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23:59 EST 17th February 2020 | BioPortfolio

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Showing "Alvotech JAMP Partner Canadian Biosimilars" PubMed Articles 1–25 of 1,300+

Powerful rare variant association testing in a copula-based joint analysis of multiple phenotypes.

In genetic association studies of rare variants, the low power of association tests is one of the main challenges. In this study, we propose a new single-marker association test called C-JAMP (Copula-based Joint Analysis of Multiple Phenotypes), which is based on a joint model of multiple phenotypes given genetic markers and other covariates. We evaluated its performance and compared its empirical type I error and power with existing univariate and multivariate single-marker and multi-marker rare-variant te...

Biosimilars in developed economies: Overview, status, and regulatory considerations.

Biotherapeutics dominate the pipelines of pharmaceutical companies across the world today with products ranging from hormones, immune-modulators, monoclonal antibodies (mAbs), blood coagulation factors, enzymes and vaccines. However, they are considerably more expensive than their small molecule counterparts (pharmaceuticals) and as a result their contribution to the already unacceptably high healthcare costs in the developed economies (Europe, United States, Japan, Canada and South Korea) has been in the l...

An In Vitro comparison of four different immunoassays for the monitoring of Infliximab biosimilars drug levels.

SB2 (Renflexis®, Merck) and CT-P13 (Inflectra®, Pfizer) are biosimilars of the reference Infliximab (Remicade®, Janssen) and are approved in Canada for use in indications for which Infliximab is approved, including inflammatory bowel disease. These biosimilars are structurally different but exhibit comparable physicochemical characteristics, pharmaceutical effectiveness and immunogenicity compared to Infliximab. Optimal Infliximab therapy currently relies on therapeutic drug monitoring offered by several...

The Era of Therapeutic Biosimilars Has Arrived: What You Need to Know.

Although complex, biologic agents are key components of modern therapy in multiple disciplines, particularly oncology. However, despite the fact that biosimilars (eg, filgrastim-sndz, bevacizumab-awwb, trastuzumab-dkst, rituximab-abbs) have been approved in the United States, many clinicians are poorly informed about their unique pathway for approval. At the NCCN 2019 Annual Congress: Hematologic Malignancies, Dr. Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, outlined important issues regardin...

Biosimilars in Rheumatology.

Biotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide. Since biosimilars are similar and more affordable versions of previously licenced biotechnologicals, they are expected to contribute to healthcare system sustainability and reduce inequities in treat...

Delivering on the Promise of Biosimilars.

Fifteen years of experience with biosimilar evaluation in Europe and advancement in the science behind biological medicines, provides a timely moment to open up debate as to whether the requirements for biosimilar approval could be further tailored. Further optimizing of data requirements to truly decisional information will allow to continuously deliver on the promise of biosimilars, providing benefits for patients and society.

Biosimilars vs originators: Are they the same?

Biological drugs have revolutionised the treatment of rheumatic diseases, and the recent expiry of the patents for many biological agents has generated considerable interest among pharmaceutical companies and regulatory agencies, and led to the marketing of highly similar, low-cost versions known as biosimilars. The increasing trend of switching patients from effective but expensive drugs to their biosimilar counterparts will have a considerable economic impact in the coming years. However, although this wi...

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.

Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2).

A new Canadian inception cohort for juvenile idiopathic arthritis: The Canadian Alliance of Pediatric Rheumatology Investigators Registry.

The aim was to describe the design, methods and initial findings of a new Canadian inception cohort of children with JIA, The Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) JIA Registry.

Are Biosimilars the Future of Oncology and Haematology?

Biological drugs are vital but often high-cost components of cancer treatment. Several biosimilar versions of these drugs have been approved in Europe and/or the USA, with many more in development. However, there is some disconnect between the biosimilars that are approved for use and those accessible in clinical practice, with availability impacted by factors including patent litigation and complex healthcare insurance policies, particularly in the USA. Provided the barriers to widespread uptake can be ove...

2019 Canadian Urological Association (CUA)-Canadian Uro Oncology Group (CUOG) guideline: Management of castration-resistant prostate cancer (CRPC).

A Canadian strategy for surgical quality improvement

The Canadian Association of General Surgeons (CAGS) Board of Directors hosted a symposium to develop a Canadian strategy for surgical quality and safety at its mid-term meeting on Feb. 24, 2018. The following 6 principles outline the consensus of this symposium, which included diverse stakeholders and surgeon leaders across Canada: 1) a Canadian quality-improvement strategy for surgery is needed; 2) quality improvement requires continuous, active and intentional effort; 3) outcome measurement alone will not...

Comparative Efficacy and Safety of Biosimilar Rituximab and Originator Rituximab in Rheumatoid Arthritis and Non-Hodgkin's Lymphoma: A Systematic Review and Meta-analysis.

