Cefepime

Standard BioTools and Next Gen Diagnostics Announce Partnership to Provide Complete Automation of Low-Cost Pathogen Sequencing

Retrieved on: 
Lundi, février 26, 2024
SAN, Hospital, NGD, OEM, Escherichia coli, Infection, NGS, Microfluidics, Life, WGS, Cefepime, Automation, Patient, Economics, Genomics, Standard BioTools, PCR, Laboratory, Partnership, Vaccine

Under the exclusive agreement, Standard BioTools™ will manufacture the NGD-100, a version of its microfluidics-based Biomark™ X9 System customized for NGD and optimized for automated pathogen WGS library preparation.

Key Points: 
  • Under the exclusive agreement, Standard BioTools™ will manufacture the NGD-100, a version of its microfluidics-based Biomark™ X9 System customized for NGD and optimized for automated pathogen WGS library preparation.
  • These systems will enable the cost efficiencies, flexibility and proven analytical performance that laboratories need to meet the increasing demands of pathogen testing.
  • “Standard BioTools’ microfluidics technology represents over 20 years of continuous refinement,” commented Michael Egholm, President and CEO of Standard BioTools.
  • “We have worked closely with NGD to develop this strategic partnership between our companies,” noted Alex Kim, Chief Operating Officer of Standard BioTools.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024

Retrieved on: 
Dimanche, février 4, 2024
Civil service commission, Pneumonia, Febrile neutropenia, Eli Lilly, Triprolidine, International, Bacteria, Schizophrenia, Myelopathy, Incidence, ALD, Cefepime, Allergic rhinitis, Nasal congestion, Neutrophil, Agency, COMP, Fever, HAP, EEIG, Headache, Static pressure, Medicine, Committee, Conditional, Spinal cord, Hospital-acquired pneumonia, PTC, Neutropenia, Public, CHMP, European, AMD, Patient, Diagnosis, Marketing, RCVS, European Commission, Brain, Disease, Infection, Inflammation, Male, PRES, PRAC, Pain, Pyelonephritis, Urinary tract infection, VAP, Ageing, EMA, Geographic atrophy, Adrenoleukodystrophy, Therapy, News, INN, Duchenne muscular dystrophy, Common, Fungal infection, Vaccine

Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.

Key Points: 
  • Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.
  • Ltd. Marketing-authorisation holderVarious companiesMore informationSynapse

DoseMe Announces 2023 Highlights; Precision Dosing Fast-Tracking to Top Trend in 2024

Retrieved on: 
Mercredi, janvier 24, 2024
Data Management, Health, Technology, Health Technology, Software, Pharmaceutical, Biotechnology, Cefepime, Application, Marker beacon, HITRUST, AKI, Algorithm, Global education, AUC, Vancomycin, FDA, Toxicity, Integration, TDM, Medicine, Certification, Pharmaceutical industry

Broaden genetic biomarker capabilities for precision dosing, enabling the capability in multiple hospitals resulting in significant improvements.

Key Points: 
  • Broaden genetic biomarker capabilities for precision dosing, enabling the capability in multiple hospitals resulting in significant improvements.
  • In a series of strategic implementations, DoseMe has partnered with several distinguished healthcare institutions looking to optimize their therapeutic protocols.
  • This educational endeavor demonstrates our commitment to supporting healthcare systems worldwide in adopting precision dosing strategies that optimize therapy outcomes.
  • Research reports continue to include precision medicine, and dosing specifically, as a key trend in 2024 and beyond.

