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https://www.readbyqxmd.com/read/29140657/sunlight-and-other-disinfectants-disclosure-obligations-under-the-federal-securities-and-drug-regulatory-regimes
#1
Joseph G Milner
Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29091995/safety-and-efficacy-of-alternating-treatment-with-ep2006-a-filgrastim-biosimilar-and-reference-filgrastim-a-phase-3-randomised-double-blind-clinical-study-in-the-prevention-of-severe-neutropenia-in-patients-with-breast-cancer-receiving-myelosuppressive-chemotherapy
#2
K Blackwell, P Gascon, A Krendyukov, S Gattu, Y Li, N Harbeck
Background: In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration (FDA) for commercial use in the United States, marketed as Zarxio®. This phase 3 randomised, double-blind registration study in patients with breast cancer receiving (neo)adjuvant myelosuppressive chemotherapy (TAC; docetaxel+doxorubicin+cyclophosphamide) compares reference filgrastim, Neupogen®, with two groups receiving alternating treatment with reference and biosimilar every other cycle...
October 28, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29071718/heterogeneity-of-clinical-trials-for-antihypertensive-drugs-in-japan-exploratory-analysis-of-confirmatory-phase-3-trials-used-for-marketing-approval
#3
Reina Kaneko, Kota Sano, Shunsuke Ono
The results of pivotal trials, which provide a rationale for marketing approval decisions for new drugs, are considered for various comparative purposes in post-marketing analyses. Using meta-regression analysis of 91 randomized controlled trials of 61 approved antihypertensive drugs in Japan, we show that mean baseline blood pressure (BP) of each arm was associated with pre-determined entry criteria (EC), age, and trial start year (TSY). BP changes following treatment were associated with EC, subject characteristics (e...
October 26, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29042750/current-perspective-on-rituximab-in-rheumatic-diseases
#4
REVIEW
Tommaso Schioppo, Francesca Ingegnoli
The steadily increasing knowledge regarding pathogenetic mechanisms in autoimmune rheumatic diseases has paved the way to different therapeutic approaches. In particular, the market entry of biologics has dramatically modified the natural history of rheumatic chronic inflammatory diseases with a meaningful impact on patients' quality of life. Among the wide spectrum of available biological treatments, rituximab (RTX), first used in the treatment of non-Hodgkin's lymphoma, was later approved for rheumatoid arthritis and anti-neutrophil cytoplasmic antibodies-associated vasculitis...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28988455/safety-profiles-of-percutaneous-left-atrial-appendage-closure-devices-an-analysis-of-the-food-and-drug-administration-manufacturer-and-user-facility-device-experience-maude-database-from-2009-2016
#5
Mohammad-Ali Jazayeri, Venkat Vuddanda, Mohit K Turagam, Valay Parikh, Madhav Lavu, Donita Atkins, Matthew Earnest, Luigi Di Biase, Andrea Natale, David Wilber, Yeruva Madhu Reddy, Dhanunjaya Lakkireddy
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc...
October 8, 2017: Journal of Cardiovascular Electrophysiology
https://www.readbyqxmd.com/read/28976217/drugs-approved-for-the-treatment-of-multiple-sclerosis-review-of-their-safety-profile
#6
Fabiana Auricchio, Cristina Scavone, Daniela Cimmaruta, Gabriella Di Mauro, Annalisa Capuano, Liberata Sportiello, Concetta Rafaniello
Multiple sclerosis (MS) is a chronic immune-mediated inflammatory disorder of the brain and spinal cord characterized by inflammation, demyelination, and axonal degeneration. Area covered: Even though the pharmacological armamentarium for MS treatment is considerably improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. In order to analyze the safety profile of drugs used for the treatment of MS, a literature review of pre-marketing, post-marketing studies and case reports was performed...
October 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28947463/maltese-antibiotic-stewardship-programme-in-the-community-maspic-protocol-of-a-prospective-quasiexperimental-social-marketing-intervention
#7
Erika A Saliba-Gustafsson, Michael A Borg, Senia Rosales-Klintz, Anna Nyberg, Cecilia StålsbyLundborg
INTRODUCTION: Antibiotic misuse is a key driver of antibiotic resistance. In 2015/2016, Maltese respondents reported the highest proportions of antibiotic consumption in Europe. Since antibiotics are prescription-only medicines in Malta, research on effective strategies targeting general practitioners' (GPs) knowledge and behaviour is needed. Multifaceted behaviour change (BC) interventions are likely to be effective. Social marketing (SM) can provide the tools to promote sustained BC; however, its utilisation in Europe is limited...
