Daptomycin

Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024

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금요일, 5월 3, 2024
Infection, Kidney, FDA, Administration, Staphylococcus, ASPR, HHS, SAB, Safety, Ceftobiprole, Methicillin-resistant Staphylococcus aureus, Food, Ceftriaxone, ESCMID, Daptomycin, Partnership, Fungal infection, Development, CABP, TARGET, ABSSSI, Patient, Staphylococcus aureus, Dialysis, Bronchopneumonia, MRSA, Vaccine

Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.

Key Points: 
  • Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.
  • In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group.
  • An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP).
  • Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid.

Bruker Further Enhances Clinical Microbiology & Infection Diagnostics Portfolio at ESCMID Global 2024 Conference

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금요일, 4월 26, 2024
Biotechnology, Health, Genetics, Science, Research, MALDI, RUO, Yeast, Infection, Gastroenteritis, Piperacillin/tazobactam, HAI, Hospital, Antimalarial medication, Certification, Mycobacterium tuberculosis, Fungal infection, Bacteria, ESCMID, Daptomycin, Patient, Microbiology, Acquisition, Multimedia, Gram-negative bacteria, Diagnosis, Colistin, IVDR, TB, IVD, Sepsis, MBT, Sirius, Vaccine

At the ESCMID Global 2024 conference, Bruker is enhancing its innovative diagnostic solutions in microbial identification, antimicrobial susceptibility testing (AST), early sepsis diagnostics, and other infectious disease assays.

Key Points: 
  • At the ESCMID Global 2024 conference, Bruker is enhancing its innovative diagnostic solutions in microbial identification, antimicrobial susceptibility testing (AST), early sepsis diagnostics, and other infectious disease assays.
  • Simplifying microbiology and infectious disease diagnostics and workflows in the clinical laboratory is a key goal for Bruker in support of earlier and improved patient treatment decisions.
  • Bruker offers additional clinical workflows for rapid functional antibiotic resistance testing, like the MBT STAR®-Carba IVD assay for the detection of carbapenemase activity.
  • Dr. Wolfgang Pusch, President of the Bruker Microbiology & Infection Diagnostics division, commented: “Bruker is committed to innovation in routine microbiology and infectious disease testing.

FDA Approves New Antibiotic for Three Different Uses

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수요일, 4월 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"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.

Basilea announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia

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목요일, 9월 28, 2023
SAB, ASPR, Staphylococcus, The New England Journal of Medicine, US Foods, Biomedical Advanced Research and Development Authority, Microbiology, MSSA, HHS, Clostridioides, Daptomycin, Overalls, Infection, Survival, MRSA, Administration for Strategic Preparedness and Response, Duke University School of Medicine, Associate, Staphylococcus aureus, Ceftobiprole, NEJM, ABSSSI, Clostridioides difficile infection, Administration, Development, Patient, Fungal infection, Disease, Mortality, Bacteria, BARDA, Food, Methicillin-resistant Staphylococcus aureus, New Drug Application, Pharmaceutical industry, Vaccine, Allschwil, Medicine

ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.

Key Points: 
  • ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.
  • Using a pre-defined non-inferiority margin of 15%, treatment with ceftobiprole was non-inferior to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group.
  • The results for the primary study outcome were consistent in key subgroups, including patients with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA).
  • Ceftobiprole was generally well tolerated and showed a safety profile consistent with previous phase 3 studies and the post-marketing experience.

ContraFect Reports Second Quarter 2023 Financial Results and Provides Business Update

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월요일, 8월 14, 2023
Exercise, Infection, PK, MIC, XDR, Hemolysis, IV, S. aureus, Methicillin-resistant Staphylococcus aureus, Daptomycin, CMC, MRSA, Pharmacokinetics, ASM, G&A, Osteomyelitis, Acinetobacter, Yersinia pestis, Gram-negative bacteria, Cons, Staphylococcus aureus, Klebsiella pneumoniae, Trial of the century, Chemistry, Pseudomonas aeruginosa, NPN, MDR, Patient, Meropenem, Campaign, R, Urinary tract infection, Research, Safety, IND, Amikacin, ChromeOS, Knee, Peptide, Staphylococcus, Pharmaceutical industry, Vaccine, Klebsiella, Pseudomonas

“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.

