Gram-negative bacteria

Filtered Far UV-C Handheld Device Effectively Reduced Surface Pathogens in Hospital Study

Retrieved on: 
Monday, June 5, 2023

Freestyle Partners, LLC, announced today that a first-of-its-kind, in-hospital field study demonstrated a filtered Far UV-C portable, handheld device effectively reduced pathogens on hospital surfaces in seconds.

Key Points: 
  • Freestyle Partners, LLC, announced today that a first-of-its-kind, in-hospital field study demonstrated a filtered Far UV-C portable, handheld device effectively reduced pathogens on hospital surfaces in seconds.
  • In the study, a variety of gram-positive and gram-negative bacteria, including E. coli and MRSA, were identified on hospital surfaces.
  • The portable, handheld filtered Far UV-C device inactivated these bacteria and other pathogens in seconds.
  • Freestyle Partners provided funding support and a portable, handheld filtered Far UV-C device for this study.

Teleflex Awarded Agreements with Premier, Inc.

Retrieved on: 
Thursday, June 1, 2023

WAYNE, Pa., June 01, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced it was awarded two group purchasing agreements with Premier, Inc.

Key Points: 
  • WAYNE, Pa., June 01, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced it was awarded two group purchasing agreements with Premier, Inc.
  • Effective July 1st, 2023, the new agreements allow Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for Teleflex’s Central Venous and Arterial Vascular Access products.
  • Premier has awarded Teleflex a national agreement for Hemodynamic Monitoring Products and Accessories, a national agreement for Central Venous Access, a Sole Source for AscenDrive Central Venous Access, and a Sole Source for SURPASS Central Venous Access.
  • “Teleflex strives to deliver vascular access products that are designed to benefit both clinicians and patients, while helping to protect against vascular access related complications like infection and thrombosis,” said Lisa Kudlacz, President and General Manager, Teleflex Vascular.

smartbax Announces Seed Financing of €1.2 Million to Develop Next-generation Antibiotics

Retrieved on: 
Tuesday, May 23, 2023

smartbax , a biotech company developing next-generation antibiotics against multi-drug resistant bacteria, today announced the close of its seed financing round of €1.2 million from Boehringer Ingelheim Venture Fund (BIVF) and High-Tech Gründerfonds (HTGF), bringing smartbax’s total capital raised to €1.9 million.

Key Points: 
  • smartbax , a biotech company developing next-generation antibiotics against multi-drug resistant bacteria, today announced the close of its seed financing round of €1.2 million from Boehringer Ingelheim Venture Fund (BIVF) and High-Tech Gründerfonds (HTGF), bringing smartbax’s total capital raised to €1.9 million.
  • In contrast to classical anti-bacterial approaches, smartbax's product candidates act via a unique, double-targeted mechanism of action.
  • smartbax was founded in 2021 by Dr. Robert Macsics, Marco Janezic, and Prof. Dr. Stephan Sieber and was supported by BIVF with a first pre-seed financing of €700,000.
  • “The novel mechanisms of action being developed by smartbax could open new pathways in the treatment of severe bacterial infections.

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

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.

Omnix Medical Announces Excellent Topline Data from the Phase I Clinical Trial of its Novel Anti-Infective OMN6

Retrieved on: 
Monday, May 8, 2023

JERUSALEM, Israel, May 8th, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced positive top-line results from the Phase I clinical trial of its lead compound OMN6, an anti-infective with a completely novel mechanism of action. All endpoints were met: No severe or serious adverse events (SEs/SAEs) were observed at any dose level in the study while clinically meaningful levels of OMN6 were achieved in the blood and complete clearance of the drug was demonstrated, allowing for multiple daily infusions as is common with anti-infective treatments.

Key Points: 
  • The secondary endpoint was to evaluate the pharmacokinetics (PK) of OMN6 in the plasma of healthy young and elderly adult volunteers.
  • As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs.
  • "We are very pleased with these results," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical.
  • We are now looking forward to preparing a Phase II trial with OMN6 in the coming months."

KRATON CORPORATION SUBMITS BIAXAM™ POLYMER TECHNOLOGY AS AN ACTIVE INGREDIENT TO THE EPA

Retrieved on: 
Tuesday, May 2, 2023

HOUSTON, May 2, 2023 /PRNewswire/ -- Kraton Corporation, a leading global sustainable producer of specialty polymers and high-value biobased products derived from pine wood pulping by-products, submitted their novel BiaXam polymer technology on February 21, 2023, to the EPA for Section 3 approval as a new active ingredient.

Key Points: 
  • HOUSTON, May 2, 2023 /PRNewswire/ -- Kraton Corporation, a leading global sustainable producer of specialty polymers and high-value biobased products derived from pine wood pulping by-products, submitted their novel BiaXam polymer technology on February 21, 2023, to the EPA for Section 3 approval as a new active ingredient.
  • The BiaXam polymer active ingredient was submitted under the Section 3 category for supplemental residual antimicrobial products, which requires one of the most complicated efficacy testing protocols by the EPA.
  • The submission included a Manufactured Use Product (MUP) polymer in a solvent system, the Technical Grade Active Ingredient (TGAI) with BiaXam as a dry polymer, and an End Use Product (EUP) with the BiaXam polymer coated on a peel and stick film.
  • BiaXam polymer technology does not include the addition of per-and polyfluoroalkyl substances (PFAS or "forever chemicals") and meets the polymer exemption definition under TSCA; it is a high molecular weight polymer.

Sulbactam-Durlobactam Unanimously Recommended for Approval by FDA Advisory Committee

Retrieved on: 
Monday, April 17, 2023

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.

ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® / Fetroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 17, 2023

These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.

Key Points: 
  • These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.
  • Cefiderocol was initiated for a documented pathogen in the majority of cases (77%), and as monotherapy in 57% of patients.
  • Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment.
  • Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients.

ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 17, 2023

These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.

Key Points: 
  • These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.
  • Cefiderocol was initiated for a documented pathogen in the majority of cases (77%) and as monotherapy in 57% of patients.
  • Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment.
  • Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients.

Landmark Publication Underscores Robust Ability of CytoSorb to Reduce Cytokine Storm during Systemic Hyperinflammation

Retrieved on: 
Wednesday, March 29, 2023

” In this landmark publication, leading sepsis researchers in the group of Prof. Dr. Peter Pickkers from Radboud University Medical Center, Nijmegen, Netherlands convincingly demonstrate the robust ability of CytoSorb® to rapidly reduce cytokine storm during systemic hyperinflammation in a well-controlled and well-established human experimental sepsis model.

Key Points: 
  • ” In this landmark publication, leading sepsis researchers in the group of Prof. Dr. Peter Pickkers from Radboud University Medical Center, Nijmegen, Netherlands convincingly demonstrate the robust ability of CytoSorb® to rapidly reduce cytokine storm during systemic hyperinflammation in a well-controlled and well-established human experimental sepsis model.
  • Endotoxin is a common culprit in sepsis that potently activates the immune system, triggering the high production of cytokines, often called a “cytokine storm,” and severe inflammation.
  • Extracorporeal blood purification with CytoSorb was then used to treat half of the volunteers for a total of 6 hours.
  • Intravenous administration of endotoxin resulted in impressive transient increases in cytokine concentrations in the control group, characteristic of levels seen in a true cytokine storm.