On March 6(th) 2015, the Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio) as the first biosimilar in the United States (US) for all indications of the reference product. Filgrastim-sndz is a biosimilar of Amgen's Neupogen and is mainly used to treat neutropenia in cancer patients receiving chemotherapy. This article presents a summary of the analytical and clinical studies submitted by Sandoz and describes how the information was integrated to provide the 'totality of the evidence' leading to the approval of the biosimilar.
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| http://dx.doi.org/10.1517/14712598.2016.1128410 | DOI Listing |
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Sweets and other sugary foods - a scoping review for Nordic Nutrition Recommendations 2023.
Food Nutr Res
December 2024
Nutritional Epidemiology, Department of Clinical Sciences, Lund University, Malmö, Sweden.
Background: Sweets, chocolate, and sweet bakery products are generally high in energy and added sugar, whereas the levels of essential nutrients and fibre are low. According to sales statistics, the consumption of sweets and chocolate is high in the Nordic and Baltic countries.
Objective: This scoping review describes the totality of evidence for the role of sweets and other sugary foods for health-related outcomes as a basis for setting and updating food-based dietary guidelines in the Nordic Nutrition Recommendations 2023 (NNR2023) project.
Homeopathic Management of Bulky Uterus with Uterine Fibroid in a 40-year-old Patient: An Evidence-Based Case Report.
Homeopathy
December 2024
Department of Clinical Research, Central Council for Research in Homoeopathy, New Delhi, India.
Background: Uterine fibroids are benign gynecological tumours that arise in the uterine smooth muscle tissue and are characterized by the production of excessive quantities of extracellular matrix. Various therapeutic options, from medical management to surgical intervention, exist for uterine fibroids, for which homeopathy has emerged as a promising therapeutic option in patient-centered care.
Case History: A 40-year-old woman presented with complaints of heavy menstrual bleeding, with pain in the pelvic region and back.
Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile.
Front Immunol
January 2025
Polpharma Biologics S.A., Gdansk, Poland.
Background: Biosimilar natalizumab (biosim-NTZ) is the first biosimilar monoclonal antibody of reference natalizumab (ref-NTZ) for treatment of relapsing forms of multiple sclerosis (MS). Within the totality of evidence for demonstration of biosimilarity, immunogenicity assessments were performed in healthy subjects and patients with relapsing-remitting MS (RRMS) to confirm a matching immunogenicity profile between biosim-NTZ and ref-NTZ.
Methods: Immunogenicity of biosim-NTZ versus ref-NTZ was evaluated in two pivotal clinical studies.
Understanding recent advances in non-amyloid/non-tau (NANT) biomarkers and therapeutic targets in Alzheimer's disease.
Alzheimers Dement (N Y)
November 2024
Alzheimer's Association Chicago Illinois USA.
Unlabelled: The Alzheimer's disease (AD) research community continues to make great strides in expanding approaches for early detection and treatment of the disease, including recent advances in our understanding of fundamental AD pathophysiology beyond the classical targets: beta-amyloid and tau. Recent clinical trial readouts implicate a variety of non-amyloid/non-tau (NANT) approaches that show promise in slowing cognitive decline for people with AD. The Alzheimer's Association Research Roundtable (AARR) meeting held on December 13-14, 2022, reviewed the current state of NANT targets on underlying AD pathophysiology and their contribution to cognitive decline, the current data on a diverse range of NANT biomarkers and therapeutic targets, and the integration of NANT concepts in clinical trial designs.
View Article and Find Full Text PDFBackground: Uptake of human papillomavirus (HPV) vaccination is generally high in high-income countries with school-based vaccination programmes; however, lower uptake in certain population subgroups could continue pre-immunisation inequalities in cervical cancer.
Methods: Six electronic databases were searched for quantitative articles published between 1 September 2006 and 20 February 2023, which were representative of the general population, with individual-level data on routine school-based vaccination (with >50% coverage) and sociodemographic measures. Titles, abstracts and full-text articles were screened for eligibility criteria and assessed for bias.
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