in up to 75% of overweight people and in more than 90% of people with severe obesity. Through a simple liver health quiz, available at ThinkLiverThinkLife.org in both English and in Spanish, anyone can find out if they're at risk and learn what to do next.

Key Points: 
  • FAIRFIELD, N.J., Sept. 29, 2023 /PRNewswire/ -- October is National Liver Awareness Month and the American Liver Foundation is encouraging everyone to find out if they are at risk for fatty liver disease through its public awareness campaign, Think Liver Think Life™.
  • "This October, we encourage everyone to do something positive for your liver by taking our free liver health quiz ," said Lorraine Stiehl, Chief Executive Officer, American Liver Foundation.
  • The Think Liver Think Life national public health campaign aims to ensure every American understands their risk for liver disease, receives the appropriate diagnostic testing and care coordination and feels well-informed and supported throughout their liver journey.
  • Nonalcoholic steatohepatitis (NASH) is a form of NAFLD causing inflammation of the liver and liver damage, which can lead to liver failure.

Inventiva reports its 2023 first-half financial results and provides a corporate update

Retrieved on: 
Thursday, September 28, 2023
Diabetes, European, SEC Rule 144A, August 31, American depositary receipt, Jefferies, Type 2 diabetes, Regulation D, G&A, Investigational New Drug, Patient, University, Risk, NAFLD, EIB, NASH, TD, Pharmacokinetics, Virtual, Research, USD, Non-alcoholic fatty liver disease, Council, Security (finance), Phase, Kidney, IND, NMPA, Conference, Data monitoring committee, Biotechnology, US, ATM, DSM-IV codes, Depreciation, Acceleration, European Parliament, ADS, Exchange, Person, Sale, Prospectus, T2D, Pharmaceutical industry, Lithium, Bank, Cryptocurrency, Medical device, Medical imaging, Audit, EU

General and administrative expenses (G&A) amounted to €6.8 million in the first half of 2023, stable compared to the first half of 2022.

Key Points: 
  • General and administrative expenses (G&A) amounted to €6.8 million in the first half of 2023, stable compared to the first half of 2022.
  • The Company’s net loss stood at (€55.3) million as of June 30, 2023 compared to (€29.5) million as of June 30, 2022.
  • R&D expenses for the first half of 2023 were up 81% compared to the first half of 2022.
  • The conference call and the slides of the presentation will be webcast live at https://edge.media-server.com/mmc/p/5tuhsaud and also available on Inventiva’s onwards in the “Investors” – “Financial results” section.

An Unforgettable Evening at Westmount Public Library Draws Rave Reviews

Retrieved on: 
Friday, September 22, 2023
Knowledge, Canada, Liver disease, Obesity, NASH, Diabetes, Culture, Liver, Human, Fatty liver disease, Language, Metabolism, Medicine, Westmount Public Library, Non-alcoholic fatty liver disease, Diagnosis, NAFLD, Health, Empowerment, Dietary supplement, Hepatology, Elastography

TORONTO, Sept. 22, 2023 (GLOBE NEWSWIRE) -- On the evening of September 19, 2023, the Fatty Liver Alliance, a Canadian not-for-profit charity, hosted, at the Westmount Public Library, in Westmount, Quebec, an extraordinary event that saw an overwhelming turnout of 50 community members.

Key Points: 
  • TORONTO, Sept. 22, 2023 (GLOBE NEWSWIRE) -- On the evening of September 19, 2023, the Fatty Liver Alliance, a Canadian not-for-profit charity, hosted, at the Westmount Public Library, in Westmount, Quebec, an extraordinary event that saw an overwhelming turnout of 50 community members.
  • This Café Scientifique community education event is a unique opportunity for an in-depth understanding of liver disease, diabetes, and metabolic health.
  • The evening was a blend of information, interaction, and insight, as evidenced by one attendee's remark: "This event exceeded all expectations.
  • The importance of the topic, notably fatty liver, was underscored by numerous participants, with many calling for greater public awareness.

Algernon Pharmaceuticals Announces Grant of U.S. Patent for Repirinast in NAFLD and NASH

Retrieved on: 
Wednesday, September 6, 2023
Telmisartan, Patent, Steatosis, Insulin resistance, Laboratory, Obesity, CSE, NASH, AGN, Inflammation, UUO, Fibrosis, Algernon, Standard of care, Patient, Risk, Fatty liver disease, Type, NAFLD, CKD, Pharmaceutical industry, Repirinast

11744808, for its lead chronic kidney Disease (CKD) program drug NP-251 (Repirinast), entitled “Compositions and Methods for Treating Non-Alcoholic Steatohepatitis.”

Key Points: 
  • 11744808, for its lead chronic kidney Disease (CKD) program drug NP-251 (Repirinast), entitled “Compositions and Methods for Treating Non-Alcoholic Steatohepatitis.”
    The invention claims treating non-alcohol fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH) and NASH-derived hepatocellular carcinoma, with Repirinast.
  • The base claims of the patent will be valid through 2039, excluding any patent term adjustments or extensions which may provide additional protection.
  • The Company has also filed corresponding patent applications in Canada, Europe, China and Japan.
  • “This is the first patent received from the USPTO by Algernon for one of its drugs being investigated under its innovative drug repurposing program and is further validation of our intellectual property strategy,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals.

ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA

Retrieved on: 
Wednesday, August 30, 2023
Health Technology, Health, Other Health, Medical Devices, Fatty liver disease, De novo, Non-alcoholic fatty liver disease, NDRA, Patient, De novo synthesis, Estar, NAFLD, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).
  • “We are very pleased that our FDA De Novo submission has advanced to the substantive review stage," stated ENDRA's Chairman and Chief Executive Officer Francois Michelon.
  • On August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system.
  • On August 29, 2023, FDA informed ENDRA that the Company's submission was entering the substantive review period.

Pottsville Residents with Non-Alcoholic Steatohepatitis (NASH) Liver Disease Can Now Join New Research Study

Retrieved on: 
Monday, August 21, 2023
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Nonalcoholic steatohepatitis (NASH) is an aggressive form of nonalcoholic fatty liver disease (NAFLD) where fat buildup in the liver can lead to inflammation and scarring, known as cirrhosis.

Key Points: 
  • Nonalcoholic steatohepatitis (NASH) is an aggressive form of nonalcoholic fatty liver disease (NAFLD) where fat buildup in the liver can lead to inflammation and scarring, known as cirrhosis.
  • The disease can cause severe liver damage with few or no symptoms.
  • The local setting provides residents of Pottsville and surrounding communities the option to participate in clinical trials close to home.
  • With a global network of over 150 research sites, Care Access supports research studies conducted by 14 of the top 20 biopharmaceutical companies.

Biostax Corp Announces the FDAs Acceptance of Three Investigational New Drug Applications (IND) Transfers for JKB-122 for the Treatment of NASH, NAFLD and AIH

Retrieved on: 
Tuesday, August 15, 2023
OTC Markets Group, NASH, Autoimmune hepatitis, Nephrology, Fibrosis, IND, NAFLD, Fatty liver disease, Orphan, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Nursing

Orlando, FL, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN) ("Biostax"), a hub-and-spoke biotech development engine, announces that they have accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122 and the U.S. Food and Drug Administration (FDA) has finalized those transfers.

Key Points: 
  • Orlando, FL, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN) ("Biostax"), a hub-and-spoke biotech development engine, announces that they have accepted the transfer of three Investigational New Drug Applications (IND) for the drug candidate, JKB-122 and the U.S. Food and Drug Administration (FDA) has finalized those transfers.
  • The INDs that were transferred to Biostax include IND 146955 for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis, IND 147347 for the treatment of Nonalcoholic Liver Disease (NAFLD) and IND 127303 for the treatment of Autoimmune Hepatitis along with the Orphan Designation for Autoimmune Hepatitis.
  • These INDs were transferred from TaiwanJ Pharmaceuticals, who licensed the development and commercialization of JKB-122 to Biostax Corp in 2022.
  • "This transaction is transformational for Biostax as it allows us to support a balanced pipeline and advance innovative therapeutic solutions that help people living with autoimmune diseases and chronic illness.”

MediciNova Receives a Notice of Intention to Grant for a New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Europe

Retrieved on: 
Tuesday, August 15, 2023
Patent, Hypertriglyceridemia, Code, NASH, Hepatocellular carcinoma, Fast Track, Tablet, Fibrosis, Capsule, Patient, Asterixis, Tokyo Stock Exchange, Ascites, NAFLD, Standard Market Design, Cirrhosis, HCC, Splenomegaly, Pharmaceutical industry

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than May 2035.

Key Points: 
  • Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than May 2035.
  • The allowed claims cover MN-001 (tipelukast) or MN-002 for the treatment of a patient diagnosed with advanced NASH.
  • In addition, the allowed claims cover MN-001 (tipelukast) or MN-002 for reducing hepatic fibrosis and hepatic scarring in a patient with advanced NASH.
  • The U.S. Patent and Trademark Office previously granted a patent which covers MN-001 and MN-002 for advanced NASH with fibrosis and similar patents were granted in Japan, Korea, and Canada.”

ENDRA Life Sciences Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Monday, August 14, 2023
Health, Other Science, Clinical Trials, Research, Science, Biotechnology, Proton, Fatty liver disease, EASL, International, Magnetic resonance, De novo, Classification, Marketing, German Diabetes Center, IP, Sale, Trial of the century, Congress, MRI, PIN, Non-alcoholic fatty liver disease, NDRA, Patient, NAFLD, European Association for the Study of the Liver, FDA, Magnetic resonance imaging, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pearson, Food, Medical imaging, Security (finance), Liver

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and six months ended June 30, 2023 and provided a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and six months ended June 30, 2023 and provided a business update.
  • Highlights from the second quarter of 2023 and recent weeks include:
    Submitted a De Novo Request to the U.S. Food and Drug Administration (FDA) for the TAEUS liver system.
  • During the second quarter, ENDRA secured four additional patents, including one in the U.S. and three in China.
  • Net loss in the second quarter of 2023 was $2.6 million, or $0.43 per share, compared with a net loss of $3.6 million, or $1.17 per share, in the second quarter of 2022.

ENDRA Life Sciences Submits De Novo Request for its TAEUS® System Liver Fat Application to the U.S. FDA

Retrieved on: 
Monday, August 14, 2023
FDA, Medical Devices, Health, Clinical Trials, Health Technology, Proton, Fatty liver disease, Magnetic resonance, De novo, Classification, Trial of the century, Non-alcoholic fatty liver disease, NDRA, Patient, NAFLD, Magnetic resonance imaging, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pearson, Food, Medical imaging

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system.
  • The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).
  • The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction.
  • TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78.