Results 81 to 90 of about 69,426 (314)

Safety and effectiveness of pembrolizumab monotherapy in Japanese patients with unresectable urothelial carcinoma: a nation-wide post-marketing surveillance

BMC Cancer, 2023
Background This study was conducted to identify factors associated with the safety and effectiveness of pembrolizumab in Japanese patients with unresectable urothelial carcinoma and to confirm the real-world safety and effectiveness of pembrolizumab in ...
Hiroyuki Nishiyama, Yu Tanaka, Masahiro Hamada, Masahiko Ozaki, Toshihiko Minegishi, Yuichiro Ito, Shinichiroh Maekawa, Nobuyuki Yamamoto   +7 more
doaj   +1 more source

Adverse outcomes among pregnant women with COVID‐19 according to hospitalization status: A prospective individual participant data meta‐analysis in Europe and North America

International Journal of Gynecology &Obstetrics, EarlyView.
Abstract Background Understanding the varied impact of COVID‐19 severity on pregnancy outcomes is crucial for informed clinical management and targeted interventions. Objective To evaluate the impact of COVID‐19 on pregnancy outcomes, distinguishing between pregnant women managed in primary care and those requiring hospitalization.
Odette de Bruin, Emeline Maisonneuve, Eimir Hurley, Hedvig M. E. Nordeng, Anick Bérard, Odile Sheehy, Padma Kaul, Mayura U. Shinde, Austin Cosgrove, Jennifer G. Lyons, Elizabeth Messenger‐Jones, Maria E. Kempner, Sengwee Toh, Wei Hua, José J. Hernández‐Muñoz, Leyla Sahin, Carolyn E. Cesta, David Hägg, Rosa Gini, Olga Paoletti, Beatriz Poblador‐Plou, Sue Jordan, Clara L. Rodríguez‐Bernal, Francisco Sánchez‐Sáez, Régis Lassalle, Marie‐Agnès Bernard, Fariba Ahmadizar, Guillaume Favre, Alice Panchaud, Kitty W. M. Bloemenkamp, Kelly Plueschke, Corinne de Vries, Satu J. Siiskonen, Miriam C. J. M. Sturkenboom, on behalf of the CONSIGN Collaboration Group, Benjamin P. Geisler, Mark Walker, Steven Hawken, Sasha Bernatsky, Sherif Eltonsy, Emma Hoffman, Andrew B. Petrone, Jolene Mosley, Jenice Ko, Claudia Bartolini, Giuseppe Roberto, Giorgio Limoncella, Anna Girardi, Giulia Hyeraci, Antonio Gimeno‐Miguel, Jonás Carmona‐Pírez, Antonio Poncel‐Falcó, Aida Moreno‐Juste, Alexandra Prados‐Torres, Daniel Thayer, Ian Farr, Saira Ahmed, Ieuan Scanlon, Gabriel Sanfélix‐Gimeno, Isabel Hurtado, Anibal Garcia‐Sempere, Salvador Peiro, Jérémy Jové, Dunia Sakr, Cécile Droz‐Perroteau, Ema Alsina, David Baud, Hilde M. Engjom, Judit Riera‐Arnau, Mònica Sabaté Gallego, Elena Ballarín Alins, Cristina Aguilera Martin, Melissa Kampman, Celline Brasil   +73 more
wiley   +1 more source

Differences Between RSV A and RSV B Subgroups and Implications for Pharmaceutical Preventive Measures

Infectious Diseases and Therapy
Introduction Understanding the differences between respiratory syncytial virus (RSV) subgroups A and B provides insights for the development of prevention strategies and public health interventions.
Charles Nuttens, Juliette Moyersoen, Daniel Curcio, Zuleika Aponte-Torres, Marc Baay, Hilde Vroling, Bradford D. Gessner, Elizabeth Begier   +7 more
doaj   +1 more source

The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway? [PDF]

, 2008
The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate.
Kaldre, Ingrid
core   +1 more source

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

British Journal of Clinical Pharmacology, EarlyView.
Christina Gao, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi   +3 more
wiley   +1 more source

Interpretable machine learning enables early and accurate detection of drug‐induced liver injury: A multicenter study with real‐world clinical translation

Interdisciplinary Medicine, EarlyView.
This study develops an interpretable gradient‐boosting model that accurately identifies drug‐induced liver injury (DILI) using routine laboratory data. The model explains key clinical features through SHapley Additive exPlanations analysis and detects DILI earlier than expert evaluation, offering a transparent and practical tool for precision ...
Jingyi Ling, Shian Zhang, Jun Lin, Zhengju Xu, Runcheng Xu, Qian Lv, Kaixiang Zhang, Sheng Liu, Jie Guo, Cheng Hua, Yin Jia, Xiaoyu Xu, Kun Qian, Shanrong Liu   +13 more
wiley   +1 more source

Reshaping study design for faster extrapolation‐based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN–NASPGHAN position paper

Journal of Pediatric Gastroenterology and Nutrition, EarlyView.
Abstract Children with inflammatory bowel diseases (IBD) have limited access to the available advanced therapies, given the lengthy gap between adult and pediatric approval. We aimed to review key hurdles for pediatric trials and recommend practical solutions.
Dan Turner, Amit Assa, Mikkel Malham, Shira Yuval Bar‐Asher, Carla Rayan, Jeffrey S. Hyams, Holm H. Uhlig, Brad Pasternak, David C. Wilson, Hilary K. Michel, Lissy de Ridder, Eric Zuckerman, Marina Aloi, Peter Szitanyi, Marla C. Dubinsky, Anne M. Griffiths, Roberto Saldana, Javier Martín‐de‐Carpi, Eytan Wine, Richard K. Russell, Jeremy Adler, Joseph Picoraro   +21 more
wiley   +1 more source

Unravelling the Major Cardiovascular Risks of Systemic Psoriasis Medications: A Literature Systematic Review

JEADV Clinical Practice, EarlyView.
ABSTRACT Background Psoriasis is a chronic inflammatory dermatological condition associated with an elevated risk of cardiovascular events (CVEs). Systemic therapies have transformed disease management, but their cardiovascular (CV) safety profiles remain incompletely understood and inconsistently reported.
Mai Thi Hoai Son, Yves Julien Mbama Biloa, Pauline Gouttefarde, Thomas Franck, Gilles Cizeron, Mathieu Oriol, François Maccari, Elisa Cinotti, Beatrice Trombert‐Paviot, Bienvenu Bongue, Jean‐Luc Perrot   +10 more
wiley   +1 more source

Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

Infectious Diseases and Therapy
Introduction Molnupiravir is an orally available prodrug of N-hydroxycytidine that received special approval for emergency treatment of coronavirus disease 2019 (COVID-19) in Japan in December 2021 and full approval in April 2023.
Shohei Shinozaki, Asuka Watanabe, Masahiro Kimata, Makoto Miyazaki, Shinichiroh Maekawa   +4 more
doaj   +1 more source

Dupilumab and Systemic Hematologic Malignancies: Case Series and Literature Review

JEADV Clinical Practice, EarlyView.
ABSTRACT Background Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting 15%–20% of children and 3%–10% of adults. An increased risk of systemic lymphomas – but not leukemias – has been reported in patients with AD. Dupilumab, a monoclonal IgG4 antibody targeting IL‐4 and IL‐13 signaling, is approved for moderate‐to‐severe AD and is ...
Nello Tommasino, Cataldo Patruno, Francesca di Vico, Maddalena Napolitano   +3 more
wiley   +1 more source