PubMed Journals Articles About "Ligand Receive Million From WuXi Biologics Licensing Clinical" RSS

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Showing "Ligand Receive Million from WuXi Biologics Licensing Clinical" PubMed Articles 1–25 of 32,000+

Biologics Delay Progression of Crohn's Disease, but Not Early Surgery, in Children.

Up to 30% of patients with Crohn's disease (CD) require surgery within the first 5 years from diagnosis. We investigated the recent risk of bowel surgery in an inception cohort of pediatric patients with CD and whether early use of biologics (tumor necrosis factor antagonists) alters later disease course.

Step Up-Not On-The Step 2 Clinical Skills Exam: Directors of Clinical Skills Courses (DOCS) Oppose Ending Step 2 CS.

Recently, a student-initiated movement to end the United States Medical Licensing Examination Step 2 Clinical Skills and the Comprehensive Osteopathic Medical Licensing Examination Level 2-Performance Evaluation has gained momentum. These are the only national licensing examinations designed to assess clinical skills competence in the stepwise process through which physicians gain licensure and certification. Therefore, the movement to end these examinations and the ensuing debate merit careful consideratio...


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.

Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma.

Recent efficacy studies of asthma biologics have included highly enriched patient populations. Using a similar approach, we examined factors that predict response to omalizumab to facilitate selection of patients most likely to derive the greatest clinical benefit from therapy.

Proposal for the development of biologics in pediatric rheumatology field.

In order to aim at the development, approval and early introduction into clinical practice of biologics in pediatric field, we investigated the present situation of the development to approval of biologics as anti-rheumatic agents for children in Japan, visualize the present problems and give a proposal for the future. As results of analysis in various directions, it is apparent that the duration of a review period required for the preparation of clinical trials and the approval in PMDA clearly reduced comp...

Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Therapeutic drug monitoring (TDM), or the measurement of drug concentrations in blood and antidrug antibodies, for biologic therapies used to treat inflammatory bowel disease (IBD) is an area of growing interest within the IBD community. When there is a definable relationship between drug concentration and clinical effect, blood concentration of biologics (and antidrug antibodies assessment) could be used to predict patient response and to titrate the biologics to maximize therapeutic benefit. This dose ind...

Infliximab Therapeutic Drug Monitoring Changes Clinical Decisions in a Virtual Biologics Clinic for Inflammatory Bowel Disease.

Virtual biologics clinics are often used to review patients with inflammatory bowel disease receiving biological therapy, with decisions whether to continue, switch, or stop therapy made based on review of symptoms, disease history, and investigations. We aimed to investigate whether therapeutic drug monitoring of infliximab (IFX) trough levels and anti-drug antibodies influences decision making within a virtual biologics clinic.

Rapid DNA replication origin licensing protects stem cell pluripotency.

Complete and robust human genome duplication requires loading MCM helicase complexes at many DNA replication origins, an essential process termed origin licensing. Licensing is restricted to G1 phase of the cell cycle, but G1 length varies widely among cell types. Using quantitative single cell analyses we found that pluripotent stem cells with naturally short G1 phases load MCM much faster than their isogenic differentiated counterparts with long G1 phases. During the earliest stages of differentiation tow...

Biologic Therapy and Asthma.

Although airway inflammation is an intrinsic and key feature of asthma, this response varies in its intensity and translation to clinical characteristics and responsiveness to treatment. The observations that clinical heterogeneity is an important aspect of asthma and a feature that likely dictates and determines responses to treatment in severe asthma, patient responsiveness to medication is incomplete, and risks for exacerbation are increased. The development of biologics, which target selected and specif...

Can We Increase the Value and Decrease the Cost of Clinical Skills Assessment?

Although the authors do not agree with medical students' bid to end the United States Medical Licensing Examination Step 2 Clinical Skills or Comprehensive Osteopathic Medical Licensing Examination Level 2-Performance Evaluation tests, they concur with Ecker and colleagues that conducting further research to support the validity argument, providing greater feedback on performance, and exploring options to reduce costs are important for addressing students' concerns. Evidence to support the validity of clini...

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.

Response to "The Role of FcRn in the Pharmacokinetics of Biologics in Patients with Multiple Myeloma".

Antirheumatic biologics in pregnant patients: a call for studies to address the knowledge gap.

68Ga-PSMA-Ligand PET/CT Uptake in Anthracosilicosis.

This interesting image illustrates a case of biopsy-proven pulmonary anthracosilicosis, a mixed dust pneumoconiosis, associated with Ga-PSMA-ligand uptake. Prostate-specific membrane antigen (PSMA) is an emerging imaging biomarker, with clinical application in evaluation of prostate cancer using Ga-PSMA-ligand PET/CT. Contrary to its name, PSMA is expressed in a number of other normal tissues and pathological states. Prostate-specific membrane antigen expression has been linked to tumor angiogenesis in vari...

