Latest news with #CDX
Yahoo
4 days ago
- Business
- Yahoo
Fresenius Medical starts US commercialisation of haemodiafiltration system
Fresenius Medical Care (FME) has commenced the US commercialisation of its high-volume haemodiafiltration (HVHDF) kidney replacement therapy, 5008X CAREsystem. The full-scale commercial launch is anticipated by the company in 2026. FME secured the Food and Drug Administration's (FDA) 510(k) clearance last week for the updated HDF-capable system. In February 2024, FME first obtained the clearance for the 5008X CAREsystem, enabling focused testing and clinical assessments. The latest clearance approves additional features, including the Fresenius Clinical Data Exchange (CDX), which facilitates ONE-TOUCH access to medical information systems, eliminating the need for extra computer stations. The CDX claims to optimise clinic workflows, mitigate cross-contamination risks, and reduce citations under the CMS V-tag by streamlining data access and freeing up the clinic area by minimising the cabling clutter. Over the coming months, FMS' Care Delivery patient care business segment will start providing HDF dialysis therapy in chosen first wave clinics within its US Fresenius Kidney Care dialysis clinics network. This gradual rollout will continue throughout the year. The 5008X CAREsystem, paired with the FDA-approved FX CorAL dialyser, represents a leap in medical device innovation by Fresenius. It not only enables HVHDF but also introduces enhancements in workflow and therapy. The CONVINCE study, funded by the EU and conducted across eight European countries, found that subjects undergoing HVHDF had a significant 23% reduction in death rates against those receiving high-flux haemodialysis. FME CEO Helen Giza said: 'Last week's FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, HVHDF dialysis therapy to the US. 'Haemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with HVHDF.' "Fresenius Medical starts US commercialisation of haemodiafiltration system" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
4 days ago
- Business
- Yahoo
Fresenius Medical starts US commercialisation of haemodiafiltration system
Fresenius Medical Care (FME) has commenced the US commercialisation of its high-volume haemodiafiltration (HVHDF) kidney replacement therapy, 5008X CAREsystem. The full-scale commercial launch is anticipated by the company in 2026. FME secured the Food and Drug Administration's (FDA) 510(k) clearance last week for the updated HDF-capable system. In February 2024, FME first obtained the clearance for the 5008X CAREsystem, enabling focused testing and clinical assessments. The latest clearance approves additional features, including the Fresenius Clinical Data Exchange (CDX), which facilitates ONE-TOUCH access to medical information systems, eliminating the need for extra computer stations. The CDX claims to optimise clinic workflows, mitigate cross-contamination risks, and reduce citations under the CMS V-tag by streamlining data access and freeing up the clinic area by minimising the cabling clutter. Over the coming months, FMS' Care Delivery patient care business segment will start providing HDF dialysis therapy in chosen first wave clinics within its US Fresenius Kidney Care dialysis clinics network. This gradual rollout will continue throughout the year. The 5008X CAREsystem, paired with the FDA-approved FX CorAL dialyser, represents a leap in medical device innovation by Fresenius. It not only enables HVHDF but also introduces enhancements in workflow and therapy. The CONVINCE study, funded by the EU and conducted across eight European countries, found that subjects undergoing HVHDF had a significant 23% reduction in death rates against those receiving high-flux haemodialysis. FME CEO Helen Giza said: 'Last week's FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, HVHDF dialysis therapy to the US. 'Haemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with HVHDF.' "Fresenius Medical starts US commercialisation of haemodiafiltration system" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Associated Press
04-05-2025
- Business
- Associated Press
IND Application for NTS071, Nutshell Therapeutics' p53 Y220C Allosteric Reactivator, Received US FDA clearance
SHANGHAI, May 4, 2025 /PRNewswire/ -- On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate Phase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric reactivator targeting p53 Y220C mutation. NTS071 is an oral small molecule allosteric reactivator targeting p53 Y220C with a novel scaffold. It selectively binds to the p53 Y220C mutant protein, improving its thermal stability, thereby enhancing the mutant protein's ability to bind with DNA and restoring its transcriptional activity as well as tumor-suppressing function. NTS071 was discovered by leveraging Nutshell's proprietary AI driven allosteric small molecule drug discovery platform ALLOSTAR™. NTS071 demonstrated potential Best-in-Class preclinical properties for its target. NTS071 achieved a picomolar-level biochemical activity which is 20 folds more potent than the competitive compound PC14586. Additionally, NTS071 shows better stability in both liver microsomes and hepatocytes across different species and exhibits lower in vivo clearance rates and higher oral exposure s in preclinical PK studies across all tested species compared to PC14586. NTS071 has relatively lower plasma protein binding and higher free fraction than PC14586, which is beneficial for in vivo efficacy. NTS071 also addresses the CYP3A4 inhibition issue of PC14586, presenting lower risks for potential drug – drug interactions. NTS071 further displays a large safety window by exhibiting an overall good safety profile in non-clinical toxicology studies. NTS071 exhibited dose-dependent in vivo anti-tumor activity in