The Art of Charm is where self-motivated people, just like you, come to learn from the company’s coaches about to how to master human dynamics, relationships, and becoming your best self with the help of Johnny and AJ, the company’s founders. Johnny and AJ bring their 11 years of coaching experience from their famous Bootcamps, where they host clients in Los Angeles from all over the world and they share their stories, best practices and themselves on this weekly podcast. Not only does The A ...
…
continue reading
Contenu fourni par Emma Nichols, PhD and Emma Hitt Nichols. Tout le contenu du podcast, y compris les épisodes, les graphiques et les descriptions de podcast, est téléchargé et fourni directement par Emma Nichols, PhD and Emma Hitt Nichols ou son partenaire de plateforme de podcast. Si vous pensez que quelqu'un utilise votre œuvre protégée sans votre autorisation, vous pouvez suivre le processus décrit ici https://fr.player.fm/legal.
Player FM - Application Podcast
Mettez-vous hors ligne avec l'application Player FM !
Mettez-vous hors ligne avec l'application Player FM !
Erdafitinib for Urothelial Carcinoma, TTFields in NSCLC, AI-Powered Device to Detect Skin Cancer, Casgevy for Beta Thalassemia, HyQvia for CIDP, Physicians' Understanding of FDA Approval Process
MP4•Maison d'episode
Manage episode 407556890 series 3561458
Contenu fourni par Emma Nichols, PhD and Emma Hitt Nichols. Tout le contenu du podcast, y compris les épisodes, les graphiques et les descriptions de podcast, est téléchargé et fourni directement par Emma Nichols, PhD and Emma Hitt Nichols ou son partenaire de plateforme de podcast. Si vous pensez que quelqu'un utilise votre œuvre protégée sans votre autorisation, vous pouvez suivre le processus décrit ici https://fr.player.fm/legal.
For the free course "ChatGPT4 for Medical Writers and Editors," go to learnAMAstyle.com Visit Nascentmc.com/podcast for detailed show notes and links.
- Erdafitinib for Urothelial Carcinoma: The FDA has fully approved erdafitinib (Balversa) for advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations in adults. This follows its initial accelerated approval and is based on the phase 3 THOR trial results, showing improved survival rates and manageable side effects. Erdafitinib reduced death risk by 36% and had a lower treatment discontinuation rate compared to chemotherapy.
- TTFields in NSCLC: The FDA is reviewing a premarket approval application for tumor treating fields (TTFields) combined with standard therapies for platinum-resistant non–small cell lung cancer. TTFields, first approved in 2011, disrupt cancer cell division and showed enhanced survival in NSCLC patients when combined with immune checkpoint inhibitors or docetaxel, without increasing systemic toxicities. The FDA's decision is expected in the second half of 2024.
- AI-Powered Device to Detect Skin Cancer: The FDA has approved the first AI-powered handheld device by DermaSensor for assisting in skin cancer detection. It uses AI-driven spectroscopy for analyzing skin lesions and is based on a study involving over 1000 patients. While not a primary screening tool, it aids in detecting melanoma and other skin cancers, especially in patients over 40, and requires further validation testing.
- Casgevy for Transfusion-Dependent Beta Thalassemia: The FDA has approved Casgevy (exa-cel), developed by Vertex Pharmaceuticals and CRISPR Therapeutics, for treating transfusion-dependent beta-thalassemia. This follows its approval for sickle cell disease and marks the first CRISPR gene-editing technology application for this condition. The approval came ahead of the anticipated date and follows Bluebird Bio's 2022 approval for a similar gene therapy.
- HyQvia for CIDP: HyQvia, an immune globulin infusion 10%, has been approved by the FDA for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Initially approved for primary immunodeficiency, HyQvia is the only product combining immunoglobulin with hyaluronidase, allowing for monthly subcutaneous infusions. The approval is based on its demonstrated efficacy in preventing neuromuscular disability relapse.
- Physicians' Understanding of FDA Approval Process: A national survey reveals that many physicians have limited understanding of the FDA's drug and medical device approval processes. Only 41% of the surveyed physicians reported moderate or better comprehension of the drug approval process. Despite believing in the adequacy of FDA standards, there's a call for more rigorous post-marketing studies and enhanced education on FDA processes to avoid misconceptions and inaccurate patient advice.
60 episodes
MP4•Maison d'episode
Manage episode 407556890 series 3561458
Contenu fourni par Emma Nichols, PhD and Emma Hitt Nichols. Tout le contenu du podcast, y compris les épisodes, les graphiques et les descriptions de podcast, est téléchargé et fourni directement par Emma Nichols, PhD and Emma Hitt Nichols ou son partenaire de plateforme de podcast. Si vous pensez que quelqu'un utilise votre œuvre protégée sans votre autorisation, vous pouvez suivre le processus décrit ici https://fr.player.fm/legal.
For the free course "ChatGPT4 for Medical Writers and Editors," go to learnAMAstyle.com Visit Nascentmc.com/podcast for detailed show notes and links.
- Erdafitinib for Urothelial Carcinoma: The FDA has fully approved erdafitinib (Balversa) for advanced or metastatic urothelial carcinoma with FGFR3 genetic alterations in adults. This follows its initial accelerated approval and is based on the phase 3 THOR trial results, showing improved survival rates and manageable side effects. Erdafitinib reduced death risk by 36% and had a lower treatment discontinuation rate compared to chemotherapy.
- TTFields in NSCLC: The FDA is reviewing a premarket approval application for tumor treating fields (TTFields) combined with standard therapies for platinum-resistant non–small cell lung cancer. TTFields, first approved in 2011, disrupt cancer cell division and showed enhanced survival in NSCLC patients when combined with immune checkpoint inhibitors or docetaxel, without increasing systemic toxicities. The FDA's decision is expected in the second half of 2024.
- AI-Powered Device to Detect Skin Cancer: The FDA has approved the first AI-powered handheld device by DermaSensor for assisting in skin cancer detection. It uses AI-driven spectroscopy for analyzing skin lesions and is based on a study involving over 1000 patients. While not a primary screening tool, it aids in detecting melanoma and other skin cancers, especially in patients over 40, and requires further validation testing.
- Casgevy for Transfusion-Dependent Beta Thalassemia: The FDA has approved Casgevy (exa-cel), developed by Vertex Pharmaceuticals and CRISPR Therapeutics, for treating transfusion-dependent beta-thalassemia. This follows its approval for sickle cell disease and marks the first CRISPR gene-editing technology application for this condition. The approval came ahead of the anticipated date and follows Bluebird Bio's 2022 approval for a similar gene therapy.
- HyQvia for CIDP: HyQvia, an immune globulin infusion 10%, has been approved by the FDA for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Initially approved for primary immunodeficiency, HyQvia is the only product combining immunoglobulin with hyaluronidase, allowing for monthly subcutaneous infusions. The approval is based on its demonstrated efficacy in preventing neuromuscular disability relapse.
- Physicians' Understanding of FDA Approval Process: A national survey reveals that many physicians have limited understanding of the FDA's drug and medical device approval processes. Only 41% of the surveyed physicians reported moderate or better comprehension of the drug approval process. Despite believing in the adequacy of FDA standards, there's a call for more rigorous post-marketing studies and enhanced education on FDA processes to avoid misconceptions and inaccurate patient advice.
60 episodes
Tất cả các tập
×Bienvenue sur Lecteur FM!
Lecteur FM recherche sur Internet des podcasts de haute qualité que vous pourrez apprécier dès maintenant. C'est la meilleure application de podcast et fonctionne sur Android, iPhone et le Web. Inscrivez-vous pour synchroniser les abonnements sur tous les appareils.