Results 181 to 190 of about 136,452 (263)

From prevention to progression: can belzutifan-based strategies deliver across the RCC disease continuum? [PDF]

Oncologist
Beckermann K.
europepmc   +1 more source

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Early steroid and anakinra use to manage axicabtagene ciloleucel toxicity reduces the total duration of CRS and ICANS. [PDF]

Blood Adv
Wang WL, Lee D, Cheung E, Jensen A, Rana MS, Goyal A, Hamilton M, Ghalehsari N, Latchford T, Scott B, Mallampet J, Heng E, Khan H, Zarak MS, Lohman C, Sahaf B, Sidana S, Weng WK, Smith M, Bharadwaj S, Frank MJ, Miklos DB, Dahiya S.   +22 more
europepmc   +1 more source

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

Sequential Safety Surveillance of RSVpreF Vaccination During Pregnancy Early in the Postapproval Period.

JAMA Netw Open
Michnick AI, MacDonald SC, Adimadhyam S, Zhang F, Cosgrove A, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Andrade SE, Platt R, Maro JC.   +20 more
europepmc   +1 more source

Using Real-World Data to Support Claim Expansion of the Cobas SARS-CoV-2 Test in Asymptomatic Testing: Data from the National Football League Occupational Surveillance Program. [PDF]

Infect Dis Ther
Yang B, Wasserman EB, Somoskovi A, Jarem D, Volkir P, Mack C, Baumfeld Andre E.   +6 more
europepmc   +1 more source

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Comment on Hernández-Lorca et al. Effects of Dry-Cured Ham Consumption on Cardiometabolic and Vascular Health in Adults: A Systematic Review and Meta-Analysis of Human Intervention Studies. <i>Foods</i> 2026, <i>15</i>, 1198. [PDF]

Foods
López-Moreno M, López-Gil JF.
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

Certolizumab Pegol Reduced Anterior Uveitis Flares Compared With Standard Non-Biologic Treatment: Results From an Overlap Weighting Analysis in High-Risk Patients With Axial Spondyloarthritis. [PDF]

Int J Rheum Dis
Haroon N, Baskurt Z, Chim T, Inman RD, Kumke T, Tham R, Kim M, van der Horst-Bruinsma I, Gensler LS.   +8 more
europepmc   +1 more source