Liver support system

BioVie Presents Positive Clinical Safety Data from Phase 2b Trial of BIV201 in Refractory Ascites at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Hepatology, Cirrhosis, Safety, Randomness, Insulin resistance, Food, TIPS, Incidence, AASLD, Liver, Ascites, Abdomen, Hyponatremia, Patient, Confirmatory trial, Liver transplantation, Control, Survival rate, Inflammation, Liver support system, Terlipressin, Dementia, Standard of care, Acceleration, Orphan, SOC, Poster, Pharmaceutical industry, Medical imaging, Boston

CARSON CITY, Nev., Nov. 13, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced positive clinical safety data from the Company’s Phase 2b open-label study evaluating the efficacy and safety of BIV201, terlipressin administered as a continuous infusion, with standard of care (SOC) in patients with refractory ascites due to cirrhosis. The data will be highlighted today in a late-breaking poster presentation titled “Safety and Tolerability of Continuous Infusion Terlipressin (BIV201) In Patients with Decompensated Cirrhosis and Refractory Ascites: A Phase 2, Randomized, Controlled, Open-Label Study” at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 in Boston, MA.

Key Points: 
  • The incidence of treatment emergent adverse events (TEAEs), including serious TEAEs, was similar in both treatment groups.
  • Two patients who received BIV201 experienced hyponatremia that developed gradually, was asymptomatic, and was resolved upon discontinuation of the study drug.
  • Primary endpoints were safety and tolerability, and incidence of certain complications (Grade ≥2) during the 180 days following randomization.
  • BIV201, a continuous infusion of terlipressin, received Orphan Drug Designation for treatment of ascites from the U.S. Food and Drug Administration in 2017.

Mirum Pharmaceuticals Presents New Data at The Liver Meeting®

Retrieved on: 
Monday, November 13, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Clinical Trials, Sleep, Hepatology, MDR3, Self-harm, Safety, Hepatocellular carcinoma, Bilirubin, Cholestasis, AASLD, Liver, Disease, Risk, Cholestatic pruritus, Hematology, Quality of life (healthcare), MYO5B, PFIC, Patient, Publication, Pregnancy, Nature, TJP2, Ascending cholangitis, GI, Hippeastrum mirum, Liver support system, Volixibat, ICP, IBAT, Progressive familial intrahepatic cholestasis, FIC, Augmented fifth, Growth, Doctor of Philosophy, Quality of life, AND, Itch, Medication, MCID, HIV disease progression rates, SBA, Chloride, Pharmaceutical industry, Nursing, Medical imaging, Dietary supplement, Boston, BSEP

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced new data from its LIVMARLI and volixibat programs presented at The Liver Meeting®, the American Association for the Study of Liver Diseases (AASLD) annual meeting in Boston, Massachusetts.
  • “PFIC is a chronic, debilitating cholestatic liver disease characterized by elevated bile acids and pruritus so severe that patients can be listed for liver transplant even in the absence of disease progression.
  • These data suggest overall improved liver health with maralixibat treatment in patients with PFIC that can be maintained long-term.
  • No clinically meaningful changes in liver enzyme levels or hematology parameters were observed after volixibat treatment.

CymaBay Reports Third Quarter and Nine Months Ended September 30, 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Itch, UDCA, Cirrhosis, Breakthrough therapy, Conditional sentence, Liver, Conference, HIV disease progression rates, PBC, Bilirubin, Caregiver, Risk, Partnership, Primary biliary cholangitis, Safety, Conference call, Therapy, Patient, Liver support system, Medical imaging, Pharmaceutical industry

ET

Key Points: 
  • ET
    NEWARK, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced corporate updates and financial results for the third quarter ended September 30, 2023.
  • Research and development expenses for the three months ended September 30, 2023, and 2022 were $20.0 million and $15.5 million, respectively.
  • Net loss for the three months ended September 30, 2023 was higher than the three months ended September 30, 2022 primarily due to higher operating expenses.
  • ET to discuss third quarter financial results and provide a business update.

GENFIT to Present Update on Scientific and Corporate Progress at The Liver Meeting® 2023

Retrieved on: 
Thursday, November 2, 2023
Transplant, Labcorp, UCSF, American Association for the Study of Liver Diseases, BMI, Hepatology, MD, University of California, MBA, ACLF, PBC, Gubra, NAS, Poster, Division, NASH, GAN, Biopsy, University, CET, Primary biliary cholangitis, FACP, Ipsen, Patient, Abstract, Liver support system, IQVIA, AASLD, Medical device, Pharmaceutical industry, Medical imaging, Euronext, Gastroenterology

Participants include study investigators, principal investigators and other healthcare professionals from the US, France, Germany and the UK.

