Ascites

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
onsdag, april 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Panbela Announces Poster Presentation at American Association for Cancer Research:

Retrieved on: 
torsdag, april 18, 2024
Cancer, Mouse, MSN, Cell, OTCQB, Doxorubicin, Survival, Doctor of Philosophy, Ascites, Therapy, Patient, Metabolism, Toxicity, Standard of care, AACR, Immune system, VEGF, Fibroadenoma, Ovarian cancer, Platinum

MINNEAPOLIS, April 18, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA)(“Panbela”), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024.

Key Points: 
  • MINNEAPOLIS, April 18, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA)(“Panbela”), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024.
  • Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines.
  • The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden.
  • Details of the presentation are as follows:
    Additional meeting information can be found on the AACR website: https://www.aacr.org/meeting/aacr-annual-meeting-2024/abstracts/

Long-term Complete Response to Can-Fite's Namodenoson in Patient with Advanced Liver Cancer: Article Published in a Leading Scientific Journal

Retrieved on: 
torsdag, april 25, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Link, Mortality, FDA, Phase, Experiment, Liver cancer, Food, Survival, American Cancer Society, Ascites, Hepatocellular carcinoma, Incidence, Patient, EMA, Inflammation, IDMC, Death, Quality of life, Child, Orphan drug, European Medicines Agency, CANF, HCC, Pharmaceutical industry

The patient participated in the Phase II Liver Cancer Study and has been treated with namodenoson for >7 years under compassionate use program.

Key Points: 
  • The patient participated in the Phase II Liver Cancer Study and has been treated with namodenoson for >7 years under compassionate use program.
  • The article describes a patient with advanced liver cancer that was enrolled in the former Can-Fite Phase II study, continues to receive treatment with namodenoson, and has now an overall survival of >7 years, with disappearance of ascites, normal liver function, good quality of life and defined as a long term complete response.
  • The study design includes a pre-planned interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients.
  • According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year.

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
torsdag, mars 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
onsdag, mars 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

BioVie Announces Pipeline Update and Near-Term Clinical Priorities

Retrieved on: 
måndag, mars 11, 2024
L-DOPA, PD, Research, MDS-UPDRS, UPDRS, FDA, Partnership, Ageing, Dopaminergic, Ascites, Part, ADAS, Food, Cirrhosis, Conference, Biomarker, Acute kidney injury, Patient, AKI, Longevity, Pharmaceutical industry

CARSON CITY, Nev., March 11, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that its recently completed funding round provides opportunity to further the Company’s clinical priorities in Parkinson’s Disease (PD), Alzheimer’s Disease (AD), and ascites/liver disease. The Company continues to explore longevity and aging in conjunction with external collaborators. 

Key Points: 
  • The Company continues to explore longevity and aging in conjunction with external collaborators.
  • The trial targets enrolling 100-150 patients in a 6-month trial with the Part 3 (motor) score on the MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) as the primary endpoint.
  • Only one Phase 3 trial is potentially needed as BIV201 has already received Orphan and Fast Track designations.
  • BIV201 remains our most de-risked program, but it unfortunately is a program that will take two years to complete.

New Case Series Demonstrates Potential of Aquadex Therapy for End-Stage Liver Disease Patients with Fluid Overload

Retrieved on: 
tisdag, februari 6, 2024
ICU, Diuretic, Mount Sinai Hospital, Patient, Cirrhosis, Ascites, FDA, Peritoneal cavity, Aquapheresis, Literature review, Food, Blood, Paracentesis, Series, Liver disease, Blood volume, Medical imaging

The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation .

Key Points: 
  • The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation .
  • The most common cause of liver disease was alcohol-related, with nine of the 14 patients presenting with alcohol-associated cirrhosis.
  • In this case series, Aquadex was shown to provide a potential additional solution to mitigate these clinical gaps.
  • Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics.

Sequana Medical announces FDA acceptance for substantive review of the Premarket Approval application for alfapump® in recurrent or refractory ascites due to liver cirrhosis

Retrieved on: 
måndag, januari 29, 2024
Ascites, Patient, Cirrhosis, Overload, Heart failure, Cancer, Food, Brussels Stock Exchange, Liver disease, FDA, PMA, Medical device

The alfapump is the Company’s fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis and received breakthrough device designation from the US FDA in 2019.

Key Points: 
  • The alfapump is the Company’s fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis and received breakthrough device designation from the US FDA in 2019.
  • Pending FDA approval, which the Company anticipates in the second half of 2024, alfapump could become the first active implantable medical device in the US for treating liver ascites.
  • Timur Resch, Global Vice President QM/QA/RA at Sequana Medical, commented: “The acceptance of our PMA file for substantive review by the FDA is an important milestone that reflects the tremendous efforts of our team.
  • This achievement means that the FDA recognizes the completeness of our application and will now begin an in-depth review.

Laborie Introduces the Next Generation RenovaRP Centesis System

Retrieved on: 
måndag, januari 8, 2024
Ascites, Abdomen, Patient, System, Paracentesis, Pleural effusion, Health, Thoracentesis, Medical device

PORTSMOUTH, N.H., Jan. 8, 2024 /PRNewswire/ -- Laborie Medical Technologies, Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, is proud to announce the launch of the RenovaRP™ Centesis System, an innovative fluid drainage device designed to advance patient care and improve efficiency for healthcare professionals.

Key Points: 
  • PORTSMOUTH, N.H., Jan. 8, 2024 /PRNewswire/ -- Laborie Medical Technologies, Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, is proud to announce the launch of the RenovaRP™ Centesis System, an innovative fluid drainage device designed to advance patient care and improve efficiency for healthcare professionals.
  • The RenovaRP Centesis System builds upon the current RenovaRP paracentesis pump by providing an expanded indication for thoracentesis and design enhancements to the handle and nest of the device to improve the overall user experience.
  • "The RenovaRP Centesis System represents a significant milestone for Laborie, empowering healthcare professionals with a cutting-edge tool to enhance patient care during paracentesis and thoracentesis procedures," said Rhett Klein, Vice President of Sales and Global Marketing at Laborie.
  • The RenovaRP Centesis System offers a safe, efficient, and minimally invasive solution to address these medical conditions, improving patient comfort and reducing recovery times.

scPharmaceuticals Announces Preliminary Unaudited Q4 and Full-Year 2023 Net FUROSCIX® Revenue

Retrieved on: 
torsdag, januari 4, 2024
Coma, Urine, Hepatic encephalopathy, Ascites, Kidney, Oliguria, Physician, Benign prostatic hyperplasia, Blood volume, Uric acid, Organic acid, Anuria, Urinary retention, NYHA, Furosemide, Cerebral edema, Hypersensitivity, Diuresis, Thrombosis, Deafness, Glucose, Azotemia, Ototoxicity, Creatinine, Tinnitus, Traction, BUN, Hypoproteinemia, Edema, Growth, Investment, Congestion, Huber loss, Patient, Bruise, Dehydration, CO2, Heart failure, Cirrhosis, Embolism, History, Erythema, Pharmaceutical industry

BURLINGTON, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced preliminary unaudited fourth quarter 2023 net FUROSCIX revenue in a range of $5.9 million to $6.1 million, representing sequential growth of 55% to 61% over $3.8 million net FUROSCIX revenue reported for the third quarter of 2023.

Key Points: 
  • For the full year 2023, the Company anticipates net revenue to be in a range of $13.4 million to $13.6 million.
  • The gross-to-net discount decreased to approximately 18% from launch through the end of Q4 versus 21% from launch through the end of Q3.
  • Inventory levels at the end of Q4 2023 were consistent with levels at the end of Q3 2023.
  • scPharmaceuticals will report its final and complete fourth quarter and full-year 2023 financial results in March.