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https://www.readbyqxmd.com/read/28088344/design-control-considerations-for-biologic-device-combination-products
#1
Dave Anderson, Roger Liu, J Anand Subramony, Jon Cammack
Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products...
January 11, 2017: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/28087644/u-s-fda-approval-summary-nivolumab-for-treatment-of-unresectable-or-metastatic-melanoma-following-progression-on-ipilimumab
#2
Maitreyee Hazarika, Meredith K Chuk, Marc R Theoret, Sirisha Mushti, Kun He, Shawna L Weis, Alexander H Putman, Whitney S Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
On December 22, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (OPDIVO®, Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received nivolumab 3 mg/kg intravenously every 2 weeks with at least 6 months follow-up in an ongoing, randomized, open-label, active-controlled clinical trial...
January 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28087313/an-m2-v27a-channel-blocker-demonstrates-potent-in-vitro-and-in-vivo-antiviral-activities-against-amantadine-sensitive-and-resistant-influenza-a-viruses
#3
Yanmei Hu, Rami Musharrafieh, Chunlong Ma, Jiantao Zhang, Donald F Smee, William F DeGrado, Jun Wang
Adamantanes such as amantadine (1) and rimantadine (2) are FDA-approved anti-influenza drugs that act by inhibiting the wild-type M2 proton channel from influenza A viruses, thereby inhibiting the uncoating of the virus. Although adamantanes have been successfully used for more than four decades, their efficacy was curtailed by emerging drug resistance. Among the limited number of M2 mutants that confer amantadine resistance, the M2-V27A mutant was found to be the predominant mutant under drug selection pressure, thereby representing a high profile antiviral drug target...
January 10, 2017: Antiviral Research
https://www.readbyqxmd.com/read/28086832/norcantharidin-inhibits-cell-growth-by-suppressing-the-expression-and-phosphorylation-of-both-egfr-and-c-met-in-human-colon-cancer-cells
#4
Peiju Qiu, Siwen Wang, Ming Liu, He Ma, Xuan Zeng, Meng Zhang, Lingling Xu, Yidi Cui, Huixin Xu, Yang Tang, Yanli He, Lijuan Zhang
BACKGROUND: Norcantharidin (NCTD) is a Chinese FDA approved, chemically synthesized drug for cancer treatment. The effect of NCTD on signaling proteins of EGFR and c-Met was systematically elucidated in current study. METHODS: Two human colon cancer cell lines, HCT116 and HT29, were used as model systems to investigate the anti-cancer molecular mechanism of NCTD. Cell cycle arrest and early/late apoptosis were analyzed by flow cytometry. The levels of EGFR, phospho-EGFR, c-Met, phospho-c-Met and other related proteins were quantified by western blot analysis...
January 13, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28080154/biocompatibility-assessments-for-medical-devices-evolving-regulatory-considerations
#5
Lesley Reeve, Paul Baldrick
Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data. Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements...
January 12, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28079301/case-study-for-lean-management-in-the-public-sector-improving-combination-product-review-at-the-food-drug-administration
#6
Michael J Rappel, Nina L Hunter, April I Alexandrow, Kyle O Hair, Rachel E Sherman, Robert M Califf
Therapeutics known as combination products because they combine drug, device, and/or biologic elements can offer important advantages relative to single-modality products. However, regulatory policy in this arena has lagged relative to increases in product submissions and complexity of these products. In this article, we describe how the US Food and Drug Administration (FDA) applied Lean management methods to improve and streamline the process by which different FDA Centers and Offices coordinate review of combination products...
January 12, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28079094/gene-edited-cows-rogue-clinics-speedier-drug-approvals-the-challenges-facing-trump-s-fda-chief
#7
Heidi Ledford
No abstract text is available yet for this article.
January 6, 2017: Nature
https://www.readbyqxmd.com/read/28078996/kinase-inhibitors-in-multitargeted-cancer-therapy
#8
Carla Gentile, Annamaria Martorana, Antonino Lauria, Riccardo Bonsignore
The old-fashioned anticancer approaches, aiming in arresting cancer cell proliferation interfering with non-specific targets (e.g. DNA), have been replaced, in the last decades, by more specific target oriented ones. Nonetheless, single-target approaches have not always led to optimal outcomes because, for its complexity, cancer needs to be tackled at various levels by modulation of several targets. Although at present, combinations of individual single-target drugs represent the most clinically practiced therapeutic approaches, the modulation of multiple proteins by a single drug, in accordance with the polypharmacological strategy, has become more and more appealing...
