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https://www.readbyqxmd.com/read/29352367/continuous-manufacturing-of-co-crystals-challenges-and-prospects
#1
REVIEW
Rahul B Chavan, Rajesh Thipparaboina, Balvant Yadav, Nalini R Shastri
The last decade has witnessed extensive growth in the field of co-crystallization for mitigating the solubility and dissolution-related issues of poorly soluble drugs. This is largely because co-crystals can modify the physicochemical properties of drugs without any covalent modification in the drug molecules. The US Food and Drug Administration (FDA) now considers drug products that are designed to contain a new co-crystal, analogous to new polymorph of the active pharmaceutical ingredient (API). This positive change in regulatory perspective coupled with successful commercialization of valsartan-sacubitril co-crystal (Entresto, Novartis) has now brought co-crystals into focus, in both industries as well as academia...
January 19, 2018: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29351202/antimicrobial-peptides-diversity-mechanism-of-action-and-strategies-to-improve-the-activity-and-biocompatibility-in-vivo
#2
REVIEW
Prashant Kumar, Jayachandran N Kizhakkedathu, Suzana K Straus
Antibiotic resistance is projected as one of the greatest threats to human health in the future and hence alternatives are being explored to combat resistance. Antimicrobial peptides (AMPs) have shown great promise, because use of AMPs leads bacteria to develop no or low resistance. In this review, we discuss the diversity, history and the various mechanisms of action of AMPs. Although many AMPs have reached clinical trials, to date not many have been approved by the US Food and Drug Administration (FDA) due to issues with toxicity, protease cleavage and short half-life...
January 19, 2018: Biomolecules
https://www.readbyqxmd.com/read/29350758/obesity-and-pediatric-drug-development
#3
Janelle D Vaughns, Laurie S Conklin, Ying Long, Panli Zheng, Fahim Faruque, Dionna J Green, John N van den Anker, Gilbert J Burckart
There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies...
January 19, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29350565/safety-and-efficacy-of-denosumab-in-osteoporotic-patients-previously-treated-with-other-medications-a-systematic-review-and-meta-analysis
#4
Andreas Fontalis, Kenanidis Eustathios, Efthymia Prousali, Potoupnis Michael, Tsiridis Eleftherios
Denosumab is a monoclonal antibody that received approval by the FDA for the treatment of osteoporosis in 2010. Available higher level research evidence concerns the treatment of patients that have not received any anti-osteoporotic medication in the past. Further investigation is warranted, since clinicians often face the challenge of administering the most efficacious drug in patients, pretreated with other medications. Areas Covered: We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of denosumab compared to other active anti-osteoporotic agents in patients formerly receiving other treatments...
January 19, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29350327/hypermutated-tumors-and-immune-checkpoint-inhibition
#5
Kristen K Ciombor, Richard M Goldberg
Microsatellite instability-high/DNA mismatch repair deficient tumors are found across the cancer spectrum and often harbor markedly increased numbers of mutations when compared to microsatellite stable/DNA mismatch repair proficient tumors. As a result of this high mutational load, tumor-infiltrating lymphocyte density is increased and more immunogenic neoepitopes are expressed, leading to upregulation of immune checkpoints in these tumors. Checkpoint inhibitors such as pembrolizumab and nivolumab, both immunoglobulin G4 (IgG4) monoclonal antibodies that block interactions between the programmed cell death receptor-1 and its ligands, have significant activity in this tumor class...
January 19, 2018: Drugs
https://www.readbyqxmd.com/read/29349833/a-systematic-assessment-of-key-design-and-performance-characteristics-of-drug-exposure-registries-requested-by-the-u-s-food-and-drug-administration
#6
Yanling Zhao, Ellen Pinnow, Jacqueline M Major
PURPOSE: The purpose of the study is to evaluate contributions to postmarket safety assessments and identify potential factors for enhancing implementation and utilization of registries in regulatory decision-making. METHODS: Registry documents (e.g., protocols, reports) submitted to the FDA were identified up to January 2016 through an extensive, systematic review of internal records and resources. We characterized nonpregnancy drug exposure registries based on prespecified design elements, performance, and regulatory impact...
