Meropenem

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

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.

New 2-gram Meropenem for Injection, USP Vial Exclusive from WG Critical Care, LLC

Retrieved on: 
Tuesday, December 5, 2023

Meropenem is the sixth largest generic anti-infective product in unit volume in hospital and alternate site settings.

Key Points: 
  • Meropenem is the sixth largest generic anti-infective product in unit volume in hospital and alternate site settings.
  • According to a 2022 IQVIA report, the market value for Meropenem is $88.7 million dollars, with unit volume at 15.9 million annually.
  • "Until now, the only way to provide a 2-gram dose was to mix two 1-gram vials or four 500-milligram vials.
  • The WGCC 2g Meropenem for injection, USP vial is free of natural rubber latex and bar coded at the unit-of-use.

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

Retrieved on: 
Thursday, November 9, 2023

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.

Innoviva Specialty Therapeutics Presents New Data on its Critical Care Antibiotic Therapy Portfolio at Infectious Disease Week (IDWeek) 2023

Retrieved on: 
Wednesday, October 11, 2023

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA.

Key Points: 
  • Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA.
  • XACDURO is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
  • In addition, four company-sponsored research studies on XACDURO will also be presented by the company’s research partners in poster sessions.
  • “Antibiotic-resistant pathogens are one of the most significant and challenging threats to healthcare providers on the frontlines of infectious disease care,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva Specialty Therapeutics.

ContraFect Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 14, 2023

“We remain on track to file an IND for our second program, CF-370, which is our engineered lysin targeting Gram-negative pathogens, in the third quarter.

Key Points: 
  • “We remain on track to file an IND for our second program, CF-370, which is our engineered lysin targeting Gram-negative pathogens, in the third quarter.
  • Research and development (R&D) expenses were $4.9 million for the second quarter of 2023 compared to $16.8 million in the comparable period in 2022.
  • General and administrative (G&A) expenses were $3.1 million for the second quarter of 2023 compared to $3.3 million in the comparable period in 2022.
  • As of June 30, 2023, ContraFect had cash and cash equivalents of $14.4 million.

Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults

Retrieved on: 
Tuesday, August 15, 2023

The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.

Key Points: 
  • The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.
  • The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 22, 2024.
  • “The NDA acceptance represents the culmination of unwavering dedication, scientific excellence, and the collaborative efforts of our talented team, partners, and clinical investigators,” said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • “Patients with cUTIs, including pyelonephritis, and their healthcare providers should have a new treatment option when confronted with infections due to these antibacterial resistant infections.”

Everest Medicines' Partner Venatorx Receives FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI)

Retrieved on: 
Tuesday, August 15, 2023

The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.

Key Points: 
  • The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of Feb. 22, 2024.
  • "We congratulate our partner for achieving this important milestone and bringing cefepime-taniborbactam a step closer to reaching patients confronted with antibacterial resistant infections.
  • "In Asia, the challenges we are facing from MDR infections are more urgent and severe.
  • The company is also actively developing other important antibacterial drug candidates for combating the increasing MDR infections in China and the rest of Asia.

ContraFect Data Presentations at ASM Microbe 2023 Demonstrate the Power of the Company’s Proprietary Platform to Discover New Agents Targeting Antibiotic-Resistant Gram-negative Pathogens

Retrieved on: 
Tuesday, June 20, 2023

“The data presented at ASM Microbe is quite powerful.

Key Points: 
  • “The data presented at ASM Microbe is quite powerful.
  • Both dose regimens of CF-370 in addition to amikacin significantly reduced bacteria counts compared to all other treatment groups (p≤0.0001).
  • The results of this study reproduce the efficacy seen in previously released data presented at ECCMID 2023 further demonstrating the bactericidal power of CF-370 against XDR strains of Gram-negative pathogens.
  • The results of this study reinforce previously released data demonstrating the power of both CF-296 and exebacase when delivered locally in the rabbit osteomyelitis model.

Melinta Therapeutics and Xediton Pharmaceuticals Announce Licensing Agreement to Commercialize Anti-Infective Products in Canada

Retrieved on: 
Monday, May 15, 2023

Melinta Therapeutics, LLC (Melinta) and Xediton Pharmaceuticals Inc (Xediton) today announced they have entered into an exclusive commercialization and licensing agreement for BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin) and VABOMERE® (meropenem and vaborbactam), four novel anti-infective products.

Key Points: 
  • Melinta Therapeutics, LLC (Melinta) and Xediton Pharmaceuticals Inc (Xediton) today announced they have entered into an exclusive commercialization and licensing agreement for BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), ORBACTIV® (oritavancin) and VABOMERE® (meropenem and vaborbactam), four novel anti-infective products.
  • Under the terms of the agreement, Xediton is responsible for the registration and commercialization of these products in Canada.
  • “We are very pleased to partner with Melinta to bring these life-saving products to Canada.
  • “We’re thrilled to enter into this partnership with Xediton, a recognized leader in specialty care pharmaceuticals in Canada.

Theriva Biologics Announces Presentation of Safety and Pharmacokinetic Data from Cohort 1 of the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

Retrieved on: 
Thursday, February 16, 2023

ROCKVILLE, Md., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the presentation of blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). These data will be featured in a poster presentation at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held in Orlando, Florida from February 15-19, 2023.

Key Points: 
  • These data will be featured in a poster presentation at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held in Orlando, Florida from February 15-19, 2023.
  • “SYN-004 (ribaxamase) is intended to address key limitations of broad-spectrum IV beta-lactam antibiotics and potentially improve treatment outcomes with this important and widely used class of therapeutics.
  • We are encouraged by the favorable safety/tolerability profile and growing evidence from our initial meropenem (MER) cohort that supports the clinical advancement of SYN-004,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
  • Consistent with previous studies of SYN-004 in healthy volunteers, SYN-004 was not observed in blood samples from the majority of the evaluable patients.