Results 31 to 40 of about 9,605 (202)

Imbalanced machine learning classification models for removal biosimilar drugs and increased activity in patients with rheumatic diseases.

PLoS ONE, 2023
ObjectivePredict long-term disease worsening and the removal of biosimilar medication in patients with rheumatic diseases.MethodologyObservational, retrospective descriptive study.
David Castro Corredor, Luis Ángel Calvo Pascual   +1 more
doaj   +1 more source

Biosimilars in oncology

ESMO Open, 2018
Biosimilars will soon become broadly available in the oncology field, raising important questions from both patients and healthcare providers. These questions need to be clarified upfront, in order to increase confidence in using these therapies. In this podcast, Teresa Amaral (Young Oncologist Committee member) talks to Josep Tabernero (ESMO President
openaire   +3 more sources

Combination Therapy in Participants With Active Psoriatic Arthritis Using Subcutaneous Guselkumab and Golimumab: Week 24 Results From a Phase 2a, Multicenter, Randomized, Double‐Blind, Proof‐of‐Concept Study

Arthritis &Rheumatology, EarlyView.
Objective To assess guselkumab + golimumab combination therapy versus guselkumab monotherapy in participants with active psoriatic arthritis (PsA) and inadequate response to tumor necrosis factor inhibitors (TNFi‐IR). Methods Adults with active TNFi‐IR PsA (three or more tender/swollen joints) were randomized (2:1) to subcutaneous guselkumab (100 mg) +
Jose U. Scher, Iain B. McInnes, Enrique R. Soriano, Joseph F. Merola, Paul Bird, Vinod Chandran, Edaire Cheng, Elena Reynoso, Warner Chen, Maoji Li, Lianne S. Gensler, Philip J. Mease, Christopher T. Ritchlin   +12 more
wiley   +1 more source

Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis

British Journal of Clinical Pharmacology, EarlyView.
Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
wiley   +1 more source

Native mass spectrometry combined with enzymatic dissection unravels glycoform heterogeneity of biopharmaceuticals

Nature Communications, 2018
The specific glycosylation patterns of biological drugs often impact the efficacy and safety of the therapeutic product. Here the authors describe a native mass spectrometry approach that allows the resolution of highly complex glycosylation patterns on ...
Therese Wohlschlager, Kai Scheffler, Ines C. Forstenlehner, Wolfgang Skala, Stefan Senn, Eugen Damoc, Johann Holzmann, Christian G. Huber   +7 more
doaj   +1 more source

Fostering medication review competence of pharmacy students: An assessment by students and their preceptors after advanced‐level practical internship

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study was to introduce a new assessment method for pharmacy students' real‐life competence in reviewing medications after obligatory advanced‐level practical internship in Finland. Methods The new medication review (MR) competence assessment method consisted of (1) a self‐assessment by pharmacy students and (2) a performance ...
Katja Leiman, Aleksi Westerholm, Tero Vahlberg, Noora Lias, Tanja Lindholm, Marja Airaksinen   +5 more
wiley   +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

Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database

Journal of Pharmaceutical Health Care and Sciences, 2019
Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown
Iku Niinomi, Keiko Hosohata, Yasuhiro Mori, Yuki Yamaguchi, Tomohito Wakabayashi, Mayako Uchida, Kazunori Iwanaga   +6 more
doaj   +1 more source

Biologics and biosimilars

Journal of Dermatological Treatment, 2015
Biological drugs are large, complex glycoprotein molecules produced in living organisms. Revolutionary treatments for many conditions, biologics used in dermatology will face patent expiration, opening opportunities for competitive versions. Biologic drugs are so complex such that it is impossible to reproduce them exactly.
Palak K, Patel, Caleb R, King, Steven R, Feldman   +2 more
openaire   +2 more sources

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source