January 19, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29349597/drug-repurposing-screening-identifies-bortezomib-and-panobinostat-as-drugs-targeting-cancer-associated-fibroblasts-cafs-by-synergistic-induction-of-apoptosis
#7
Hak-Min Lee, Eunmyong Lee, So-Young Yeo, Sang Shin, Hyun-Kyu Park, Do-Hyun Nam, Seok-Hyung Kim
Cancer associated fibroblasts (CAFs) are the most abundant components of cancer-microenvironment. They play important roles in cancer initiation, progression, and metastasis. In addition, CAFs can confer drug-resistance to cancer cells. Considering their pro-tumorigenic roles, it is recommended to remove CAFs to prevent cancer recurrence after chemotherapy. Despite their clinical significance, few anti-CAF drugs have been developed. The objective of this study was to find a drug that could suppress the viability of patient-derived CAFs through repurposed screening of 51 drugs that were in clinical trials or received FDA approval...
January 18, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29349359/resensitization-of-methicillin-resistant-staphylococcus-aureus-by-amoxapine-an-fda-approved-antidepressant
#8
Tyler J Wilson, Meghan S Blackledge, Patrick A Vigueira
The rapid increase in bacterial resistance to antibiotics is a global healthcare crisis. Non-antibiotic pharmaceuticals that have attained approval by the United States Food and Drug Administration have the potential to be repurposed as bacterial resistance-modifying agents and therefore could become valuable resources in our battle against antibiotic-resistant microbes. Amoxapine is a tetracyclic antidepressant used in the treatment of major depressive disorder. Here we demonstrate the ability of amoxapine to resensitize methicillin-resistant Staphylococcus aureus strain ATCC 43300 to oxacillin in both agar diffusion and broth microdilution assays...
January 2018: Heliyon
https://www.readbyqxmd.com/read/29349263/worldviews-and-trust-of-sources-for-health-information-on-electronic-nicotine-delivery-systems-effects-on-risk-perceptions-and-use
#9
Scott R Weaver, Amelia Jazwa, Lucy Popova, Paul Slovic, Richard B Rothenberg, Michael P Eriksen
Public health agencies, the news media, and the tobacco/vapor industry have issued contradictory statements about the health effects of electronic nicotine delivery systems (ENDS). We investigated the levels of trust that consumers place in different information sources and how trust is associated with cultural worldviews, risk perceptions, ENDS use, and sociodemographic characteristics using a nationally representative sample of 6051 U.S. adults in 2015. Seventeen percent of adults were uncertain about their trust for one or more potential sources...
December 2017: SSM—Population Health
https://www.readbyqxmd.com/read/29348679/market-watch-2017-fda-drug-approvals-number-rebounds-but-average-value-slips
#10
Mathias Baedeker, Michael Ringel, Valery Panier, Ulrik Schulze
No abstract text is available yet for this article.
January 19, 2018: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/29348678/2017-fda-drug-approvals
#11
Asher Mullard
No abstract text is available yet for this article.
January 19, 2018: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/29348316/evaluation-of-next-generation-anti-cd20-antibodies-labeled-with-zirconium-89-in-human-lymphoma-xenografts
#12
Jason T Yoon, Mark S Longtine, Bernadette V Marquez-Nostra, Richard L Wahl
Radioimmunotherapies with monoclonal antibodies (mAbs) to the B-lymphocyte antigen 20 (CD20) are effective treatments for B-cell lymphomas, but United States Food and Drug Administration (FDA)-approved radioimmunotherapies exclusively use radiolabeled murine antibodies, potentially limiting re-dosing. The FDA recently approved two unlabeled anti-CD20 monoclonal antibodies, obinutizumab and ofatumumab, termed "next generation" as they are humanized (obinituzumab) or fully human (ofatumumab), thus potentially allowing a greater potential for re-dosing than with previous generation anti-CD20 antibodies, including rituximab (chimeric) and tositumumab (murine) which contain more murine peptide sequences...
