Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma

xlomafota13 shared this article with you from Inoreader Administrative delays of temporary recommendation for use: Impact on access to innovation in melanoma Via Association française pour l'étude du cancer Bull Cancer. 2021 Dec 28:S0007-4551(21)00514-2. doi: 10.1016/j.bulcan.2021.11.007. Online ahead of print. ABSTRACT INTRODUCTION: Melanoma has benefited in recent years from therapeutic innovations, which have improved overall survival of patients. France has developed a regulatory arsenal allowing faster access to innovative drugs before marketing authorization: temporary authorization for use (ATU) and temporary recommendation for use (RTU). METHOD: We describe here the decision-making processes that led to the non-publication of the decree on the funding of three RTU in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib, and we analyse the fate of these drugs in order to quantify the potential loss of chance. RESULTS: On 03AUG2018, the French National Agency for Medicines and Health Product Safety (ANSM) published 3 RTU in order to give rapid access to major innovations in adjuvant melanoma therapy: nivolumab, pembrolizumab and the combination of dabrafenib and trametinib. These drugs have respectively demonstrated reductions in the risk of recurrence by 35 %, 43% and 55% for target populations of 2200, 1900 and 650 patients per year. Despite a favourable opinion on reimbursement from the French National Authority for Health (HAS), the decrees on reimbursement will never be published, prohibiting the use of these products before the marketing authorisation, and depriving many patients of a potential cure. CONCLUSION: Despite a favourable opinion from scientists and health agencies for the rapid availability of a drug, the French public health code does not systematically imply access to a therapeutic innovation. The reform of access to innovation implemented on 01JUL2021 may help tackle this issue. PMID:34972538 | DOI:10.1016/j.bulcan.2021.11.007 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Establishment and Characterization of FusionRed Stable Transfected Canine Prostate Adenocarcinoma and Transitional Cell Carcinoma Cells

xlomafota13 shared this article with you from Inoreader Establishment and Characterization of FusionRed Stable Transfected Canine Prostate Adenocarcinoma and Transitional Cell Carcinoma Cells Via In vivo (Athens, Greece) In Vivo. 2022 Jan-Feb;36(1):170-179. doi: 10.21873/invivo.12688. ABSTRACT BACKGROUND/AIM: Cancer cell inoculation is routinely used to evaluate novel therapeutic approaches in vivo. However, without reporter genes enabling deep tissue imaging, study of early tumor progression and therapeutic responses is often limited. We describe the establishment and characterization of two canine cancer cell lines stably expressing red fluorescence proteins as tools for later in vivo imaging. MATERIALS AND METHODS: Two red fluorescence cell lines were generated by plasmid transfection. Fluorescence protein expression was confirmed by flow cytometry and microscopy. Deep tissue imaging was demonstrated in mice using a NightOWL LB 983. Gene expression changes after transfection were analyzed by RNAseq. RESULTS: Both cell lines were detectable in vivo by subcutaneous injection of 1×106 cells. RNAseq revealed up to 2005 transfection-induced differentially expressed genes but no significant changes in cellular key pathways. CONCLUSION: The fluorescent cell lines provide a solid basis for future in vivo studies on canine cancer. PMID:34972712 | DOI:10.21873/invivo.12688 View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Framework for Indirect Spatial Calibration of the Horizontal Plane of Endoscopic Laryngeal Images

xlomafota13 shared this article with you from Inoreader Framework for Indirect Spatial Calibration of the Horizontal Plane of Endoscopic Laryngeal Images Via Journal of Voice Calibrated horizontal-plane measurements from laryngeal images could contribute significantly to refining evidence-based practice and developing patient-specific models and precision-medicine approaches. Laser-projection endoscopes can address the need for direct calibrated measures; however, these systems are not widely available. This study presents the framework for an alternative indirect horizontal-plane calibration approach. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.