Hepatorenal syndrome

Ocelot Bio Receives FDA Orphan Drug Designation for OCE-205 for the Treatment of Ascites

Retrieved on: 
Wednesday, December 20, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Peritoneal cavity, Ascites, Food, Cirrhosis, Orphan, Cancer, Abdomen, Patient, Diagnosis, Therapy, ESLD, Hepatorenal syndrome, Pharmaceutical industry

“The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio.

Key Points: 
  • “The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio.
  • The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.
  • Orphan Drug Designation provides Ocelot Bio certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.
  • This is the second Orphan Drug Designation for OCE-205, which previously received the designation in hepatorenal syndrome.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023
Chronic kidney disease, Neutrophil, Acute respiratory distress syndrome, STEC-HUS, Cardiorenal syndrome, Safety, Food, Hepatorenal syndrome, University, AKI, HDE, Risk, ICU, Clinical trial, Monocyte, Mortality, CBER, Sepsis, Patient, Nephrology, Insurance, Research, Letter, Dialysis, Approvable letter, FDA, G&A, Child, Standard of care, Acute kidney injury, Partnership, Nephron, Clinical study design, R, Hospital, SCD, Physician, CKRT, Karger Publishers, PMA, HIV disease progression rates, Pharmaceutical industry, Nursing, Dietary supplement, Cryptocurrency

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Mallinckrodt to Present Breadth of Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting

Retrieved on: 
Wednesday, November 8, 2023
Patient, Medical Affairs Bureau, Cohort (statistics), Respiratory failure, Oxygen saturation (medicine), Boxed warning, Use, Physician, MD, Blood, Kidney, Research, ACLF, Hepatorenal syndrome, American Association for the Study of Liver Diseases, Database, Risk, Volume overload, Safety, HRS, Abstract, Hypoxia, AASLD, Pharmaceutical industry, Dietary supplement, Nursing, Mallinckrodt, Hepatology

DUBLIN, Nov. 8, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the presentation of 11 scientific abstracts with findings from the latest clinical and health economics research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 during the American Association for the Study of Liver Diseases (AASLD) 2023 Liver Meeting, taking place November 10-14, 2023 in Boston, MA.

Key Points: 
  • Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9111651-mallinckrodt-aasld-2023-...
    Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
  • Data collected in retrospective, pooled, database, or post hoc analyses may have errors or omissions.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

FDA Issues Approvable Letter for SeaStar Medical’s Selective Cytopheretic Device for Pediatric Patients

Retrieved on: 
Monday, October 30, 2023
FDA, Standard of care, Center for Biologics Evaluation and Research, HDE, Humanitarian Device Exemption, Food, SCD, Mortality, MD, Acute kidney injury, Inflammation, AKI, Hepatorenal syndrome, Dialysis, Cardiorenal syndrome, SeaStar, Intensive care medicine, CKRT, Letter, Neutrophil, Hospice and palliative medicine, Monocyte, Sepsis, Patient, Label, Infection, ICU, Pharmaceutical industry, Medical device, Research

As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.

Key Points: 
  • As announced in early October 2023, SeaStar Medical expected the FDA to issue this approvable letter within a month of such announcement.
  • The issuance by the FDA of an Approvable Letter is a standard step in the approval process of a Humanitarian Device Exemption (HDE) application.
  • The Approvable Letter indicates that SeaStar Medical’s HDE application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • The SCD-PED-01 (weight range ≥15 kg) and PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% reductions in mortality, respectively.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting

Retrieved on: 
Wednesday, November 1, 2023
Patient, Comorbidity, Incidence, Respiratory failure, Alcoholic hepatitis, Oxygen saturation (medicine), Boxed warning, Use, Renal replacement therapy, Blood, Health, Kidney, ACLF, Society, American Society of Nephrology, Hepatorenal syndrome, Phase, ASN, Risk, Volume overload, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Mallinckrodt, MD

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ® (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 – including its impact on patient care, key HRS endpoints and patient comorbidity – will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023.

Key Points: 
  • "1
    These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
    TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

FDA Grants SeaStar Medical’s Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome

Retrieved on: 
Wednesday, October 18, 2023
FDA, Center for Biologics Evaluation and Research, Food, SCD, Mortality, MD, Liver transplantation, Liver, Acute kidney injury, University, AKI, Society, Hepatorenal syndrome, Cardiorenal syndrome, NASH, COVID-19, Fatty liver disease, Immunomodulation, Kidney, Cirrhosis, Hospital, Sepsis, Patient, Food and Drug Administration, Prognosis, ICU, Pharmaceutical industry, Research

This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

Key Points: 
  • This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.
  • An investigator-initiated pilot study conducted at the University of Michigan assessed treatment with the SCD in two patients with type 1 hepatorenal syndrome.
  • “We are grateful for FDA’s decision to award Breakthrough Device Designation to the SCD in hepatorenal syndrome, which follows similar awards for adult AKI in 2022 and for cardiorenal syndrome last month,” said Eric Schlorff, SeaStar Medical CEO.
  • “The SCD now has three Breakthrough Device Designations in total granted by the FDA’s Center for Biologics Evaluation and Research (CBER).

