ESBL

Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, February 27, 2024
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, ESBL, GAIN, Second Continental Congress, Urinary tract infection, Supervisory board, Pharmaceutics, Cutis, Partnership, Food, Pyelonephritis, Gram-negative bacteria, Patient, Congress, Medication, Pharmaceutical industry

Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.

Key Points: 
  • Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.
  • Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
  • "Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals.
  • Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013.

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Thursday, November 9, 2023
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Wellcome Trust, Government, FDA, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Meropenem, PDUFA, Food, Cutis laxa, United States Department of Health and Human Services, Pyelonephritis, Melinta Therapeutics, End-user license agreement, Prescription Drug User Fee Act, Human services, Regulation of tobacco by the U.S. Food and Drug Administration, Urinary tract infection, R, Administration, QIDP, CDC, Pseudomonas aeruginosa, Regulation, Medicine, Partnership, Infection, AP, ESBL, NDA, License, Therapy, Patient, Bangladesh Technical Education Board, Pharmaceutical industry

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Study Published in Science Translational Medicine Shows Exbaq’s Experimental Vaccine Protects Against Many of the Most Dangerous Antibiotic Resistant Superbugs Causing Hospital Acquired Infections

Retrieved on: 
Thursday, October 5, 2023
Patent, Partnership, Klebsiella pneumoniae, Infection, Methicillin-resistant Staphylococcus aureus, Homeland, Homeland security, Innovation, Acinetobacter baumannii, IND, Fungus, National Institute of Allergy and Infectious Diseases, Fungal infection, Hulk, Laboratory, Pseudomonas aeruginosa, Patient, FDA, Mucormycosis, R01, Macrophage, Escherichia coli, Immune system, USC, Bangladesh Technical Education Board, Vancomycin-resistant Enterococcus, ESBL, Korea Disease Control and Prevention Agency, Blood, Enterococcus, Translational medicine, Denise Spellberg, NIH, Vaccine, Pharmaceutical industry, Klebsiella, Science

Multiple studies in different laboratories have confirmed the vaccine protected against serious infections within 24 hours and lasts for up to 28 days.

Key Points: 
  • Multiple studies in different laboratories have confirmed the vaccine protected against serious infections within 24 hours and lasts for up to 28 days.
  • Early data suggest that a second dose may extend the window to prevent infection.
  • The study was published in Science and Translational Medicine.
  • These infections are often caused by highly antibiotic-resistant superbugs, many of which are targeted by this new ExBaq vaccine.

Venatorx Announces Presentation of Analysis of Cefepime-Taniborbactam in vitro Activity against Clinically Significant Gram-Negative Bacteria Isolated from Patients with Cancer at IDWeek 2023

Retrieved on: 
Monday, October 16, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Infectious Diseases, Clinical Trials, PWC, Infection, Incidence, CRE, Gram-negative bacteria, Extended-spectrum penicillin, Bacteria, GN, Risk, Escherichia coli, UICC, Enterobacterales, Ceftolozane/tazobactam, Cancer, MD Anderson Cancer Center, Pseudomonas aeruginosa, MDR, University, Ceftazidime/avibactam, Medication, ESBL, Serine, Patient, AMR, Pharmaceutical industry

Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with drug-resistant bacterial infections and hard-to-treat viral infections, today announces the presentation of data during IDWeek 2023 , October 11-15, 2023, in Boston, MA on the in vitro activity of cefepime-taniborbactam, an investigational antibacterial agent, in comparison to other antibiotics against clinically significant gram-negative bacteria isolated from patients with cancer.

Key Points: 
  • Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with drug-resistant bacterial infections and hard-to-treat viral infections, today announces the presentation of data during IDWeek 2023 , October 11-15, 2023, in Boston, MA on the in vitro activity of cefepime-taniborbactam, an investigational antibacterial agent, in comparison to other antibiotics against clinically significant gram-negative bacteria isolated from patients with cancer.
  • The bacterial isolates tested included Extended Spectrum β-lactamase (ESBL) producing Enterobacterales and Carbapenem Resistant Enterobacterales (CRE) isolates, and MDR Pseudomonas aeruginosa.
  • In the study, cefepime-taniborbactam demonstrated higher in vitro activity than the tested comparators.
  • While cefepime-taniborbactam has not yet been approved for clinical use, only 3 of the 270 isolates (1.1%; 2 CRE Escherichia coli and 1 MDR P. aeruginosa) were found to be resistant to cefepime-taniborbactam at its provisional breakpoint.

The Clinical Impact of Early Detection of Extended-Spectrum Beta Lactamase (ESBL) Bacteremia in Hospitalized Patients, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Friday, November 18, 2022
Adult, GN, Northwell Health, Mortality, ESBL, Length of stay, Patient, Doctor of Pharmacy, BCID, Microbiology, Pathology, Subclinical infection, Culture, Hospital, patients, health, territories, Food, Vaccine, Pharmaceutical industry, Medicine, Pharmacy, Bloodstream infections

TORONTO, Nov. 18, 2022 /PRNewswire-PRWeb/ -- With the recent improvements of molecular blood culture identification (BCID) panels, time to pathogen and resistance profile identification generated from a positive blood culture has been drastically reduced. Compared to conventional culture and antibiotic susceptibility testing, this rapid turnaround allows the microbiology lab to deliver results to the clinical teams more efficiently to allow for prompt administration of the correct regimen of antibiotics and antifungals. More specifically when looking at gram-negative (GN) pathogens, organisms harboring extended-spectrum beta-lactamases (ESBL), can be reported within three hours after a blood culture turns positive and the molecular test, inclusive of genotypic resistance genes, such as CTX-M, can be reported out at Northwell Health Laboratories. Until now, the clinical impact remained unclear.

Key Points: 
  • Attendees will take a closer look at the improvements that can be made by implementing rapid molecular diagnostics for bloodstream infections.
  • The featured speaker will dive further into how results from rapid diagnostics for bloodstream infections can impact overall therapeutic interventions in a healthcare system.
  • Register to learn about the clinical impact of early detection of ESBL bacteremia in hospitalized patients.
  • For more information, or to register for this event, visit The Clinical Impact of Early Detection of Extended-Spectrum Beta Lactamase (ESBL) Bacteremia in Hospitalized Patients .

Qpex Biopharma Announces Presentations on Phase 1 and Nonclinical Data on Three Clinical Stage Oral and IV Products Targeting Antibiotic-Resistant Bacterial Infections at 2022 ID Week Meeting

Retrieved on: 
Monday, October 17, 2022
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, LinkedIn, Doctor of Pharmacy, CDC, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Office of Inspector General, U.S. Department of Health and Human Services, PD, Society of Infectious Diseases Pharmacists, Infection, Biopharma LLC, Pharmacist, Twitter, Partnership, WHO, BARDA, World, Acinetobacter, Acinetobacter baumannii, Aivo Orav, Society, Pseudomonas aeruginosa, Health, PIDS, OTA, Infectious Diseases Society of America, Beta-lactam, World Health Organization, Lipopeptide, IDSA, Pharmacokinetics, Drug of last resort, ID, ESBL, Pharmaceutical industry, Hospital, Tolerability, Pseudomonas, FIDSA, Safety

Qpex Biopharma today announced that clinical and preclinical data on its portfolio of clinical stage investigational antibiotic programs will be featured in several presentations at the upcoming 2022 ID Week Meeting in Washington, DC on October 19-23.

Key Points: 
  • Qpex Biopharma today announced that clinical and preclinical data on its portfolio of clinical stage investigational antibiotic programs will be featured in several presentations at the upcoming 2022 ID Week Meeting in Washington, DC on October 19-23.
  • The presentations will describe progress on three Qpex investigational products that the recent WHO pipeline analysis identified as addressing drug-resistant pathogens for which there is a critical need for new drugs.
  • QPX9003: a next-generation, IV-administered synthetic lipopeptide with an enhanced therapeutic profile designed to focus on highly drug-resistant infections caused by Pseudomonas and Acinetobacter.
  • The company also has a partnership with Brii Biosciences for the development and commercialization of three of its products in greater China.

Allecra Therapeutics Publishes Final Phase 3 ALLIUM Data in JAMA: Cefepime/Enmetazobactam Met Criteria for Superiority

Retrieved on: 
Wednesday, October 5, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, European Medicines Agency, Robert Wood Johnson Medical School, Union, LinkedIn, Urinary tract infection, Therapy, Infection, Review, EMA, Bacterial pneumonia, Carbapenem, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Investor, Standard of care, MPH, Division, Piperacillin/tazobactam, UTI, Partnership, Food, Company, Marketing, MD, Esbly, Pyelonephritis, Adult, Cutis, Cutis marmorata telangiectatica congenita, American Medical Association, Journal, United Kingdom, Rutgers University, FDA, Tazobactam, Data analysis, ESBL, Pharmaceutical industry, EU

The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Key Points: 
  • The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
  • Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
  • Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

Qpex Biopharma Announces Presentation of Clinical Data for Ultra-Broad Spectrum β-lactamase Inhibitor Xeruborbactam and the Lipopeptide QPX9003 at ECCMID 2022 Meeting

Retrieved on: 
Thursday, April 21, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Online, Adult, Acinetobacter, Office of Inspector General, U.S. Department of Health and Human Services, OTA, Human services, Office of the Assistant Secretary for Preparedness and Response, CDC, Twitter, WHO, Pseudomonas aeruginosa, CET, Nature Communications, European, Infection, Date-time group, Lipopeptide, Biomedical Advanced Research and Development Authority, Patient, ESBL, World Health Organization, Drug of last resort, LinkedIn, Pharmacokinetics, World, Development, Congress, Health, Doctor of Pharmacy, Assistant, BARDA, Partnership, Pharmaceutical industry, Pseudomonas, Safety, Tolerability

Qpex Biopharma, Inc. (Qpex), a clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, today announced the company will present new clinical data for their -lactamase inhibitor xeruborbactam (formerly QPX7728) and synthetic lipopeptide QPX9003 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) being held on April 23-26, 2022.

Key Points: 
  • Qpex Biopharma, Inc. (Qpex), a clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, today announced the company will present new clinical data for their -lactamase inhibitor xeruborbactam (formerly QPX7728) and synthetic lipopeptide QPX9003 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) being held on April 23-26, 2022.
  • The ECCMID meeting will be held as a hybrid event both online, as well as onsite in Lisbon, Portugal.
  • QPX9003: a next-generation, IV-administered synthetic lipopeptide with an enhanced therapeutic profile designed to focus on highly drug-resistant infections caused by Pseudomonas and Acinetobacter.
  • Advancing a robust portfolio of best-in-class, clinical-stage products, the companys lead program are based on xeruborbactam, a novel ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists.

Qpex Biopharma Announces Progress on Three Clinical Stage Programs for Antibiotic-Resistant Pathogens and Corporate Update

Retrieved on: 
Wednesday, January 19, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, CDC, Office of the Assistant Secretary for Preparedness and Response, ESBL, World Health Organization, Urinary tract infection, Acinetobacter, LinkedIn, Publication, Exercise, Aivo Orav, Office of Inspector General, U.S. Department of Health and Human Services, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Drug of last resort, Achievement, Biomedical Advanced Research and Development Authority, Human services, Assistant, Â, World, BARDA, Health, QIDP, Development, U.S. Department of Defense Strategy for Operating in Cyberspace, Infection, Program, WHO, Ventilator-associated pneumonia, Food, Twitter, Pharming, FDA, Pseudomonas aeruginosa, Partnership, OTA, Pharmaceutical industry, Pseudomonas

Qpex Biopharma, Inc. , (Qpex) a clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, today announced continued clinical progress of its entire pipeline and highlights the companys strategic advancements.

Key Points: 
  • Qpex Biopharma, Inc. , (Qpex) a clinical-stage biopharmaceutical company discovering and developing innovative anti-infective therapies, today announced continued clinical progress of its entire pipeline and highlights the companys strategic advancements.
  • OMNIvance (IV) and ORAvance (oral) are investigational products based on Qpexs ultra-broad-spectrum beta-lactamase inhibitor xeruborbactam (formerly known as QPX7728).
  • QIDP designation is granted by the FDA for product candidates that have the potential to treat life-threatening infections due to certain qualifying pathogens, including multi-drug resistant gram-negative pathogens.
  • The QIDP designation received by all three Qpex products include multiple potential indications, including treatment of complicated urinary tract infections and ventilator-associated pneumonia.

Global Cell Wall Synthesis Inhibitors Pipeline Insight Market Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, October 4, 2021
Health, Pharmaceutical, AP, VIM, CRE, Food, News, Clinical trial, BLI, NDM, United States Department of Health and Human Services, Mergers and acquisitions, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Urinary tract infection, Federal, National, FDA, Patient, Infection, IV, Spero, KPC, National Institutes of Health, Contract manufacturing organization, Marketing, Cutis, New Drug Application, Pyelonephritis, Esbly, Human services, MBL, ESBL, Ceftibuten, National Institute, Cutis laxa, HBR, QIDP, National Institute of Allergy and Infectious Diseases, Enzyme, Discovery, Department, Fine chemical, Pharmaceutical industry

The "Cell Wall Synthesis Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cell Wall Synthesis Inhibitors - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This Cell Wall Synthesis Inhibitors - Pipeline Insight, 2021 report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Cell Wall Synthesis Inhibitors pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Cell Wall Synthesis Inhibitors R&D.
  • The therapies under development are focused on novel approaches to treat/improve Cell Wall Synthesis Inhibitors.