Aztreonam

European Commission Approves Pfizer’s EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options

Retrieved on: 
Monday, April 22, 2024

(NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.

Key Points: 
  • (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.
  • It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.
  • “For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study.
  • Marketing authorization applications for EMBLAVEO are planned for submission in other countries.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

Retrieved on: 
Wednesday, November 29, 2023

“These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX.

Key Points: 
  • “These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • Patients were on the same inhaled antibiotic (tobramycin, aztreonam, or colistin) from Day 1-10 (treatment period) and through Day 28 of the study.
  • BX004 vs. placebo showed a positive clinical effect in a predefined subgroup of patients with reduced baseline lung function (FEV1
  • BiomX management will host a conference call and webcast today at 9:00 am ET to review the results of Part 2 of the Phase 1b/2a trial results.

Public Advisory - Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials

Retrieved on: 
Saturday, March 18, 2023

Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots (032168 and 033357) of the cystic fibrosis drug Cayston (aztreonam) (DIN 02329840) on March 1, 2023 , due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.

Key Points: 
  • Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots (032168 and 033357) of the cystic fibrosis drug Cayston (aztreonam) (DIN 02329840) on March 1, 2023 , due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.
  • A cracked glass vial could cause potential injury or lead to potential contamination or a reduced dose.
  • Cayston is a prescription antibacterial medicine used for the management of chronic infections in cystic fibrosis patients.
  • The manufacturer has not received any customer complaints in relation to cracked glass vials in the recalled lots, or any other Cayston lots distributed in Canada.

Generic Pharmaceuticals Global Markets Report 2022: Focus on CNS; Cardiovascular; Dermatology; Genitourinary/Hormonal; Respiratory; Rheumatology; Diabetes; Oncology - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 16, 2022

Generic drugs are manufactured after the expiration of the exclusive rights or patent of the branded drugs.

Key Points: 
  • Generic drugs are manufactured after the expiration of the exclusive rights or patent of the branded drugs.
  • For example, some of the generic drugs in the generic pharmaceuticals market include metformin, metoprolol, acarbose, acebutolol, aztreonam and many more.
  • The main types of generic pharmaceuticals are biosimilar; simple generic and super generic.
  • The low cost and same chemical composition and strength of generic drugs make a patient buy generic drugs instead of branded drugs.

Global Aztreonam Injection Market (2020 to 2025) - Impact of COVID-19 - ResearchAndMarkets.com

Retrieved on: 
Friday, May 22, 2020

This report is a professional and in-depth study on the current state of the global Aztreonam Injection market with a focus on the Chinese market.

Key Points: 
  • This report is a professional and in-depth study on the current state of the global Aztreonam Injection market with a focus on the Chinese market.
  • Key points of Aztreonam Injection Market Report:
    The report provides a basic overview of Aztreonam Injection industry including: definition, applications and manufacturing technology.
  • The global Aztreonam Injection market is further divided by company, by country, and by application/type for the competitive landscape analysis.
  • Overall, the report provides an in-depth insight of the 2015-2025 global and Chinese Aztreonam Injection market covering all important parameters.