Pyelonephritis

Recce Pharmaceuticals Completes Dosing Cohort in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis

Retrieved on: 
Tuesday, March 19, 2024
Urinary tract infection, Global health, Patient, ASX, RCE, Infection, Pyelonephritis, Pharmaceutical industry

“Completing dosing of our latest cohort marks another milestone in our journey toward advancing R327 as a potential frontline treatment for patients with UTIs or urosepsis,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Key Points: 
  • “Completing dosing of our latest cohort marks another milestone in our journey toward advancing R327 as a potential frontline treatment for patients with UTIs or urosepsis,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • “We are dedicated to delivering impactful solutions to combat infectious diseases and improve global health outcomes.”
    An Independent Safety Committee will now review and evaluate the comprehensive data from the 4-subject cohort.
  • Data from this trial is expected to pave the way for a Phase II trial to establish the potential of R327 as a frontline treatment for patients with UTIs or urosepsis.
  • The administration of antibiotics via rapid intravenous infusions is a proven safe and effective method of administration, impacting patient treatment, wait times, and nursing workloads globally.

Recce Pharmaceuticals Doses Next Cohort in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis

Retrieved on: 
Thursday, March 14, 2024
Phase, Urinary tract infection, Patient, Pyelonephritis, ASX, RCE, Recce, Pharmaceutical industry

The next cohort of healthy subjects dosed at 3,000mg over 20 minutes, with the remaining subjects to be dosed over the coming days

Key Points: 
  • The next cohort of healthy subjects dosed at 3,000mg over 20 minutes, with the remaining subjects to be dosed over the coming days
    RECCE® 327 now tested at four infusion times, achieving these timestamps in line with intended future regulatory submissions
    SYDNEY, Australia, March 14, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it dosed the next cohort of healthy subjects at 3,000mg within a fast infusion rate of 20-minutes in a Phase I/II trial evaluating its lead candidate, RECCE® 327 (R327).
  • “We're pleased to continue advancing the clinical profile of R327, which has demonstrated safe and efficacious potential against a broad range of antibiotic-resistant pathogens across multiple studies,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • The Company has established that the dose of 3,000mg, administered at varying infusion times between 15 and 60 minutes, has been proven safe in participants.
  • The efficacy of R327 via intravenous administration will be made available at the completion of the Phase I/II trial in line with the study protocol.

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

Retrieved on: 
Wednesday, March 13, 2024
Gram-negative bacteria, Department of Defence, Urinary tract infection, GSK, Patient, Human services, Quality of life, IND, Tebipenem, Clinical trial, Therapy, Infection, Research, Policy, Treasurer, Carbapenem-resistant enterobacteriaceae, Safety, Pharmacokinetics, Federal, Food, AP, Drug discovery, Disease, Kidney, SPA, Acinetobacter baumannii, MDR, Pyelonephritis, Annual report, FDA, Army, HBR, Government, Unitary state, NTM, Assistant, Fungal infection, Pseudomonas aeruginosa, Hope, National Institutes of Health, ID, Mycobacterium avium complex, Bangladesh Technical Education Board, Administration, Pharmaceutical industry

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points: 
  • “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
  • Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
  • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
  • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

Recce Pharmaceuticals Continues Strategic Partnership with Murdoch Children’s Research Institute

Retrieved on: 
Thursday, February 29, 2024
Mycobacteroides abscessus, Urinary tract infection, Neisseria gonorrhoeae, Pyelonephritis, MCRI, Escherichia coli, Recce, RCE, Murdoch, Health, Streptococcus pneumoniae, Bacteria, ASX, AIR, Global Health, Organization, Partnership, Pharmaceutical industry

In 2023, Recce established its dedicated AIR Unit led by researcher Sohinee Sarkar, Ph.D., within MCRI’s state-of-the-art research facilities, underscoring the commitment of both organizations to drive innovation for anti-infective therapeutics.

