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https://www.readbyqxmd.com/read/29786658/melatonin-as-a-therapy-for-traumatic-brain-injury-a-review-of-published-evidence
#1
REVIEW
Nicole Osier, Emily McGreevy, Lan Pham, Ava Puccio, Dianxu Ren, Yvette P Conley, Sheila Alexander, C Edward Dixon
Melatonin (MEL) is a hormone that is produced in the brain and is known to bind to MEL-specific receptors on neuronal membranes in several brain regions. MEL's documented neuroprotective properties, low toxicity, and ability to cross the blood-brain-barrier have led to its evaluation for patients with traumatic brain injury (TBI), a condition for which there are currently no Food and Drug Administration (FDA)-approved therapies. The purpose of this manuscript is to summarize the evidence surrounding the use of melatonin after TBI, as well as identify existing gaps and future directions...
May 22, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29785254/low-rates-of-patient-reported-outcome-claims-for-orphan-drugs-approved-by-the-us-food-and-drug-administration
#2
Szymon Jarosławski, Pascal Auquier, Borislav Borissov, Claude Dussart, Mondher Toumi
Background : Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs' benefits and risks. Objective : We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive set of US FDA orphan drug approvals dated between 1/1/2012 and 31/12/2016, and characterize them. Study design : Orphan drug approval documentation was obtained from the US FDA website. Drug Package Inserts (PI) were analyzed to extract information on PRO-related language...
2018: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/29784734/new-nccn-guidelines-recognition-and-management-of-immunotherapy-related-toxicity
#3
John A Thompson
Immune checkpoint inhibitors (ICIs) are now FDA-approved for the treatment of 8 different cancers, and more approvals are likely, including use of these drugs in combinations. Although ICIs represent a true advance in cancer care, they can cause a range of immune-related adverse events. As more experience with ICIs is gained, more information is becoming available on immunotoxicity and optimal management. Physicians and patients need to be educated about potential adverse events and management of ICI-associated toxicity...
May 2018: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/29784458/efficacy-of-antiepileptic-drugs-in-the-adjunctive-treatment-of-refractory-partial-onset-seizures-meta-analysis-of-pivotal-trials
#4
Jeremy Slater, Steve Chung, Lynn Huynh, Mei Sheng Duh, Brian Gorin, Carolyn McMicken, Adam Ziemann, Jouko Isojarvi
OBJECTIVE: In the absence of randomized clinical trials (RCTs) assessing the relative efficacy of antiepileptic drugs (AEDs), meta-analyses are useful resources for informing treatment choices. This meta-analysis assesses the relative efficacy and tolerability of AEDs for adjunctive treatment of refractory partial onset seizures (POS). METHODS: A systematic literature review was conducted to identify pivotal AED trials serving as the basis for US Food and Drug Administration (FDA) approval...
July 2018: Epilepsy Research
https://www.readbyqxmd.com/read/29784433/fda-and-nist-collaboration-on-standards-development-activities-supporting-innovation-and-translation-of-regenerative-medicine-products
#5
Judith A Arcidiacono, Steven R Bauer, David S Kaplan, Clare M Allocca, Sumona Sarkar, Sheng Lin-Gibson
The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine...
May 18, 2018: Cytotherapy
https://www.readbyqxmd.com/read/29783894/fulvestrant-in-management-of-hormone-receptor-positive-metastatic-breast-cancer
#6
Maryam Nemati Shafaee, Matthew James Ellis
Fulvestrant is a steroidal selective estrogen receptor degrader that was approved by the US FDA in 2002 for treatment of ER-positive metastatic breast cancer (ER + MBC) post-progression on aromatase inhibitors. In 2016, the label was updated to include endocrine therapy naive ER + MBC. While initially fulvestrant was thought to be equivalent to aromatase inhibitors with monthly dose of 250 mg intramuscular injection, several postmarketing trials challenged this understanding. Subsequently, the recommended dose changed to 500 mg monthly plus loading dose, and this was proven to be superior to anastrozole in efficacy...