Rituximab is a biologic medicine widely used for the treatment of autoimmune diseases and lymphoma. Several biosimilars of rituximab have been developed and marketed with the expiration of the originator rituximab's patent; thus, systematic combination and analysis of the latest data on the efficacy and safety of biosimilars and the demonstration of the interchangeability of biosimilar agents are required.

Factors associated with condom use during sexual intercourse with a new partner among Scandinavian women.

In this population-based, cross-sectional questionnaire study among 18-45-year-old women from Denmark, Sweden, and Norway conducted during 2011-2012 we examine factors associated with using condoms with a new partner. Condom use with a new partner was assessed among 6202 women having had a new partner in the recent six months. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for the associations between sociodemographic and lifestyle factors, and sexual behavior, respectively, and condom us...

Accelerometer-measured moderate-to-vigorous physical activity of Canadian adults, 2007 to 2017.

Surveillance of physical activity among Canadian adults has typically relied on questionnaire-based data, which have many limitations. The Canadian Health Measures Survey (CHMS) has been collecting objective, accelerometer-based physical activity data on a nationally representative sample of Canadian adults since 2007.

Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer.

Concordance of self- and partner-reported alcohol consumption among couples experiencing intimate partner violence in Zambia.

Hazardous alcohol use is a predictor of intimate partner violence (IPV) and both are increasingly prevalent in sub-Saharan Africa. The accurate measurement of alcohol consumption is therefore critical in IPV intervention studies that target hazardous drinking. Collecting a collateral report in addition to self-report is one convergent validity approach to improve alcohol measurement. We investigated concordance between self- and partner-reported alcohol use among women who reported recent IPV and their male...

Perceived neighborhood disorder and psychological distress among Latino adults in the United States: Considering spousal/partner relationship.

It has been well-established that neighborhood disorder and disadvantage are detrimental to mental health and psychological well-being. There has been growing research interest in minority stress issues, however, less is known about how perceived neighborhood disorder matters for psychological well-being among Latino adults in the United States. Analyzing data from National Latino Asian American Study, 2002-2003, the present study investigates the relationships among perceived neighborhood disorder, spousal...

Factors Associated With Human Immunodeficiency Virus Infections Linked in Genetic Clusters But Disconnected in Partner Tracing.

Successful partner notification can improve community-level outcomes by increasing the proportion of persons living with human immunodeficiency virus (HIV) who are linked to HIV care and virally suppressed, but it is resource intensive. Understanding where HIV transmission pathways may be undetected by routine partner notification may help improve case finding strategies.

The contribution of mental health and gender attitudes to intimate partner violence in the context of war and displacement: Evidence from a multi-informant couple survey in Iraq.

Intimate partner violence is a prevalent issue in refugee and internally displaced populations in post-war and migration settings including camps in the Middle East. In this context, partner violence has been associated with war-related trauma, camp factors, individual characteristics, and gender attitudes.

Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars.

Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care systems. During the development of a biosimilar, data that directly compare the proposed biosimilar with the reference product are required. Such comparative data are generated in a stepwise hierarchical process that begins with extensive laboratory-based structural analyses and functional assays. This initial analytical phase serves as the foundation for the demonstration of biosimilarity and is f...

Does Drinking Together Promote Relationship Intimacy? Temporal Effects of Daily Drinking Events.

Although research has documented harms associated with drinking within intimate relationships, there is evidence that some drinking patterns-characterized by congruent or shared partner drinking-may be associated with positive relationship functioning. The present dyadic daily diary study allowed us to consider whether congruent drinking events and drinking with partner increase the likelihood of experiencing intimacy with one's partner within the next few hours.

Need of education on biosimilars amongst ophthalmologists: combating the nocebo effect.

Ultraviolet Radiation Exposure of One Eye Stimulates Sympathizing Expression of Neurokinin-1 Receptor but Not Monocyte Chemoattractant Protein-1 in the Partner Eye.

To investigate the influence of unilateral ultraviolet radiation (UVR) exposure on the unexposed, partner eye in vivo. To characterize the immunological cross-talk between the eyes and verify a sympathizing reaction of the partner eye via a neurokinin-dependent signaling pathway of substance P and its neurokinin-1 receptor (NKR-1) and/or monocyte chemoattractant protein-1 (MCP-1).

An alternative to standard lumpectomy: a 5-year case series review of oncoplastic breast surgery outcomes in a Canadian setting

Oncoplastic surgery (OPS) is becoming the new standard of care for breast-conserving surgery (BCS). It has become increasingly popular in Europe; however, it has not yet been widely accepted in North America. This study aims to describe the experience with OPS at a Canadian tertiary care centre.

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