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Biotech Premarket Movers Sucampo Intellia Cytokinetics PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Biotech Premarket Movers Sucampo Intellia Cytokinetics articles that have been published worldwide.
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We used longitudinal information on area deprivation status to explore the relationship between residential-deprivation mobility and Cardiovascular Disease (CVD). Data from 2,418,397 individuals who were: enrolled in any Primary Health Organisation within New Zealand (NZ) during at least 1 of 34 calendar quarters between 1st January 2006 and 30th June 2014; aged between 30 and 84 years (inclusive) at the start of the study period; had no prior history of CVD; and had recorded address information were analys...
The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption...
Williams, MR Jr, Hendricks, DS, Dannen, MJ, Arnold, AM, and Lawrence, MA. Activity of shoulder stabilizers and prime movers during an unstable overhead press. J Strength Cond Res XX(X): 000-000, 2018-Overhead reaching is a common movement that relies heavily on muscles for dynamic stability. Stabilizer muscle activation increased during squatting and bench pressing with an unstable load, but the overhead press (OHP) has yet to be examined. The purpose of this study is to compare muscle activity of the shoul...
Transcatheter aortic valve replacement (TAVR) is a less invasive alternative approach to surgery. Individual randomized clinical trials evaluating the safety and efficacy of TAVR were mostly underpowered for conducting separate analyses for women and men. We pooled data from premarket TAVR clinical trials comparing short (30 days)- and long-term (∼2 years) outcomes by sex.
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device, a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassi...
Over the last three decades, various biotech companies, mostly in North America, have become experts in the production, processing and analysis of large volumes of genetic data. They have surpassed the performance of traditional academic platforms, by appropriating a new economic model: the two-sided market. Thus, by applying web 2.0 ideas, these biotech companies have made it possible for millions of users to produce and "share" data including genetic data, with each other and with third parties through a...
To verify and evaluate the performance characteristics of a creatine kinase phosphokinase isoenzymes MB (CK-MB) assay kit, which produced by Xiamen Innodx Biotech Co. Ltd.
The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and
The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devi...
The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a huma...
The Food and Drug Administration (FDA) initiated the Expedited Access Pathway (EAP) to accelerate approval of novel therapies targeting unmet needs for life-threatening conditions. EAP allows for the possibility of initial FDA approval using intermediate end points with postapproval demonstration of improved outcomes.
The ideal filler should be long-lasting, biocompatible, chemically inert, soft and easy to use, and have a long history of safety. This review focuses on the evolution and development of the PMMA-collagen gel, Bellafill, and the 10 years of postmarketing experience of Bellafill since it received premarket approval (PMA) from the FDA as Artefill in 2006. Artefill was rebranded to Bellafill in 2015.
In the context of a food product label, the term "claim" refers to information that attributes value to the product. The term extends to many different types of information, from product identity, descriptors of intended use, and identification of characteristic properties to the physiologic effects in the body of substances in the food, including the reduction of risk of disease. Food labeling, which includes claims, provides information that consumers want and use to improve their diets. Consumers prefer ...
To evaluate and compare the recall rates of Obstetric and Gynecologic devices approved via the Food and Drug Administration's (FDA) 510(k) and Premarket Approval (PMA) processes DESIGN: Retrospective Observational Study (Canadian Task Force Classification II-2) SETTING: Clinical settings in the United States of America that use Obstetric and Gynecologic devices SUBJECTS: 2,249 FDA approved Obstetric and Gynecologic Devices that were recalled between November 1, 2002 and December 31, 2017.
Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (...
The diagnostic tests for autoimmune disease include screening for autoantibodies for nuclear antigens (ANA) and antibodies against extractable nuclear antigens (ENA). Using the line immunoassay (LIA) method, various kinds of ENA antibodies can be detected simultaneously. We evaluated the performance of the newly launched LIA-ANA-Profile-17S (Shenzhen YHLO Biotech, Shenzhen, China) as compared to a conventional LIA kit.
Innovations in medical imaging technologies have revolutionized medicine and generated examples of rapid translation to the clinic. Magnetic resonance elastography (MRE) is a noninvasive technique to quantify tissue stiffness. In this commentary, key events in the translation of MRE from laboratory into clinical practice are highlighted. We focus on key science and technology, application to chronic liver diseases, key clinical studies, the FDA approval process, and its influence on current and future medic...
Orlowski has received research funding from Amgen, BioTheryX, Bristol-Myers Squibb, Celgene Corporation, and Takeda Pharmaceuticals; honoraria from Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Millennium Pharmaceuticals, and Onyx Pharmaceuticals; and is a member of advisory boards for Amgen, Bristol-Myers Squibb, Celgene Corporation, Incyte, Kite, Legend Biotech, Sanofi-Aventis, and Takeda Pharmaceuticals.