multiple CDX and PDX models harboring p53 Y220C mutation, spanning a number of different cancer types, including ovarian cancer, lung cancer, gastric cancer, breast cancer, head and neck cancer, esophageal cancer, pancreatic cancer, and bladder cancer, etc. Therefore, NTS071 has the potential to be a tumor-agnostic therapy for patients carrying p53 Y220C mutation. Compared to PC14586, NTS071 has shown significantly lower effective doses or better efficacy at the same dose level in all comparative preclinical in vivo studies, implying that NTS071 may overcome the limitation of its competitor that has a higher dose requirement, thereby potentially achieving better therapeutic effects. NTS071 is anticipated to initiate Phase 1 clinical trial in second half of 2025 and expected to benefit patients with solid tumors harboring this mutation. p53 Y220C mutation is widespread in various solid tumors. Studies show that there are 125,000 to 150,000 new cases worldwide annually, representing a significant market potential. Enriched with years of accumulated experience with its proprietary computation-based allosteric drug development technology and breakthrough innovation capabilities at Nutshell Therapeutics, NTS071 has the potential to stand out among peer products and become the most competitive drug molecule for this target. The NTS071 Poster presented at the EORTC-NCI-AACR (ENA) 2024 conference can be accessed here: About Nutshell Nutshell Therapeutics ( ) is an innovative biotech company developing small molecule drugs for historically challenging targets employing allosteric mechanisms. Founded by Professor Zhang Jian, one of the leading figures in the allosteric drug discovery field globally, the company has established an integrated R&D platform with diverse dry and wet lab functions and has focused intensely on allosteric small - molecule drug discovery and development for many years. The company has successfully raised more than US$75 million from various well-known venture capitals. View original content to download multimedia: SOURCE Nutshell Therapeutics
Malaysian Reserve
04-05-2025
- Business
- Malaysian Reserve
IND Application for NTS071, Nutshell Therapeutics' p53 Y220C Allosteric Reactivator, Received US FDA clearance
SHANGHAI, May 4, 2025 /PRNewswire/ — On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate Phase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric reactivator targeting p53 Y220C mutation. NTS071 is an oral small molecule allosteric reactivator targeting p53 Y220C with a novel scaffold. It selectively binds to the p53 Y220C mutant protein, improving its thermal stability, thereby enhancing the mutant protein's ability to bind with DNA and restoring its transcriptional activity as well as tumor-suppressing function. NTS071 was discovered by leveraging Nutshell's proprietary AI driven allosteric small molecule drug discovery platform ALLOSTAR™. NTS071 demonstrated potential Best-in-Class preclinical properties for its target. NTS071 achieved a picomolar-level biochemical activity which is 20 folds more potent than the competitive compound PC14586. Additionally, NTS071 shows better stability in both liver microsomes and hepatocytes across different species and exhibits lower in vivo clearance rates and higher oral exposure s in preclinical PK studies across all tested species compared to PC14586. NTS071 has relatively lower plasma protein binding and higher free fraction than PC14586, which is beneficial for in vivo efficacy. NTS071 also addresses the CYP3A4 inhibition issue of PC14586, presenting lower risks for potential drug – drug interactions. NTS071 further displays a large safety window by exhibiting an overall good safety profile in non-clinical toxicology studies. NTS071 exhibited dose-dependent in vivo anti-tumor activity in multiple CDX and PDX models harboring p53 Y220C mutation, spanning a number of different cancer types, including ovarian cancer, lung cancer, gastric cancer, breast cancer, head and neck cancer, esophageal cancer, pancreatic cancer, and bladder cancer, etc. Therefore, NTS071 has the potential to be a tumor-agnostic therapy for patients carrying p53 Y220C mutation. Compared to PC14586, NTS071 has shown significantly lower effective doses or better efficacy at the same dose level in all comparative preclinical in vivo studies, implying that NTS071 may overcome the limitation of its competitor that has a higher dose requirement, thereby potentially achieving better therapeutic effects. NTS071 is anticipated to initiate Phase 1 clinical trial in second half of 2025 and expected to benefit patients with solid tumors harboring this mutation. p53 Y220C mutation is widespread in various solid tumors. Studies show that there are 125,000 to 150,000 new cases worldwide annually, representing a significant market potential. Enriched with years of accumulated experience with its proprietary computation-based allosteric drug development technology and breakthrough innovation capabilities at Nutshell Therapeutics, NTS071 has the potential to stand out among peer products and become the most competitive drug molecule for this target. The NTS071 Poster presented at the EORTC-NCI-AACR (ENA) 2024 conference can be accessed here: About Nutshell Nutshell Therapeutics ( is an innovative biotech company developing small molecule drugs for historically challenging targets employing allosteric mechanisms. Founded by Professor Zhang Jian, one of the leading figures in the allosteric drug discovery field globally, the company has established an integrated R&D platform with diverse dry and wet lab functions and has focused intensely on allosteric small – molecule drug discovery and development for many years. The company has successfully raised more than US$75 million from various well-known venture capitals.