Key Points: 
  • Participants include study investigators, principal investigators and other healthcare professionals from the US, France, Germany and the UK.
  • Two Patient Advocacy Council sessions will be held on Saturday November 11, 2023.
  • Participants in this event include Dr. Jennifer Lai (MD, MBA, FACP) and the Global Liver Institute.
  • GENFIT will present new data on its NASH diagnostics technology, including:
    The impact of BMI on NIS2+™ and established non-invasive tests for the evaluation of non-alcoholic liver disease (15’ Oral Presentation #238, Pr.

CymaBay’s RESPONSE Phase 3 Data Evaluating Seladelpar for Primary Biliary Cholangitis to be Featured in an Oral Late-Breaking Presentation at The Liver Meeting® 2023

Retrieved on: 
Wednesday, October 18, 2023
Randomness, American Association for the Study of Liver Diseases, Hepatology, Liver, Congress, Conditional sentence, Safety, Placebo-controlled study, PBC, Obeticholic acid, Research and development, Primary biliary cholangitis, Toronto Centre, Therapy, Liver disease, Abstract, Liver support system, AASLD, Pharmaceutical industry, Patient, Research

NEWARK, Calif., Oct. 18, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that a late-breaking presentation highlighting results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA (November 10th – 14th). Seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC).

Key Points: 
  • Seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC).
  • The oral presentation titled “Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study,”1 will be delivered by Professor Gideon Hirschfield, M.D., Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Centre for Liver Disease.
  • We are extremely grateful to our team, investigators, and especially patients in the participation and collaboration in this endeavor.
  • Presentations at the Liver Meeting® 2023 include:
    1“Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study” (Abstract #5002)
    Congress attendees can visit CymaBay throughout the meeting at booth D3034.

GENFIT Reports Full-Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, April 13, 2023
KRAS, US Foods, Hepatic encephalopathy, Safety, MEK, Journal, Acquisition, Patient, Disease, NASH, PBC, Drug discovery, UCD, Methylmalonic acidemia, Pharmacokinetics, HE, American Association for the Study of Liver Diseases, Primary biliary cholangitis, Orphan drug, Ascites, Diagnosis, FDA, Cirrhosis, IND, Conference, Cholangiocarcinoma, Conference call, CCA, SOC, Liver, OA, Standard of care, English, Metabolism, Hepatology, Bank statement, NTZ, Elafibranor, Liver support system, Kidney, Itch, Chronic liver disease, Poster, Food, Pharmaceutical industry, Rare-earth element, Ipsen, ACLF, Euronext

Throughout 2022 GENFIT and Ipsen stepped up their collaboration in order to minimize the time to filing as well as prepare for the commercial launch next year, if approved.

Key Points: 
  • Throughout 2022 GENFIT and Ipsen stepped up their collaboration in order to minimize the time to filing as well as prepare for the commercial launch next year, if approved.
  • In September 2022, GENFIT acquired clinical-stage biopharmaceutical company Versantis based in Zurich (Switzerland), significantly expanding its pipeline.
  • Two Pipeline Days were organized in October 2022 in Paris and New York, to present these programs in detail.
  • In October 2022, GENFIT announced the development of NIS2+TM, a next-generation technology for the diagnosis of at-risk NASH, and the presentation of results on NIS2TM+’s clinical performance in three poster presentations at The Liver Meeting® 2022 organized by the AASLD2.

Fera Pet Organics Introduces Two New Supplements for Canines and Felines

Retrieved on: 
Tuesday, February 21, 2023
Liver support system, DVM, Animal, Choline, Silybum, Accreditation, Probiotic, Relaxation, Absorption, Vitamin, Amazon, PSC, Pet, Dietary supplement

LOS ANGELES, Feb. 21, 2023 /PRNewswire/ -- Fera Pet Organics, the AAPI- and female-founded line of clean pet supplements and vitamins, is thrilled to launch new solutions for keeping furry companions healthy and comfortable. The brand's newest items include Calming Support and Liver Support, which both utilize specific, hand-picked strains of probiotics with science-backed research to promote maximum effectiveness.

