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FDA Research

08:29 EDT 20th August 2018 | BioPortfolio

Acute oral toxicity and anti-inflammatory evaluation of methanolic extract of Rotula aquatica roots in Wistar rats.

The plant Rotula aquatica Lour. was traditionally well known due to its large number of pharmacological action and medicinal uses. The plant is a necessary component of many Ayurvedic drug preparations since historical times. It is widely used as a crucial ancient drug for kidney and bladder stones.

FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the V600 Mutation.

On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to vemurafenib for the treatment of adult patients with Erdheim-Chester disease (ECD) with V600 mutation. ECD is a type of histiocytosis, a rare disorder characterized by an abnormal accumulation and behavior of cells of the mononuclear phagocytic system, which includes antigen-processing cells, dendritic cel...

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse Station, NJ) for the treatment of patients with recurrent, locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after two or more systemic therapies, including fluoropyrimidine-...

Epigenetic dysregulation of naive CD4+ T-cell activation genes in childhood food allergy.

Food allergy poses a significant clinical and public health burden affecting 2-10% of infants. Using integrated DNA methylation and transcriptomic profiling, we found that polyclonal activation of naive CD4+ T cells through the T cell receptor results in poorer lymphoproliferative responses in children with immunoglobulin E (IgE)-mediated food allergy. Reduced expression of cell cycle-related targ...

Visceral adiposity and insular networks: associations with food craving.

Accumulation of visceral adiposity can disrupt the brain's sensitivity to interoceptive feedback, which is coded in the insula. This study aimed to test the link between visceral fat and the functional connectivity of two insulae regions relevant for eating behavior: the middle-dorsal insula (mIns), which codes homeostatic changes, and the rostral insula (rIns), which codes stable representations ...

The impact of rising food prices on obesity in women: a longitudinal analysis of 31 low-income and middle-income countries from 2000 to 2014.

To examine whether changes in food prices are associated with changes in obesity prevalence among women in developing countries, and assess effect modification by individual socioeconomic status (SES).

Combined Effect of NF-κB Inhibitor and β2-Adrenoreceptor Agonist on Mouse Mortality and Blood Concentration of Proinflammatory Cytokines in Sepsis.

Experiments on random-bred albino mice showed that NF-κB inhibitor (BAY 11-7082) and β2-adrenoreceptor agonist (dexmedetomidine hydrochloride) significantly reduced mouse mortality in 4 and 24 h after sepsis modeling (intraperitoneal administration of E. coli) by reducing blood levels of proinflammatory cytokines TNFα, IL-1β, and IL-6. The combined administration of NF-κB inhibitor and β2-ad...

Proportionate palliative sedation and the giving of a deadly drug: the conundrum.

Among the oldest extant medical ethics, the Hippocratic Oath prohibits the giving of a deadly drug, regarding this act as an egregious violation of a medical ethic that is exclusively therapeutic. Proportionate palliative sedation involves the administration of a deadly drug. Hence it seems to violate the venerable Hippocratic promise associated with the dawn of Western medicine not to give a dead...

Sources of Stress among Adults with Co-occurring Drug Use and Depressive Symptoms.

Stress, drug use, and depression are interconnected, but less is understood about sources of stress among adults with co-occurring drug use and depressive symptoms. The current study aimed to identify sources of stress and correlates among these adults. Data come from a cross-sectional baseline survey, including participants (n = 336) 18 to 55 years old, who reported past 6-month heroin or co...

Any reward will do: Effects of a reverse-reward contingency on size preference with pet dogs (Canis lupus familiaris).

The reverse-reward contingency (RRC) task involves presenting subjects with a choice between one plate containing a large amount of food and a second plate containing a small amount of food. Subjects are then required to select the smaller of the two options in order to receive the larger-magnitude reward. The RRC task is a commonly used paradigm for assessing complex cognition, such as inhibitory...

Evaluation of renal excretion and pharmacokinetics of furosemide in rats after acute exposure to high altitude at 4300m.

With studies indicative of altered renal excretion under high altitude (HA)-induced hypobaric hypoxia (HH), consideration of better therapeutic approaches has continuously been aimed in research for HA related illness management. Pharmacokinetics of drugs like furosemide might be altered under hypoxic condition, which makes essential to establish different dose-regimen to maintain therapeutic effi...

Defining Regional Differences in Drug-Induced Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Tool to Improve Drug Safety?

A RAPID AND RELIABLE ASSAY TO DETERMINE FLUMEQUINE, MARBOFLOXACIN, DIFLOXACIN AND SARAFLOXACIN IN THE MOST CONSUMED MEAT BY MICELLAR LIQUID CHROMATOGRAPHY.

Micellar liquid chromatography - fluorescence detection was used to determine the antibiotics flumequine, marbofloxacin, difloxacin and sarafloxacin in porcine, bovine, poultry, ovine, caprine, rabbit and equine meat, to verify their compliance with the EU Regulation 37/2010 about the occurrence of veterinary drugs in food.

Current and Investigational Agents Targeting the Phosphoinositide 3-Kinase Pathway.

Prevalent molecular alterations of the phosphoinositide 3-kinase (PI3K) pathway are found on solid tumors and are expressed in leukocytes, making it a desirable target in both solid and hematologic malignancies. In recent years, two agents targeting this pathway have been approved by the United States Food and Drug Administration, idelalisib and copanlisib, with many others under investigation. Du...

Neighborhood food environment, dietary fatty acid biomarkers, and cardiac arrest risk.

We explored links between food environments, dietary intake biomarkers, and sudden cardiac arrest in a population-based longitudinal study using cases and controls accruing between 1990 and 2010 in King County, WA. Surprisingly, presence of more unhealthy food sources near home was associated with a lower 18:1 trans-fatty acid concentration (-0.05% per standard deviation higher count of unhealthy ...

Resolving the predator first paradox: arthropod predator food webs in pioneer sites of glacier forelands.

Primary succession on bare ground surrounded by intact ecosystems is, during its first stages, characterized by predator-dominated arthropod communities. However, little is known on what prey sustains these predators at the start of succession and which factors drive the structure of these food webs. As prey availability can be extremely patchy and episodic in pioneer stages, trophic networks migh...

Design, synthesis and evaluation of novel diphenyl ether derivatives against drug susceptible and resistant strains of Mycobacterium tuberculosis.

In our efforts to develop druggable diphenyl ethers as potential antitubercular agents, a series of novel diphenyl ether derivatives (5a-f, 6a-f) were designed and synthesized. The representative compounds showed promising in vitro activity against drug susceptible, isoniazid resistant and multi drug resistant strains of Mycobacterium tuberculosis with MIC values of 1.56 μg/mL (6b), 6.25 μg/mL (...

Characterization of SPR994, an Orally Available Carbapenem, with Activity Comparable to Intravenously Administered Carbapenems.

Carbapenems are potent antibacterials with broad-spectrum activity. However, poor oral absorption generally confines this important drug class to in-hospital use by intravenous (IV) administration. The continued rise in drug resistant pathogens creates a need for alternative oral therapies with broad-spectrum activity. SPR994 is a novel formulation of the orally bioavailable pivoxil prodrug of SPR...

Acquired partial lipodystrophy treated with poly-L-lactic acid and hyaluronic acid fillers: a case report.

Acquired partial lipodystrophy (APL), also known as Barraquer-Simons syndrome, is a rare disorder characterized by progressive fat loss in the upper body. Use of poly-L-lactic acid and hyaluronic acid (HA) fillers for the treatment of APL is neither approved by the Food and Drug Administration nor described in the literature. Herein, we describe a case of APL that achieved significant improvement ...

Microbial Biotransformation - An Important Tool for the Study of Drug Metabolism.

1. Metabolite identification is an integral part of both preclinical and clinical drug discovery and development. Synthesis of drug metabolites is often required to support definitive identification, preclinical safety studies and clinical trials. 2. Here we describe the use of microbial biotransformation as a tool to produce drug metabolites, complementing traditional chemical synthesis and other...

Acceptability of Injectable and On-Demand Pre-Exposure Prophylaxis Among an Online Sample of Young Men Who Have Sex with Men in California.

Pre-exposure prophylaxis (PrEP) is an effective strategy to prevent HIV. However, low uptake of daily oral PrEP since Food and Drug Administration approval and low medication adherence among users have stimulated the investigation of other modalities for delivery, such as injectable PrEP and on-demand PrEP. The objective of this study was to determine the demographic and behavioral predictors of w...

Food Safety Knowledge and Self-Reported Food-Handling Practices in Cancer Treatment.

To explore awareness of foodborne infection risk during chemotherapy treatment, to assess knowledge of risk-reducing food safety practices in patients with cancer and their family caregivers, and to determine self-reported food-handling practices.

Cocaine self-administration is increased after frontal traumatic brain injury and associated with neuroinflammation.

Traumatic brain injury (TBI) has been linked to the development of numerous psychiatric diseases, including substance use disorder. However, it can be difficult to ascertain from clinical data whether the TBI is cause or consequence of increased addiction vulnerability. Surprisingly few studies have taken advantage of animal models to investigate the causal nature of this relationship. In terms of...

Impact of transporters and enzymes from blood-cerebrospinal fluid barrier and brain parenchyma on CNS drug uptake.

In parallel with the blood-brain barrier (BBB), transporters and enzymes on the blood-cerebrospinal fluid barrier (BCSFB) serve as the first barrier for drug brain uptake. In addition, their expressions on the brain parenchyma are considered as the secondary barrier for central nervous system (CNS) drug delivery. Currently, a lack of information on transporters and enzymes expressed on both BCSFB ...

Fighting Kinase Drug Resistance with Caspase Activators.

Kinase inhibitors are effective cancer therapies. Unfortunately, drug resistance emerges in response to kinase inhibition leading to loss of drug efficacy. In this issue of Cell Chemical Biology, Peh et al. (2018) demonstrate that caspase activators effectively delay onset of resistance to kinase inhibitors and are excellent co-therapeutics for a number of tumor types.

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