Pyelonephritis

Venatorx Pharmaceuticals Announces Organizational Changes

Retrieved on: 
Tuesday, December 20, 2022
General Health, Pharmaceutical, Health, Clinical Trials, Pyelonephritis, Infection, Patient, BARDA, Food, Tuberculosis verrucosa cutis, Retirement, Melioidosis, Medication, FDA, Degenerative disease, Urinary tract infection, Research, Bacteria, Regulation of tobacco by the U.S. Food and Drug Administration, Pharmaceutical industry

Venatorx Pharmaceuticals, a late-stage pharmaceutical company focused on advancing new therapies for infectious diseases, today announced two organizational changes: the retirement of its Chief Medical Officer, Timothy Henkel, M.D., Ph.D., and the step-down of Vincent Milano from the Board of Directors.

Key Points: 
  • Venatorx Pharmaceuticals, a late-stage pharmaceutical company focused on advancing new therapies for infectious diseases, today announced two organizational changes: the retirement of its Chief Medical Officer, Timothy Henkel, M.D., Ph.D., and the step-down of Vincent Milano from the Board of Directors.
  • “Tim’s contributions to Venatorx have been invaluable across our drug candidate pipeline, most notably in guiding the strategy and clinical development programs for both cefepime-taniborbactam and ceftibuten-ledaborbactam,” said Christopher J. Burns, Ph.D. , President and CEO of Venatorx.
  • “On behalf of the entire Venatorx team, I would like to thank Tim for his commitment and leadership over nearly a decade.
  • For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com .

Spero Therapeutics to Present at the 5th Annual Evercore ISI HealthCONx Conference

Retrieved on: 
Tuesday, November 22, 2022
GSK, Infection, Degenerative disease, Conference, Bacteria, Therapy, Patient, Cutis verticis gyrata, HBR, Pyelonephritis, Research, MDR, FDA, Tebipenem, Pharmaceutical industry, Spero

A replay of the fireside chat will be available on the website following the conclusion of the event.

Key Points: 
  • A replay of the fireside chat will be available on the website following the conclusion of the event.
  • Spero Therapeutics, headquartered in Cambridge, Massachusetts,is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
  • However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

Retrieved on: 
Wednesday, November 23, 2022
Observation, IX, Lightheadedness, Swelling, Pediatrics, Factor IX, Joint, Nausea, Pain scale, Rash, Iron deficiency, Hepatocellular carcinoma, University, Research, Muscle, CSL Behring, Patient, Incidence, Blood, Caregiver, CSL, Death, Pain, Haemophilia B, Pyelonephritis, Vaccine, Pathology, Haemophilia, AAV, Bleeding, Headache, Semen, Shivering, Safety, Liver cancer, ASX, Disease, Risk, Research and development, Nephrology, Abdominal pain, Padua, ABR, Cell, Cardiogenic shock, Immunodeficiency, Professor, Food, Development, Tissue, Clinical trial, Flushing, Freedom, Dialysis, Biotechnology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Transplant, FDA, Lance, Liver, Coalition, Fatigue, R, Medical device, Pharmaceutical industry, Dietary supplement

KING OF PRUSSIA, Pa., Nov. 22, 2022 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced that the U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B. HEMGENIX is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes. In the ongoing clinical trial, HEMGENIX reduced the rate of annual bleeds and 94 percent of patients discontinued factor IX prophylaxis and remained prophylaxis-free.

Key Points: 
  • "We are thrilled to witness this milestone in hemophilia B treatment," shared Kim Phelan, Chief Operating Officer of The Coalition for Hemophilia B.
  • The FDA approval is supported by results from the ongoing HOPE-B trial, the largest gene therapy trial in hemophilia B to date.
  • CSL Behring, a CSL business, will make HEMGENIX available for eligible people with hemophilia B as soon as possible.
  • HEMGENIX is a gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B.

Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, Adult, Cutis verticis gyrata, Infection, Pyelonephritis, Tebipenem, Nasdaq, MDR, Research, Therapy, U.S. Securities and Exchange Commission, No, GSK, HBR, Degenerative disease, Patient, Bacteria, Urinary tract infection, FDA, Limited, Pharmaceutical industry, Vaccine, Spero, Meiji Seika

3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr, an investigational drug being developed as the potentially first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Key Points: 
  • 3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr, an investigational drug being developed as the potentially first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.
  • In exchange, GSK has been granted an exclusive license to develop and commercialize tebipenem pivoxil and tebipenem pivoxil HBr in all territories, except Japan, and certain other Asian countries, territories which will be retained by Spero partner, Meiji Seika.
  • Under the terms of the license agreement, Spero is responsible for the execution and costs of a follow-up Phase 3 clinical trial of tebipenem HBr.
  • GSK is responsible for the execution and costs of additional development, including Phase 3 regulatory filing and commercialization activities for tebipenem HBr outside of the Meiji Seika territory.

Spero Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results on Monday, November 14, 2022

Retrieved on: 
Monday, November 7, 2022
Cutis verticis gyrata, Company, HBR, MDR, GLOBE, FDA, Adult, Infection, Therapy, Nasdaq, Pyelonephritis, Bacteria, Degenerative disease, ID, Spero, Patient, Tebipenem, Pharmaceutical industry

ET to report its third quarter 2022 financial results and provide an update on its business and pipeline.

Key Points: 
  • ET to report its third quarter 2022 financial results and provide an update on its business and pipeline.
  • To access the call, please dial 1-855-327-6837 (domestic) or 1-631-891-4304 (international) and refer to conference ID 10020538.
  • The audio webcast can be accessed under "Events and Presentations" in the Investor and Media section of the Company's website at www.sperotherapeutics.com .
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.

Nabriva Therapeutics to Report Third Quarter 2022 Financial Results and Recent Corporate Highlights on November 10, 2022

Retrieved on: 
Monday, November 7, 2022
Cuties, Merck, Food, Infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Private Securities Litigation Reform Act, Conference, Pyelonephritis, Tablet, COVID-19, Therapy, Marketing, U.S. Securities and Exchange Commission, NASDAQ, Bronchopneumonia, Fosfomycin, Urinary tract infection, Food and Drug Administration, Pharmaceutical industry

ET to discuss the financial results and recent corporate highlights.

Key Points: 
  • ET to discuss the financial results and recent corporate highlights.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics views as of the date of this press release.
  • These forward-looking statements should not be relied upon as representing Nabriva Therapeutics views as of any date subsequent to the date of this press release.

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

Retrieved on: 
Thursday, October 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: 
Tuesday, October 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.

Allecra Therapeutics Publishes Final Phase 3 ALLIUM Data in JAMA: Cefepime/Enmetazobactam Met Criteria for Superiority

Retrieved on: 
Wednesday, October 5, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, European Medicines Agency, Robert Wood Johnson Medical School, Union, LinkedIn, Urinary tract infection, Therapy, Infection, Review, EMA, Bacterial pneumonia, Carbapenem, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Investor, Standard of care, MPH, Division, Piperacillin/tazobactam, UTI, Partnership, Food, Company, Marketing, MD, Esbly, Pyelonephritis, Adult, Cutis, Cutis marmorata telangiectatica congenita, American Medical Association, Journal, United Kingdom, Rutgers University, FDA, Tazobactam, Data analysis, ESBL, Pharmaceutical industry, EU

The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Key Points: 
  • The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
  • Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
  • Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

Recce Pharmaceuticals Announces Expansion and Acceleration of Clinical Programs

Retrieved on: 
Monday, October 3, 2022
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SYDNEY Australia, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing new classes of synthetic anti-infectives, is pleased to provide an updated timeline on its clinical programs with several significant data read-outs in 2022 and 2023.

Key Points: 
  • We have therefore established an ambitious development plan, aiming to get new anti-infective therapies into market as expediently possible.
  • Recces anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE 327, RECCE 435, and RECCE 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.
  • Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials.
  • Recces anti-infective pipeline seeks to exploit the unique capabilities of RECCE technologies targeting synergistic, unmet medical needs.