Andira Pharmaceuticals’ US Patent Allowed in Breakthrough Therapeutic Treatment to Address Deadly Antibiotic-Resistant Infections

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목요일, 8월 10, 2023
Patent, Daptomycin, United States patent law, IP, Pharmacotherapy, Antimalarial medication, Hospital, Fungal infection, United States capital, Pharmaceutical industry

Andira has announced that it has received a Notice of Allowance from the United States Patent & Trademark Office (USPTO) for US Patent Application No.

Key Points: 
  • Andira has announced that it has received a Notice of Allowance from the United States Patent & Trademark Office (USPTO) for US Patent Application No.
  • 17/589,588 “Antibiotic Cannabinoid-Terpene Formulations.” Andira Pharmaceuticals is the sole exclusive worldwide licensee of the patent.
  • “The allowance of this patent is an important milestone toward successfully addressing hospital-acquired infections that are resistant to antibiotics.” said Dr. Dana Lambert, President and CEO of Andira.
  • “Andira has an extensive global IP portfolio, and this issuance from USPTO is another significant milestone achievement for Andira.

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

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화요일, 6월 20, 2023
MIC, XDR, Hemolysis, S. aureus, Methicillin-resistant Staphylococcus aureus, Daptomycin, MRSA, Cancer, ASM, Osteomyelitis, Acinetobacter, Yersinia pestis, Gram-negative bacteria, Staphylococcus aureus, Cons, Klebsiella pneumoniae, Pseudomonas aeruginosa, NPN, Knee, ECCMID, Animal, Lower respiratory tract infection, Patient, Ventilator-associated pneumonia, Meropenem, Fungal infection, Bacteria, Campaign, Amikacin, Food, Peptide, Staphylococcus, Vaccine, Yersinia, Burkholderia, MD, Klebsiella, Pseudomonas

“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.

Oragenics Announces Positive Results in Several Lantibiotics Compounds Against MRSA and VRE

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화요일, 3월 14, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Methicillin-resistant Staphylococcus aureus, NYSE, Infection, VRE, Daptomycin, Phenotype, Enterococcus-1 RNA motif, Methicillin, MRSA, Vancomycin, Oxacillin, Vaccine, Antibiotics, Oragene

Lantibiotics are a novel class of antibiotics with the potential to treat serious, life-threatening infections.

Key Points: 
  • Lantibiotics are a novel class of antibiotics with the potential to treat serious, life-threatening infections.
  • Oragenics’ lantibiotics platform is focused on the development of new antibiotics effective against certain pathogens including vancomycin-resistant Enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA).
  • Oragenics is focused on addressing this unmet medical need through its novel lantibiotics platform, and the results of its work with Linnaeus Bioscience advance Oragenics’ long-term mission to become a provider of effective treatments for infectious diseases.
  • Oragenics remains committed to fighting infectious diseases through the development of its lantibiotics pipeline against MRSA and VRE pathogens.

ContraFect Provides Update from the Futility Analysis of the Phase 3 DISRUPT Study of Exebacase

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월요일, 12월 19, 2022
Drug of last resort, Infection, Peptide, Staphylococcus, Fosfomycin, SOC, Knee, Data monitoring committee, Risk, Daptomycin, APACHE II, MRSA, APACHE, Patient, Mortality, Safety, Campaign, DSMB, Data set, Subclinical infection, Diagnosis, COVID, Pharmaceutical industry, MD

All patients in the DISRUPT study have now been independently adjudicated and the study database has been locked.

Key Points: 
  • All patients in the DISRUPT study have now been independently adjudicated and the study database has been locked.
  • The Phase 3 DISRUPT study of exebacase is a randomized, double-blind, placebo-controlled clinical study conducted in the United States in 259 of the planned 348 patients with S. aureus bacteremia, including right-sided endocarditis.
  • Enrollment in the trial was stopped following a review of the pre-specified, interim futility analysis by the independent Data Safety Monitoring Board (DSMB).
  • The company is planning a virtual fireside chat in the first quarter of 2023 for an in-depth review and discussion of the DISRUPT study.

Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-up

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금요일, 12월 23, 2022
Online, FDA, Completeness, EST, Knowledge, Accord, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Dietary supplement, Daptomycin

Daptomycin for Injection 350 mg/vial and 500 mg/vial were distributed nationwide to wholesale.

Key Points: 
  • Daptomycin for Injection 350 mg/vial and 500 mg/vial were distributed nationwide to wholesale.
  • Accord is notifying or has notified its Wholesalers and Distributors by letter and is arranging for return of all recalled products.
  • Wholesalers and Distributors that have product which is being recalled should discontinue distribution of the product.
  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.