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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 global area of biotech crops in 2016 increased from 179.7 million hectares to 185.1 million hectares, a 3% increase equivalent to 5.4 million hectares. Some 26 countries planted biotech crops, 19 of which were developing countries and seven were industrial. Information and data collected from various credible sources showed variations from the previous year. Fluctuations in biotech crop area (both increases and decreases) are influenced by factors including, among others, acceptance and commercializatio...
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...
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 US Food and Drug Administration (FDA) has premarket review authority over food additives, but a food manufacturer may, according to the legislation, intentionally add a substance to human food or animal food without their premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use. Generally recognized as safe (GRAS) implies that the current scientific community agrees on the adequacy of how data is generated. This s...
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.
The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental device changes via supplemental applications, which are not subjected to such vetting measures and can cause understudied changes that lead to drift from a device's original design.
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...
Accurate fingerprinting of critical raw materials that have significant impact on process performance and product quality is a necessary precursor for implementation of QbD in process and product development. This article presents a review of major developments in this space in the last 10 years, with a special emphasis on those in last 5 years. A step by step approach for managing raw materials in the QbD paradigm has been proposed. We think that it is necessary for the biotech industry to better manage va...