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

12:36 EDT 19th June 2018 | BioPortfolio

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Showing "Biotech Premarket Movers Sucampo Intellia Cytokinetics" PubMed Articles 1–25 of 60

Biotech Crop Planting Resumes High Adoption in 2016.

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...

Sex-Specific Outcomes After Transcatheter Aortic Valve Replacement: FDA Patient-Level Meta-Analysis of Premarket Clinical Trials.

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.

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...

Multiparameter cytometric analysis of complex cellular response.

Complex analysis of cellular responses after experimental treatment is important for screening, mechanistic understanding of treatment effects, and the identification of sensitive and resistant cell phenotypes. Modern multicolor flow cytometry has demonstrated its power for such analyses. Here, we introduce a multiparametric protocol for complex analysis of cytokinetics by the simultaneous detection of seven fluorescence parameters. This analysis includes the detection of two surface markers for immunopheno...

Just how good an investment is the biopharmaceutical sector?

Uncertainty surrounding the risk and reward of investments in biopharmaceutical companies poses a challenge to those interested in funding such enterprises. Using data on publicly traded stocks, we track the performance of 1,066 biopharmaceutical companies from 1930 to 2015-the most comprehensive financial analysis of this sector to date. Our systematic exploration of methods for distinguishing biotech and pharmaceutical companies yields a dynamic, more accurate classification method. We find that the perfo...

Third-quarter biotech job picture.

Research biotech patenting 2017.

The ethics of access to patented biotech research tools from universities and other research institutions.

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US.

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...

Optimizing outcomes with polymethylmethacrylate fillers.

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.

Performance evaluation of a chemiluminescence microparticle immunoassay for CK-MB.

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.

Transparency and Dermatologic Device Approval by the US Food and Drug Administration.

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.

Perspective: Structure-Function Claims on Infant Formula.

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 ...

Assessment of Obstetric and Gynecologic FDA Device Approvals and Recalls.

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.

Next Generation Biopharmaceuticals: Product Development.

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 (...

Evaluation of the LIA-ANA-Profile-17S for the detection of autoantibodies to nuclear antigens.

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.

Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting.

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...

Letter--Incorporating Real-World Evidence and Patient Value Criteria into Value-Based Frameworks for Relapsed/Refractory Multiple Myeloma.

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.

A Comparative Study of Medical Device Regulations:: US, Europe, Canada, and Taiwan.

The medical device industry is an industry dealing with multiple types of products covering a wide range of applications. As the safety and effectiveness of medical devices are vital to human health, the products must be managed by strict regulations according to the different risk levels. A total product life cycle regulatory system including product design, manufacture, premarket gate keeping, and postmarket monitoring is a common framework for medical device regulations. However, the variety and innovati...

Development of new hepatitis E vaccines.

Hepatitis E virus (HEV) infection is an emerging zoonotic disease posing a severe threat to public health in the world, especially to pregnant women. Currently, no specific treatments are available for HEV infection. Therefore, it is crucial to develop vaccine to prevent this infection. Although several potential candidate vaccines against HEV have been studied for their immunogenicity and efficacy, only Hecolin® which is developed by Xiamen Innovax Biotech Co., Ltd. and approved by China Food and Drug Adm...

Solvent Tolerance in Bacteria: Fulfilling the Promise of the Biotech Era?

The challenge of sustainably producing highly valuable chemical compounds requires specialized microbial cell factories because many of these compounds can be toxic to microbial hosts. Therefore, solvent-tolerant bacteria are promising production hosts because of their intrinsic tolerance towards these compounds. Recent studies have helped to elucidate the molecular mechanisms involved in solvent tolerance. Advances in synthetic biological tools will enable further development of streamlined solvent-toleran...

Bioremediation potential of hydrocarbon-utilizing fungi from select marine niches of India.

Ten fungal isolates with an ability to degrade crude oil were isolated from select marine substrates, such as mangrove sediments, Arabian Sea sediments, and tarballs. Out of the ten isolates, six belonged to Aspergillus, two to Fusarium and one each to Penicillium and Acremonium as identified using ITS rDNA sequencing. The selected ten fungal isolates were found to degrade the long-chain n-alkanes as opposed to short-chain n-alkanes from the crude oil. Mangrove fungus #NIOSN-M126 (Penicillium citrinum) was ...

Bioactive characteristics and optimization of tamarind seed protein hydrolysate for antioxidant-rich food formulations.

Tamarind seed has been a source of valuable nutrients such as protein (contains high amount of many essential amino acids), essential fatty acids, and minerals which are recognized as additive to develop perfect balanced functional foods. The objective of present work was to optimize the process parameters for extraction and hydrolysis of protein from tamarind seeds. Papain-derived hydrolysates showed a maximum degree of hydrolysis (39.49%) and radical scavenging activity (42.92 ± 2.83%) at optimized c...

In vitro fermentation of copra meal hydrolysate by chicken microbiota.

The aim of this study was to carry out preliminary investigations on the in vitro fermentation selectivity of copra meal hydrolysate (CMH) by chicken gut microbiota. The ileum and cecum contents from three 35-day-old birds were used as inocula. Yeast mannooligosaccharide (yeast-MOS) or α-mannan was selected as a positive control. Batch culture fermentation with fecal bacteria was performed at 42 °C for 24 h in an anaerobic chamber. Samples were collected at 0, 6, 12, 18 and 24 h of fermentation and eva...

Exposure to Night-Time Traffic Noise, Melatonin-Regulating Gene Variants and Change in Glycemia in Adults.

Traffic noise has been linked to diabetes, with limited understanding of its mechanisms. We hypothesize that night-time road traffic noise (RTN) may impair glucose homeostasis through circadian rhythm disturbances. We prospectively investigated the relationship between residential night-time RTN and subsequent eight-year change in glycosylated hemoglobin (ΔHbA1c) in 3350 participants of the Swiss Cohort Study on Air Pollution and Lung and Heart Diseases in Adults (SAPALDIA), adjusting for diabetes risk fac...

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