May 22, 2018: Future Oncology
https://www.readbyqxmd.com/read/29783113/automated-uhplc-separation-of-10-pharmaceutical-compounds-using-software-modeling
#7
A Zöldhegyi, H-J Rieger, I Molnár, L Fekhretdinova
Human mistakes are still one of the main reasons of underlying regulatory affairs that in a compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) must be eliminated. To develop smooth, fast and robust methods that are free of human failures, a state-of-the-art automation was presented. For the scope of this study, a commercial software (DryLab) and a model mixture of 10 drugs were subjected to testing. Following AQbD-principles, the best available working point was selected and conformational experimental runs, i...
March 20, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29781779/comparisons-of-false-negative-rates-from-a-trend-test-alone-and-from-a-trend-test-jointly-with-a-control-high-groups-pairwise-test-in-the-determination-of-the-carcinogenicity-of-new-drugs
#8
Karl K Lin, Mohammad A Rahman
Interest has been expressed in using a joint test procedure that requires that the results of both a trend test and a pairwise comparison test between the control and the high groups be statistically significant simultaneously at the levels of significance recommended in the FDA 2001 draft guidance for industry document for the separate tests in order for the drug effect on the development of an individual tumor type to be considered as statistically significant. Results of our simulation studies show that there is a serious consequence of large inflations of the false negative rate through large decreases of false positive rate in the use of the above joint test procedure in the final interpretation of the carcinogenicity potential of a new drug if the levels of significance recommended for separate tests are used...
May 21, 2018: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29779849/how-much-progress-has-there-been-in-the-second-line-treatment-of-multiple-sclerosis-a-2017-update
#9
REVIEW
A Maarouf, C Boutière, A Rico, B Audoin, J Pelletier
In 1993, the US Food and Drug Administration (FDA) approved the first drug specifically for treating multiple sclerosis (MS). More than two decades later, a dozen such treatments are now available. Of these, four are considered second-line treatments for use in escalation strategies and two new drugs are currently undergoing accreditation procedures. Soon, they will provide clinicians with a range of six effective disease-modifying treatments (DMTs) to thwart the inflammatory processes in MS patients with active disease...
May 17, 2018: Revue Neurologique
https://www.readbyqxmd.com/read/29779531/orphan-drugs-and-their-impact-on-pharmaceutical-development
#10
REVIEW
Misty M Attwood, Mathias Rask-Andersen, Helgi B Schiöth
High levels of productivity, with an increasing number of approvals for new molecular entities (NMEs) by the FDA during the past decade, have coincided with the emergence of innovative drugs for treatments of rare diseases that have utilized the FDA orphan drug program. Since 2000, NMEs with orphan designation encompass a significant portion of approved drugs and constitute about 80% of the approved drugs that have established novel human genome-encoded products in recent years. Biological approvals are also expanding, with 40% of the approved biological agents having orphan designation...
June 2018: Trends in Pharmacological Sciences
https://www.readbyqxmd.com/read/29778492/tanovea%C3%A2-for-the-treatment-of-lymphoma-in-dogs
#11
REVIEW
Erik De Clercq
Tanovea® (first named GS-9219, then VDC-1101, generic name: rabacfosadine) is a pro-prodrug or "double" prodrug of PMEG [9-(2-phosphonylmethoxyethyl)guanine], which has been conditionally approved by the US FDA (Food and Drug Administration) for the treatment of lymphoma in dogs. Tanovea has been demonstrated to be effective against non-Hodgkin's lymphoma (NHL) in dogs, as well as canine cutaneous T-cell lymphoma, spontaneous canine multiple myeloma, naïve canine multicentric lymphoma and relapsed canine B-cell lymphoma...
