Drug Approvals Research

13:02 EST 12th December 2017 | BioPortfolio

Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current m...

Exosomes derived from imatinib-resistant chronic myeloid leukemia cells mediate a horizontal transfer of drug-resistant trait by delivering miR-365.

Chronic myeloid leukemia (CML) is a malignant disorder of hematopoietic stem/progenitor cells. Majority of patients can be effectively treated with tyrosine kinase inhibitors (TKIs) such as imatinib, but a portion of patients will develop drug resistance. Accumulated evidences have identified exosomes in cancer as promoters of tumor progression. Herein, we found that exosomes derived from imatinib...

Polymeric gels for intravaginal drug delivery.

Intravaginal drug delivery can elicit a local effect, or deliver drugs systemically without hepatic first pass metabolism. There are a number of emerging areas in intravaginal drug delivery, but the vagina is a challenging route of administration, due to the clearance mechanisms present which result in poor retention of dosage forms, and the potential for irritation and other adverse reactions. Ge...

Recent encounters with atropisomerism in drug discovery.

Atropisomerism is stereochemistry arising from restricted bond rotation that creates a chiral axis. Atropisomers are subject to time-dependent inversion of chirality via bond rotation, a property which in drug molecules introduces complexity and challenges for drug discovery and development processes. Greater recognition of the occurrence of atropisomerism and improved characterization techniques ...

The role of targeted therapy in the management of patients with AML.

Drug therapy for acute myeloid leukemia (AML) is finally undergoing major changes in 2017. This is due to the US Food and Drug Administration's approval of several new, targeted agents (midostaurin, enasidenib, and gemtuzumab ozogamicin). Paired with the recent approval of a novel liposomal formulation of daunorubicin/cytarabine (CPX-351/Vyxeos), the standard of care is changing rapidly in AML for...

Non-chemotherapy drug-induced neutropenia: key points to manage the challenges.

Non-chemotherapy idiosyncratic drug-induced neutropenia (IDIN) is a relatively rare but potentially fatal disorder that occurs in susceptible individuals, with an incidence of 2.4 to 15.4 cases per million population. Affected patients typically experience severe neutropenia within several weeks to several months after first exposure to a drug, and mortality is ∼5%. The drugs most frequently ass...

Coefficient of Friction Between Carboxymethylated Hyaluronic Acid-Based Polymer Films and the Ocular Surface.

Hyaluronic acid-based polymer films are emerging as drug-delivery vehicles for local and continuous drug administration to the eye. The highly lubricating hyaluronic acid increases comfort, but displaces films from the eye, reducing drug exposure and efficacy. Previous studies have shown that careful control of the surface interaction of the film with the eye is critical for improved retention.

Venetoclax for Treating Chronic Lymphocytic Leukaemia: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

Venetoclax is licensed to treat relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL). As part of the Single Technology Appraisal (STA) ID944, the National Institute for Health and Care Excellence (NICE) invited AbbVie, the manufacturer, to submit evidence on the use of venetoclax, within its licensed indication. The Evidence Review Group (ERG), Warwick Evidence, was asked to provide an...

Categorization and association analysis of risk factors for adverse drug events.

Adverse drug events (ADE) are among the leading causes of morbidity and hospitalization. This review analyzes risk factors for ADE, particularly their categorizations and association patterns, the prevalence, severity, and preventability of ADE, and method characteristics of reviewed studies.

Nonmedical prescription opioids and pathways of drug involvement in the US: Generational differences.

This study sought to specify (1) the position of nonmedical prescription opioids (NMPO) in drug initiation sequences among Millennials (1979-96), Generation X (1964-79), and Baby Boomers (1949-64) and (2) gender and racial/ethnic differences in sequences among Millennials.

Interaction between pre-treatment drug use and heterogeneity of psychiatric diagnosis predicts outcomes in outpatients with co-occurring disorders.

We examined whether the interaction of baseline stimulant use, assessed by urine drug tests, and type of serious mental illness (SMI) diagnosis predicted stimulant use in a trial of contingency management (CM). The interaction between baseline stimulant use and SMI diagnoses was significant in the overall sample (p=0.002) when controlling for the main effects of treatment condition, baseline stimu...

High-Content Screening Comparison of Cancer Drug Accumulation and Distribution in Two-Dimensional and Three-Dimensional Culture Models of Head and Neck Cancer.

High cancer drug development attrition rates have provoked considerable debate about whether the two-dimensional tumor growth inhibition high-throughput screening assays used in pre-clinical lead discovery adequately reflect solid tumor complexity. We used automated high-content screening image acquisition and analysis methods to compare fluorescent drug uptake, accumulation, and distribution in C...

New and Incremental FDA Black Box Warnings from 2008 to 2015.

The boxed warning (also known as "black box warning [BBW]") is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval.

