Cutis laxa

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

Retrieved on: 
Thursday, November 9, 2023
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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.

Nabriva Therapeutics to Report Second Quarter 2022 Financial Results and Recent Corporate Highlights on August 3, 2022

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Wednesday, July 20, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MRSA, Patient, Streptococcus agalactiae, MSSA, Streptococcus anginosus group, Bacteria, Food and Drug Administration, Tablet, Culture, Drug of last resort, Marketing, Pyelonephritis, ABSSSI, Review, Staphylococcus aureus, Infection, Streptococcus constellatus, Diarrhea, U.S. Securities and Exchange Commission, Human, Union, Research, Enterococcus, Merck, Moxifloxacin, Streptococcus intermedius, Private Securities Litigation Reform Act, Urinary tract infection, GLOBE, Streptococcus anginosus, Food, COVID-19, Conference, Nausea, Streptococcus pyogenes, Vomiting, Cutis laxa, Linezolid, Fosfomycin, Enterococcus faecalis, Bronchopneumonia, Complicated, Therapy, NASDAQ, Gram, Cystic fibrosis, Pharmaceutical industry, Streptococcus

ET to discuss the financial results and recent corporate highlights.

Key Points: 
  • ET to discuss the financial results and recent corporate highlights.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • Nabriva Therapeutics is also developing CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.
  • However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

New Real-World Evidence Shows Improvements in Outcomes and Reduction in Healthcare Costs with Guidance® UTI Precision Diagnostic Test Compared to Standard Urine Culture in Patients with Complicated Urinary Tract Infections

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Saturday, May 14, 2022
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IRVINE, Calif., May 14, 2022 /PRNewswire/ -- Real-world evidence from a Medicare database analysis presented today at the 2022 American Urology Association (AUA) Meeting shows that Guidance UTI testing is associated with reductions in critical adverse outcomes, healthcare resource utilization and costs for complicated urinary tract infections (cUTIs) compared to standard urine culture (SUC). The comparative analysis was designed to examine outcomes of one year of cUTI treatment guided by either Guidance UTI or SUC.

Key Points: 
  • The findings reinforce the real-world benefits of Guidance UTI's increased sensitivity, reduced time to results, and P-AST results to patients, providers, and the healthcare system."
  • UTI-related clinical, healthcare use and costs outcomes were then tracked for one year.
  • Guidance UTI testing was associated with 44% lower total costs and 77% lower clinically-advanced costs* compared to SUC, and cUTIs in the Guidance UTI cohort were likelier to be managed successfully as outpatients.
  • The rate of outpatient emergency visits was 13% lower and inpatient admissions were 67% lower when using Guidance UTI compared to SUC.

Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients

Retrieved on: 
Wednesday, January 19, 2022
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BARDA added, and exercised, a new option on the contract originally awarded to Spero in 2018.

Key Points: 
  • BARDA added, and exercised, a new option on the contract originally awarded to Spero in 2018.
  • Theadditional $12.9Moption is expected to provide support for a clinical trial and related activities for orally administered tebipenem pivoxils use in treating pediatric patients with cUTI, including AP.
  • We are pleased to expand our relationship with BARDA and look forward to continuing our productive collaboration, said Ankit Mahadevia, M.D., Chief Executive Officer ofSpero Therapeutics.
  • However, while Spero may elect to update these forward-looking statements at somepoint in the future, it specifically disclaims any obligation to do so.

Spero Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis

Retrieved on: 
Monday, January 3, 2022
Degenerative disease, Growth, MDR, AP, COVID-19, Infection, Ertapenem, Pyelonephritis, Health, Prescription Drug User Fee Act, U.S. Securities and Exchange Commission, Tebipenem, QIDP, United, NDA, FDA, PDUFA, GLOBE, New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Agency, Physician, Drug of last resort, Priority review, Therapy, IV, Adult, Review, Patient, Nasdaq, Urinary tract infection, Cutis laxa, HBR, Advisory Committee, Pharmaceutical industry, Spero

Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these cUTI indications.

Key Points: 
  • Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track, and Priority Review designations for these cUTI indications.
  • The FDA acceptance of this NDA is a major step forward in our mission to provide patients the first and only oral carbapenem antibiotic to treat cUTI.
  • Speros lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis.
  • Tebipenem HBr is an investigational drug inthe United Statesand is currently not approved for the treatment of complicated urinary tract infection, including pyelonephritis.

Nabriva Announces Availability of XENLETA® (lefamulin) in a 10-Count Oral Pack

Retrieved on: 
Thursday, November 11, 2021
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XENLETA has in vitro activity and demonstrated clinical efficacy against the most common pathogens that cause community-acquired bacterial pneumonia (CABP).

Key Points: 
  • XENLETA has in vitro activity and demonstrated clinical efficacy against the most common pathogens that cause community-acquired bacterial pneumonia (CABP).
  • Our community-based sales force is excited to communicate the availability of the 10-count oral pack or X pack to their target customers.
  • XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team.
  • Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.

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

Retrieved on: 
Monday, October 4, 2021
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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.

Shionogi to Present In Vitro and Real-World Data at IDWeek 2021 Demonstrating Activity of FETCROJA® (cefiderocol) Against Gram-Negative Pathogens

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Wednesday, September 29, 2021
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Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 11 abstracts on FETCROJA (cefiderocol) will be shared at IDWeek.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 11 abstracts on FETCROJA (cefiderocol) will be shared at IDWeek.
  • Abstracts will be available in the IDWeek Interactive Program and include:
    Poster #1058: In Vitro and in Vivo Antibacterial Activity of Cefiderocol against Burkholderia spp.
  • Cefiderocol is a siderophore cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore.
  • Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years.