A Sponsor ’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
ConclusionsThe reexamination process did not result in regulatory changes for any of the examined drugs. The Japan new-drug application (J-NDA) review and approval process, including implementation of the initial Japan product label, assures acceptable benefit/risk at the time of approval such that mandatory GDUI or SI studies for all products should be reconsidered. In the case of genuine scientific uncertainty to the extent that the benefit/risk of the product is not clear, a PMS is warranted. (Source: Pharmaceutical Medicine)
Source: Pharmaceutical Medicine - March 31, 2024 Category: Drugs & Pharmacology Source Type: research
Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study
Lancet Oncol. 2024 Apr;25(4):474-487. doi: 10.1016/S1470-2045(24)00034-2.ABSTRACTBACKGROUND: The PI3K-mTOR pathway is frequently dysregulated in breast cancer. Combining an inhibitor targeting all class I PI3K isoforms and mTOR complex 1 (mTORC1)-mTOR complex 2 (mTORC2) with endocrine therapy and a CDK4/6 inhibitor might provide more effective tumour control than standard-of-care therapy. To evaluate this hypothesis, gedatolisib, a pan-PI3K-mTOR inhibitor, was assessed in a phase 1b trial combined with palbociclib and endocrine therapy in patients with hormone receptor-positive, HER2-negative, advanced breast cancer. Resul...
Source: Cancer Control - March 28, 2024 Category: Cancer & Oncology Authors: Rachel M Layman Hyo S Han Hope S Rugo Erica M Stringer-Reasor Jennifer M Specht E Claire Dees Peter Kabos Samuel Suzuki Sarah C Mutka Brian F Sullivan Igor Gorbatchevsky Robert Wesolowski Source Type: research
COVID-19 vaccine reactogenicity among participants enrolled in the GENCOV study
CONCLUSIONS: We provide evidence of relatively mild and short-lived reactions reported by participants who have received approved COVID-19 vaccines.PMID:38521677 | DOI:10.1016/j.vaccine.2024.03.030 (Source: Vaccine)
Source: Vaccine - March 23, 2024 Category: Allergy & Immunology Authors: Gregory Morgan Selina Casalino Sunakshi Chowdhary Erika Frangione Chun Yiu Jordan Fung Elisa Lapadula Saranya Arnoldo Erin Bearss Alexandra Binnie Bjug Borgundvaag Laurent Briollais Marc Dagher Luke Devine Steven M Friedman Zeeshan Khan Chloe Mighton Koni Source Type: research
COVID-19 vaccine reactogenicity among participants enrolled in the GENCOV study
CONCLUSIONS: We provide evidence of relatively mild and short-lived reactions reported by participants who have received approved COVID-19 vaccines.PMID:38521677 | DOI:10.1016/j.vaccine.2024.03.030 (Source: Vaccine)
Source: Vaccine - March 23, 2024 Category: Allergy & Immunology Authors: Gregory Morgan Selina Casalino Sunakshi Chowdhary Erika Frangione Chun Yiu Jordan Fung Elisa Lapadula Saranya Arnoldo Erin Bearss Alexandra Binnie Bjug Borgundvaag Laurent Briollais Marc Dagher Luke Devine Steven M Friedman Zeeshan Khan Chloe Mighton Koni Source Type: research
Chemical tools for the Gid4 subunit of the human E3 ligase C-terminal to LisH (CTLH) degradation complex
RSC Med Chem. 2024 Mar 5;15(3):1066-1071. doi: 10.1039/d3md00633f. eCollection 2024 Mar 20.ABSTRACTWe have developed a novel chemical handle (PFI-E3H1) and a chemical probe (PFI-7) as ligands for the Gid4 subunit of the human E3 ligase CTLH degradation complex. Through an efficient initial hit-ID campaign, structure-based drug design (SBDD) and leveraging the sizeable Pfizer compound library, we identified a 500 nM ligand for this E3 ligase through file screening alone. Further exploration identified a vector that is tolerant to addition of a linker for future chimeric molecule design. The chemotype was subsequently optimi...
Source: Cancer Control - March 22, 2024 Category: Cancer & Oncology Authors: Aliakbar Khalili Yazdi Sumera Perveen Cheng Dong Xiaosheng Song Aiping Dong Magdalena M Szewczyk Matthew F Calabrese Agustin Casimiro-Garcia Subramanyam Chakrapani Matthew S Dowling Emel Ficici Jisun Lee Justin I Montgomery Thomas N O'Connell Grzegorz J S Source Type: research
The Use of Therapy Dogs in the Pediatric COVID-19 Vaccination at the University of Puerto Rico Medical Sciences Campus
We report the experiences at a COVID-19 vaccination center after authorizing children's vaccines. When the Pfizer-BioNTech vaccine for children aged 5 to 11 years was authorized for emergency use, we adapted the center's space to receive children, adding cartoon posters and balloons and using children's adhesive bandages, among others. Located at a Campus with six health professional schools, medical students dressed as storybook or movie characters. Children were asked to make drawings during the post vaccination observation period. We incorporated therapy dogs as part of our strategy for a child-friendly center during va...
Source: Puerto Rico Health Sciences Journal - March 21, 2024 Category: International Medicine & Public Health Authors: Carmen D Zorrilla Humberto M Guiot Wanda T Maldonado-D ávila Francico J Jim énez-Ramírez Luz V Camacho Suane S ánchez Barbara Segarra Leyra Figueroa Source Type: research
