Results 191 to 200 of about 2,756,439 (291)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Understanding adverse events following immunisation: evidence of vaccine safety and coincidental events from 3 years of surveillance. [PDF]

BMJ Paediatr Open
Mathew M, Sanathan SR, Ravi MD.
europepmc   +1 more source

Efficacy, safety and cost‐effectiveness of CAR‐T therapy

British Journal of Clinical Pharmacology, EarlyView.
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher, Amina Džidić‐Krivić, Emma Pinjic, Nejra Selak, Kanita Omerbasic, Alexandar Chupin, Andrej Belancic, Almir Fajkic   +7 more
wiley   +1 more source

Zimbabwe adverse events following immunisation surveillance system: A descriptive study with COVID-19 vaccine safety updates. [PDF]

S Afr J Infect Dis
Nyambayo PPM, Manyevere R, Chirinda L, Marekera SF, Nyamandi T, Chaitezvi RP, Rukwata RT, Mehta U, Gold MS.   +8 more
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

MMRV vaccine safety: A comprehensive analysis of adverse events recorded among pediatric populations. [PDF]

Hum Vaccin Immunother
Yan K, Yang G, Yan L, Wu R, Wu L, Wang Y, He P, Yu Q.   +7 more
europepmc   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Mapping Pediatric Seasonal Influenza Vaccine Safety and Immunogenicity Evidence: A Systematic Review of Clinical Trials. [PDF]

Vaccines (Basel)
Munoz A, Olivares B, Yepes-Perez Y, Chen Y, Ortiz J, Amin M, Zeng M.   +6 more
europepmc   +1 more source

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF‐07261271 in healthy participants

British Journal of Clinical Pharmacology, EarlyView.
Aim There is an unmet need for more effective therapies in inflammatory bowel disease (IBD). A single drug that blocks multiple distinct pathogenic pathways may offer therapeutic benefit superior to current monotherapies. PF‐07261271, a bispecific antibody targeting both the p40 subunit of interleukin‐12/23 and tumour necrosis factor‐like cytokine 1A ...
Srividya Neelakantan, Christopher Banfield, Kenneth Hung, Anna Sapone, Vivek Pradhan, Yuxi Zhao, Dana Parsons‐Rich, Grace Lee, Bryce G. Johnson, Elena Peeva, Michael S. Vincent, Valerie M. Clerin   +11 more
wiley   +1 more source

Safety of COVID-19 and influenza vaccines in children and adolescents with immunocompromised or autoimmune conditions: Findings from the Canadian National Vaccine Safety (CANVAS) network. [PDF]

Hum Vaccin Immunother
Turner C, Vanderkooi OG, Kellner JD, Shulha HP, Muller MP, Sadarangani M, Isenor JE, Marty K, Soe P, Kiely M, Valiquette L, McGeer A, Bettinger JA.   +12 more
europepmc   +1 more source