Biosimilars Research

15:22 EST 7th December 2019 | BioPortfolio

Randomized, Double-Blind, Pharmacokinetic Equivalence Trial Comparing DRL-Rituximab With MabThera in Patients With Diffuse Large B-Cell Lymphoma.

We sought to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in patients with diffuse large B-cell lymphoma (DLBCL). Efficacy, pharmacodynamics (PDs), safety, and immunogenicity were also compared.

Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.

Voluntary medical male circumcisions (MCs) are safe: the majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where there is high mobile phone ownership, severe health care worker shortages, and rapid MC scale up intersect, we tested a 2-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety.

The Long-Term Efficacy of Suicide Prevention Gatekeeper Training: A Systematic Review.

The practice of educating individuals (known as 'gatekeepers' [GK]) at the informal social level with the knowledge, skills, and confidence to identify an at-risk individual and provide support has been shown as an effective suicide prevention method. Despite the efficacy of gatekeeper training (GKT) in the short-term, there are concerns over the long-term efficacy of these outcomes. The objective...

Efficacy and safety of insulin aspart biosimilar SAR341402 versus originator insulin aspart in people with diabetes treated for 26 weeks with multiple daily injections in combination with insulin glargine: A randomized, open-label trial (GEMELLI 1).

This study compared the efficacy, safety, and immunogenicity of insulin aspart biosimilar/follow-on biologic product SAR341402 (SAR-Asp) with originator insulin aspart-NovoLog®/NovoRapid® (NN-Asp) in people with type 1 diabetes (T1D) or type 2 diabetes (T2D) ) treated with multiple daily injections in combination with insulin glargine (Lantus®; Gla-100).

Intratendinous Injection of Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A 2-Year Follow-Up Study.

To assess the mid-term safety and efficacy of an intratendinous injection of autologous adipose tissue derived MSCs (AD MSCs) for rotator cuff disease at 2-year follow-up.

Autologous BPTB ACL Reconstruction Results in Lower Failure Rates Than ACL Repair with and without Synthetic Augmentation at 30 Years of Follow-up: A Prospective Randomized Study.

The aim of this study was to compare the 30-year follow-up results after treatment of anterior cruciate ligament (ACL) ruptures with 3 different surgical procedures.

Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial.

The aim of this study was to evaluate the safety and feasibility of nonoperative treatment of acute nonperforated appendicitis in children during 5 years of follow-up.

Work accidents with biological material: factors associated with abandoning clinical and laboratory follow-up.

To analyze the epidemiology of abandoning clinical and laboratory follow-up among health workers who suffered accidents with biological material.

Second cancers in patients with locally advanced prostate cancer randomized to lifelong endocrine treatment with or without radical radiotherapy. Long term follow- up of the Scandinavian Prostate Cancer Group-7 trial.

Curative radiotherapy (RT) constitute a cornerstone in prostate cancer (PC) treatment. We present long-term follow-up estimates for second cancer (SC) risk and overall survival (OS) in patients randomized to endocrine therapy (ET) alone or combined with 70Gy prostatic radiotherapy (RT) in the Scandinavian Prostate Cancer Group -7 study (SPCG-7). We explored the effect of salvage RT (≥60Gy to ET-...

Cancer biologics made in plants.

Plants are routinely utilized as efficient production platforms for the development of anti-cancer biologics leading to novel anti-cancer vaccines, immunotherapies, and drug-delivery modalities. Various biosimilar/biobetter antibodies and immunogens based on tumor-associated antigens have been produced and optimized for plant expression. Plant virus nanoparticles, including those derived from cowp...

Conservative management of odontogenic keratocyst with long-term 5-year follow-up: Case report and literature review.

Odontogenic Keratocyst (OKC) is a benign lesion recently considered an odontogenic cyst in the present World Health Organization (WHO) classification of Head and Neck tumors (2017) mainly based on its clinical and histopathological features. Several studies, systematic reviews and meta-analyses have shown a multimodal approach to reducing the high recurrence rates inherently exhibited by this path...

Predicting the Long-term Outcomes of Biologics in Psoriasis Patients using Machine Learning.

Despite the vast amount of data on the efficacy of biologics in psoriasis treatment, therapeutic decision-making is still based on a trial-and-error approach. In a real world setting over 50% of patients needing dose adjustment during therapy and 20-50% of patients experiencing a relapse of the disease requiring a switch to another medication.

Comparison of Health Care Costs Among Patients with Psoriasis Initiating Ixekizumab, Secukinumab, or Adalimumab.

As more biologics become available for the treatment of psoriasis (PsO), there is a lack of direct comparisons of health care costs between patients who are treated by different medications, including ixekizumab (IXE), secukinumab (SEC), and adalimumab (ADA).