Key Points: 
  • LOS ANGELES, Feb. 21, 2023 /PRNewswire/ -- Fera Pet Organics , the AAPI- and female-founded line of clean pet supplements and vitamins, is thrilled to launch new solutions for keeping furry companions healthy and comfortable.
  • Fera Pet Organics has joined the PSC in its Packaging Pledge, a program to support pet companies to move to 100% recyclable, reusable, or compostable packaging by 2025.
  • Fera Pet Organics Calming Support and Liver Support are available for purchase beginning February 20 on Amazon and ferapetorganics.com .
  • Pet parents can also pick up these new supplements in person using the store locator on Fera Pet Organic's website.

Intercept Announces Two Analyses Demonstrating Improvement in Outcomes, Including Transplant-Free Survival, for PBC Patients Treated with OCA to be Presented at AASLD The Liver Meeting® 2022

Retrieved on: 
Sunday, November 6, 2022
Komodo, Therapy, EC, Primary biliary cholangitis, SMR, GLOBE, PBC, FDA, Death, Safety, Liver support system, Nasdaq, AASLD, Originality, Fatty liver disease, OCA, MELD, Obeticholic acid, Association, Patient, Pharmaceutical industry, Dietary supplement, Medical imaging

MORRISTOWN, N.J., Nov. 06, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral liver diseases, today announced that results from two analyses assessing the potential of obeticholic acid (OCA) to improve outcomes for patients with primary biliary cholangitis (PBC), including death, liver transplant and hepatic decompensation, will be presented at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

Key Points: 
  • COBALT was a randomized, double-blind, placebo-controlled confirmatory trial designed to assess efficacy and safety of OCA in patients with advanced PBC.
  • The study looked at a pre-defined group of patients with PBC who were treated with OCA and a comparable group of PBC patients who were eligible, but who were not treated with OCA.
  • Characteristics of patients who initiated treatment with OCA were SMR-weighted to OCA-eligible patients not treated with OCA.
  • This press release contains forward-looking statements (FLS), including regarding the results of our clinical studies, and the safety and efficacy of OCA.

Ocelot Bio to Present Data Highlighting Pharmacodynamic Activity and Safety of OCE-205 at AASLD The Liver Meeting®

Retrieved on: 
Monday, October 24, 2022
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Physician, Bio, Orphan, Therapy, Ocelot, Liver disease, Hepatorenal syndrome, Science, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Liver support system, Interest group, Venrock, Acute kidney injury, Fatty liver disease, Liver, Food, American Association, Association, Cirrhosis, Safety, Ascites, American Association for the Study of Liver Diseases, Digital, Institute of Liver and Biliary Sciences, SIG, ESLD, Portal hypertension, AASLD, Poster, Pharmaceutical industry, Tolerability

We look forward to this opportunity to present, for the first time, data from our Phase 1 trial that underscores the potential of OCE-205 to address these limitations.

Key Points: 
  • We look forward to this opportunity to present, for the first time, data from our Phase 1 trial that underscores the potential of OCE-205 to address these limitations.
  • The full poster presentation will also be made available to registered meeting attendees via The Liver Meeting Digital Experience within 72 hours of presentation, and the poster will be available online at Ocelot Bios website.
  • The company has received Orphan Drug Designation for OCE-205 in the treatment of hepatorenal syndrome from the U.S. Food and Drug Administration.
  • Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease.

Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)

Retrieved on: 
Thursday, September 15, 2022
Hospital, Terlipressin, Dialysis, Therapy, Safety, Trial of the century, Liver support system, Hypoxia, Hepatorenal syndrome, American College, AASLD, Risk, FDA, Food, Breathe Me, Diarrhea, American Association for the Study of Liver Diseases, American Association, ACG, Verified, Renal replacement therapy, Survival, Oxygen saturation (medicine), Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Severe cutaneous adverse reactions, The New England Journal of Medicine, Physician, 2021 Essex County Council election, Terminology, Use, American College of Gastroenterology, Volume overload, Caregiver, Boxed warning, Kidney failure, SCR, Abdominal pain, Association, Nausea, Mortality, Kidney, ACLF, HRS, Institute of Liver and Biliary Sciences, Pharmaceutical industry, Mallinckrodt

DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 

Key Points: 
  • DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection.
  • The CONFIRM trial was completed prior to the updated diagnostic criteria and terminology published in the 2021 AASLD guidance on hepatorenal syndrome.
  • * Note, Terlivaz was not evaluated in comparison to other treatment options in a head-to-head clinical study.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.