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https://www.readbyqxmd.com/read/28070733/glp-1-ra-treatment-patterns-among-type-2-diabetes-patients-in-five-european-countries
#1
Victoria Divino, Mitch DeKoven, Farhad Ali Khan, Kristina S Boye, Hélène Sapin, Kirsi Norrbacka
INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a relatively new class of injectable drugs used in the treatment of type 2 diabetes (T2D). This retrospective database study evaluated real-world treatment patterns of T2D patients initiating GLP-1 RAs in Belgium (BE), France (FR), Germany (DE), The Netherlands (NL) and Sweden (SE). METHODS: Adult T2D patients initiating exenatide twice daily (exBID), exenatide once weekly (exQW), liraglutide (LIRA) or lixisenatide (LIXI) during 2013 were identified using the QuintilesIMS (QuintilesIMS, Durham, NC, and Danbury, CT, USA) longitudinal retail pharmacy databases (LRx; BE/FR/DE/NL) and national health register data (SE)...
January 9, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28048121/tu-ab-204-01-device-approval-process
#2
J Delfino
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/27978936/-current-status-of-treatment-of-chronic-hepatitis-c-and-related-challenges-in-the-pre-daa-era-in-china
#3
P Hu, H Ren
The condition of chronic hepatitis C is becoming more and more serious in China, and its disease burden and social and economic burdens are growing heavier. Currently, the standard regimen for the treatment of chronic hepatitis C in China is the PR regimen, namely pegylated interferon combined with ribavirin; however, there are still many shortcomings in this regimen. In the world, there is rapid clinical progress in direct-acting antiviral agents (DAAs) for the treatment of hepatitis C, and DAAs will soon be approved and marketed in China, ushering the "DAA Era" of hepatitis C treatment...
November 20, 2016: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
https://www.readbyqxmd.com/read/27968891/crowdsourcing-health-communication-about-condom-use-in-men-who-have-sex-with-men-in-china-a-randomised-controlled-trial
#4
Weiming Tang, Jessica Mao, Chuncheng Liu, Katie Mollan, Haochu Li, Terrence Wong, Ye Zhang, Songyuan Tang, Michael Hudgens, Yilu Qin, Baoli Ma, Meizhen Liao, Bin Yang, Wei Ma, Dianmin Kang, Chongyi Wei, Joseph D Tucker
BACKGROUND: The Chinese government now encourages innovation, and more specifically, crowdsourcing. Crowdsourcing, the process of shifting individual tasks to a large group, might reimagine health communication, making it more people-centred. We aimed to compare the effectiveness of a crowdsourced versus social marketing condom promotion video to promote condom use. METHODS: A non-inferiority randomised controlled trial was conducted in November 2015 in China. Men who have sex with men (MSM) aged 16 years or older who reported having had sexual contact without use of a condom in the preceding 3 months were recruited through a nationwide MSM website...
October 2016: Lancet
https://www.readbyqxmd.com/read/27936976/exon-skipping-a-first-in-class-strategy-for-duchenne-muscular-dystrophy
#5
Erik H Niks, Annemieke Aartsma-Rus
Exon skipping is a therapeutic approach for Duchenne muscular dystrophy (DMD) that has been in development for close to two decades. This approach uses antisense oligonucleotides (AONs) to modulate pre-mRNA splicing of dystrophin transcripts to restore the disrupted DMD reading frame. The approach has moved from in vitro proof of concept studies to the clinical trial phase and marketing authorization applications with regulators. The first AON (eteplirsen) has recently received accelerated approval by the Food and Drug Administration in the US...
December 23, 2016: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/27881103/demonstration-of-early-efficacy-results-of-the-delayed-release-combination-of-doxylamine-pyridoxine-for-the-treatment-of-nausea-and-vomiting-of-pregnancy
#6
Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Jason G Umans, Menachem Miodovnik, Donald R Mattison, Ilan Matok
BACKGROUND: Nausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers. In April 2013 the FDA approved the delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis®) for NVP, based in part, on the results of a phase III randomized trial demonstrating the efficacy of this drug combination [study drug marketed under the trade name Diclectin® in Canada and Diclegis® in the United States] compared to placebo in pregnant women. Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies...
