Read by QxMD icon Read

Pre-market approval

Kyriaki Tzogani, Elisabeth Penninga, Marie Louise Schougaard Christiansen, Doris Hovgaard, Sinan B Sarac, Jorge Camarero Jimenez, Isabel Garcia, Marta Lafuente, Arantxa Sancho-López, Tomas Salmonson, Christian Gisselbrecht, Francesco Pignatti
On May 20, 2016, a conditional marketing authorization valid through the European Union (EU) was issued for daratumumab as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who had demonstrated disease progression on the last therapy. The review of daratumumab was conducted under the EMA's accelerated assessment program for drugs that are of major interest for public health, especially from the point of view of therapeutic innovation...
January 25, 2018: Oncologist
Nawaraj Upadhaya, Mark J D Jordans, Dristy Gurung, Ruja Pokhrel, Ramesh P Adhikari, Ivan H Komproe
BACKGROUND: Psychotropic drugs play an important role in the treatment of mental, neurological and substance use disorders. Despite the advancement of the use of psycho-pharmaceuticals in the developed countries, the psychotropic drug production and supply chain management in low- and middle- income countries are still poorly developed. This study aims to explore the perceptions of stakeholders involved in all stages of the psychotropic drug supply chain about the need, quality, availability and effectiveness of psychotropic drugs, as well as barriers to their supply chain management...
January 24, 2018: Globalization and Health
Nilan T Jacob
Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from pre-clinical studies to multi-centric clinical trials and post-marketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved; which puts pressure on the manufacturers to maximise the profit from approved drugs. It is in this key area, the practice of drug promotion plays its role...
January 18, 2018: British Journal of Clinical Pharmacology
Emily Boozalis, Yevgeniy R Semenov, Shawn G Kwatra
AIM: The purpose of this review is to elucidate the steps involved in the FDA's approval of new dermatology drugs. METHODS: To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals). RESULTS: In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three phases of clinical trials in humans before undergoing review by the Food and Drug Administration (FDA)...
January 26, 2018: Journal of Dermatological Treatment
Monica M Johnson, Kristy M Ainslie
Purpose of review: Burkholderia pseudomallei's and Burkholderia mallei's high rate of infectivity, limited treatment options, and potential use as biological warfare agents underscore the need for development of effective vaccines against these bacteria. Research efforts focused on vaccines against these bacteria are in pre-clinical stages, with no approved formulations currently on the market. Recent findings: Several live attenuated and subunit vaccine formulations have been evaluated in animal studies, with no reports of significant long term survival after lethal challenge...
September 2017: Current Tropical Medicine Reports
Laura Desveaux, James Shaw, Ross Wallace, Onil Bhattacharyya, R Sacha Bhatia, Trevor Jamieson
Virtual technologies have the potential to mitigate a range of challenges for health care systems. Despite the widespread use of mobile devices in everyday life, they currently have a limited role in health service delivery and clinical care. Efforts to integrate the fast-paced consumer technology market with health care delivery exposes tensions among patients, providers, vendors, evaluators, and system decision makers. This paper explores the key tensions between the high bar for evidence prior to market approval that guides health care regulatory decisions and the "fail fast" reality of the technology industry...
December 8, 2017: JMIR Medical Informatics
Michael T Solotke, Sanket S Dhruva, Nicholas S Downing, Nilay D Shah, Joseph S Ross
BACKGROUND: The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. METHODS: We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites...
February 2018: Expert Opinion on Drug Safety
G Barbanti Bròdano, C Griffoni, A Nataloni, M Manfrini, G Giavaresi, S Bandiera, A Gasbarrini, S Terzi, R Ghermandi, G Tedesco, M Girolami, M Tognon, M Fini
Vertebral fusion is performed in order to stabilize the spine in the presence of degenerative, traumatic or oncological pathologies that alter its stability. The autologous bone, harvested from the patient’s iliac crest or from the lamina during surgery, is still considered the “gold standard” for spine fusion due to its osteogenic, osteoinductive and osteoconductive properties. However, several biological and synthetic bone substitutes have been introduced as alternatives for regenerating bone tissue...
October 2017: Journal of Biological Regulators and Homeostatic Agents
Udo Bonnet, Norbert Scherbaum
In the last ten years, the prescriptions of the gabapentinoids gabapentin and pregabalin increased largely also in Germany. Since several national and international pharmacovigilance-databases have warned for abuse liabilities and overdose fatalities in association with both gabapentinoids, which moreover, became to be sold on internet and black-markets, their addictive power has been subject to an ongoing clinical debate. As pre- and post-approval clinical trials did not reveal significant signs of dependence on gabapentin or pregabalin, we systematically searched in PubMed and Scopus for clinical studies and case reports being associated with abuse of and dependence on these drugs...
November 27, 2017: Fortschritte der Neurologie-Psychiatrie
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
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
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
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
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 R 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...
January 2018: Journal of Cardiovascular Electrophysiology
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...
December 2017: Expert Opinion on Drug Safety
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
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
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
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)
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
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"