DoseMe Adds Cefepime to Its Model-informed Precision Dosing Platform

Retrieved on: 
Lundi, décembre 4, 2023
Technology, Biotechnology, FDA, Health, Pharmaceutical, Other Science, University, Research, Software, Infectious Diseases, Education, Health Technology, Science, Data Management, Hospice and palliative medicine, Neutropenia, Genetically modified bacteria, Cefepime, BCPS, TDM, Pneumonia, Doctor of Pharmacy, Risk, Fungal infection, Serum, Patient, Infection, Midwestern University, Pharmacokinetics, University of Illinois Chicago, Kidney, Owen Scheetz, Bacteria, Creatinine, Neurotoxicity, EGFR, Bias, Postgraduate education, Skin, Therapeutic drug monitoring, Pharmaceutical industry, Pharmacology, Dosem

DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced the availability of its Cefepime model.

Key Points: 
  • DoseMe , a leading provider of precision dosing software for therapeutic drug monitoring (TDM) and creators of DoseMeRx and DoseMe Analytics, today announced the availability of its Cefepime model.
  • His research continues to highlight three keys to infectious disease monitoring - real time beta lactam monitoring, therapeutic drug monitoring and precision dosing.
  • “Similar to many beta lactam treatments, Cefepime displays a large amount of variability between patients and having DoseMeRx enables precision dosing,” stated Scheetz.
  • Greater recognition of the benefits of Model-informed Precision Dosing (MIPD) software for enhancing TDM and dosing precision necessitates thorough validation of models and reassessment of current workflows.

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

Retrieved on: 
Mercredi, octobre 11, 2023
FDA, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Nursing care plan, FCCP, Philippe Ciais, Food, Doctor of Philosophy, Division, Multidrug-resistant bacteria, Development, MD, Synergy, Infection, Meropenem, Therapy, Sulbactam, Combination, Food and Drug Administration, Fungal infection, Cefepime, Pseudomonas aeruginosa, FIDSA, Doctor of Pharmacy, Hartford Hospital, Research, Pharmaceutical industry, Vaccine, Antibiotics, Imipenem, Enterobacterales

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.

Allecra Therapeutics Submits New Drug Application to the U.S. FDA for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Mardi, juin 27, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, QIDP, NDA, Gram-negative bacteria, Cutis, Urinary tract infection, Esbly, Patient, Supervisory board, Cefepime, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs).

Key Points: 
  • Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs).
  • Upon approval, the antibiotic combination will be marketed under the trademark name, EXBLIFEP®.
  • EXBLIFEP® has been designed to combat anti-microbial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs).
  • "This filing marks the culmination of a journey that began ten years ago with the formation of Allecra by a syndicate of European venture capital interests.

Theriva Biologics Announces First Patient Dosed in Second Cohort of Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

Retrieved on: 
Jeudi, novembre 3, 2022
Patient, VRE, Piperacillin/tazobactam, Infection, Neoplasm, Private Securities Litigation Reform Act, Washington University School of Medicine, Form 8-K, Therapy, Growth, Time, Maintenance, Washington University in St. Louis, Cohort, IV, CGMP, CDI, Sale, GLOBE, Meropenem, Vancomycin, Clostridioides difficile infection, Clostridioides, Washington University School of Law, NYSE, Safety, Incidence, Terminology, Marketing, Subclinical infection, Degenerative disease, HCT, Annual report, Cefepime, Hematological Cancer Research Investment and Education Act, Clinical trial, Fever, GI, Risk, VCN, Absorption, IAP, SEC, Cancer, Pharmaceutical industry

ROCKVILLE, Md., Nov. 03, 2022 (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 first patient has been dosed in Cohort 2 of its 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).

Key Points: 
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • The trial is designed to evaluate the safety, tolerability, and potential absorption of oral SYN-004 (150 mg q.i.d.
  • for a maximum of 28 days) into the systemic circulation of allogeneic HCT recipients who receive an IV antibiotic to treat fever.
  • Patients in Cohorts 2 and 3 will be administered piperacillin/tazobactam and cefepime respectively, each of which can be metabolized by SYN-004.