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Sunday, October 22, 2023
Gastroenterology, FDA, Comorbidity, Hepatorenal syndrome, American College, Respiratory failure, PDT, EDT, Heart rate, Boxed warning, Oxygen saturation (medicine), Use, DBP, Physician, ACG, Cirrhosis, Mortality, Effect, Treatment, Post hoc analysis, MAP, SBP, Acute kidney injury, American College of Gastroenterology, Research, ACLF, Baylor University Medical Center, Phase, White, Chronic liver disease, Risk, Hospital, Maryland School, Volume overload, University, Stanford University School of Medicine, CLD, Blood pressure, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Medical device, Nursing, Communications satellite, Mallinckrodt, Patient, MD, Terlipressin

DUBLIN, Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

Key Points: 
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
  • If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (EASL) Congress 2023

Retrieved on: 
Thursday, June 15, 2023
University College London, PFS, EASL, ACLF, Use, Royal Free Hospital, HRS, SCR, International Club Crosby, Research, Transplant, MNK, Doctor of Philosophy, EDT, Bachelor of Science, Congress, California Pacific Medical Center, Volume overload, Hepatorenal syndrome, Oxygen saturation (medicine), MD, Patient, Risk, CEST, Boxed warning, Kidney, Diagnosis, Terlipressin, Hypoxia, European Association for the Study of the Liver, ICA, Digestate, UCL Institute of Ophthalmology, NYSE, Respiratory failure, Dietary supplement, Pharmaceutical industry, Nursing, Mallinckrodt, Liver

DUBLIN, June 15, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that two scientific posters detailing Mallinckrodt's latest research findings on the clinical outcomes of treatment with TERLIVAZ® (terlipressin) for injection and clinical management criteria for adult patients with hepatorenal syndrome (HRS) will be presented at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria, taking place June 21-24, 2023. Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.

Key Points: 
  • Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.
  • The CONFIRM trial is the largest-ever prospective, randomized clinical trial of terlipressin compared to placebo in patients with HRS type 1 (HRS-1).
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Can-Fite Reports First Quarter 2023 Financial Results & Provides Clinical Update

Retrieved on: 
Thursday, June 1, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Acumen, Survival rate, Travel, Hepatocellular carcinoma, Pancreatic cancer, Liver cancer, Safety, Survival, American Society of Clinical Oncology, Rabin Medical Center, Journal, Hepatorenal syndrome, Patent, Patient, Liver failure, NYSE, HCC, A3, Disease, Therapy, NASH, Institutional review board, Food, EMA, Pancreas, Ascites, Liver, Cancer, Cirrhosis, FDA, Soroka Medical Center, Hepatic encephalopathy, Liver transplantation, Psoriasis, Fibrosis, Jaundice, CANF, Kidwai Memorial Institute of Oncology, TASE, Decompensation, American Journal of Clinical Oncology, Hepatology, Progression-free survival, Microsoft Access, WNT, ASCO, Green Light, Pivotal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Pharmaceutical industry, Medical imaging, Cryptocurrency

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.
  • Safety and efficacy endpoints including objective response, progression-free survival, duration of response, disease control, and overall survival will be monitored.
  • The mechanism of action entails de-regulation of the Wnt signal transduction pathway, a key modulator of pancreatic carcinoma cell growth.
  • The Company's consolidated financial results for the three months ended March 31, 2023 are presented in accordance with US GAAP Reporting Standards.

Mallinckrodt Presents Clinical Data for TERLIVAZ® (terlipressin) for Injection in Adults with Hepatorenal Syndrome (HRS) at Digestive Disease Week (DDW) 2023

Retrieved on: 
Monday, May 8, 2023
Gastrointestinal disease, Bradycardia, Use, HRS, Aes, Cardiovascular disease, MNK, Arrhythmia, DDW, Incidence, SS-N-22, Alcoholic hepatitis, Hepatorenal syndrome, Patient, Boxed warning, Virginia Commonwealth University, Internal medicine, School, Kidney, Terlipressin, NYSE, Pharmaceutical industry, Mallinckrodt

DUBLIN, May 8, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 treated with TERLIVAZ® (terlipressin) for injection at Digestive Disease Week® (DDW) 2023, taking place in Chicago, Ill. from May 6-9. Mallinckrodt's pooled analysis of three North American Phase III studies on the incidence of adverse events (AEs) related to bradycardia and arrhythmias in adults with HRS treated with terlipressin was awarded Poster of Distinction status from DDW, and was presented on Sunday, May 7, 2023, 12:30 – 1:30 p.m. CDT.2 Additionally, Mallinckrodt's subgroup analysis of the CONFIRM Phase III study to assess terlipressin treatment outcomes in adults with HRS compounded by alcoholic hepatitis (AH) will be presented in an oral lecture session today, May 8, 2023, 10:30 – 10:45 a.m. CDT.3

Key Points: 
  • DUBLIN, May 8, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 treated with TERLIVAZ® (terlipressin) for injection at Digestive Disease Week® (DDW) 2023, taking place in Chicago, Ill. from May 6-9.
  • The incidence of episodes of bradycardia was higher in terlipressin-treated patients (6.3%; n=22) compared with placebo-treated patients (0.8%; n=2; P
  • In CONFIRM (n=300), 41% (81/199) of patients in the terlipressin group and 39% (39/101) of the patients in the placebo group had AH at baseline.
  • In the subgroup of patients with AH (n=120), the median Maddrey discriminant function score was similar across treatment groups (terlipressin: 96.9 vs. placebo: 97.7; P=0.681).