January 12, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28078868/minoxidil-dose-response-study-in-female-pattern-hair-loss-patients-determined-to-be-non-responders-to-5-topical-minoxidil
#9
J McCoy, A Goren, M Kovacevic, J Shapiro
Topical minoxidil is the only US FDA approved drug for the treatment of female pattern hair loss (FPHL). 5% minoxidil foam is only effective at re-growing hair in a minority of women (approximately 40%). Thus, the majority of FPHL patients remain untreated. Previously, we demonstrated that nonresponders to 5% minoxidil have low metabolism of minoxidil in hair follicles. As such, we hypothesized that increasing the dosage of topical minoxidil to low metabolizers would increase the number of responders without increasing the incidence of adverse events...
October 2016: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/28078628/3d-printed-drugs-for-children-are-we-ready-yet
#10
REVIEW
Maren Preis, Heidi Öblom
The first medicine manufactured by three-dimensional (3D) printing was recently approved by the Food and Drug Administration (FDA). The advantages of printing as a manufacturing route enabling more flexibility regarding the dose, and enlarging individual treatment options, have been demonstrated. There is a particular need for flexible drug delivery solutions when it comes to children. Printing as a new pharmaceutical manufacturing technology brings manufacturing closer to the patient and can easily be adjusted to the required dosing scheme, offering more flexibility for treatments...
January 11, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28077314/biological-or-pharmacological-activation-of-protein-kinase-c-alpha-constrains-hepatitis-e-virus-replication
#11
Wenshi Wang, Yijin Wang, Yannick Debing, Xinying Zhou, Yuebang Yin, Lei Xu, Elena Herrera Carrillo, Johannes H Brandsma, Raymond A Poot, Ben Berkhout, Johan Neyts, Maikel P Peppelenbosch, Qiuwei Pan
Although hepatitis E has emerged as a global health issue, there is limited knowledge of its infection biology and no FDA-approved medication is available. Aiming to investigate the role of protein kinases in hepatitis E virus (HEV) infection and to identify potential antiviral targets, we screened a library of pharmacological kinase inhibitors in a cell culture model, a subgenomic HEV replicon containing luciferase reporter. We identified protein kinase C alpha (PKCα) as an essential cell host factor restricting HEV replication...
January 8, 2017: Antiviral Research
https://www.readbyqxmd.com/read/28075559/one-component-supramolecular-filament-hydrogels-as-theranostic-label-free-magnetic-resonance-imaging-agents
#12
Lye Lin Lock, Yuguo Li, Xinpei Mao, Hanwei Chen, Verena Staedtke, Renyuan Bai, Wang Ma, Ran Lin, Yi Li, Guanshu Liu, Honggang Cui
Gadolinium (Gd)-based compounds and materials are the most commonly used magnetic resonance imaging (MRI) contrast agents in the clinic; however, safety concerns associated with their toxicities in the free ionic form have promoted the development of new generations of metal-free contrast agents. Here we report a supramolecular strategy to convert an FDA-approved anticancer drug, Pemetrexed (Pem), to a molecular hydrogelator with inherent chemical exchange saturation transfer (CEST) MRI signals. The rationally designed drug-peptide conjugate can spontaneously associate into filamentous assemblies under physiological conditions and consequently form theranostic supramolecular hydrogels for injectable delivery...
January 11, 2017: ACS Nano
https://www.readbyqxmd.com/read/28075420/the-trend-of-voluntary-warnings-in-electronic-nicotine-delivery-system-magazine-advertisements
#13
Ce Shang, Frank J Chaloupka
Some manufacturers of electronic nicotine delivery systems (ENDS) voluntarily carried health warnings in their advertisements. This study examined these voluntary warnings in magazine ads and plotted their trends between 2012 and early 2015. ENDS magazine ads were obtained through Kantar media and warnings were collected from the Chicago Public Library or the Trinkets and Trash surveillance system. The prevalence of voluntary warnings, warnings with the specific capitalized word "WARNING", and MarkTen warnings were examined after being weighted using factors related to exposure between January 2012 and March 2015...
