Carbapenem

Shionogi to Present New Data on FETROJA® (cefiderocol) at IDWeek 2020

Retrieved on: 
Monday, October 19, 2020

Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 18 abstracts on FETROJA (cefiderocol), including two oral presentations, will be shared at IDWeek.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 18 abstracts on FETROJA (cefiderocol), including two oral presentations, will be shared at IDWeek.
  • FETROJA has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases.
  • FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA.
  • Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit www.shionogi.com .

OpGen Announces Award of German Government Grant Funding to its Subsidiary Curetis and Collaborators

Retrieved on: 
Wednesday, September 30, 2020

Furthermore, the project aims to address resistance mechanisms in difficult-to-treat Gram-negative pathogens such as Enterobacteria, Pseudomonas and Acinetobacter.

Key Points: 
  • Furthermore, the project aims to address resistance mechanisms in difficult-to-treat Gram-negative pathogens such as Enterobacteria, Pseudomonas and Acinetobacter.
  • Curetis role during the collaborative research project is to provide research on innovative detection methods for carbapenem resistance based on porin loss and efflux pump overexpression.
  • Resistance is often conferred by mechanisms such as porin loss or efflux pump overexpression, not adequately covered by current diagnostics.
  • This press release includes statements regarding the receipt of a grant from the German government by Curetis GmbH.

Spero Therapeutics Hosting Key Opinion Leader Call on Oral Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Thursday, September 24, 2020

If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval inthe United States.

Key Points: 
  • If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval inthe United States.
  • Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by theFDAfor the treatment of cUTI and AP.
  • In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis.
  • Spero is also advancing SPR720, its novel oral therapy product candidate designed for the treatment of rare, orphan pulmonary disease caused by non-tuberculous mycobacterial (NTM) infections.

Shionogi Launches FETCROJA® (cefiderocol) in the United Kingdom for the Treatment of Infections Due to Aerobic Gram-Negative Bacteria in Adults With Limited Treatment Options

Retrieved on: 
Tuesday, September 15, 2020

Cefiderocol can now be used to treat some of the most life-threatening infections in patients for whom there are limited or no alternative treatment options.

Key Points: 
  • Cefiderocol can now be used to treat some of the most life-threatening infections in patients for whom there are limited or no alternative treatment options.
  • Similar to nosocomial pneumonia patients with carbapenem-resistant Gram-negative infections, cefiderocol may be considered as a treatment option.
  • Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years.
  • Shionogi B.V. is the European headquarters of Shionogi & Co., Ltd. For more information on Shionogi B.V., please visit www.shionogi.eu .

Venatorx Pharmaceuticals Awarded up to $44.2 Million to Advance Novel Inhibitors of Penicillin Binding Proteins targeting WHO Critical Priority Pathogen

Retrieved on: 
Monday, July 27, 2020

75N93020C00016, the total estimated cost of the base period for this contract is approximately $3.2 million.

Key Points: 
  • 75N93020C00016, the total estimated cost of the base period for this contract is approximately $3.2 million.
  • Venatorx has the potential to receive funding of up to $44.2 million, if all project milestones are met.
  • A. baumannii is ranked as a Priority 1: Critical carbapenem resistant pathogen on the World Health Organizations list of bacteria for which new antibiotics are urgently needed.
  • Venatorx is a private pharmaceutical company focused on the discovery and development of novel anti-infectives to treat multi-drug-resistant bacterial infections and hard-to-treat viral infections.

ContraFect Announces up to $18.9 Million in Funding from CARB-X to Support Acceleration of the CF-370 Program for Treating Pseudomonas aeruginosa Infections towards Clinical Stage Development

Retrieved on: 
Monday, July 20, 2020

This award provides initial funding of $4.9 million, and ContraFect could receive additional funding if certain project milestones are met.

Key Points: 
  • This award provides initial funding of $4.9 million, and ContraFect could receive additional funding if certain project milestones are met.
  • Any funding beyond the initial $4.9 million is at the sole discretion of CARB-X and subject to available funds.
  • At ContraFect, we remain committed to developing superior therapeutic agents with the potential to improve clinical outcomes and save lives.
  • Invasive P. aeruginosa infections, including ventilator-associated pneumonia, blood stream infections, complicated urinary tract infections, and infections following surgery carry some of the highest rates of mortality among hospital acquired infections.

FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Retrieved on: 
Friday, June 5, 2020

RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO.

Key Points: 
  • RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO.
  • RECARBRIO is a combination of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor.
  • RECARBRIO met the primary and key secondary endpoints, demonstrating non-inferiority to PIP/TAZ in 28-day all-cause mortality and clinical response at early follow-up, respectively.
  • Todays approval is further affirmation of Mercks steadfast commitment to meeting the needs of the health care community.

FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

Retrieved on: 
Thursday, June 4, 2020

SILVER SPRING, Md., June 4, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.

Key Points: 
  • SILVER SPRING, Md., June 4, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.
  • Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.
  • "These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible."
  • This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act.

FDA Accepts Shionogi’s Supplemental New Drug Application with Priority Review for FETROJA® (cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

Retrieved on: 
Monday, June 1, 2020

Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens.

Key Points: 
  • Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens.
  • Safety was investigated up to 28 days after the end of treatment unless there was an ongoing serious adverse event(s).
  • The safety and efficacy of FETROJA have not been established for the treatment of nosocomial pneumonia, bloodstream infections or sepsis.
  • Reserve FETROJA for use in patients who have limited or no alternative treatment options for the treatment of cUTI.

Zai Lab Announces First Chinese Patient Dosed in the Global Phase 3 ATTACK Trial of Sulbactam-Durlobactam for Patients with Carbapenem-Resistant Acinetobacter Infections

Retrieved on: 
Monday, May 18, 2020

With over 200,000 occurrences estimated each year, China ranks among the countries with the highest incidence of A. baumannii infections in the world.

Key Points: 
  • With over 200,000 occurrences estimated each year, China ranks among the countries with the highest incidence of A. baumannii infections in the world.
  • ATTACK is a global, two-part Phase 3 registrational trial enrolling approximately 300 patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii.
  • A Phase 2 trial and several Phase 1 trials of SUL-DUR have recently been completed with positive results for pharmacokinetics and safety/tolerability.
  • These forward-looking statements should not be relied upon as representing Zai Labs views as of any date subsequent to the date of this press release.