January 18, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29347995/index-of-the-human-papillomavirus-hpv-vaccine-industry-clinical-study-programmes-and-non-industry-funded-studies-a-necessary-basis-to-address-reporting-bias-in-a-systematic-review
#13
Lars Jørgensen, Peter C Gøtzsche, Tom Jefferson
BACKGROUND: Unabridged access to drug industry and regulatory trial registers and data reduces reporting bias in systematic reviews and may provide a complete index of a drug's clinical study programme. Currently, there is no public index of the human papillomavirus (HPV) vaccine industry study programmes or a public index of non-industry funded studies. METHODS: By cross-verification via study programme enquiries to the HPV vaccine manufacturers and regulators and searches of trial registers and journal publication databases, we indexed clinical HPV vaccine studies as a basis to address reporting bias in a systematic review of clinical study reports...
January 18, 2018: Systematic Reviews
https://www.readbyqxmd.com/read/29346485/adverse-events-in-facial-implant-surgery-and-associated-malpractice-litigation
#14
Hani M Rayess, Peter Svider, Curtis Hanba, Vivek Sagar Patel, Michael Carron, Giancarlo Zuliani
Importance: Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. Objective: To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. Design, Setting, and Participants: A cross-sectional study reviewed complications following facial implants...
January 18, 2018: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/29344310/drug-repurposing-screening-identifies-tioconazole-as-an-atg4-inhibitor-that-suppresses-autophagy-and-sensitizes-cancer-cells-to-chemotherapy
#15
Pei-Feng Liu, Kun-Lin Tsai, Chien-Jen Hsu, Wei-Lun Tsai, Jin-Shiung Cheng, Hsueh-Wei Chang, Chung-Wai Shiau, Yih-Gang Goan, Ho-Hsing Tseng, Chih-Hsuan Wu, John C Reed, Lee-Wei Yang, Chih-Wen Shu
Background: Tumor cells require proficient autophagy to meet high metabolic demands and resist chemotherapy, which suggests that reducing autophagic flux might be an attractive route for cancer therapy. However, this theory in clinical cancer research remains controversial due to the limited number of drugs that specifically inhibit autophagy-related (ATG) proteins. Methods: We screened FDA-approved drugs using a novel platform that integrates computational docking and simulations as well as biochemical and cellular reporter assays to identify potential drugs that inhibit autophagy-required cysteine proteases of the ATG4 family...
2018: Theranostics
https://www.readbyqxmd.com/read/29344272/cancer-vaccine-learning-lessons-from-immune-checkpoint-inhibitors
#16
REVIEW
ZhenLong Ye, Qiming Qian, HuaJun Jin, QiJun Qian
Cancer vaccines have been exclusively studied all through the past decades, and have made exceptional achievements in cancer treatment. Few cancer vaccines have been approved by the US Food and Drug Administration (FDA), for instance, Provenge, which was approved for the treatment of prostate carcinoma in 2012. Moreover, more recently, T-VEC got approval for the treatment of melanoma. While, the overall therapeutic effects of cancer vaccines have been taken into consideration as below expectations, low antigenicity of targeting antigen and tumor heterogeneity are the two key limiting barriers encountered by the cancer vaccines...