January 10, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28074747/liraglutide-a-glucagon-like-peptide-1-agonist-for-chronic-weight-management
#14
Kendra R Manigault, Maria Miller Thurston
OBJECTIVE: To review the efficacy and safety of liraglutide 3.0 mg for weight loss. DATA SOURCE: A literature search was performed using PubMed and MEDLINE from 2000 to 2016. The following key terms were used alone or in combination: glucagon-like peptide-1 agonist, liraglutide, obesity, overweight, and weight loss. Additional supporting literature was identified utilizing the reference lists of the preceding articles. STUDY SELECTION: Analyzed studies were published in English and investigated use of liraglutide and its impact on weight loss...
December 1, 2016: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
https://www.readbyqxmd.com/read/28073963/in-vitro-activity-of-daptomycin-combined-with-dalbavancin-and-linezolid-and-dalbavancin-with-linezolid-against-mrsa-strains
#15
Gulseren Aktas, Sengul Derbentli
OBJECTIVES: Combination therapies have a distinct advantage over monotherapies in terms of their broad spectrum, synergistic effect and prevention of the emergence of drug resistance. In the present study, the in vitro antibacterial activity of daptomycin combinations with linezolid and dalbavancin, and dalbavancin with linezolid were evaluated against 30 clinical MRSA strains. METHODS: The MICs of all antibiotics were determined using microbroth dilution as described by the CLSI...
September 28, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28073844/fda-approval-of-nivolumab-for-the-first-line-treatment-of-patients-with-brafv600-wild-type-unresectable-or-metastatic-melanoma
#16
Julia A Beaver, Marc R Theoret, Sirisha Mushti, Kun He, Meredith Libeg, Kirsten Goldberg, Rajeshwari Sridhara, Amy E McKee, Patricia Keegan, Richard Pazdur
On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO®, Bristol Myers Squibb, Co.) as a single agent for the first-line treatment of patients with BRAFV600 wild-type, unresectable or metastatic melanoma. An international, double-blind, randomized (1:1) trial conducted outside of the U.S. allocated 418 patients to receive nivolumab 3mg/kg intravenously every 2 weeks (n=210) or dacarbazine 1000mg/m2 intravenously every 3 weeks (n=208). Patients with disease progression who met protocol-specified criteria (~25% of each trial arm) were permitted to continue with the assigned treatment in a blinded fashion until further disease progression is documented...
January 10, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28073840/fda-approval-summary-sonidegib-for-locally-advanced-basal-cell-carcinoma
#17
Denise Casey, Suzanne Demko, Stacy Shord, Hong Zhao, Huanyu Chen, Kun He, Alexander Putman, Whitney S Helms, Patricia Keegan, Richard Pazdur
On July 24, 2015, the U. S. Food and Drug Administration (FDA) approved sonidegib (ODOMZO®, Novartis) for treatment of patients with locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiation therapy. The approval was based on data from one randomized, double-blind, non-comparative trial of two doses of sonidegib administered to 230 hedgehog inhibitor-naïve patients with metastatic basal cell carcinoma (mBCC, n=36) or laBCC (n=194). Patients were randomized 2:1 to receive sonidegib 800 mg (n=151) or 200 mg (n=79) daily...
January 10, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28073687/adverse-event-detection-using-the-fda-post-marketing-drug-safety-surveillance-system-cardiotoxicity-associated-with-loperamide-abuse-and-misuse
#18
Kimberley A Swank, Eileen Wu, Cindy Kortepeter, Jana McAninch, Robert L Levin
OBJECTIVE: The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. METHODS: We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016...
January 7, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28073152/characterizing-pharmacogenomic-guided-medication-use-with-a-clinical-data-repository
#19
Patrick C Mathias, Nathaniel Hendrix, Wei-Jhih Wang, Katelyn Keyloun, Maher Khelifi, Peter Tarczy-Hornoch, Beth Devine
The extent to which pharmacogenomic-guided medication use has been adopted in various health systems is unclear. To assess the uptake of pharmacogenomic-guided medication use, we determined its frequency across our health system, which does not have a structured testing program. Using a multi-site clinical data repository, we identified adult patients' first prescribed medications between January 2011 and December 2013 and investigated the frequency of germline and somatic pharmacogenomic testing, by PharmGKB level of FDA label information...
January 10, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28071877/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or-combination-products-amendments-to-regulations-regarding-intended-uses-final-rule
#20
(no author information available yet)
The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
9, 2017: Federal Register
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