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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/29784744/the-changing-treatment-landscape-for-metastatic-urothelial-carcinoma
#3
Thomas W Flaig
Urothelial carcinoma is the predominant histologic type of bladder cancer. After 30 years of minimal progress in the treatment of advanced-stage disease, recent advances in the genomic characterization of urothelial cancer and breakthroughs in bladder cancer therapeutics have rejuvenated the field. Nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab are among the exciting recent novel therapeutic advances gaining approvals by the FDA for treatment of advanced-stage urothelial carcinoma. Yet the challenge for clinicians is to determine the optimal choice of agents as first-line or second-line therapy and which offers the best chance for overall survival for the individual patient in this rapidly changing field...
May 2018: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/29784734/new-nccn-guidelines-recognition-and-management-of-immunotherapy-related-toxicity
#4
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
#5
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
#6
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
#7
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/29783732/hyaluronic-acid-influence-on-normal-and-osteoarthritic-tissue-engineered-cartilage
#8
Shabnam Hemmati-Sadeghi, Jochen Ringe, Tilo Dehne, Rainer Haag, Michael Sittinger
The aim of this study is to identify gene expression profiles associated with hyaluronic acid (HA) treatment of normal and osteoarthritis (OA)-like tissue-engineered cartilage. 3D cartilage micromasses were treated with tumour necrosis factor-α (TNF-α) (OA-inducer) and/or HA for 7 days. Viability was examined by PI/FDA staining. To document extracellular matrix (ECM) formation, glycosaminoglycans (GAG) were stained with Safranin-O and cartilage-specific type II collagen was detected immunohistochemically...
May 19, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29783126/systemic-therapy-for-intermediate-and-advanced-hepatocellular-carcinoma-sorafenib-and-beyond
#9
REVIEW
Jean-Luc Raoul, Masatoshi Kudo, Richard S Finn, Julien Edeline, Maria Reig, Peter R Galle
The hepatocellular carcinoma (HCC) treatment landscape changed a decade ago, with sorafenib demonstrating survival benefit in the first-line setting and becoming the first systemic therapy to be approved for HCC. More recently, regorafenib and nivolumab have received approval in the second-line setting after sorafenib, with further positive phase 3 studies emerging in the first line (lenvatinib non-inferior to sorafenib) and second line versus placebo (cabozantinib and ramucirumab). A key recommendation in the management of patients receiving sorafenib is to promote close communication between the patient and the physician so that adverse events (AEs) are detected early and severe AEs can be prevented...
May 17, 2018: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29783113/automated-uhplc-separation-of-10-pharmaceutical-compounds-using-software-modeling
#10
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
#11
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/29781751/posology-adjustments-of-oral-antineoplastic-agents-for-special-populations-patients-with-renal-impairment-hepatic-impairment-and-hematologic-toxicities
#12
Julieta González, Matías Quiroga, Vicente Escudero-Vilaplana, Roberto Collado-Borrell, Ana Herranz-Alonso, María Sanjurjo Sáez
BACKGROUND: Oral antineoplastic agents (OAA) have reached 30-50% of all antineoplastic treatments. Although they seem safer than parenteral therapy, many severe problems can occur if the dose is not adequately adjusted in special situations. Our objective is to create a comprehensive guide with dosage adjustment recommendations for OAA in cases of renal and hepatic impairment and hematologic toxicities. RESEARCH DESIGN AND METHODS: We analyzed all OAA approved by EMA in July 2017...
May 21, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29780965/cochlear-implantation-in-infants-below-12-months-of-age
#13
Richard T Miyamoto, Bethany Colson, Shirley Henning, David Pisoni
Objectives: To provide safety and efficacy data on infants implanted below 12 months of age. Methods: With the wide application of newborn hearing screening programs, infants with deafness are being identified at birth. When a hearing aid trial fails, cochlear implantation is the only option to restore hearing. Mounting evidence suggests that age at implantation is a strong predictor of language outcomes. Using the minimally invasive surgical technique we have employed for nearly two decades, a limited clinical trial was initiated in the year 2000 because this age limitation fell outside of FDA guidelines...
December 2017: World Journal of Otorhinolaryngology—Head and Neck Surgery
https://www.readbyqxmd.com/read/29779849/how-much-progress-has-there-been-in-the-second-line-treatment-of-multiple-sclerosis-a-2017-update
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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/29777351/development-of-a-patient-reported-outcome-measure-of-recovery-after-abdominal-surgery-a-hypothesized-conceptual-framework
#20
Roshni Alam, Sabrina M Figueiredo, Saba Balvardi, Bénédicte Nauche, Tara Landry, Lawrence Lee, Nancy E Mayo, Liane S Feldman, Julio F Fiore
BACKGROUND: We initiated a research program to develop a novel patient-reported outcome measure (PROM) to assess postoperative recovery from the perspective of abdominal surgery patients. In light of FDA recommendations, the first stage of our program aimed to, based on previous literature and expert input, develop a hypothesized conceptual framework portraying the health domains that are potentially relevant to the process of recovery after abdominal surgery. METHODS: This study was conducted in three phases: (1) systematic review to identify PROMs with measurement properties appraised in the context of recovery after abdominal surgery, (2) content analysis to categorize the health domains covered by the PROMs according to the ICF, and (3) two-round Delphi study to gain expert input regarding which of these health domains are relevant to the process of recovery...
May 17, 2018: Surgical Endoscopy
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