November 24, 2016: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/27875916/new-era-in-treatment-options-of-chronic-hepatitis-c-focus-on-safety-of-new-direct-acting-antivirals-daas
#7
Cristina Scavone, Liberata Sportiello, Concetta Rafaniello, Annamaria Mascolo, Maurizio Sessa, Francesco Rossi, Annalisa Capuano
New direct-acting antivirals have changed hepatitis C virus infection management extremely. Areas covered: The pharmacological management of HCV infection and the main characteristics of new DAA therapies have been discussed. In order to analyse safety data regarding DAA therapies, a narrative review was performed searching for safety results of main second generation DAAs pivotal and post-marketing studies. Data on main DAAs drug-drug interactions have also been discussed. Results of main DAAs pivotal studies revealed that these drugs were frequently associated to adverse events such as asthenia, headache, nausea, and insomnia...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27819246/21st-century-pharmacovigilance-efforts-roles-and-responsibilities
#8
REVIEW
Peter J Pitts, Hervé Le Louet, Yola Moride, Rena M Conti
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27777897/chronic-cholestatic-liver-injury-attributable-to-vedolizumab
#9
Jonathan G Stine, Jennifer Wang, Brian W Behm
Drug-induced liver injury is a rare but clinically important diagnosis. Vedolizumab is an α4β7 integrin inhibitor recently approved for use in patients with moderate-to-severe inflammatory bowel disease. Cases of hepatoxicity due to vedolizumab in the pre-marketing stage were rare, and all cases resolved upon drug withdrawal. We present here the first reported case of hepatotoxicity attributable to vedolizumab, which despite drug cessation persisted with chronic cholestatic liver injury.
September 28, 2016: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/27754016/br-04-2-concentration-response-modeling-of-antihypertensive-drugs-implication-in-clinical-development
#10
Dong-Seok Yim
In the early phase of clinical development of antihypertensive drugs, quantitative modeling to predict their dose-concentration-response relationship is important to plan future clinical development and finding optimal dosage regimen at marketing approval. Two cases of concentration-response models of antihypertensive are presented here.Case 1: Carvedilol is a α1- and nonselective β- adrenergic receptor antagonist currently used for the management of mild-to-moderate essential hypertension and congestive heart failure...
September 2016: Journal of Hypertension
https://www.readbyqxmd.com/read/27723249/microbial-alkane-production-for-jet-fuel-industry-motivation-state-of-the-art-and-perspectives
#11
Lorena Jiménez-Díaz, Antonio Caballero, Natalia Pérez-Hernández, Ana Segura
Bio-jet fuel has attracted a lot of interest in recent years and has become a focus for aircraft and engine manufacturers, oil companies, governments and researchers. Given the global concern about environmental issues and the instability of oil market, bio-jet fuel has been identified as a promising way to reduce the greenhouse gas emissions from the aviation industry, while also promoting energy security. Although a number of bio-jet fuel sources have been approved for manufacture, their commercialization and entry into the market is still a far way away...
October 10, 2016: Microbial Biotechnology
https://www.readbyqxmd.com/read/27642927/br-04-2-concentration-response-modeling-of-antihypertensive-drugs-implication-in-clinical-development
#12
Dong-Seok Yim
In the early phase of clinical development of antihypertensive drugs, quantitative modeling to predict their dose-concentration-response relationship is important to plan future clinical development and finding optimal dosage regimen at marketing approval. Two cases of concentration-response models of antihypertensive are presented here.Case 1: Carvedilol is a α1- and nonselective β- adrenergic receptor antagonist currently used for the management of mild-to-moderate essential hypertension and congestive heart failure...
September 2016: Journal of Hypertension
https://www.readbyqxmd.com/read/27610084/current-status-of-the-new-antiepileptic-drugs-in-chronic-pain
#13
REVIEW
Harpreet S Sidhu, Akshay Sadhotra
Antiepileptic drugs (AEDs) are extensively used worldwide to treat a wide range of disorders other than epilepsy, such as neuropathic pain, migraine, and bipolar disorder. Due to this situation more than 20 new third-generation AEDs have been introduced in the market recently. The future design of new AEDs must also have potential to help in the non-epileptic disorders. The wide acceptance of second generation AEDs for the management of various non-epileptic disorders has caused the emergence of generics in the market...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27609249/overview-of-the-2016-u-s-food-and-drug-administration-circulatory-system-devices-advisory-panel-meeting-on-the-absorb-bioresorbable-vascular-scaffold-system
#14
Arie Steinvil, Toby Rogers, Rebecca Torguson, Ron Waksman
OBJECTIVES: This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. BACKGROUND: The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U...