Biologics for idiopathic inflammatory myopathies.

As treatment of refractory cases of idiopathic inflammatory myopathies (IIMs) has been challenging, there is growing interest in assessing novel biologics that target various pathways implicated in the pathogenesis of IIM.

Attitudes toward placebo-controlled clinical trials among depressed patients in Japan.

Placebo-controlled clinical trials are the standard in the design of clinical studies for the licensing of new drugs. Medical and ethical concerns regarding placebo use still exist in clinical trials of depressed patients. The aim of this study was to investigate the attitudes toward placebo-controlled clinical trials and to assess factors related to the willingness to participate in such trials among depressed patients in Japan.

Scope and Nature of Pain- and Analgesia-Related Content of the United States Medical Licensing Examination (USMLE).

"The ongoing opioid crisis lies at the intersection of two substantial public health challenges-reducing the burden of suffering from pain and containing the rising toll of the harms that can result from the use of opioid medications" [1]. Improved pain education for health care providers is an essential component of the multidimensional response to both still-unmet challenges [2,3]. Despite the importance of licensing examinations in assuring competency in health care providers, there has been no prior app...

When Should "Pre" Carry as Much Weight in the Diabetes Comorbidity Debate? Insights From a Population-Based Survey.

Estimates indicate that 86 million people in the United States fit the clinical definition of prediabetes, which contributes to the epidemic of nearly 2 million new diagnoses of type 2 diabetes mellitus each year. Effort has focused on preventing prediabetes from progressing to clinical diabetes. We investigated the sociodemographic, behavioral, and health factors in people diagnosed with diabetes or prediabetes and associated leading indicators and comorbidities.

Neutralization of CD40 ligand costimulation promotes bone formation and accretion of vertebral bone mass in mice.

Immunosuppressive biologics are used in the management of RA and additional immunomodulators are under investigation including modulators of the CD40/CD40 ligand (CD40L) costimulation pathway. Tampering with immune function can have unanticipated skeletal consequences due to disruption of the immuno-skeletal interface, a nexus of shared cells and cytokine effectors serving discrete functions in both immune and skeletal systems. In this study, we examined the effect of MR1, a CD40L neutralizing antibody, on ...

Performance of candidates disclosing dyslexia with other candidates in a UK medical licensing examination: cross-sectional study.

The aim of this study was to compare performance of candidates who declared an expert-confirmed diagnosis of dyslexia with all other candidates in the Applied Knowledge Test (AKT) of the Membership of the Royal College of General Practitioners licensing examination.

Non-protein biologic therapeutics.

While the therapeutic biologics are dominated by therapeutic proteins, particularly monoclonal antibodies, a wide range of non-protein therapeutic biologics are rapidly gaining ground both in clinical studies and approved products. Many of these first-in-class therapies provide novel treatment modalities and address previously untreatable conditions or undruggable targets. In particular, novel treatments for rare genetic disorders and qualitatively different oncology therapeutics have been approved in the l...

Buccal delivery of small molecules and biologics: of mucoadhesive polymers, films, and nanoparticles.

Buccal delivery of macromolecules (biologics) sets a great challenge for researchers. Although several niche small molecule products have been approved as simple sprays, tablets and oral films, it is not simply a case of adapting existing technologies to biologics. Buccal delivery of insulin has reached clinical trials with two approaches: oromucosal sprays of the peptide with permeation enhancers, and embedded gold nanoparticles in a dissolvable film. However, neither of these approaches have led to FDA ap...

Expression of Programmed Death Ligand 1 (PD-L1) in Posttreatment Primary Inflammatory Breast Cancers and Clinical Implications.

Inflammatory breast carcinoma (IBC) is rare but is the most lethal type of breast cancer. Programmed death ligand 1 (PD-L1) expression in IBCs has been understudied.

Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries.

Biologics have greatly improved psoriasis management. However, primary and secondary non-response to treatment requires innovative strategies to optimize outcomes.

Long-Term Increase of Radiographic Damage and Disability in Patients with RA in Relation to Disease Duration in the Era of Biologics. Results from the SCQM Cohort.

There is little information on the relation between disease duration, disability and radiographic outcome since the introduction of biologics into the therapy of rheumatoid arthritis (RA). No long -term cohort studies have been conducted on this subject so far. To analyse radiographic damage, disability, and disease activity in RA-patients dependent on disease duration in the Swiss national RA cohort (SCQM).

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