1-adrenoceptor in the central amygdala is required for unconditioned stimulus-induced drug memory reconsolidation.

Drug memories become labile and reconsolidated after retrieval by presentation of environmental cues (conditioned stimulus, CS) or drugs (unconditioned stimulus, US). Whether CS- and US-retrieval trigger different memory reconsolidation processes is not clear.

Basics of Compounding: 3D Printing--Pharmacy Applications: Geometric Shape Effects on 3D Printing.

As patient therapy becomes more specialized and individualized, one applicable method of drug delivery is through 3D printing. With 3D printing, pharmacists can provide either immediate or modified drug release of either an individual drug or multiple drugs in a singledosage unit. The release rates can be varied, not only by excipients in the formulation, but also to some extent by the shapes of t...

Hospitalizations due to drug poisoning in under-five-year-old children in Brazil, 2003-2012.

to describe hospitalizations due to drug poisonings in children under five years old, in Brazil, from 2003 to 2012.

Improvement in Ocular Bioavailability and Prolonged Delivery of Tobramycin Sulfate Following Topical Ophthalmic Administration of Drug-Loaded Mucoadhesive Microparticles Incorporated in Thermosensitive In Situ Gel.

Conventional topical delivery in hyperacute bacterial conjunctivitis and endophthalmitis is associated with low drug bioavailability due to rapid precorneal clearance. Hence, in the present investigation, an attempt has been made to enhance ocular bioavailability of tobramycin sulfate by formulating drug-loaded microparticles dispersed in thermosensitive in situ gel.

Alcohol-abuse drug disulfiram targets cancer via p97 segregase adaptor NPL4.

Cancer incidence is rising and this global challenge is further exacerbated by tumour resistance to available medicines. A promising approach to meet the need for improved cancer treatment is drug repurposing. Here we highlight the potential for repurposing disulfiram (also known by the trade name Antabuse), an old alcohol-aversion drug that has been shown to be effective against diverse cancer ty...

Parent-infant co-sleeping and the implications for sudden infant death syndrome.

In 2015 the National Institute for Health and Care Excellence (NICE) updated its 2006 guideline to clarify the association between parent infant co-sleeping and sudden infant death syndrome (SIDS). The practice of co-sleeping is a topic of continuing controversy and debate. Rather than highlighting the risks, the emphasis of the NICE guideline is to provide parents with balanced information so tha...

ADVERPred - web service for prediction of adverse effects of drugs.

Application of structure-activity relationships (SARs) for the prediction of adverse effects of drugs (ADEs) has been reported in many published studies. Training sets for the creation of SAR models are usually based on drug label information which allows for the generation of datasets for many hundreds of drugs. Since many ADEs may not be related to drug consumption, one of the main problems in s...

Drug-induced sleep endoscopy: from obscure technique to diagnostic tool for assessment of obstructive sleep apnea for surgical interventions.

Provide a practical update on drug-induced sleep endoscopy (DISE) for anesthesia providers, which can also serve as a reference for those preparing to establish a DISE program.

Comparison of the Arktm Immunoassay With Hplc-Uv for Therapeutic Drug Monitoring of Linezolid.

An enzymatic immunoassay is under development by ARK Diagnostics, Inc. for the quantification of plasma concentrations of linezolid (LZD). In the present study, the authors aimed to assess the performance of this immunoassay using a validated HPLC-UV method as reference.

Key Factors Influencing the Emergence of Human Immunodeficiency Virus Drug Resistance in Low- and Middle-Income Countries.

The emergence and spread of human immunodeficiency virus (HIV) drug resistance from antiretroviral roll-out programs remain a threat to long-term control of the HIV-AIDS epidemic in low- and middle-income countries (LMICs). The patterns of drug resistance and factors driving emergence of resistance are complex and multifactorial. The key drivers of drug resistance in LMICs are reviewed here, and r...

The Role of HIV-1 Drug-Resistant Minority Variants in Treatment Failure.

Human immunodeficiency virus type 1 (HIV-1) drug resistance genotyping is recommended to help in the selection of antiretroviral therapy and to prevent virologic failure. There are several ultrasensitive assays able to detect HIV-1 drug-resistance minority variants (DRMVs) not detectable by standard population sequencing-based HIV genotyping assays. Presence of these DRMVs has been shown to be cli...

Mental disorders and drug/alcohol use in patients commencing extensively drug-resistant tuberculosis treatment.

Mental disorders and alcohol/drug use worsen treatment outcomes for multidrug-resistant tuberculosis (TB), but data are lacking for extensively drug-resistant (XDR) TB. We investigated the association of baseline mental disorders and alcohol/drug use on XDR-TB treatment outcomes in a retrospective study of 53 XDR-TB Peruvian patients during 2010-2012. Logistic regression estimated the odds ratios ...

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