2018: Journal of Cancer
https://www.readbyqxmd.com/read/29343970/a-retrospective-examination-of-the-us-food-and-drug-administration-s-clinical-pharmacology-reviews-of-oncology-biologics-for-potential-use-of-therapeutic-drug-monitoring
#17
Brett Fleisher, Sihem Ait-Oudhia
Background: Biologics have gained traction for use in oncology, but have demonstrate clinical variability for efficacy and safety. Therapeutic drug monitoring (TDM) can benefit patients' outcomes from a biologic therapy when the latter has a defined therapeutic window. A clinically relevant therapeutic window may exist for biologics with established exposure-response (E-R) relationships for efficacy and/or safety and a documented maximum tolerated dose (MTD). Additionally, the inter-individual variability (IIV) on the clearance (CL) parameter could determine risks for patients falling outside the proposed therapeutic window...
2018: OncoTargets and Therapy
https://www.readbyqxmd.com/read/29343523/a-novel-l-asparaginase-with-low-l-glutaminase-coactivity-is-highly-efficacious-against-both-t-and-b-cell-acute-lymphoblastic-leukemias-in-vivo
#18
Hien Anh Nguyen, Ying Su, Jenny Yu Zhang, Aleksandar Antanasijevic, Michael Caffrey, Amanda M Schalk, Li Liu, Damiano Rondelli, Annie Oh, Dolores L Mahmud, Maarten C Bosland, Andre Kajdacsy-Balla, Sofie Peirs, Tim Lammens, Veerle Mondelaers, Barbara De Moerloose, Steven Goossens, Michael J Schlicht, Kasim K Kabirov, Alexander V Lyubimov, Bradley J Merrill, Yogen Saunthararajah, Pieter Van Vlierberghe, Arnon Lavie
Acute lymphoblastic leukemia (ALL) is the most common type of pediatric cancer, although about 4 of every 10 cases occur in adults. The enzyme drug L-asparaginase serves as a cornerstone of ALL therapy and exploits the asparagine-dependency of ALL cells. In addition to hydrolyzing the amino acid L-asparagine, all FDA-approved L-asparaginases also have significant L-glutaminase coactivity. Since several reports suggest that L-glutamine depletion correlates with many of the side effects of these drugs, enzyme variants with reduced L-glutaminase coactivity might be clinically beneficial if their anti-leukemic activity would be preserved...
January 17, 2018: Cancer Research
https://www.readbyqxmd.com/read/29343521/t-type-ca2-channels-t-for-targetable
#19
REVIEW
Marta C Sallán, Anna Visa, Soni Shaikh, Mireia Nàger, Judit Herreros, Carles Cantí
In the past decade, T-type Ca2+ channels (TTCC) have been unveiled as key regulators of cancer cell biology and thus have been proposed as chemotherapeutic targets. Indeed, in vitro and in vivo studies indicate that TTCC pharmacologic blockers have a negative impact on the viability of cancer cells and reduce tumor size, respectively. Consequently mibefradil, a TTCC blocker approved in 1997 as an antihypertensive agent but withdrawn in 1998 because of drug-drug interactions, was granted 10 years later the orphan drug status by the FDA to investigate its efficacy against brain, ovary, and pancreatic cancer...
January 17, 2018: Cancer Research
https://www.readbyqxmd.com/read/29342845/anesthetic-preconditioning-as-endogenous-neuroprotection-in-glaucoma
#20
Tsung-Han Chou, Ganeswara Rao Musada, Giovanni Luca Romano, Elizabeth Bolton, Vittorio Porciatti
Blindness in glaucoma is the result of death of Retinal Ganglion Cells (RGCs) and their axons. RGC death is generally preceded by a stage of reversible dysfunction and structural remodeling. Current treatments aimed at reducing intraocular pressure (IOP) are ineffective or incompletely effective in management of the disease. IOP-independent neuroprotection or neuroprotection as adjuvant to IOP lowering in glaucoma remains a challenge as effective agents without side effects have not been identified yet. We show in DBA/2J mice with spontaneous IOP elevation and glaucoma that the lifespan of functional RGCs can be extended by preconditioning RGCs with retrobulbar lidocaine in one eye at four months of age that temporary blocks RGC axonal transport...
January 13, 2018: International Journal of Molecular Sciences
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