Sepsis

CPSC Warns Consumers to Immediately Stop Using Pedetid High-Powered Magnetic Ball Sets Due to Ingestion Hazard; Failure to Meet Federal Safety Regulation for Toy Magnet Sets; Sold Exclusively on Walmart.com

Retrieved on: 
Thursday, January 18, 2024
Magnet, Death, Extrapyramidal system, Risk, Human, CPSC, Pedetidae, Infection, Sepsis, Tin, Toy

CPSC is aware of seven deaths involving the ingestion of hazardous magnets, including two outside of the United States.

Key Points: 
  • CPSC is aware of seven deaths involving the ingestion of hazardous magnets, including two outside of the United States.
  • CPSC issued a Notice of Violation to the seller, Pedetid Store, of China, but the firm has not agreed to recall these magnetic ball sets or offer a remedy to consumers.
  • The sets were sold in a set of multi-colored magnetic balls in the form of a cube.
  • CPSC urges consumers to stop using the magnetic balls sets immediately, take them away from children, and dispose of them.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

Retrieved on: 
Tuesday, January 16, 2024
Intellectual property, Death, Clostridioides difficile infection, Patient, Research, DSM-IV codes, Hospital, Health, Urine, Dark Enlightenment, Colitis, Tuberculosis, UTI, Clostridioides difficile, DCS, Tetracycline, QIDP, Risk, Infection, Cephalosporin, Pulmonary fibrosis, Sepsis, FDA, Priority review, Penicillin, New Drug Application, Pyelonephritis, Urinary tract infection, Literature, Contra, NMDA, CNS, Pharmaceutical industry

Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.

Vibra Healthcare and Monument Health Collaborate to Open the Rehabilitation and Critical Care Hospital of the Black Hills in Rapid City, South Dakota

Retrieved on: 
Thursday, January 11, 2024
Bed, Learning, Patient, Heart, Hospital, Health, City, Trust, Rehabilitation, Stroke, RAPID, Weaning, Vibra Healthcare, Infection, Medicine, Sepsis, Vibra, DSM-IV codes, Nursing care plan, Brain, Monument, Nursing

and MECHANICSBURG, Pa., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Vibra Healthcare and Monument Health are pleased to announce the opening of the Rehabilitation and Critical Care Hospital of the Black Hills.

Key Points: 
  • and MECHANICSBURG, Pa., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Vibra Healthcare and Monument Health are pleased to announce the opening of the Rehabilitation and Critical Care Hospital of the Black Hills.
  • This innovative new healthcare facility, situated at 2115 Promise Road in Rapid City, South Dakota, seamlessly integrates two types of specialized hospital care under one roof: inpatient medical rehabilitation and critical care, also known as long-term acute care.
  • “I am honored to introduce the Rehabilitation and Critical Care Hospital of the Black Hills to our community,” Richards remarked.
  • The Rehabilitation and Critical Care Hospital of the Black Hills is currently open and accepting referrals for rehabilitation services, with plans to launch critical care services in the coming weeks.

Spectral Medical Enrolls Patient 82 in Its Phase 3 FDA Tigris Septic Shock Trial

Retrieved on: 
Wednesday, January 10, 2024
Baxter International, PMX, Lipopolysaccharide, Septic shock, Mortality, Patient, Sepsis, TSX, Randomized controlled trial, Nursing

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
  • Initiated 2024 with robust site activity to start the new year:
    Enrolled patient 82 during the first week of January.
  • This resumes the strong enrollment into Tigris which we experienced since holding our Investigator Meeting this past May.
  • “Additionally, with 68 patients to go, we are entering the final push to fully enroll and finish the Tigris trial.”

SELLAS Life Sciences Receives FDA Fast Track Designation for SLS009 for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Provides Updated Data for Phase 2a Study of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia Patients

Retrieved on: 
Tuesday, January 9, 2024
Venetoclax, Patient, CRC, MRD, EFS, MD, OS, Acute myeloid leukemia, SLS, COVID, PD, Standard of care, Azacitidine, Food, COVID 19, Disease, Safety, Doctor of Science, Sepsis, Fast Track, FDA, AML, Treatment, CDK9, Pharmaceutical industry

NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009 (formerly GFH009), its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML). The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.
  • Importantly, as of the last follow-up, eight of the nine patients enrolled in the 45 mg cohort were alive.
  • The first patient enrolled in the study achieved a complete response (CR) and continues on study in the seventh month with full peripheral blood recovery.
  • Eight patients (89%) remain alive (one patient succumbed to sepsis having previously contracted COVID 19) and six continue treatment.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Retrieved on: 
Friday, January 12, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Histopathology, Weight loss, Gynaecology, Bevacizumab, Cisplatin, Hypothyroidism, University, Cancer, Risk, COVID-19, Diarrhea, Hyperthyroidism, Brachytherapy, Neoplasm, Perforated ulcer, Hepatitis, FIGO, CRT, Pyelonephritis, Colitis, Vagina, ClinicalTrials.gov, PD-L1, RECIST, Disease, Patient, Fever, CPS, Chemoradiotherapy, Vomiting, MRK, Death, Nephritis, Progression-free survival, OS, Radiation, Anemia, Survival, EBRT, Abdominal pain, Intraparenchymal hemorrhage, Uterus, Cervical cancer, Constipation, PFS, Fatal, Obstetrics, Hematopoietic stem cell transplantation, Pneumonitis, Nausea, Pelvic pain, Dysuria, Fatigue, GOG, Arm, Rash, Food, Merck & Co., Sepsis, Toxicity, News, Urinary tract infection, Appetite, Pharmaceutical industry

Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Key Points: 
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
  • The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.
  • In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303).

Arkstone Launches Innovative Clinical Study to Evaluate OneChoice Report's Impact on Antimicrobial Prescribing, Stewardship, and Patient Outcomes

Retrieved on: 
Tuesday, January 9, 2024
Mortality, Death, Patient, Fungal infection, Infection, Research, Hospital, Culture, Septic shock, Intelligence, Antimicrobial stewardship, Drug, Risk, Bloodstream infections, Sepsis, Allergy, Molecular Informatics, Machine learning, BOCA, Trial of the century, Pharmaceutical industry

This joint effort marks a significant advancement in the appropriate antimicrobial prescribing and the fight against antibiotic resistance.

Key Points: 
  • This joint effort marks a significant advancement in the appropriate antimicrobial prescribing and the fight against antibiotic resistance.
  • The study aims to evaluate the clinical utility and benefits of Arkstone's innovative clinical decision support software, the OneChoice Report®, and its impact on selecting appropriate antibiotic therapy.
  • "The OneChoice Report is the most advanced antimicrobial stewardship program available, providing guidance to clinicians on optimal therapy for infections.
  • The study will also investigate the relationship between the use of the OneChoice Report®, clinician usage, antibiotic selection, patient outcomes, and healthcare cost-effectiveness.

ABIONYX Pharma appoints Rob Scott, MD, as Chief Medical Officer and Head of R&D

Retrieved on: 
Monday, January 8, 2024
Biotechnology, Pharmaceutical, Health, PEA, Sepsis, Partnership, Pharmaceutical industry

Rob Scott as Chief Medical Officer and Head of R&D with immediate effect.

Key Points: 
  • Rob Scott as Chief Medical Officer and Head of R&D with immediate effect.
  • Cyrille Tupin, CEO of ABIONYX Pharma, commented: "We are excited to welcome Rob to our team just before the start of the J.P. Morgan Healthcare annual conference in San Francisco.
  • As we develop our portfolio of clinical stage assets based on our unique apoA-I platform, Rob will bring us a wealth of experience to accelerate our programs.
  • I look forward to working with Rob to transform ABIONYX Pharma into a successful biotech company focused on sepsis and other critical indications based on the only recombinant apoA-I in the industry."

miRNA Sequencing And Assay Market Research Report 2023: Global Size, Share & Trends Analysis and Forecasts to 2030 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 8, 2024
Biotechnology, Genetics, Health, Oncology, RNA, Partnership, Sepsis, Prognosis, Antibody, Research, Workflow, Plasma, Breast, Ion semiconductor sequencing, MicroRNA, Cancer, USD, Mutation, COVID-19, Nervous system, Biomarker, Coronavirus, PerkinElmer, Library, Growth, Patient, Diagnosis, Application, Qiagen, Fine chemical

The "miRNA Sequencing And Assay Market Size, Share & Trends Analysis Report By Product & Service (Library Preparation Kits), By Technology, By Workflow, By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "miRNA Sequencing And Assay Market Size, Share & Trends Analysis Report By Product & Service (Library Preparation Kits), By Technology, By Workflow, By Application, By End-use, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global miRNA sequencing and assay market size is expected to reach USD 823.5 Million by 2030, registering a CAGR of 13.3% from 2023 to 2030.
  • Thus, miRNA sequence analysis is significantly employed for gene regulation analysis in clinical disorders.
  • For instance, an article published in frontiers, in March 2022, stated that blood-based miRNA biomarkers could be used to correlate brain-based miRNA expression.

Niterra Leads $10M Growth Funding Round for Imbed Biosciences

Retrieved on: 
Monday, January 8, 2024
Cardiology, Biotechnology, FDA, Health, General Health, Oncology, Neurology, Health Technology, Other Science, Medical Devices, Science, Quality of life, Risk, Multimedia, Infection, Physician, CVC, Hypertension, Environment, Doctor of Philosophy, Matrix, Energy, Burns, Amputation, Biofilm, Growth, Mobility, Sepsis

Niterra today announced its participation in the $10M convertible debt financing for Imbed Biosciences, Inc. (Imbed) , a tissue engineering company developing advanced biomaterials for soft-tissue repair.

Key Points: 
  • Niterra today announced its participation in the $10M convertible debt financing for Imbed Biosciences, Inc. (Imbed) , a tissue engineering company developing advanced biomaterials for soft-tissue repair.
  • View the full release here: https://www.businesswire.com/news/home/20240108469239/en/
    Imbed Biosciences has developed the world’s first and only fully-synthetic and antimicrobial wound matrix, which is FDA-cleared.
  • The antimicrobial matrix provides a healing environment conducive to tissue growth and suppresses the growth of microbes and biofilms.
  • With this latest round of financing, Imbed Biosciences will further establish its position as the leading developer of advanced devices for the management of burns, wounds and soft-tissue repair.