Key Points: 
  • In 2023, Recce established its dedicated AIR Unit led by researcher Sohinee Sarkar, Ph.D., within MCRI’s state-of-the-art research facilities, underscoring the commitment of both organizations to drive innovation for anti-infective therapeutics.
  • “The partnership between Recce and MCRI will advance efforts and promote Australian leadership in the fight against antibiotic resistance.”
    The collaboration between Recce’s AIR Unit and MCRI exemplifies the power of partnership in driving medical breakthroughs.
  • As both organizations work together to advance anti-infective research, they remain committed to improving patient outcomes and addressing global health challenges.
  • James Graham, Chief Executive Officer of Recce Pharmaceuticals, added, “Our continued work at the AIR Unit aligns with Murdoch Children’s mission to address the global health threat of anti-microbial resistance through innovative research.

Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, February 27, 2024
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, ESBL, GAIN, Second Continental Congress, Urinary tract infection, Supervisory board, Pharmaceutics, Cutis, Partnership, Food, Pyelonephritis, Gram-negative bacteria, Patient, Congress, Medication, Pharmaceutical industry

Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.

Key Points: 
  • Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.
  • Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
  • "Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals.
  • Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013.

Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-Taniborbactam

Retrieved on: 
Friday, February 23, 2024
Research, Infectious Diseases, FDA, Hospitals, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Urinary tract infection, CRL, New Drug Application, Multimedia, Chemistry, Food, Pyelonephritis, Symantec Endpoint Protection, Patient, Medicine, Melinta Therapeutics, Medication, NDA, CMC, Pharmaceutical industry

This press release features multimedia.

Key Points: 
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240223169844/en/
    The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam.
  • The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
  • “While we are disappointed with this setback, we maintain utmost confidence in cefepime-taniborbactam.

New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3 CERTAIN-1 Study of Patients with Complicated Urinary Tract Infection

Retrieved on: 
Tuesday, February 20, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Hospitals, Clinical Trials, Senior, Urinary tract infection, Infection, Multimedia, MDR, MD, Physician, Marketing, Antimalarial medication, Klebsiella pneumoniae, Pyelonephritis, NEJM, Safety, Therapy, Patient, UTI, AP, Melinta Therapeutics, Medication, Pseudomonas aeruginosa, Fungal infection, Pharmaceutical industry

Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.

Key Points: 
  • Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.
  • The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240220917017/en/
    “Gram-negative infections such as cUTI have become increasingly difficult to treat due to acquired bacterial resistance to multiple classes of antibiotics.

PathogenDx Launches Novel D3 Array Multiplexed Molecular Diagnostics Technology for Urinary Tract Infection (UTI) Pathogen Detection and Antibiotic Resistance

Retrieved on: 
Wednesday, February 7, 2024
Workflow, Patient, Safety, Pain, Running, Diagnosis, Urinary tract infection, Temperature, Sepsis, Laboratory, Data analysis, Real-time, Physician, Pyelonephritis, D3, Health, UTI, PCR

Powered by the Company's novel multiplexed molecular diagnostics technology, D3 Array™-UTI features testing in triplicate for quality assurance, with qualitative and quantitative results in the same reaction, as well as automated, cloud-based data analysis, reporting and management.

Key Points: 
  • Powered by the Company's novel multiplexed molecular diagnostics technology, D3 Array™-UTI features testing in triplicate for quality assurance, with qualitative and quantitative results in the same reaction, as well as automated, cloud-based data analysis, reporting and management.
  • "Providing a proper UTI diagnosis is a race against the clock," said PathogenDx Co-founder and CEO, Milan Patel .
  • "An individual is risking continued pain and discomfort, chronic infections, kidney infection, and in severe cases, sepsis.
  • The array is equipment agnostic, making it compatible with routine molecular instrumentation and existing workflow.

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

Retrieved on: 
Sunday, February 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

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

Retrieved on: 
Tuesday, January 16, 2024
Intellectual property, Death, Clostridioides difficile infection, Patient, Research, DSM-IV codes, Hospital, Health, Urine, Dark Enlightenment, Colitis, Tuberculosis, UTI, Clostridioides difficile, DCS, Tetracycline, QIDP, Risk, Infection, Cephalosporin, Pulmonary fibrosis, Sepsis, FDA, Priority review, Penicillin, New Drug Application, Pyelonephritis, Urinary tract infection, Literature, Contra, NMDA, CNS, Pharmaceutical industry

Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.