Orbital design of topological insulators from two-dimensional semiconductors.

Two-dimensional (2D) materials have attracted much attention because they exhibit various intrinsic properties, which are, however, usually not interchangeable. Here we propose a generic approach to convert 2D semiconductors to 2D topological insulators (TIs) via atomic adsorption. The approach is underlined by an orbital design principle that involves introducing an extrinsic s-orbital state of t...

Follow-up of Intervention to Prevent Dental Caries Among Indigenous Children in Australia: A Secondary Analysis of a Randomized Clinical Trial.

For an intervention delivered in early childhood to have meaningful translational effect, long-term follow-up is necessary, especially among underserved indigenous children among whom preventable dental disease is common.

Endovascular stent repair of celiac arterial aneurysm.

The aim of this study was to evaluate the safety and clinical effectiveness of endovascular stent repair of celiac arterial aneurysm (CAA).From January 2015 to December 2018, 11 patients (7 males, 4 females with a mean age of 52.2 ± 7.9 years) underwent endovascular stent repair of CAA in our center. A covered stent was used to occlude the CAA neck. Follow-up was performed 2 weeks and 1, 3, 6...

Instabilities in Aortic Length after TEVAR and Reoperation: 12 Years of Follow-up Imaging.

TEVAR remains an important minimally invasive tool for the treatment of descending thoracic aneurysm. The long term effects of these repairs in both reduction of the aneurysmal sac size as well as stability of the stented portion require study. We report the results of 12 years of radiographic follow-up.

Modified Arthroscopic Latarjet Procedure: Suture-Button Fixation Achieves Excellent Remodeling at 3-Year Follow-up.

Some studies have advocated the use of suture-button fixation during the Latarjet procedure to reduce complications associated with screw fixation. However, the sample size of these studies is relatively small, and their follow-up period is short.

Relation of public health staffing to follow-up after newborn hearing screening in three health districts in Georgia, 2009-2015.

To describe the association, or non-association, of public health district staffing (specifically, Early Hearing Detection and Intervention [EHDI] coordinator/navigator) and loss to follow-up in newborns who did not pass hearing screening in selected public health districts in Georgia, USA.

Common carotid artery kinking is a predictor of cardiovascular events: A long-term follow-up study using carotid ultrasonography.

Kinking of the internal carotid artery is a cardiovascular (CV) risk factor. However, it remains unclear as to whether kinking of the common carotid artery (CCA) can also predict CV events. We conducted a long-term follow-up study to examine whether CCA kinking as assessed by carotid ultrasonography is a predictor of CV events in asymptomatic patients with CV risk factors.

Persistence of treatment with conventional systemic agents for patients with psoriasis: a real-world analysis of 73,168 new-users from the French National Health Insurance database (SNDS).

Psoriasis is a chronic inflammatory skin disorder which can have a significant effect on the quality of life . There is currently no cure for psoriasis, but there are numerous treatments which are useful in controlling symptoms; thus, long-term treatment is usually required. Conventionals are among the oldest interventions given to clear psoriasis. Treatment persistence, a relevant indicator of th...

The mediating role of low-grade inflammation on the prospective association between sleep and cognitive function in older men and women: 8-year follow-up from the English Longitudinal Study of Ageing.

Suboptimal sleep patterns predict poorer cognitive function in older adults and induce inflammatory responses. Inflammation could also adversely affect cognitive function. This study explored whether systemic inflammation may be one biological mechanism through which sleep influences cognitive performance. Participants were 4877 men and women from the English Longitudinal Study of Ageing who were ...

Trajectory of ambulatory blood pressure after adenotonsillectomy in children with obstructive sleep apnea: comparison at three- and six-month follow-up.

Limited information is currently available on 24-h ambulatory blood pressure (ABP) changes after adenotonsillectomy (T&A) in children with obstructive sleep apnea (OSA). In this study, the trajectory of 24-h ABP changes after surgery in children with OSA was examined at three-month and six-month follow-up.

Elucidating molecular design principles for charge-alternating peptides.

The therapeutic potential of protein drugs has been hindered by difficulties with long-term stability and rapid clearance from the body. Recombinant fusion proteins provide a scalable platform for engineered biologics, whereby a polypeptide domain is appended to alter the physical characteristics of a therapeutic protein and enhance its pharmaceutical viability. Two simple design principles for re...

Association of Food Parenting Practices on Child BMI z Score and Waist Circumference in Mexican Preschool Children After 1 Year of Follow-Up.

To evaluate the association between food parenting practices (FPPs) and weight status among preschoolers and the directionality of this association at 1-year follow-up.

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