Carbapenem

T2 Biosystems Receives FDA 510(k) Clearance for the Expanded T2Bacteria Panel

Retrieved on: 
Monday, February 12, 2024
Pseudomonas aeruginosa, Infection, ICU, Escherichia coli, Catheter, Acinetobacter baumannii, FDA, Food, Carbapenem, Bloodstream infections, Risk, Intensive care medicine, Bacteria, World Health Organization, Patient, Septic shock, S. aureus, Mortality

LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.

Key Points: 
  • LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.
  • “We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The FDA-cleared T2Bacteria Panel now detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli, and A. baumannii.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.

Global Pseudomonas Aeruginosa Infection Treatment Market Report 2023 and 2024-2030: North America and Asia Pacific Earmarked for Exceptional Growth Trajectories - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 16, 2024
Biotechnology, Pharmaceutical, Health, Cystic fibrosis, Pseudomonas aeruginosa, Infection, Research, Carbapenem, Novartis, Cancer, Gilead Sciences, Acquisition, USD, Prevalence, Pharmaceutical industry

The "Global Pseudomonas Aeruginosa Infection Treatment Market" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Pseudomonas Aeruginosa Infection Treatment Market" report has been added to ResearchAndMarkets.com's offering.
  • The report uncloaks nuanced market trajectories and dynamics, providing insights into the promising developments toward antibiotic resistance.
  • Predicted to rise rapidly, the Asia Pacific market's growth orbit is propelled by heightened healthcare awareness and escalating healthcare investments.
  • North America and Asia Pacific regions earmarked for exceptional growth trajectories.

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

Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 8, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Medical Subject Headings, Diarrhea, Marketing, Agency, INN, Infection, Allergy, ATC, Carbapenem, International, Cough, Nausea, Language, Urinary tract infection, European Medicines Agency, Cilastatin, Bloodstream infections, Imipenem, Select, Patient, Iron, Bacteria, Anatomy, Penicillin, Vomiting, IIA, Gram-negative bacteria, Medical device

Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 8, Status: Authorised

Carbapenem Market Research Report 2023-2030: Analysis by Drug Class (Meropenem, Imipenem, Ertapenem), and Application (UTI, Blood Stream Infections, Pneumonia) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 28, 2023
General Health, Pharmaceutical, Health, USFDA, Fungal infection, Research, Urinary tract infection, Prevalence, Market, Developed country, Infection, ICU, Meropenem, Patient, Carbapenem, Death, USD, UTI, COVID-19, Bacteria, AMR, American Lung Association, Growth, MEM, Pfizer, Pharmaceutical industry, Antibiotics, Ertapenem, Application, Pneumonia, Imipenem

The "Carbapenem Market Size, Share & Trends Analysis Report By Drug Class (Meropenem, Imipenem, Ertapenem), By Application (UTI, Blood Stream Infections, Pneumonia), By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Carbapenem Market Size, Share & Trends Analysis Report By Drug Class (Meropenem, Imipenem, Ertapenem), By Application (UTI, Blood Stream Infections, Pneumonia), By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global carbapenem market size is expected to reach USD 5.24 billion by 2030., exhibiting a CAGR of 4.78% from 2023 to 2030.
  • In May 2023, Antabio initiated its Phase I trial by administering the initial dose of antibiotic therapy to healthy volunteers for hospital-acquired infections.
  • Based on drug class, the meropenem segment dominated the market in 2022, owing to their broad-spectrum activity against various bacteria, including multidrug-resistant strains.

T2 Biosystems Announces FDA 510(k) Submission to Expand the Pathogen Detection on its FDA-Cleared T2Bacteria Panel to Include Detection of Acinetobacter baumannii

Retrieved on: 
Thursday, October 12, 2023
Bloodstream infections, Food, Bacteria, Intensive care medicine, Acinetobacter baumannii, Risk, Carbapenem, Mortality, World Health Organization, FDA, CE, Escherichia coli, Catheter, ICU, Regulation of tobacco by the U.S. Food and Drug Administration, Pseudomonas aeruginosa, Patient, Infection, Septic shock, Vaccine, Antibiotics

A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock.

Key Points: 
  • A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock.
  • In a large study of nosocomial bloodstream infections, A. baumannii was the tenth most common pathogen and has a crude ICU mortality rate of 34.0% to 43.4%.
  • “We are excited about the potential to expand the number of pathogens detected by our FDA-cleared T2Bacteria Panel to include the detection of A. baumannii,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.

XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults

Retrieved on: 
Monday, September 18, 2023
Biotechnology, Infectious Diseases, Hospitals, Health, Pharmaceutical, Anaphylaxis, Infection, Colistin, Acinetobacter, Drug resistance, Incidence, Death, Nursing, VABP, Hospital, MD, Patient, Sulbactam, Carbapenem, Disease, Mortality, Nursing care plan, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins.

Key Points: 
  • The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins.
  • This has caused Acinetobacter to become increasingly difficult to treat with no clear standard of care antibiotic regimen for these resistant infections.
  • “Every minute matters when managing critical care patients with life-threatening pneumonia, especially when caused by carbapenem-resistant Acinetobacter baumannii pathogen.
  • Antibiotic-resistant pathogens can complicate treatment strategies and compromise treatment efficacy, often resulting in increased mortality rates for intensive care unit patients,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva.

Recce Pharmaceuticals Announces RECCE® Trademark Registered in Vietnam, Strengthening Global IP Portfolio

Retrieved on: 
Thursday, September 7, 2023
Antibiotic, International Trademark Association, Intellectual property, ASX, Colistin, FSE, IP, Intensive care medicine, World Organization of the Scout Movement, Hospital, Carbapenem, RCE, Pharmaceutical industry

SYDNEY, Australia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, is pleased to announce it has been issued a trademark registration for RECCE® from the Intellectual Property Office of Vietnam, strengthening the Company’s global intellectual property (IP) portfolio.

Key Points: 
  • SYDNEY, Australia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, is pleased to announce it has been issued a trademark registration for RECCE® from the Intellectual Property Office of Vietnam, strengthening the Company’s global intellectual property (IP) portfolio.
  • The International Trademark Registration No.
  • 1289603 has been formally assigned to the International Bureau (World Intellectual Property Organization), classified under Class 5 for antibiotics, antibiotics for human use, and pharmaceutical preparations, namely mixed antibiotic preparations.
  • “We are thrilled to receive this newly awarded trademark in Vietnam, further strengthening Recce’s intellectual property portfolio in the Asia-Pacific region,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Results from Pivotal Phase 3 ATTACK Trial of Investigational Sulbactam-Durlobactam for Treatment of Serious Infections Caused by Acinetobacter Published in The Lancet Infectious Diseases

Retrieved on: 
Thursday, May 11, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Clinical Trials, Priority review, Nephrotoxicity, Safety, Infection, Antimicrobial spectrum, New Drug Application, NDA, World Health Organization, Colistin, Acinetobacter, Gram-negative bacteria, Centers for Disease Control and Prevention, CDC, Acinetobacter baumannii, The Lancet, Aminoglycoside, Incidence, Death, Rutgers University, Cephalosporin, Robert Wood Johnson Medical School, Patient, Chronic kidney disease, Penicillin, Division, Carbapenem, Disease, PDUFA, Mortality, Nursing care plan, WHO, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gene, MPH, Food, Pharmaceutical industry, Vaccine, MD

The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.

Key Points: 
  • The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.
  • The Phase 3 trial evaluated the safety and efficacy of sulbactam-durlobactam versus colistin in patients with infections caused by Acinetobacter.
  • In the trial, sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.
  • The sulbactam-durlobactam NDA has a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.

Sulbactam-Durlobactam Unanimously Recommended for Approval by FDA Advisory Committee

Retrieved on: 
Monday, April 17, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Priority review, Nephrotoxicity, Infection, Antimicrobial spectrum, New Drug Application, NDA, Colistin, Acinetobacter, Gram-negative bacteria, Centers for Disease Control and Prevention, Committee, CDC, Acinetobacter baumannii, Aminoglycoside, Incidence, Death, Cephalosporin, MD, Patient, Chronic kidney disease, Penicillin, Carbapenem, Disease, PDUFA, Mortality, WHO, Therapy, Gene, Food, Safety, Pharmaceutical industry, Vaccine

The FDA will take the Committee’s recommendation into consideration when it makes a final determination.

Key Points: 
  • The FDA will take the Committee’s recommendation into consideration when it makes a final determination.
  • Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortality1 and long, expensive hospital stays.
  • Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 20193.
  • Carbpenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO)4.