Chronic kidney disease

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

Retrieved on: 
Wednesday, March 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.

Mineralys Therapeutics to Announce Fourth Quarter and Full Year 2023 Financial Results and Host Conference Call on Thursday, March 21, 2024

Retrieved on: 
Wednesday, March 13, 2024
Chronic kidney disease, CKD, Therapy, Hypertension

RADNOR, Pa., March 13, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the fourth quarter and full year ended December 31, 2023, before the financial markets open on Thursday, March 21, 2024.

Key Points: 
  • RADNOR, Pa., March 13, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the fourth quarter and full year ended December 31, 2023, before the financial markets open on Thursday, March 21, 2024.
  • Thursday, March 21st @ 8:30 a.m.
  • ET

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

Retrieved on: 
Tuesday, March 12, 2024
CKRT, Randomness, Sepsis, Survival rate, Neutrophil, Monocyte, AKI, Humanitarian Device Exemption, Patient, Hospital, Acute respiratory distress syndrome, Mortality, Acute kidney injury, Standard of care, MD, HDE, KRT, Safety, Dialysis, Chronic kidney disease, SCD, FDA, Food, Pharmaceutical industry

DENVER, March 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

Key Points: 
  • “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements In Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease

Retrieved on: 
Tuesday, March 12, 2024
Human, Conference, ATTD, CKD, Patient, Diabetes, EGFR, Safety, Chronic kidney disease, DKA, Hypoglycemia, Pharmaceutical industry

In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort.

Key Points: 
  • In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort.
  • The efficacy and safety data were presented last week at ATTD 2024 - 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy.
  • Relative to placebo, treatment with sotagliflozin led to similar reductions in A1C, body weight and systolic blood pressure in the CKD and total cohorts.
  • “We are optimistic that sotagliflozin may become an important new treatment option for this important population.”

AliveGen Announces Successful Completion of Phase 1b Multiple-Ascending Dose Clinical Trial for ALG-801

Retrieved on: 
Monday, March 18, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Atrophy, Clinical study design, Obesity, PD, DSM-IV codes, Weight, Liver disease, Doctor of Philosophy, MD, Trial of the century, Woman, Pharmacovigilance, Fibrosis, Clinical trial, TGF, Triple test, Chronic kidney disease, Therapy, Family, HQ, Pharmaceutical industry

AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801.

Key Points: 
  • AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801.
  • Study Design: The Phase 1b MAD study is a randomized double-blind placebo-controlled trial in postmenopausal women.
  • Next Step: Following the successful Phase 1b MAD study, AliveGen plans to advance ALG-801 to Phase 2 clinical development.
  • “We are grateful to the healthy volunteers and healthcare professionals who actively participated in our Phase 1b clinical trial,” said HQ Han, MD, PhD, CEO of AliveGen.

New KDIGO Guideline Supports Genetic Testing for the Majority of CKD Patients to Establish Cause of Disease

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, Genetics, Clinical Trials, Research, Science, Biotechnology, Nephrology, Prevalence, Chronic kidney disease, Genetic testing, Disease, CKD, Kidney disease, Patient, CGC, Evaluation, DNA, NTRA, Guideline

The updated guideline includes consensus statements supporting the use of genetic testing to establish the cause of chronic kidney disease (CKD) for a majority of patients with this condition.

Key Points: 
  • The updated guideline includes consensus statements supporting the use of genetic testing to establish the cause of chronic kidney disease (CKD) for a majority of patients with this condition.
  • The KDIGO guideline, specifically in Practice Points 1.1.4.1 and 1.1.4.2, states that genetic tests should be used, among other factors, to establish cause for CKD, and that genetic testing can impact the clinical management of people with CKD.
  • The guideline also lists specific gene categories, aligned with Natera’s Renasight gene panel, that are actionable for CKD patients.
  • “KDIGO makes it clear that most CKD patients and healthcare providers would prefer to identify the underlying cause of disease, which should include a genetic diagnosis when such tests are available,” said Maggie Westemeyer, MS, CGC, and director of clinical genetic services at Natera.

Saghmos Therapeutics Announces Receipt of Notice of Allowance from Japanese Patent Office for Phase 3-Ready Cardiorenal Metabolic Modulator ST-62516

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, FDA, Professional Services, Other Health, Health, General Health, Pharmaceutical, Other Science, Research, Legal, Science, Growth, Patent, CKD, Risk, Diabetes, AKI, Patient, Ageing, Trimetazidine, Acute kidney injury, MD, IND, Therapy, PCI, Safety, Chronic kidney disease, Unstable angina, Percutaneous coronary intervention, Pharmaceutical industry

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced that it has received a Notice of Allowance from the Japanese Patent Office for a patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced that it has received a Notice of Allowance from the Japanese Patent Office for a patent for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.
  • The patent will provide exclusivity through 2037, with broad claims for the reduction of acute kidney injury in patients with chronic kidney disease (CKD) undergoing procedures with contrast dyes.
  • "We are excited about the continued growth of Saghmos’ patent estate, with an issued US patent and Notices of Allowance for a second US patent and a Japanese patent,” commented Anna Kazanchyan, MD, Founder and CEO of Saghmos Therapeutics.
  • ST-62516 could benefit all PCI patients, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

Empowering Change: AMCP Foundation partners with Moda Health and Novo Nordisk Inc., launching a Health Disparities Research Internship

Retrieved on: 
Wednesday, April 3, 2024
Pharmacist, Health, Doctor of Pharmacy, Health equity, Partnership, Diabetes, Howard University, Knowledge, Regression analysis, Research, Moda Health, Walker, Chronic kidney disease, Geography, Hypertension, Collection, Medicine, Assistant director, Nursing

Sinclair brings a wealth of knowledge and a passion for health care research with a keen interest in addressing health disparities.

Key Points: 
  • Sinclair brings a wealth of knowledge and a passion for health care research with a keen interest in addressing health disparities.
  • The collaboration among AMCP Foundation and intern alumni Carly Rodriguez, PharmD, FAMCP VP & Chief Pharmacy Officer, Moda Health, and Courtney Walker, PharmD, RPh, Medical Account Director – Employers West, Novo Nordisk Inc. represents a critical alliance in health disparities research, focusing on unveiling insights into medication adherence disparities.
  • This strategic partnership exemplifies the synergy essential for impactful research, emphasizing a collective commitment to addressing health disparities.
  • In her unique role, Sinclair is at the forefront of research addressing health disparities related to GLP-1s, medications crucial in diabetes treatment.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.

CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Retrieved on: 
Tuesday, April 2, 2024
Chronic kidney disease, DCB, Kidney disease, Patient, Arteriovenous fistula, IDE, Sirolimus, Quality of life, Trial of the century, Fistula, Clinical trial, Kidney, AVF, PMA, US FDA, Safety, Food, FDA, Health, Pharmaceutical industry

Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

Key Points: 
  • Concept Medical a leader in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA Breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.
  • The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.
  • This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the MagicTouch Sirolimus Coated Balloon in A.V.
  • With a focus on advancing patient care through innovation, Concept Medical remains dedicated to improving patients' lives worldwide.