Venatorx Pharmaceuticals Presents Data on Investigational Cefepime-Taniborbactam at IDWeek 2022

Retrieved on: 
Jeudi, octobre 20, 2022
General Health, Pharmaceutical, Health, Clinical Trials, National Institutes of Health, Degenerative disease, QIDP, Infection, Diarrhea, TOC, Genetically modified bacteria, Treatment, Test, Administration, National, Gram-positive bacteria, CEO, Bacteria, Pyelonephritis, MDR, United States Department of Health and Human Services, Urinary tract infection, Biomedical Advanced Research and Development Authority, Population, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-negative bacteria, BARDA, Company, Department, Medication, CRE, FDA, AP, National Institute, Hypertension, Constipation, Nausea, Human services, LFU, Cefepime, Headache, Cutis marmorata, Wellcome Trust, New Drug Application, Patient, Food, BLI, Complicated, Adult, National Institute of Allergy and Infectious Diseases, Medical microbiology, Pseudomonas aeruginosa, Melioidosis, Pharmaceutical industry, Antibiotics, Safety, Meropenem

Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with difficult-to-treat drug resistant gram-negative bacterial infections and viral infections, today will present new data during IDWeek 2022 for its novel investigational antibiotic cefepime-taniborbactam.

Key Points: 
  • Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with difficult-to-treat drug resistant gram-negative bacterial infections and viral infections, today will present new data during IDWeek 2022 for its novel investigational antibiotic cefepime-taniborbactam.
  • The presentations, along with the four other posters detailing additional cefepime-taniborbactam data at IDWeek 2022 (see release ), will be available on the companys website.
  • We believe this data is meaningful given the sustained clinical benefit versus meropenem up to 3 to 4 weeks after treatment, said Christopher J. Burns, Ph.D. , President and CEO of Venatorx.
  • The safety data for cefepime-taniborbactam was consistent with the historical safety data for cefepime.

Venatorx Pharmaceuticals to Present at IDWeek 2022

Retrieved on: 
Mardi, octobre 11, 2022
FDA, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Degenerative disease, Urinary tract infection, New Drug Application, Infection, QIDP, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Gram-negative bacteria, Meropenem, Pyelonephritis, BARDA, Food, Company, Gram-positive bacteria, BLI, Adult, Safety, Tuberculosis verrucosa cutis, Bacteria, CRE, FDA, Pseudomonas aeruginosa, Melioidosis, Pharmaceutical industry, Cefepime

Cefepime-taniborbactam recently completed a Phase 3 study (CERTAIN-1) in adults with complicated urinary tract infections (cUTI), including pyelonephritis.

Key Points: 
  • Cefepime-taniborbactam recently completed a Phase 3 study (CERTAIN-1) in adults with complicated urinary tract infections (cUTI), including pyelonephritis.
  • In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections.
  • Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections.
  • In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections.

Synthetic Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

Retrieved on: 
Mardi, septembre 27, 2022
Data, Synthetic biological circuit, Piperacillin/tazobactam, Safety, Meropenem, Clostridioides difficile infection, GI, Infection, Patient, Clinical trial, Form 8-K, Absorption, Washington University School of Medicine, Cohort, Time, IV, Sale, Sepsis, CGMP, Clostridioides, Company, Acquisition, Growth, Washington University School of Law, AES, Annual report, SYN, SEC, HCT, CDI, ECL, NYSE, Risk, Population, VCN, Review, Neoplasm, VRE, SAE, GLOBE, Marketing, Șaeș, Plasma, IAP, Therapy, Cefepime, Washington University in St. Louis, AMR, Private Securities Litigation Reform Act, Maintenance, DSMC, Terminology, Pharmacokinetics, Fever, Degenerative disease, Pharmaceutical industry, Antibiotics

ROCKVILLE, Md., Sept. 27, 2022 (GLOBE NEWSWIRE) -- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the first Cohort of its 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).

Key Points: 
  • A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations including sepsis.
  • None of the three ECL positive plasma samples were found to contain active SYN-004 using a functional enzyme activity assay.
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis.