PubMed Journals Articles About "Biotech Premarket Movers Sucampo Intellia Cytokinetics" RSS

13:59 EST 20th January 2019 | BioPortfolio

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Showing "Biotech Premarket Movers Sucampo Intellia Cytokinetics" PubMed Articles 1–25 of 36

No evidence of inequality aversion in the investment game.

We report experimental evidence on second-movers' behavior in the investment game (also known as the trust game) when there exists endowment heterogeneity. Using a within-subject analysis, we investigate whether or not second-movers exhibit some taste for inequality aversion by returning a larger (smaller) share of the available funds to first-movers who are initially endowed with a lesser (larger) endowment, respectively. Our data suggest that second-movers do not take into consideration the level of endow...

Longitudinal deprivation trajectories and risk of cardiovascular disease in New Zealand.

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...

Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit. Final order.

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...

General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order.

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...

Activity of Shoulder Stabilizers and Prime Movers During an Unstable Overhead Press.

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...

Third-quarter biotech job picture.

Second-quarter biotech job picture.

Gates unveils biotech-within-a-charity.

Public biotech in 2017-the numbers.

New Nonprofit Biotech From Bill and Melinda Gates.

Biotech leaders call for free press.

US law threatens flow of foreign capital to biotech sector.

Genetic data sharing: a new type of capital.

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...

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...

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

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...

First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF.

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.

Long-term (8.5 years) analysis of the type and rate of reoperation after transvaginal mesh repair (Prolift) in 349 patients.

Polypropylene meshes have specific complications, and in 2016 the Food and Drug Administration required a Premarket Approval for their use in pelvic prolapse repair, as there was a lack of long-term data. Our objectives were to determine the long-term reoperation rates and type in our patients after transvaginal mesh repair and to study their risk factors.

Premarket approval through the 510(k) process: Lessons from the translation process of Magnetic Resonance Elastography.

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...

Detection of Transgenic Proteins by Immunoassays.

Rapid development and global cultivation of genetically modified (GM) crops necessitated the use of analytical tools that detect GM crops throughout the product life cycle. Antibody-based immunoassays such as enzyme-linked immunosorbent assays (ELISA) are instrumental in detecting protein expression in transgenic plants. These analytical tools are used throughout development, regulatory registration, commercialization, and stewardship of biotech products. Here we describe the Cry1F ELISA analytical method p...

Multiscale heterogeneity in filamentous microbes.

Microbial cells within clonal populations can display different morphologies or carry out different tasks. This heterogeneity is beneficial at the population level and allows microbes to spread risk or separate incompatible activities. Heterogeneity is also evident in filamentous bacteria and fungi, which form mycelial networks consisting of interconnected hyphae. Here, heterogeneity is observed between clonal mycelial particles, between different zones of colonies, between adjacent hyphae and even between ...

An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration.

Introduction Orthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years. Methods The Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devices from 20...

Effect of Unstable Loads on Stabilizing Muscles and Bar Motion During the Bench Press.

Lawrence, MA, Ostrowski, SJ, Leib, DJ, and Carlson, LA. Effect of unstable loads on stabilizing muscles and bar motion during the bench press. J Strength Cond Res XX(X): 000-000, 2018-Unstable loads are anecdotally used to increase muscle stabilizer strength and utilization; however, there is little evidence to support these claims. Twelve male powerlifters (age 28.6 ± 5.2 years, body mass 105.6 ± 14.5 kg, lifting experience 9.8 ± 6.0 years, and bench press 5 repetition maximum [5RM] 133.6 ± 30.9 kg) pr...

Programmable Molecular Scissors: Applications of a New Tool for Genome Editing in Biotech.

Targeted genome editing is an advanced technique that enables precise modification of the nucleic acid sequences in a genome. Genome editing is typically performed using tools, such as molecular scissors, to cut a defined location in a specific gene. Genome editing has impacted various fields of biotechnology, such as agriculture; biopharmaceutical production; studies on the structure, regulation, and function of the genome; and the creation of transgenic organisms and cell lines. Although genome editing is...

Creating Targeted Gene Knockouts in Brassica oleracea Using CRISPR/Cas9.

While public and political views on genetic modification (inserting "foreign" genes to elicit new traits) have resulted in limited exploitation of the technology in some parts of the world, the new era of genome editing (to edit existing genes to gain new traits/genetic variation) has the potential to change the biotech landscape. Genome editing offers a faster and simpler approach to gene knockout in both single and multiple genetic locations, within a single or small number of generations, in a way that h...

Seed coats as an alternative molecular factory: thinking outside the box.

Seed coats as commodities. Seed coats play important roles in the protection of the embryo from biological attack and physical damage by the environment as well as dispersion strategies. A significant part of the energy devoted by the mother plant to seed production is channeled into the production of the cell layers and metabolites that surround the embryo. Nevertheless, in crop species these are often discarded post-harvest and are a wasted resource that could be processed to yield co-products. The produc...

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