Sepsis

Inotrem Successfully Reaches Agreement with the FDA for a Phase 3 Registration Trial for Nangibotide in Septic Shock

Retrieved on: 
Monday, January 8, 2024
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Biometrics, Other Science, Research, Infectious Diseases, Science, Clinical Trials, Roche, Risk, ACCURATE, Septic shock, Mortality, Disease, Blood, Incidence, Immunomodulation, Death, Intensive care medicine, Patient, Sepsis, Pharmaceutical industry

The ACCURATE trial design is built upon Phase 2 (ASTONISH) data that confirmed nangibotide’s strong efficacy and safety profile.

Key Points: 
  • The ACCURATE trial design is built upon Phase 2 (ASTONISH) data that confirmed nangibotide’s strong efficacy and safety profile.
  • This unique biomarker-guided approach allows for a single Phase 3 registration trial with a manageable number of subjects.
  • “Inotrem is now in a leading position to conduct a single Phase 3 registration trial in a prospectively defined population of septic shock patients that are at high risk of morbidity and mortality.
  • With nangibotide, Inotrem has developed a novel approach of immunomodulation targeting the TREM-1 pathway to restore appropriate inflammatory response, vascular function and improve post septic shock survival.

New antibiotic zosurabalpin shows promise against drug-resistant bacteria – an expert explains how it works

Retrieved on: 
Friday, January 5, 2024
World, Cell death, Infection, Carbapenem, Roche, Crab, Hospital, Mouse, Human, News, Clinical trial, Cell wall, Acinetobacter baumannii, Animal, System, World Health Organization, Toxicity, Patient, Bacteria, Sepsis, Antibiotics

Researchers have identified an entirely new class of antibiotic that can kill bacteria that are resistant to most current drugs.

Key Points: 
  • Researchers have identified an entirely new class of antibiotic that can kill bacteria that are resistant to most current drugs.
  • It is responsible for around 20% of infections in places like hospitals, care homes or other similar healthcare settings.
  • Antibiotics commonly work by crossing the cell wall that surrounds infectious bacteria to reach the vital machinery inside.
  • Crab is a clinical challenge as it has a double-layered cell wall, a feature that microbiologists describe as “gram negative”.

Zosurabalpin

  • Researchers tested zosurabalpin against more than 100 Crab samples from patients suffering from the infection.
  • The research team, found that zosurabalpin was able to kill all of these bacterial strains.
  • Zosurabalpin works by blocking a molecular machine called LptB2FGC that transports the lipopolysaccharide toxin from the inside barrier to the outside one.
  • The bad news is that zosurabalpin will only kill Crab infections and not those caused by other types of bacteria.
  • Zosurabalpin is now in phase 1 clinical trial for use in patients infected with Crab.
  • This early testing in humans will help the company developing the drug, Roche, to work out any side effects of the drugs as well as potential toxicity.


Jonathan Cox receives research funding from UKRI, charities and industry.

He is Co-Director of the Antibiotic Discovery Accelerator (ABX) Network

Global Continuous Renal Replacement Therapy Market Analysis and Forecast Report 2024-2033 - ResearchAndMarkets.com

Retrieved on: 
Friday, January 5, 2024
Biotechnology, Pharmaceutical, Health, AKI, Prevalence, Competitive landscape, Incidence, Hemofiltration, Renal replacement therapy, Hospice and palliative medicine, Growth, Patient, CRRT, Sepsis, Pharmaceutical industry

The "Global Continuous Renal Replacement Therapy Market: Focus on Modality, Product, Region, and Competitive Landscape - Analysis and Forecast, 2024-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Continuous Renal Replacement Therapy Market: Focus on Modality, Product, Region, and Competitive Landscape - Analysis and Forecast, 2024-2033" report has been added to ResearchAndMarkets.com's offering.
  • Key Questions Answered in this Report:
    What are the focus segments of the global continuous renal replacement therapy market in the upcoming years?
  • What are the major opportunities for existing market players and new entrants in the global continuous renal replacement therapy market?
  • What are the major opportunities for existing market players and new entrants in the global continuous renal replacement therapy market?

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Retrieved on: 
Friday, January 5, 2024
Patient, Medical Subject Headings, Marketing, Febrile neutropenia, Agency, INN, Fever, Immune system, Risk, Infection, Diffusion, Allergy, DLBCL, ATC, Bone marrow, Cytokine release syndrome, CD20, Platelet, International, Headache, Disease, Neutropenia, Blood, Language, Pleural effusion, Cancer, B-cell lymphoma, Thrombocytopenia, Neutrophil, Rituximab, COVID-19, European Medicines Agency, Select, Bacteria, Anatomy, Anemia, IIA, Sepsis, CD3, Rash, Medical device

Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Columvi, glofitamab, Date of authorisation: 07/07/2023, Revision: 1, Status: Authorised

Immunexpress Announces U.S. FDA Clearance of EDTA Blood Compatible Cartridges for SeptiCyte RAPID®

Retrieved on: 
Thursday, January 4, 2024
RNA, HHS, Food, Ellery Sedgwick, Collection, Heart, Drive, Research, FDA, Sepsis, Lung, Assistant, Patient, Diagnosis, Development, EDTA, Medical device

SEATTLE and BRISBANE, Australia, Jan. 4, 2024 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the clearance of EDTA blood compatible cartridges by the U.S. Food and Drug Administration (FDA) for use with SeptiCyte RAPID®. The updated SeptiCyte® RAPID cartridges add undiluted EDTA blood as a validated sample type within the U.S. healthcare market and have been available on the European market since August 2022.