September 12, 2016: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/27554637/no-meaningful-association-between-suicidal-behavior-and-the-use-of-il-17a-neutralizing-or-il-17ra-blocking-agents
#15
Andrea Chiricozzi, Marco Romanelli, Rosita Saraceno, Tiago Torres
An emerging class of agents blocking IL-17 signaling represents a very promising therapeutic approach. One of these agents, brodalumab, has been associated with an increased risk of suicide behavior. Areas covered: This review sought to provide an overview strictly focused on suicide behavior signals related to the use of IL-17 agents. Data collection regarding this peculiar safety aspect was primarily based on: (i) a revision of safety outcomes belonging to phase II and phase III trials; (ii) a systematic search using the Pubmed Medline database; and (iii) collecting recent data issued as posters or communications in eminent international meetings...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27551882/peginesatide-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-an-unfulfilled-promise
#16
Terhi Hermanson, Charles L Bennett, Iain C Macdougall
INTRODUCTION: The introduction of recombinant human erythropoietin revolutionized the management of anemia in patients with chronic kidney disease (CKD). In order to circumvent costly recombinant DNA technology, synthetic chemistry techniques were used to manufacture peginesatide, a synthetic peptide that bore no resemblance to previous erythropoiesis-stimulating agents (ESAs), and yet was capable of stimulating erythropoiesis. Compared with other ESAs, peginesatide was deemed to have advantages related to immunogenicity, administration schedule, and cost...
October 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27540636/utilizing-national-and-international-registries-to-enhance-pre-market-medical-device-regulatory-evaluation
#17
Lilly Q Yue, Gregory Campbell, Nelson Lu, Yunling Xu, Bram Zuckerman
Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices...
August 19, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27401360/smartpill%C3%A2-as-an-objective-parameter-for-determination-of-severity-and-duration-of-postoperative-ileus-study-protocol-of-a-prospective-two-arm-open-label-trial-the-pidusa-study
#18
Tim O Vilz, Dimitrios Pantelis, Philipp Lingohr, Rolf Fimmers, Anke Esmann, Thomas Randau, Jörg C Kalff, Martin Coenen, Sven Wehner
INTRODUCTION: Postoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill(®), a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo...
July 8, 2016: BMJ Open
https://www.readbyqxmd.com/read/27297974/regulatory-approaches-to-non-clinical-reproductive-toxicity-testing-of-anti-cancer-drugs
#19
Georg Schmitt, Paul Barrow
This paper reviews the non-clinical reproductive toxicity testing of 15 drugs currently approved in the USA or Europe for the treatment of cancer. The list includes cytotoxic anti-tumour agents, small molecule inhibitors of pathways involved in neoplastic proliferation, monoclonal antibodies that target specific antigens expressed by neoplastic cells and supportive therapies used to counter the effects of chemotherapy. Most, but not all, drugs were tested for developmental or reproductive toxicity in animals prior to marketing and most were found to be embryotoxic or teratogenic...
June 13, 2016: Anti-cancer Agents in Medicinal Chemistry
https://www.readbyqxmd.com/read/27285978/medicare-and-amyloid-pet-imaging-the-battle-over-evidence
#20
Karen J Maschke, Michael K Gusmano
We examine a recent dispute regarding the Centers for Medicare and Medicaid Services's (CMS) refusal to unconditionally pay for amyloid PET imaging for Medicare beneficiaries being assessed for Alzheimer's disease. CMS will only pay for amyloid PET imaging when patients are enrolled in clinical trials that meet certain criteria. The dispute reflects CMS's willingness in certain circumstances to require effectiveness evidence that differs from the Food and Drug Administration's standard for pre-market approval of a medical intervention and reveals how stakeholders with differing perspectives about evidentiary standards have played a role in attempting to shape the Medicare program's coverage policies...
June 10, 2016: Journal of Aging & Social Policy
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