May 17, 2018: Biochemical Pharmacology
https://www.readbyqxmd.com/read/29778401/high-intensity-focused-ultrasound-the-fundamentals-clinical-applications-and-research-trends
#12
I A Shehata Elhelf, H Albahar, U Shah, A Oto, E Cressman, M Almekkawy
Diagnostic ultrasound has been clinically used for decades. More recently, high intensity focused ultrasound (HIFU) has been developed for therapeutic use as a non-invasive technique for tissue ablation. HIFU is also being investigated for advanced applications at the cellular level. Under guidance by magnetic resonance or ultrasound imaging, HIFU can achieve precise biological effects in tissue with a high safety profile. In this article, we discuss the basic principles, advantages and limitations of HIFU...
May 17, 2018: Diagnostic and Interventional Imaging
https://www.readbyqxmd.com/read/29777871/pain-therapeutics-from-cone-snail-venoms-from-ziconotide-to-novel-non-opioid-pathways
#13
Helena Safavi-Hemami, Shane E Brogan, Baldomero M Olivera
There have been numerous attempts to develop non-opioid drugs for severe pain, but the vast majority of these efforts have failed. A notable exception is Ziconotide (Prialt®), approved by the FDA in 2004. In this review, we summarize the present status of Ziconotide as a therapeutic drug and introduce a wider framework: the potential of venom peptides from cone snails as a resource providing a continuous pipeline for the discovery of non-opioid pain therapeutics. An auxiliary theme that we hope to develop is that these venoms, already a validated starting point for non-opioid drug leads, should also provide an opportunity for identifying novel molecular targets for future pain drugs...
May 16, 2018: Journal of Proteomics
https://www.readbyqxmd.com/read/29777783/accelerated-lipid-catabolism-and-autophagy-are-cancer-survival-mechanisms-under-inhibited-glutaminolysis
#14
Anna Halama, Michal Kulinski, Shaima S Dib, Shaza B Zaghlool, Kodappully S Siveen, Ahmad Iskandarani, Jonas Zierer, Kirti S Prabhu, Noothan J Satheesh, Aditya M Bhagwat, Shahab Uddin, Gabi Kastenmüller, Olivier Elemento, Steven S Gross, Karsten Suhre
Suppressing glutaminolysis does not always induce cancer cell death in glutamine dependent tumors because cells may switch to alternative energy sources. To reveal compensatory metabolic pathways, we investigated the metabolome-wide cellular response to inhibited glutaminolysis in cancer cells. Glutaminolysis inhibition with C.968 suppressed cell proliferation but was insufficient to induce cancer cell death. We found that lipid catabolism was activated as a compensation for glutaminolysis inhibition. Accelerated lipid catabolism, together with oxidative stress induced by glutaminolysis inhibition, triggered autophagy...
May 16, 2018: Cancer Letters
https://www.readbyqxmd.com/read/29777201/novel-smoothened-inhibitors-for-therapeutic-targeting-of-na%C3%A3-ve-and-drug-resistant-hedgehog-pathway-driven-cancers
#15
Qing-Rou Li, Hui Zhao, Xue-Sai Zhang, Henk Lang, Ker Yu
The G protein-coupled receptor (GPCR) smoothened (SMO) is a key signaling component of the sonic hedgehog (Hh) pathway and a clinically validated target for cancer treatment. The FDA-approved SMO inhibitors GDC-0449/Vismodegib and LDE225/Sonidegib demonstrated clinical antitumor efficacy. Nevertheless, relatively high percentage of treated patients would eventually develop acquired cross resistance to both drugs. Here, based on published structure and activity of GDC-0449 inhibitor class, we replaced its amide core with benzimidazole which retained bulk of the SMO-targeting activity as measured in our Hh/SMO/Gli1-reporter system...
May 18, 2018: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/29776968/liraglutide-modulates-appetite-and-body-weight-via-glp-1r-expressing-glutamatergic-neurons
#16
Jessica M Adams, Hongjuan Pei, Darleen A Sandoval, Randy J Seeley, Rui B Chang, Stephen D Liberles, David P Olson
Glucagon-like peptide-1 receptor (GLP-1R) agonists are FDA-approved weight loss drugs. Despite their widespread use, the sites of action through which GLP-1R agonists (GLP1RAs) impact appetite and body weight are still not fully understood. Here, we determined whether GLP-1Rs in either GABAergic or glutamatergic neurons are necessary for the acute and chronic effects of the GLP1RA liraglutide on food intake, visceral illness, body weight and neural network activation. We found that mice lacking GLP-1Rs in vGAT -expressing GABAergic neurons responded identically to controls in all parameters measured, whereas deletion of GLP-1Rs in vGlut2 -expressing glutamatergic neurons eliminated liraglutide-induced weight loss and visceral illness and severely attenuated its effects on feeding...
May 18, 2018: Diabetes
https://www.readbyqxmd.com/read/29775725/anti-hepatitis-c-virus-activity-and-synergistic-effect-of-nymphaea-alba-extracts-and-bioactive-constituents-in-liver-infected-cells
#17
Sidra Rehman, Usman Ali Ashfaq, Bushra Ijaz, Sheikh Riazuddin
BACKGROUND: Without an effective vaccine, hepatitis C virus (HCV) remains a global threat, inflicting 170-300 million carriers worldwide at risk of cirrhosis and hepatocellular carcinoma (HCC). Though various direct acting antivirals have been redeemed the hepatitis C treatment, a few restraints persist including possible side effects, viral resistance emergence, excessive cost which restricts its availability to a common person. HYPOTHESIS: There is no preventive HCV vaccine available today so the discovery of potent antiviral natural flora and their bioactive constituents may help to develop preventive cures against HCV infection...
May 15, 2018: Microbial Pathogenesis
https://www.readbyqxmd.com/read/29774778/an-overview-of-glycopyrrolate-eflow%C3%A2-cs-in-copd
#18
Edward Kerwin, Gary T Ferguson
COPD is highly prevalent in the US and globally, requiring new treatment strategies due to the high disease burden and increase in the aging population. Here, we profile the newly FDA-approved LONHALA MAGNAIR (glycopyrrolate [GLY]/eFlow® Closed System [CS]; 25 mcg twice daily), a nebulized long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of COPD, including chronic bronchitis and/or emphysema. Areas covered: An overview of COPD and the treatment landscape, focusing on GLY/eFlow CS, is reported by reviewing the published literature pertinent to the drug/device combination...
May 18, 2018: Expert Review of Respiratory Medicine
https://www.readbyqxmd.com/read/29774560/high-resolution-separation-of-monoclonal-antibodies-mixtures-and-their-charge-variants-by-an-alternative-and-generic-cze-method
#19
Alexandre Goyon, Yannis Nicolas Francois, Olivier Colas, Alain Beck, Jean Luc Veuthey, Davy Guillarme
The determination of mAb critical quality attributes (CQA) is crucial for their successful application in health diseases. A generic CZE method was developed for the high-resolution separation of various mAb charge variants, which are often recognized as important CQA. A dynamic coating of the capillary was obtained with polyethylene oxide (PEO), whereas Bis-Tris allowed the analysis of mAbs under native conditions at pH 7.0. The effect of PEO and Bis-Tris concentrations, as well as the nature of the acidic counter ion on the method performance were systematically studied...
May 17, 2018: Electrophoresis
https://www.readbyqxmd.com/read/29774446/contemporary-review-of-peyronie-s-disease-treatment
#20
REVIEW
Edward Capoccia, Laurence A Levine
PURPOSE: To analyze the literature on the current treatment options for Peyronie's disease (PD). RECENT FINDINGS: Intracavernosal injection therapy using collagenase clostridium histolyticum (CCH) has been widely adopted since its FDA approval in 2013. Based on the current evidence, it appears to be moderately efficacious for men with mild curvatures. Although a recent study has shown similar outcomes using a modified protocol requiring fewer injections, CCH remains an expensive medication...
May 17, 2018: Current Urology Reports
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