September 24, 2017: BMJ Open
https://www.readbyqxmd.com/read/28946874/design-of-a-single-arm-clinical-trial-of-regenerative-therapy-by-periurethral-injection-of-adipose-derived-regenerative-cells-for-male-stress-urinary-incontinence-in-japan-the-adresu-study-protocol
#8
Shinobu Shimizu, Tokunori Yamamoto, Shinobu Nakayama, Akihiro Hirakawa, Yachiyo Kuwatsuka, Yasuhito Funahashi, Yoshihisa Matsukawa, Keisuke Takanari, Kazuhiro Toriyama, Yuzuru Kamei, Kazutaka Narimoto, Tomonori Yamanishi, Osamu Ishizuka, Masaaki Mizuno, Momokazu Gotoh
BACKGROUND: Male stress urinary incontinence is a prevalent condition after radical prostatectomy. While the standard recommendation for the management of urine leakage is pelvic floor muscle training, its efficacy is still unsatisfactory. Therefore, we have focused on regenerative therapy, which consists of administering a periurethral injection of autologous regenerative cells from adipose tissue, separated using the Celution® system. Based on an interim data analysis of our exploratory study, we confirmed the efficacy and acceptable safety profile of this treatment...
September 25, 2017: BMC Urology
https://www.readbyqxmd.com/read/28942181/novel-adverse-events-of-vortioxetine-a-disproportionality-analysis-in-usfda-adverse-event-reporting-system-database
#9
Viswam Subeesh, Hemendra Singh, Eswaran Maheswari, Elsa Beulah
BACKGROUND: Signal detection is one of the most advanced and emerging field in pharmacovigilance. It is a modern method of detecting new reaction (which can be desired or undesired) of a drug. It facilitates early adverse drug reaction detection which enables health professionals to identify adverse events that may not have been identified in pre-marketing clinical trials. Vortioxetine, the first mixed serotonergic antidepressant was initially approved by the US Food and Drug Administration (USFDA) on September 30, 2013 for the treatment of adults with Major Depressive Disorder (MDD)...
September 14, 2017: Asian Journal of Psychiatry
https://www.readbyqxmd.com/read/28930603/centchroman-a-safe-reversible-postcoital-contraceptive-with-curative-and-prophylactic-activity-in-many-disorders
#10
Ved P Kamboj, Suprabhat Ray, Nitya Anand
Centchroman (INN: Ormeloxifene), a reversible post-coital/weekly oral contraceptive (half-life of about 168 hours), designed and developed at CDRI, Lucknow is the only non-steroidal oral contraceptive in clinical use in the world today. Synthesized in 1967 and completing pre-clinical and clinical studies in 1989, this drug was approved for marketing in 1991, social marketing in 1995 and NFPW in April 2016. It acts by preventing implantation of blastocyst in endometrium. It is the only contraceptive which neither suppresses ovulation nor interferes with the hypothalamic-pituitary-ovarian axis...
January 1, 2018: Frontiers in Bioscience (Elite Edition)
https://www.readbyqxmd.com/read/28853987/forced-degradation-of-recombinant-monoclonal-antibodies-a-practical-guide
#11
Christine Nowak, Jason K Cheung, Shara M Dellatore, Amit Katiyar, Ram Bhat, Joanne Sun, Gomathinayagam Ponniah, Alyssa Neill, Bruce Mason, Alain Beck, Hongcheng Liu
Forced degradation studies have become integral to the development of recombinant monoclonal antibody therapeutics by serving a variety of objectives from early stage manufacturability evaluation to supporting comparability assessments both pre- and post- marketing approval. This review summarizes the regulatory guidance scattered throughout different documents to highlight the expectations from various agencies such as the Food and Drug Administration and European Medicines Agency. The various purposes for forced degradation studies, commonly used conditions and the major degradation pathways under each condition are also discussed...
November 2017: MAbs
https://www.readbyqxmd.com/read/28844164/fingolimod-hydrochloride-for-the-treatment-of-relapsing-remitting-multiple-sclerosis
#12
Katja Thomas, Undine Proschmann, Tjalf Ziemssen
Fingolimod was the first oral and the first in class disease modifying treatment in multiple sclerosis that acts as sphingosine-1-phospathe receptor agonist. Since approval in 2010 there is a growing experience with fingolimod use in clinical practice, but also next-generation sphingosin-1-receptor agonists in ongoing clinical trials. Growing evidence demonstrates additional effects beyond impact on lymphocyte circulation, highlighting further promising targets in multiple sclerosis therapy. Areas covered: Here we present a systematic review using PubMed database searching and expert opinion on fingolimod use in clinical practice...
October 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28833803/important-statistical-considerations-in-the-evaluation-of-post-market-studies-to-assess-whether-opioids-with-abuse-deterrent-properties-result-in-reduced-abuse-in-the-community
#13
Kunthel By, Jana K McAninch, Stephine L Keeton, Alex Secora, Cynthia J Kornegay, Catherine S Hwang, Thomas Ly, Mark S Levenson
PURPOSE: Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community...
August 23, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28766389/pharmacokinetics-efficacy-and-safety-of-the-rituximab-biosimilar-ct-p10
#14
REVIEW
Bertrand Coiffier
Rituximab, an anti-CD20 monoclonal antibody, is a key therapeutic in the treatment of B cell lymphomas and rheumatoid arthritis (RA). Global rates of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and RA are increasing, with a concomitant rise in individual and overall treatment costs. As such, biosimilar development may help facilitate greater access to treatment. The rituximab biosimilar CT-P10 (Truxima®) has recently received approval in Europe and South Korea for all indications held by reference rituximab (RTX)...
September 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28740620/use-and-cost-comparison-of-clobazam-to-other-antiepileptic-drugs-for-treatment-of-lennox-gastaut-syndrome
#15
Clément François, John M Stern, Augustina Ogbonnaya, Tasneem Lokhandwala, Pamela Landsman-Blumberg, Amy Duhig, Vivienne Shen, Robin Tan
Background: Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy associated with serious injuries due to frequent and severe seizures. Of the antiepileptic drugs (AEDs) approved for LGS, clobazam is a more recent market entrant, having been approved in October 2011. Recent AED budget impact and cost-effectiveness analyses for LGS suggest that adding clobazam to a health plan formulary may result in decreased medical costs; however, research on clinical and economic outcomes and treatment patterns with these AED treatments in LGS is limited...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28674261/preliminary-evaluation-of-three-dimensional-primary-human-hepatocyte-culture-system-for-assay-of-drug-metabolizing-enzyme-inducing-potential
#16
Hiroshi Arakawa, Hiroki Kamioka, Tomoko Jomura, Satoshi Koyama, Yoko Idota, Kentaro Yano, Hajime Kojima, Takuo Ogihara
Drug-induced liver injury (DILI) is a common reason for withdrawal of candidate drugs from clinical trials, or of approved drugs from the market. DILI may be induced not only by intact parental drugs, but also by metabolites or intermediates, and therefore should be evaluated in the enzyme-induced state. Here, we present a protocol for assay of drug-metabolizing enzyme-inducing potential using three-dimensional (3D) primary cultures of human hepatocytes (hepatocyte spheroids). Hepatocyte spheroids could be used up to 21 d after seeding (pre-culture for 7 d and exposure to inducer for up to 14 d), based on preliminary evaluation of basal activities of CYP subtypes and mRNA expression of the corresponding transcription factor and xenobiotic receptors (aryl hydrocarbon receptor (AhR), constitutive androstane receptor (CAR) and pregnane X receptor (PXR))...
2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28665972/sample-size-determination-for-a-specific-region-in-multiregional-clinical-trials-with-multiple-co-primary-endpoints
#17
Wong-Shian Huang, Hui-Nien Hung, Toshimitsu Hamasaki, Chin-Fu Hsiao
Recently, multi-regional clinical trials (MRCTs), which incorporate subjects from many countries/regions around the world under the same protocol, have been widely conducted by many global pharmaceutical companies. The objective of such trials is to accelerate the development process for a drug and shorten the drug's approval time in key markets. Several statistical methods have been purposed for the design and evaluation of MRCTs, as well as for assessing the consistency of treatment effects across all regions with one primary endpoint...
2017: PloS One
https://www.readbyqxmd.com/read/28637741/the-closed-trial-clonidine-compared-with-midazolam-for-sedation-of-paediatric-patients-in-the-intensive-care-unit-study-protocol-for-a-multicentre-randomised-controlled-trial
#18
Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost van Rosmalen, Joseph F Standing, Yucheng Sheng, Wolfgang Rascher, Deborah Roberts, Jackie Winslade, Louise Rawcliffe, Sara M Hanning, Tuuli Metsvaht, Viviana Giannuzzi, Peter Larsson, Pavla Pokorná, Alessandra Simonetti, Dick Tibboel
INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28617434/lispro-mitigates-%C3%AE-amyloid-and-associated-pathologies-in-alzheimer-s-mice
#19
Ahsan Habib, Darrell Sawmiller, Song Li, Yang Xiang, David Rongo, Jun Tian, Huayan Hou, Jin Zeng, Adam Smith, Shengnuo Fan, Brian Giunta, Takashi Mori, Glenn Currier, Douglas Ronald Shytle, Jun Tan
Lithium has been marketed in the United States of America since the 1970s as a treatment for bipolar disorder. More recently, studies have shown that lithium can improve cognitive decline associated with Alzheimer's disease (AD). However, the current United States Food and Drug Administration-approved lithium pharmaceutics (carbonate and citrate chemical forms) have a narrow therapeutic window and unstable pharmacokinetics that, without careful monitoring, can cause serious adverse effects. Here, we investigated the safety profile, pharmacokinetics, and therapeutic efficacy of LISPRO (ionic co-crystal of lithium salicylate and l-proline), lithium salicylate, and lithium carbonate (Li2CO3)...
June 15, 2017: Cell Death & Disease
https://www.readbyqxmd.com/read/28464562/pattern-mixture-models-for-clinical-validation-of-biomarkers-in-the-presence-of-missing-data
#20
Fei Gao, Jun Dong, Donglin Zeng, Alan Rong, Joseph G Ibrahim
Targeted therapies for cancers are sometimes only effective in a subset of patients with a particular biomarker status. In clinical development, the biomarker status is typically determined by an investigational-use-only/laboratory-developed test. A market ready test (MRT) is developed later to meet regulatory requirements and for future commercial use. In the USA, the clinical validation of MRT showing efficacy and safety profile of the targeted therapy in the biomarker subgroups determined by MRT is needed for pre-market approval...
May 2, 2017: Statistics in Medicine
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