Yahoo
04-05-2025
- Business
- Yahoo
IND Application for NTS071, Nutshell Therapeutics' p53 Y220C Allosteric Reactivator, Received US FDA clearance
SHANGHAI, May 4, 2025 /PRNewswire/ -- On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate Phase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric reactivator targeting p53 Y220C mutation. NTS071 is an oral small molecule allosteric reactivator targeting p53 Y220C with a novel scaffold. It selectively binds to the p53 Y220C mutant protein, improving its thermal stability, thereby enhancing the mutant protein's ability to bind with DNA and restoring its transcriptional activity as well as tumor-suppressing function. NTS071 was discovered by leveraging Nutshell's proprietary AI driven allosteric small molecule drug discovery platform ALLOSTAR™. NTS071 demonstrated potential Best-in-Class preclinical properties for its target. NTS071 achieved a picomolar-level biochemical activity which is 20 folds more potent than the competitive compound PC14586. Additionally, NTS071 shows better stability in both liver microsomes and hepatocytes across different species and exhibits lower in vivo clearance rates and higher oral exposure s in preclinical PK studies across all tested species compared to PC14586. NTS071 has relatively lower plasma protein binding and higher free fraction than PC14586, which is beneficial for in vivo efficacy. NTS071 also addresses the CYP3A4 inhibition issue of PC14586, presenting lower risks for potential drug – drug interactions. NTS071 further displays a large safety window by exhibiting an overall good safety profile in non-clinical toxicology studies. NTS071 exhibited dose-dependent in vivo anti-tumor activity in multiple CDX and PDX models harboring p53 Y220C mutation, spanning a number of different cancer types, including ovarian cancer, lung cancer, gastric cancer, breast cancer, head and neck cancer, esophageal cancer, pancreatic cancer, and bladder cancer, etc. Therefore, NTS071 has the potential to be a tumor-agnostic therapy for patients carrying p53 Y220C mutation. Compared to PC14586, NTS071 has shown significantly lower effective doses or better efficacy at the same dose level in all comparative preclinical in vivo studies, implying that NTS071 may overcome the limitation of its competitor that has a higher dose requirement, thereby potentially achieving better therapeutic effects. NTS071 is anticipated to initiate Phase 1 clinical trial in second half of 2025 and expected to benefit patients with solid tumors harboring this mutation. p53 Y220C mutation is widespread in various solid tumors. Studies show that there are 125,000 to 150,000 new cases worldwide annually, representing a significant market potential. Enriched with years of accumulated experience with its proprietary computation-based allosteric drug development technology and breakthrough innovation capabilities at Nutshell Therapeutics, NTS071 has the potential to stand out among peer products and become the most competitive drug molecule for this target. The NTS071 Poster presented at the EORTC-NCI-AACR (ENA) 2024 conference can be accessed here: About Nutshell Nutshell Therapeutics ( is an innovative biotech company developing small molecule drugs for historically challenging targets employing allosteric mechanisms. Founded by Professor Zhang Jian, one of the leading figures in the allosteric drug discovery field globally, the company has established an integrated R&D platform with diverse dry and wet lab functions and has focused intensely on allosteric small - molecule drug discovery and development for many years. The company has successfully raised more than US$75 million from various well-known venture capitals. View original content to download multimedia: SOURCE Nutshell Therapeutics Sign in to access your portfolio
