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PubMed Journals Articles About "Accepts Filing Supplemental Biologics License Application SBLA Xeomin" RSS

17:27 EDT 15th July 2018 | BioPortfolio

Accepts Filing Supplemental Biologics License Application SBLA Xeomin PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Accepts Filing Supplemental Biologics License Application SBLA Xeomin articles that have been published worldwide.

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Showing "Accepts Filing Supplemental Biologics License Application sBLA Xeomin" PubMed Articles 1–25 of 7,500+

The Current Status of Drug Discovery and Development as Originated in US Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development.

Academic drug discovery is a vital component to current drug discovery and development environments. In this study we investigated 798 drug discovery projects that took place between 1991 and 2015 at 36 academic institutions in the US. The observed success rates of academic drug discovery and development were 75% at Phase 1, 50% at Phase 2, 59% at Phase 3, and 88% at the new drug application/biologics license application (NDA/BLA) phase. These results were similar to the corresponding success rates of the p...


Top-of-License Nursing Practice: Describing Common Nursing Activities and Nurses' Experiences That Hinder Top-of-License Practice, Part 1.

The aims of this study were to describe nurses' perceptions of nursing activities and analyze for consistency with top-of-license (TOL) practice.

Chlorine Countermeasures: Supplemental Oxygen Equals Supplemental Lung Injury?


Effects of supplemental β-carotene on colostral immunoglobulin and plasma β-carotene and immunoglobulin in Japanese Black cows.

Data from 26 Japanese Black cows were collected to clarify the effects of supplemental β-carotene on colostral immunoglobulin (Ig) and plasma β-carotene and Ig in the cows. Cows were assigned to control or β-carotene groups from 21 days before the expected calving date to 60 days after parturition. Supplemental β-carotene was provided at 500 mg/day in the β-carotene group. Supplemental β-carotene drastically increased plasma β-carotene concentrations in the cows from parturition to 60 days after ...

Correction: Patient experience and utility of genetic information: a cross-sectional study among patients tested for cancer susceptibility and thrombophilia.

This article was originally published under an incorrect license. This has now been amended and is available under a CC BY-NC-ND 4.0 license. The PDF and HTML versions of the paper have been modified accordingly.

Biologics for pityriasis rubra pilaris treatment: a review of the literature.

Pityriasis rubra pilaris (PRP) is a rare inflammatory papulosquamous skin disease, often refractory to conventional therapies. The off-label use of biologics, such as anti-TNF, -IL-12/IL-23, -IL-17 agents, has been proven successful, in the last two decades, in PRP treatment. Our aim was to analyse the literature for the use of biologics in PRP treatment. We conducted a review by "Pubmed" and "clinicaltrial.gov" searches. 68 articles met our selection criteria and were herein discussed. Out of 86 PRP patien...

Correction to: Risk of Adverse Outcomes for Older People with Dementia Prescribed Antipsychotic Medication: A Population Based e-Cohort Study.

This article was originally published under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0), but has now been made available under a Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were mad...

Facilitated recruitment of mesenchymal stromal cells by bone marrow concentrate and platelet rich plasma.

Biologics containing growth factors are frequently used to enhance healing after musculoskeletal injuries. One mechanism of action is thought to be though the ability of biologics to induce homing and migration of endogenous mesenchymal stromal cells (MSCs) to a target tissue. However, the ability of biologics to stimulate chemotaxis (directed migration of cells) and chemokinesis (increase rate of cell migration) of MSCs is unknown.

Deterrent effects of demerit points and license sanctions on drivers' traffic law violations using a proportional hazard model.

Current traffic law enforcement places an emphasis on reducing accident risk from human factors such as drunk driving and speeding. Among the various strategies implemented, demerit points and license sanction systems have been widely used as punitive and educational measures. Limitations, however, exist in previous studies in terms of estimating the interaction effects of demerit points and license sanctions. To overcome such limitations, this work focused on identifying the interaction effects of demerit ...

Persistence of treatment with biologics for patients with psoriasis: a real-world analysis of 16,545 biologic-naïve patients from the French national health insurance database (SNIIRAM).

Long-term clinical effectiveness of biologics in psoriasis is needed.

Biologics Monitoring: Incongruity between Recommendations and Clinician Monitoring Trends.

Biologics are a commonly used treatment for moderate to severe psoriasis. Monitoring laboratory test overuse provide little definitive benefit to patients.

A Portable Structural Analysis Library for Reaction Networks.

The topology of a reaction network can have a significant influence on the network's dynamical properties. Such influences can include constraints on network flows and concentration changes or more insidiously result in the emergence of feedback loops. These effects are due entirely to mass constraints imposed by the network configuration and are important considerations before any dynamical analysis is made. Most established simulation software tools usually carry out some kind of structural analysis of a ...

Using insurance claims to predict and improve hospitalizations and biologics use in members with inflammatory bowel diseases.

Inflammatory Bowel Disease (IBD) is an inflammatory disorder of the gastrointestinal tract that can necessitate hospitalization and the use of expensive biologics. Models predicting these interventions may improve patient quality of life and reduce expenditures.

Patient reported outcomes more important than objective inflammatory markers for sick leave in biologics-treated rheumatoid arthritis patients.

To study the impact of common, non-composite disease activity measures on sick leave in biologics-treated RA-patients.

A GUIDE TO FOLLOW-ON BIOLOGICS AND BIOSIMILARS WITH A FOCUS ON INSULIN.

Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system.

GMC accepts another test as proof of language skills.

What Is the Evidence for Use of a Supplemental Feeding Tube Device as an Alternative Supplemental Feeding Method for Breastfed Infants?

According to the Healthy People 2020 goals, the sustainability of breastfeeding duration rates within the United States has not been achieved. To increase these rates, it is important that women with breastfeeding difficulties receive the support needed to continue breastfeeding. When supplementation occurs, it is essential that the breastfeeding relationship be preserved. Various methods of supplementation are often recommended including use of the supplemental feeding tube device (SFTD).

Efficacy and safety of biologics targeting IL-17 and IL-23 in the treatment of moderate-to-severe plaque psoriasis: A systematic review and meta-analysis of randomized controlled trials.

Numerous biologics are currently licensed for the treatment of psoriasis, including new drugs targeting interleukin-17 (IL-17) and interleukin-23 (IL-23). This meta-analysis evaluated the short-term (12-16 weeks) efficacy and safety of biologics targeting IL-17 and IL-23 in the treatment of moderate-to-severe plaque psoriasis. Twenty-one randomized clinical trials met the defined inclusion criteria. Our results showed that Ixekizumab (160 mg wk0 + 80 mg q2w) had the greatest probability of achievi...

Biologics and Cardiovascular Disease.

The advent of biologic therapy has enhanced our ability to augment disease in an increasingly targeted manner. The use of biologics in cardiovascular disease (CVD) has steadily increased over the past several decades. Much of the early data on biologics and CVD were derived from their use in rheumatologic populations. Atherosclerosis, myocardial infarction, and heart failure have been closely linked to the inflammatory response. Accordingly, cytokines such as tumor necrosis factor (TNF)-alpha and interleuki...

US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.

Purpose The outcome and proportion of patients with bone-only (BO) metastatic breast cancer (MBC) has not been well described. We sought to describe the differential outcomes of patients with BO MBC in clinical trials and explore whether there was a discrepancy in radiographic reads between investigator and blinded independent central review. Methods We pooled and analyzed data on 10,521 patients from 13 prospective trials submitted for MBC treatment in initial or supplemental New Drug or Biologics License ...

Effects of vitamin E on growth performance, tissue α-tocopherol, and lipid peroxidation of starter White Pekin ducks.

Two experiments were conducted to evaluate the effects of vitamin E on growth performance, tissue α-tocopherol, and lipid peroxidation of White Pekin ducks from hatch to 21 d of age. The 6 supplemental vitamin E levels (0, 5, 10, 20, 40, and 100 mg DL-α-tocopheryl acetate/kg) and 4 supplemental vitamin E levels (0, 10, 20, and 100 mg DL-α-tocopheryl acetate/kg) were utilized in experiments 1 and 2, respectively. All treatments were replicated 8 times using 7 ducklings per pen in experiment 1 and 6 time...

Postoperative course of Crohn disease according to timing of bowel resection: Results from the CONNECT Study.

Previous studies have demonstrated that early surgery in Crohn disease (CD) can result in a better clinical course than late surgery. The aim of this study was to compare the clinical course of CD following bowel resection performed at the time of diagnosis (early surgery) and during the course of the disease (late surgery).We reviewed medical records from a hospital-based cohort database that includes Korean CD patients diagnosed before 2009. Patients who underwent bowel resection were included. Age, sex, ...

Stopping Biologics in IBD-What Is the Evidence?

Biologic treatments have revolutionized the way we treat inflammatory bowel disease patients (IBD). Anti-tumor necrosis factor (anti-TNF) antibodies are superior to conventional therapies to achieve sustained remission without steroids and mucosal healing. The objective of IBD treatment has evolved from symptom alleviation to a combination of absence of symptoms and intestinal healing. Nevertheless, biologics are expensive and are associated with an increased risk of infections and possibly skin cancers. Th...

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or life-threatening.

Poor Dietary Guidelines Compliance among Low-Income Women Eligible for Supplemental Nutrition Assistance Program-Education (SNAP-Ed).

The Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program aims to improve nutritional intakes of low-income individuals (


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