Associated tags: Urinary tract infection, Patient, Melioidosis, Pyelonephritis, Viral, Bacteria, Food, Pharmaceutical industry, Health, Pharmaceutical, Research, Infection, Clinical Trials, Medication, Infectious Diseases, Biotechnology, Science, FDA, Medicine, AMR, NDA
Locations: PENNSYLVANIA, SWITZERLAND, SRI LANKA, MARYLAND, BALTIMORE, UNITED STATES, NORTH AMERICA, BURDETTE, ERNST, GIRARD, ALBANY, BARDA
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Management "These additions to our senior leadership team are critical to ensure we are prepared for our NDA resubmission and are strategically positioned for continued success."
Key Points:
- "These additions to our senior leadership team are critical to ensure we are prepared for our NDA resubmission and are strategically positioned for continued success."
- He joined Venatorx from Aimmune/Nestle Health Science where he was a Senior Vice President and Head of Technical Operations.
- Before this, he was the Senior Vice President of Technical Operations with Paratek Pharmaceuticals and over the years has worked at Eagle Pharmaceuticals, Shire with aaiPharma, Elan Pharmaceuticals, Sandoz, and Mylan Pharmaceuticals.
- Previously, he was Vice President, Technical Assessment and Senior Director for Business Development at Shire Pharmaceuticals to build the product pipeline and support Shire's strategic venture arm through investments.
Retrieved on:
Friday, February 23, 2024
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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.
Retrieved on:
Tuesday, February 20, 2024
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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.
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Pharmaceutical industry Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, and Menarini Group, an Italian biopharmaceutical group, today announced that they have entered into an agreement under which Menarini will acquire the exclusive rights to commercialize, upon approval of relevant health authorities, cefepime-taniborbactam in 96 countries in Europe, Latin America, Middle East, Turkey and North Africa and the Commonwealth of Independent States (CIS).
Key Points:
- Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, and Menarini Group, an Italian biopharmaceutical group, today announced that they have entered into an agreement under which Menarini will acquire the exclusive rights to commercialize, upon approval of relevant health authorities, cefepime-taniborbactam in 96 countries in Europe, Latin America, Middle East, Turkey and North Africa and the Commonwealth of Independent States (CIS).
- Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
- “With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets,” said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
- “By leveraging our expertise and Menarini’s expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint.”
Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
Key Points:
- Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
- "With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets," said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
- "At Menarini, we believe that the addition of cefepime-taniborbactam expands our existing AMR anti infectives portfolio and provides the opportunity to further strengthen our building of an important antibiotics portfolio focused on the critical pathogens responsible for the vast majority of antibiotic resistance" said Elcin Barker Ergun, CEO of the Menarini Group.
- "By leveraging our expertise and Menarini's expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint."
Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
Key Points:
- Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
- "With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets," said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
- "At Menarini, we believe that the addition of cefepime-taniborbactam expands our existing AMR anti infectives portfolio and provides the opportunity to further strengthen our building of an important antibiotics portfolio focused on the critical pathogens responsible for the vast majority of antibiotic resistance" said Elcin Barker Ergun, CEO of the Menarini Group.
- "By leveraging our expertise and Menarini's expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint."
Retrieved on:
Thursday, November 9, 2023
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Pharmaceutical industry The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
Key Points:
- The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
- Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
- The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
- Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.
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Pharmaceutical industry Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with drug-resistant bacterial infections and hard-to-treat viral infections, today announces the presentation of data during IDWeek 2023 , October 11-15, 2023, in Boston, MA on the in vitro activity of cefepime-taniborbactam, an investigational antibacterial agent, in comparison to other antibiotics against clinically significant gram-negative bacteria isolated from patients with cancer.
Key Points:
- Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with drug-resistant bacterial infections and hard-to-treat viral infections, today announces the presentation of data during IDWeek 2023 , October 11-15, 2023, in Boston, MA on the in vitro activity of cefepime-taniborbactam, an investigational antibacterial agent, in comparison to other antibiotics against clinically significant gram-negative bacteria isolated from patients with cancer.
- The bacterial isolates tested included Extended Spectrum β-lactamase (ESBL) producing Enterobacterales and Carbapenem Resistant Enterobacterales (CRE) isolates, and MDR Pseudomonas aeruginosa.
- In the study, cefepime-taniborbactam demonstrated higher in vitro activity than the tested comparators.
- While cefepime-taniborbactam has not yet been approved for clinical use, only 3 of the 270 isolates (1.1%; 2 CRE Escherichia coli and 1 MDR P. aeruginosa) were found to be resistant to cefepime-taniborbactam at its provisional breakpoint.
Retrieved on:
Tuesday, October 10, 2023
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Pharmaceutical industry Venatorx has recently completed multiple Phase 1 clinical studies with ceftibuten-ledaborbactam etzadroxil and will advance directly to global Phase 3 clinical trial testing under this contract.
Key Points:
- Venatorx has recently completed multiple Phase 1 clinical studies with ceftibuten-ledaborbactam etzadroxil and will advance directly to global Phase 3 clinical trial testing under this contract.
- “We thank BARDA, ASPR, and HHS for their dedication to scientific innovation and commitment to this private-public partnership.
- BARDA and Venatorx will share the costs of all studies needed to bring the drug to market, including a planned pivotal global Phase 3 clinical trial to treat cUTI.
- Venatorx will lead all regulatory activities necessary to seek FDA approval of ceftibuten-ledaborbactam etzadroxil under the contract.
Retrieved on:
Wednesday, September 27, 2023
Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, today announced seven presentations during IDWeek 2023 , October 11-15, 2023, in Boston, MA for its novel antibiotics cefepime-taniborbactam and ceftibuten-ledaborbactam, including:
Key Points:
- Venatorx Pharmaceuticals, a private, clinical-stage pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, today announced seven presentations during IDWeek 2023 , October 11-15, 2023, in Boston, MA for its novel antibiotics cefepime-taniborbactam and ceftibuten-ledaborbactam, including:
