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

13:41 EST 16th November 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 7,700+

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...


Between-Race Differences in Supplemental Breast Cancer Screening Before and After Breast Density Notification Law.

Guidelines recommend supplemental breast cancer screening for women at increased breast cancer risk; however, the passage of breast density notification laws may lead to supplemental screening that is incongruent with women's risk. We examined supplemental screening (ie, MRI, ultrasound, or tomosynthesis within 6 months of screening mammogram) among a sample of 2,764 African American (AA) and 691 European American (EA) women with negative or benign screening mammograms for whom we had data from both before ...

Considerations for implementing an informatics system to support biologics drug discovery.

A comprehensive, well-functioning and scientifically aware informatics environment is of the utmost importance in supporting effective drug discovery programs. However, implementing such a system can, without a carefully crafted and enacted strategy, be a disruptive and time-consuming process, fraught with risks of cost overruns and the potential to end up with a system that ultimately does not meet the ever-evolving needs of the organization. In this review, using our experience from the software provider ...


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.

The US Biosimilar Market: Stunted Growth and Possible Reforms.

In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the Food and Drug Administration had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations ...

Advanced formulations for Intranasal Delivery of Biologics.

The global biologics market has been ever increasing over the last decades and is predicted to top Euro 350 by 2020. Facing this scenario, the parenteral route of biologics administration as hitherto standard route is inconvenient for the future. Among the alternatives, the intranasal delivery of therapeutic biologicals seems to be most promising but researchers are still facing challenges as indicated by the scarce number of successfully marketed peptide drugs.

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 ...

Eligibility for Supplemental Service-Disabled Veterans' Insurance. Final rule.

The Department of Veterans Affairs (VA), in this final rule, amends its regulations governing the Service-Disabled Veterans' Insurance (S-DVI) program in order to explain that a person who was granted S-DVI as of the date of death is not eligible for supplemental S-DVI because the insured's total disability did not begin after the date of the insured's application for insurance and while the insurance was in force under premium-paying conditions.

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.

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.

Dose Increase beyond Labelled Dose of Biologics Is Associated With Incremental Pharmacy Costs: Results from a Real-World Study In the UK.

Evidence regarding dosing patterns of biologics among moderate to severe psoriasis patients and impact on costs in the United Kingdom (UK) is limited.

Dosing considerations for inhaled biologics.

The number of biologics in the therapeutic development pipeline is increasing including those delivered though inhalation (Morales, 2017; Fathe, 2016). Biologics comprise a broad variety of complex macromolecules with unique physicochemical characteristics. These distinctive characteristics control their pharmacological mechanisms of action, stability, and ultimately affect their processing, formulation, and delivery requirements. This review systematically covers crucial aspects of biologic powders formula...

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 ...

Adherence and resource use among psoriasis patients treated with biologics.

The emergence of immune-modulating drugs such as biologics has altered the treatment landscape for psoriasis. However, their use presents high financial costs to patients and healthcare systems. Patient demographic and socioeconomic status may influence adherence to biologic medications and usage of healthcare resources. Areas covered: We performed a systematic literature review to summarize the available evidence pertaining to biologic medication adherence and resource use. PubMed was searched using the te...

Introduction of a Process Mass Intensity Metric for Biologics.

Biopharmaceuticals (or biologics), large molecule therapeutics typically produced using biotechnology, are a rapidly growing segment of the pharmaceutical market. As such, the environmental footprint of the production of these molecules is coming under scrutiny from various stakeholders such as healthcare providers, investors, and even employees. Process mass intensity (PMI), originally adopted for small molecules by the Green Chemistry Institute Pharmaceutical Roundtable, is a simple metric that can also b...

Supplemental LED inter-lighting compensates for a shortage of light for plant growth and yield under the lack of sunshine.

Supplemental lighting can enhance yield when sunlight is limited, as in winter. As the effect of frequent cloudy or rainy days in other seasons on plant growth and yield remains unclear, we investigated the effect on tomato (Solanum lycopersicum) and compensation by supplemental LED inter-lighting. Plants were grown under 30% shade cloth on 0%, 40%, or 60% of days. Lower leaves were illuminated with red and blue LED inter-lighting modules from right after first anthesis, or not illuminated. Shading during 4...

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.

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...

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, ...

Biologics and Small Molecule Agents in Allergic and Immunologic Skin Diseases.

Biologics and small molecules are key therapeutic options in the treatment of chronic immunologic and allergic skin conditions. By directly targeting innate and inflammatory responses within the skin, including pro-inflammatory cytokines and cellular signaling pathways, these new agents have the potential to counteract the inflammatory cascade responsible for various conditions, including psoriasis and atopic dermatitis. Over the past decade, groundbreaking research identifying key cytokines and receptors i...

The role of biologic in foot and ankle trauma-a review of the literature.

The use of biologics in orthopedics is becoming increasingly popular as an adjuvant in healing musculoskeletal injuries. Though many biologics involved in the management of foot and ankle injuries are used based on physician preference, reports of improved outcomes when combined with standard operative treatment has led to further clinical interest especially in foot and ankle trauma.

Tofacitinib Versus Non-Tumor Necrosis Factor Biologics for Patients With Active Rheumatoid Arthritis.

This study aims to compare the disease status of patients with active rheumatoid arthritis (RA) after treatment with tofacitinib or non- tumor necrosis factor (TNF) biologics.

The complexities of biosimilars and the regulatory approval process.

Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without a...


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