Key Points: 
  • SEATTLE and BRISBANE, Australia, Jan. 4, 2024 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the clearance of EDTA blood compatible cartridges by the U.S. Food and Drug Administration (FDA) for use with SeptiCyte RAPID®.
  • The updated SeptiCyte® RAPID cartridges add undiluted EDTA blood as a validated sample type within the U.S. healthcare market and have been available on the European market since August 2022.
  • Their implementation allows for the use of standard EDTA blood collection tubes in place of proprietary PAXgene® blood RNA tubes.
  • BARDA awarded this grant to Immunexpress in 2020 as part of the DRIVe Solving Sepsis program.

Sigyn Therapeutics Releases Letter to Shareholders

Retrieved on: 
Thursday, January 4, 2024
Fresenius Medical Care, FDA, Hope, Health, Cancer, Inflammation, Patent, Lipopolysaccharide, Kidney disease, Horizon, Annual report, Death, University, IDE, Letter, Merck, Dialysis, Sepsis, Life, Antibody, Mortality, Therapy, Risk, Toxicity, Patient, Acquisition, AB toxin, ESRD, Hospital, Infection, SAN, DaVita Inc., Community-acquired pneumonia, Horizon Therapeutics, Roivant Sciences, Cardiovascular disease, Security (finance), Pharmaceutical industry

SAN DIEGO, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce.

Key Points: 
  • SAN DIEGO, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce.
  • The goal of this letter is to help you better understand our opportunities, our challenges, and decision-making processes.
  • In that submission, our endeavors were solely predicated on the development and clinical advancement of Sigyn TherapyTM.
  • This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties.

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Erelzi, etanercept, Date of authorisation: 23/06/2017, Revision: 14, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, DSM-IV codes, MRI, TNF, INN, Risk, Polyarthritis, Magnetic resonance imaging, Infection, PUVA, ATC, Joint, Lung, Pain, Psoriatic arthritis, Itch, Bleeding, International, Disease, Arthritis, Nose, Blood, Language, Ageing, Rheumatoid arthritis, Swelling, Inflammation, Red, Nonsteroidal anti-inflammatory drug, Ankylosing spondylitis, European Medicines Agency, Spine, Back pain, Select, Juvenile idiopathic arthritis, Human, Patient, Safety, Bacteria, Anatomy, CRP, IIA, Sepsis, Methotrexate, Skin, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Erelzi, etanercept, Date of authorisation: 23/06/2017, Revision: 14, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Erelzi, etanercept, Date of authorisation: 23/06/2017, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Benepali, etanercept, Date of authorisation: 13/01/2016, Revision: 22, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Marketing, C-reactive protein, MRI, INN, Risk, Polyarthritis, Lung, Inflammation, Red, Ankylosing spondylitis, Infection, Diagnosis, Bacteria, Anatomy, IIA, CHMP, Skin, ATC, Joint, Pain, Psoriatic arthritis, Itch, Bleeding, Syringe, European, Disease, Ageing, Nonsteroidal anti-inflammatory drug, Safety, CRP, Rheumatoid arthritis, Sepsis, Magnetic resonance imaging, Patient, Medical Subject Headings, Agency, European Commission, Immune system, ACR, International, Arthritis, Language, Blood, Select, Juvenile idiopathic arthritis, Medicine, Methotrexate, Common, TNF, PUVA, Swelling, Spine, Committee, Oligoarthritis, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Benepali, etanercept, Date of authorisation: 13/01/2016, Revision: 22, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Benepali, etanercept, Date of authorisation: 13/01/2016, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Marketing, MP, Heart, MRI, INN, Risk, MTX, Pneumonia, Fungus, AZA, UC, Eating, Inflammation, Ankylosing spondylitis, Infection, Fungal infection, Diagnosis, Anatomy, Ulcer, Lymphoma, IIA, Skin, Vasculitis, Yeast, Psoriasis, ATC, Joint, Pain, Psoriatic arthritis, Syringe, Disease, Nose, Allergy, Lower respiratory tract infection, Nonsteroidal anti-inflammatory drug, Hepatitis B virus, Safety, Heart failure, CRP, Disorder, Rheumatoid arthritis, Sepsis, Magnetic resonance imaging, Leukemia, Patient, Medical Subject Headings, Walking, Immune system, Ulcerative colitis, International, Arthritis, Language, Blood, Hepatitis B, Medication package insert, Tuberculosis, Select, Medicine, Methotrexate, Azathioprine, TNF, X-ray, Mercaptopurine, European Medicines Agency, Spine, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised