keyword
MENU ▼
Read by QxMD icon Read
search

Pre-market approval

keyword
https://www.readbyqxmd.com/read/29782188/an-evaluation-of-nivolumab-for-the-treatment-of-metastatic-renal-cell-carcinoma
#1
Kevin Zarrabi, Shenhong Wu
The treatment paradigm for metastatic renal cell carcinoma (mRCC) has undergone a revolution with the rapid market approval of multiple agents over a three-year period. The immunogenicity of RCC provided the biological rationale to assess the clinical efficacy of nivolumab, an immune checkpoint inhibitor. Nivolumab is approved for second-line treatment after failure of angiogenesis targeted therapy and in combination therapy with ipilimumab for previously untreated intermediate or poor-risk advanced renal cell carcinoma...
May 21, 2018: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/29724236/patient-consent-to-publication-and-data-sharing-in-industry-and-nih-funded-clinical-trials
#2
O'Mareen Spence, Richie Onwuchekwa Uba, Seongbin Shin, Peter Doshi
BACKGROUND: Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. Therefore, non-publication trials-and, more recently, lack of data sharing-are widely considered to violate the trust of trial participants. Existing practices regarding patient consent to publication and data sharing have not been evaluated. Analyzing informed consent forms (ICFs), we studied what trial participants were told regarding investigators' intention to contribute to medical knowledge, publish trial results, and share de-identified trial data...
May 3, 2018: Trials
https://www.readbyqxmd.com/read/29714521/what-to-know-about-medicines-with-new-active-ingredients-approved-in-fy-2016-2016-in-japan-and-eu-a-brief-comparison-of-new-medicines-approved-in-japan-and-the-eu-in-2016
#3
Hideyuki Kondo, Agnès Saint-Raymond, Naoyuki Yasuda
The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU...
March 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29707095/a-case-of-a-reversible-neurologic-adverse-reaction-to-apixaban-confirmed-by-re-challenge
#4
James A Josyln, Furqan H Khattak, Stephen A Geraci
Post-marketing reporting of adverse drug events is essential for new medications, as pre-FDA approval studies lack sufficient subject numbers to detect signals for rare events. Prescriptions for the novel oral anticoagulant factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) have equaled or exceeded those for vitamin K antagonists in many clinical settings requiring chronic anticoagulation, and those of injectable heparins for deep vein thrombosis prophylaxis. We report the case of a 60-year-old woman followed for permanent atrial fibrillation who was prescribed apixaban...
June 2018: Journal of Clinical Medicine Research
https://www.readbyqxmd.com/read/29681236/an-industry-update-what-is-the-latest-news-in-the-therapeutic-delivery-field
#5
Catarina Pinto Reis
The present industry update covers the period 1-31 December 2017. Information was sourced primarily from scientific literature and various news websites, company press releases, regulatory and patent agencies. The most representative (not all) examples of research are herein described and they are mainly focused on metabolic diseases, cancer, blood pressure diseases, eyes diseases and, in some cases, in rare diseases. In this paper, there was a clear positive approval tendency for several companies where they offered novel therapeutic delivery candidates...
May 2018: Therapeutic Delivery
https://www.readbyqxmd.com/read/29629815/data-monitoring-committees-current-issues
#6
Thomas R Fleming, Susan S Ellenberg, David L DeMets
Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study participants and enhancing the integrity and credibility of clinical trials. Even with the wide recognition of these principles, there are circumstances where confidentiality issues remain challenging, controversial or inconsistently addressed. First, consider settings where a clinical trial's interim data could provide the evidence regulatory authorities require for decisions about marketing approval, yet where such a trial would be continued post-approval to provide more definitive evidence about principal safety and/or efficacy outcomes...
April 1, 2018: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29601839/japan-specific-key-regulatory-aspects-for-development-of-new-biopharmaceutical-drug-products
#7
REVIEW
Kashappa Goud Desai, Hirokazu Obayashi, James D Colandene, Douglas P Nesta
Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies due to differences in language and culture...
March 28, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29569947/tivanisiran-a-novel-sirna-for-the-treatment-of-dry-eye-disease
#8
Javier Moreno-Montañés, Anne-Marie Bleau, Ana Isabel Jimenez
Dry eye disease (DED) is characterized by an alteration of the tear film with ocular inflammation and neurosensory abnormalities. The main clinical signs of this condition are tear instability and ocular damage. Although DED has gained significant attention in the past few years, limited prescription treatment options are available for patients. Areas covered: The current manuscript summarizes the pre-clinical and clinical development of tivanisiran, a novel small interfering oligonucleotide of RNA (siRNA) used for the treatment of DED...
March 23, 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29563353/first-approval-of-improved-medical-device-conditional-on-use-result-survey-in-japan-regulatory-review-of-polymer-free-drug-coated-biofreedom-coronary-stent
#9
Akihide Konishi, Mami Ho, Yuko Shirai, Haruki Shirato
A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month...
March 21, 2018: Circulation Journal: Official Journal of the Japanese Circulation Society
https://www.readbyqxmd.com/read/29371479/ema-review-of-daratumumab-for-the-treatment-of-adult-patients-with-multiple-myeloma
#10
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
https://www.readbyqxmd.com/read/29368618/psychotropic-drugs-in-nepal-perceptions-on-use-and-supply-chain-management
#11
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
https://www.readbyqxmd.com/read/29349812/drug-promotion-practices-a-review
#12
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 preclinical studies to multicentric clinical trials and postmarketing 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 maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role...
January 18, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29304565/food-and-drug-administration-approval-process-for-dermatology-drugs-in-the-united-states
#13
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
https://www.readbyqxmd.com/read/29242769/vaccines-for-the-prevention-of-melioidosis-and-glanders
#14
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
https://www.readbyqxmd.com/read/29222075/examining-tensions-that-affect-the-evaluation-of-technology-in-health-care-considerations-for-system-decision-makers-from-the-perspective-of-industry-and-evaluators
#15
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
https://www.readbyqxmd.com/read/29215916/new-and-incremental-fda-black-box-warnings-from-2008-to-2015
#16
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
https://www.readbyqxmd.com/read/29188680/biomaterials-as-bone-graft-substitutes-for-spine-surgery-from-preclinical-results-to-clinical-study
#17
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
https://www.readbyqxmd.com/read/29179227/-on-the-risk-of-dependence-on-gabapentinoids
#18
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...
February 2018: Fortschritte der Neurologie-Psychiatrie
https://www.readbyqxmd.com/read/29140657/sunlight-and-other-disinfectants-disclosure-obligations-under-the-federal-securities-and-drug-regulatory-regimes
#19
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-iii-randomised-double-blind-clinical-study-in-the-prevention-of-severe-neutropenia-in-patients-with-breast-cancer-receiving-myelosuppressive-chemotherapy
#20
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 for commercial use in the United States, marketed as Zarxio® (Sandoz). This phase III randomised, double-blind registration study in patients with breast cancer receiving (neo)adjuvant myelosuppressive chemotherapy (TAC; docetaxel + doxorubicin + cyclophosphamide) compares reference filgrastim, Neupogen® (Amgen), with two groups receiving alternating treatment with reference and biosimilar every other cycle...
January 1, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
keyword
keyword
57642
1
2
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"