PubMed Journals Articles About "Expands Label Amgen Repatha" RSS

13:50 EDT 19th June 2018 | BioPortfolio

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Showing "expands label Amgen Repatha" PubMed Articles 1–25 of 1,000+

Letter--Incorporating Real-World Evidence and Patient Value Criteria into Value-Based Frameworks for Relapsed/Refractory Multiple Myeloma.

Orlowski has received research funding from Amgen, BioTheryX, Bristol-Myers Squibb, Celgene Corporation, and Takeda Pharmaceuticals; honoraria from Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Millennium Pharmaceuticals, and Onyx Pharmaceuticals; and is a member of advisory boards for Amgen, Bristol-Myers Squibb, Celgene Corporation, Incyte, Kite, Legend Biotech, Sanofi-Aventis, and Takeda Pharmaceuticals.

Evolocumab (Repatha®) : a human monoclonal antibody against PCSK9 protein as potent cholesterol-lowering therapy.

Evolocumab is a fully human monoclonal antibody (mAb) targeting ProProtein Convertase Subtilisin/Kexin 9 (PCSK9). PCSK9 is a circulating enzyme secreted by the liver and plays a key role in the LDL-Receptors (LDL-R) turnover. Binding of PCSK9 on the extracellular part of LDL-R is responsible for its degradation in the lysosome instead of its recycling to the cell surface, thereby producing a reduction in the number of LDL-R on the cell surface, a decreased LDL-C uptake and increased levels of LDL-C. Inhibit...

Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.

Labelling fashion magazine advertisements: Effectiveness of different label formats on social comparison and body dissatisfaction.

The experiment investigated the impact on women's body dissatisfaction of different forms of label added to fashion magazine advertisements. Participants were 340 female undergraduate students who viewed 15 fashion advertisements containing a thin and attractive model. They were randomly allocated to one of five label conditions: no label, generic disclaimer label (indicating image had been digitally altered), consequence label (indicating that viewing images might make women feel bad about themselves), inf...

Amgen cholesterol antibody feud could kill key IP rule.

The Supreme Court Ruling in Sandoz v Amgen: A Victory for Follow-on Biologics.

The Urgent Need for Optimal Monitoring of Metabolic Adverse Effects in Children and Youngsters Who Take On-label or Off-label Antipsychotic Medication.

Off-label antidepressant prescription in pediatric outpatients based on China Food and Drug Administration and Food and Drug Administration regulations: a Chinese retrospective study.

The objective of this study was to evaluate the prevalence and relative risk of off-label prescription of antidepressants in Chinese pediatric outpatients according to China Food and Drug Administration (C-FDA) and USFDA regulations. Medical records of 18 459 pediatric outpatients were identified between 2013 and 2015. Patient characteristics, prevalence of off-label antidepressant prescriptions, and relative risk factors associated with off-label prescribing were analyzed. The results indicate that patie...

Quantitative Peptidomics with Isotopic and Isobaric Tags.

In differential peptidomics, peptide profiles are compared between biological samples and the resulting expression levels are correlated to a phenotype of interest. This, in turn, allows us insight into how peptides may affect the phenotype of interest. In quantitative differential peptidomics, both label-based and label-free techniques are often employed. Label-based techniques have several advantages over label-free methods, primarily that labels allow for various samples to be pooled prior to liquid chro...

Sequence requirements of intrinsically fluorescent G-quadruplexes.

G-quadruplexes are four-stranded nucleic acid structures typically stabilized by GGGG tetrads. These structures are intrinsically fluorescent, which expands the known scope of nucleic acid function and raises the possibility that they could eventually be used as signaling components in label-free sensors constructed from DNA or RNA. In this study we systematically investigated the effects of mutations in tetrads, loops, and overhanging nucleotides on the fluorescence intensity and emission wavelength of mor...

The effect of a tactile-to-visual shift on young children's tendency to map novel labels onto novel objects.

When taught a label for an object and then asked whether an exemplar of that object or a novel object is the referent of a novel label, children favor the novel object. Preschool-aged children tend not to show this so-called disambiguation effect, however, when the test objects are presented in a different sense modality than the original object. The current experiments used a touch-to-vision paradigm to test two explanations for this unexpected pattern. Experiment 1 asked whether children might fail to ret...

Off-label prescription of antipsychotics.

Antipsychotic medication is frequently prescribed for off-label use in individuals with intellectual disability and elderly persons, in particular to reduce challenging behaviour. However, clear evidence for effectiveness is scarce and long-term use of antipsychotics is associated with a wide range of serious side-effects, including movement disorders and metabolic syndrome. Therefore, off-label use of antipsychotics in these populations has been widely debated. Nevertheless, non-pharmacological interventio...

Publisher Correction: NCoR/SMRT co-repressors cooperate with c-MYC to create an epigenetic barrier to somatic cell reprogramming.

In the version of this Article originally published, in Fig. 2c, the '+' sign and 'OSKM' were superimposed in the label '+OSKM'. In Fig. 4e, in the labels, all instances of 'Ant' should have been 'Anti-'. And, in Fig. 7a, the label '0.0' was misplaced; it should have been on the colour scale bar. These figures have now been corrected in the online versions.

Why do open-label placebos work? A randomized controlled trial of an open-label placebo induction with and without extended information about the placebo effect in allergic rhinitis.

Several studies demonstrated that placebo treatment may have a significant impact on many different symptoms. While in the traditional view concealment of the placebo is essential, recent studies report intriguing evidence that placebos may work even without deception. For example, it has been demonstrated that open-label placebos can improve symptoms in allergic rhinitis. However, the mechanisms of how placebos without concealment work remain unknown.

Evaluating off-label uses of acetazolamide.

Current off-label uses of acetazolamide in hospitalized patients are reviewed.

ASJ Expands to Monthly Publication.

Manifold regularized matrix completion for multi-label learning with ADMM.

Multi-label learning is a common machine learning problem arising from numerous real-world applications in diverse fields, e.g, natural language processing, bioinformatics, information retrieval and so on. Among various multi-label learning methods, the matrix completion approach has been regarded as a promising approach to transductive multi-label learning. By constructing a joint matrix comprising the feature matrix and the label matrix, the missing labels of test samples are regarded as missing values of...

Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label.

Juvenile animal testing has become an established part of drug development to support safe clinical use in the human pediatric population and for eventual drug product label use.

Use of cholera vaccines expands, raising hopes.

Seeing More: A Future of Augmented Microscopy.

Microscope images are information rich. In this issue of Cell, Christiansen et al. show that label-free images of cells can be used to predict fluorescent labels representing cell type, state, and organelle distribution using a deep-learning framework. This paves the way for computationally multiplexed assays derived from inexpensive label-free microscopy.

Off-label Prescribing Trends for ADHD Medications in Very Young Children.

This study examines off-label medication prescribing use and trends in children on Medicaid with ADHD with particular focus on the very young (under age 6 years).

South African Men Who Have Sex With Both Men and Women and How They Differ From Men Who Have Sex With Men Exclusively.

The label "men who have sex with men" (MSM) is used to categorize a diverse population exclusively on the basis of its sexual behavior. Understanding the diversity that this label comprises is critical for the development of health interventions that effectively reach the various populations subsumed under this label. In this cross-sectional study of South African MSM (N = 480) recruited through respondent-driven sampling (RDS), we explored differences between men who had sex with both men and women (MSMW...

Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe.

To report and discuss estimated prevalence of potential off-label use and associated methodological challenges using a case study of dabigatran.

Alirocumab in high-risk patients: Observations from the open-label expanded use program.

The alirocumab expanded use program provided open-label access to alirocumab before its commercial availability to patients with severe hypercholesterolemia not controlled with maximally tolerated doses of standard-of-care lipid-lowering therapy.

Prescribing Placebos: An Experimental Examination of the Role of Dose, Expectancies, and Adherence in Open-Label Placebo Effects.

Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect.

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