Associated tags: Pain, Research, Infection, Cardiology, Inflammation, Gastroenterology, Research and development, Development, Patient, Pharmaceutical industry, Woman, Menarini, Therapy, HIV disease progression rates, Neoplasm, Breast cancer, Medical imaging, ESR1, Death, Safety, Nausea, ER, Cancer, MD, SOC, MBC, PFS, Oncology
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, January 4, 2024
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Medical imaging Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
Key Points:
- Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
- This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
- Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.
- Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.
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Thursday, January 4, 2024
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Medical imaging Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
Key Points:
- Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
- This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
- Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.
- Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.
Retrieved on:
Thursday, January 4, 2024
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Medical imaging This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance.
Key Points:
- This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance.
- Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.
- Insilico presented data on the molecule at the San Antonio Breast Cancer Symposium in early December.
- Currently, endocrine therapy in combination with CDK4/6 inhibitors is the standard treatment for ER+/HER2- breast cancer patients with advanced or metastatic disease.
Retrieved on:
Monday, December 11, 2023
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MD Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
Key Points:
- Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
- Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
- The ELEVATE study is evaluating elacestrant in combination with inhibitors of the PI3K/AKT/mTOR pathway (everolimus and alpelisib) and cell-cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib).
- Additional cohorts are currently under evaluation to assess pharmacokinetics (PK) and determine the recommended phase 2 dose (RP2D) for each combination.
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Pharmaceutical industry This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
Key Points:
- This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
- ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
- “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
- See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.
Retrieved on:
Monday, November 20, 2023
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Medical imaging In September 2023 , ORSERDU was approved by the European Commission.
Key Points:
- In September 2023 , ORSERDU was approved by the European Commission.
- Updated data, including a spotlight discussion on additional biomarker and clinical subgroup analyses from the Phase 3 EMERALD trial, along with new safety updates evaluating elacestrant in multiple combination settings, will be presented at the San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
- Updated data, including an oral presentation of updated real-world results in treatment-naïve patients with BPDCN demonstrating durable outcomes and a manageable safety profile leading to prolonged survival, will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 9-12, 2023.
- “The breadth of data on our novel oncology therapies, spanning solid tumors and hematologic malignancies, underscore our commitment to addressing significant unmet medical needs in difficult-to-treat cancers,” said Elcin Barker Ergun, CEO of the Menarini Group.
