Scienmag
JUNE 12, 2022
Many dog lovers want to know what goes on in their furry friends’ minds. Now scientists are finally getting closer to the answer. In a new study just published in the journal of Animal Cognition, researchers from the Family Dog Project (Eötvös Loránd University University, Budapest) found out that dogs have a “multi-modal mental image” […].
BioSpace
JUNE 12, 2022
Ahead of a scheduled Advisory Committee meeting this week, the FDA released favorable remarks about the Pfizer-BioNTech and Moderna COVID-19 vaccines for children under the age of five.
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Scienmag
JUNE 12, 2022
ATLANTA—Hospitalized patients with diabetes or hyperglycemia who receive goal-directed glycemic management that includes new technologies for glucose monitoring and pre-discharge diabetes self-management education may have better outcomes and less likelihood of readmission, according to a Clinical Practice Guideline issued today by the Endocrine Society at ENDO 2022.
BioSpace
JUNE 12, 2022
While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Scienmag
JUNE 12, 2022
Low-tech – just what the doctor ordered Credit: University of Leeds/Dr Pete Culmer Low-tech – just what the doctor ordered Medical equipment that can be manufactured at low cost, is simple to use and can be easily maintained will help extend surgery to the 5 billion people worldwide who currently cannot get access to it, […].
BioSpace
JUNE 12, 2022
A new study that looks into employment has found that doctoral recipients enjoy extremely high employment rates, especially in the fields of science and engineering.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 12, 2022
???????ION582 is uniquely formulated using RNA technology to provide relief to patients with Angelman syndrome, a rare disorder for which limited treatment options are available.
Scienmag
JUNE 12, 2022
Concerns about rising atmospheric carbon dioxide levels and global warming have made it an environmental imperative to replace fossil fuels with cleaner and more sustainable alternatives. In this regard, hydrogen, a clean energy source, has emerged as an excellent potential candidate. Credit: AC Transit hydrogen fuel cell bus by Eric Fischer. Concerns about rising atmospheric […].
BioSpace
JUNE 12, 2022
CRISPR Therapeutics shared positive initial data from its Phase I COBALT-LYM trial of CTX130 for cancer which demonstrated safety and efficacy when used to target CD70.
Scienmag
JUNE 12, 2022
The potential of Millimeter-wave Wireless Power Transfer as a solution for Massive Internet of Things has finally been harnessed by researchers from Tokyo Tech, who have created a device for simultaneous transmission of power and 5G signal. This transceiver for 5G network signal is fully wirelessly powered and has high power conversion efficiency at large […].
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
JUNE 12, 2022
SPACs – special purpose acquisition companies – have lost their luster and may never regain it. BioSpace spoke with Neal Gerber Eisenberg's Gregory D. Grove.
Scienmag
JUNE 12, 2022
New research has shown that normal human brain temperature varies much more than we thought, and this could be a sign of healthy brain function. In healthy men and women, where oral temperature is typically less than 37°C, average brain temperature is 38.5°C, with deeper brain regions often exceeding 40°C, particularly in women during the […].
BioSpace
JUNE 12, 2022
Shape Therapeutics is evolving programmable RNA medicines that push the limits of current gene editing capabilities. BioSpace spoke with CSO David Huss.
JAMA Internal Medicine
JUNE 12, 2022
This cohort study uses data from the national health care databases of the US Department of Veterans Affairs to compare the risks of adverse events associated with BNT162b2 and mRNA-1273 vaccines reported among US veterans.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
JUNE 12, 2022
The approval of AMX0035, which will be marketed under the brand name Albrioza, marks the first new ALS drug approved in Canada since 2018.
Scienmag
JUNE 12, 2022
Washington, D.C. – June 12, 2022 – According to new research by investigators at the Mayo Clinic and Washington State University, e-bandages could be an effective alternative to antibiotics for managing wound infections. The findings are presented at ASM Microbe 2022, the annual meeting of the American Society for Microbiology. In a recent study conducted in mice, novel hydrogen peroxide producing bandages with electrical/chemical properties (electro-chemical bandages or e-bandages), under [R
BioSpace
JUNE 12, 2022
OptiNose announced positive top-line results from its Phase III ReOpen2 clinical trial testing OptiNose’s XHANCE, a fluticasone propionate nasal spray for chronic sinusitis.
Scienmag
JUNE 12, 2022
Washington, D.C. – June 12, 2022 – Chemical pre-treatments that deconstruct certain types of plastics can help naturally occurring microbial communities break down plastic waste more quickly, according to researchers at Michigan Technological University. The research will be presented at Microbe, the annual meeting of the American Society for Microbiology, on June 12, 2022 in […].
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioSpace
JUNE 12, 2022
Versanis Bio's data reveals the results of a pooled analysis, showing that its lead asset, bimagrumab, improves body composition in both diabetic and non-diabetic patients.
Scienmag
JUNE 12, 2022
Washington, D.C. – June 12, 2022 – Plastic pollution in the ocean may serve as a source for novel antibiotics, according to a new student-led study conducted in collaboration with the Scripps Institution of Oceanography. The research will be presented at the American Society for Microbiology’s conference in Washington, D.C. on June 9-13, 2022. Scientists […].
BioSpace
JUNE 12, 2022
Initial data from Novo Nordisk's Phase III trial on Sogroya (somapacitan) to treat growth hormone deficiency (GHD) demonstrated safety and efficacy in prepubertal children.
pharmaphorum
JUNE 12, 2022
A gene-editing drug developed by CRISPR Therapeutics and Vertex Pharma has continued to show impressive results in clinical trial, with an update at the EHA congress showing long-term effects on the symptoms of both beta thalassaemia and sickle cell disease. New data from the CLIMB-111, CLIMB-121, and CLIMB-131 presented in a late breaker at the EHA yesterday came from 75 patients with thalassaemia and SCD who had been treated with CTX001 (exagamglogene autotemcel or exa-cel) for between around
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
BioSpace
JUNE 12, 2022
BioSpace looks at several companies developing new gene therapies in the wake of the FDA recommending two of bluebird bio’s lentiviral vector gene therapies.
pharmaphorum
JUNE 12, 2022
bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. By the end of the week, it was two for two, with both recommended for approval by a unanimous vote. Thursday saw the Cellular, Tissue and Gene Therapies advisory committee back elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD) – see our report here – and the following day it was the turn of b
BioSpace
JUNE 12, 2022
It was an extraordinarily busy week for clinical trial news and updates due to several prominent international conferences. Here’s a look at some of the highlights.
Scienmag
JUNE 12, 2022
Vienna, Austria: Combining information about the pattern of blood vessels in the retina with genetic data can enable accurate prediction of an individual’s risk of coronary artery disease (CAD) and its potentially fatal outcome, myocardial infarction (MI), commonly known as a heart attack. The discovery could lead to a simple screening process where an MI […].
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
The Pharma Data
JUNE 12, 2022
Investigational phase 3 data for Sogroya ® ( somapacitan ) injection in children with growth hormone deficiency presented today at the ENDO 2022 Congress 1. Today, Novo Nordisk announced results of once-weekly Sogroya ® (somapacitan) injection in helping children achieve growth targets of annualised height velocity (AHV). 1 These phase 3 results from the REAL 4 study, in prepubertal children with growth hormone deficiency (GHD), were presented today at the Endocrine Society’s Annual Me
Scienmag
JUNE 12, 2022
A new study finds overweight and obese people maintained an average weight loss of 10.6% over 3 to 5 years with a program of lifestyle changes in combination with anti-obesity medications. Weight loss of more than 10% provides significant health benefits, according to researchers who are presenting their findings Sunday, June 12 at ENDO 2022, […].
Drug Patent Watch
JUNE 12, 2022
Annual Drug Patent Expirations for RYANODEX Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent expiration for Eagle Pharms drug RYANODEX appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 12, 2022
Arlington, Va., and Indianapolis – June 13, 2022 – The Personal Protective Equipment (PPE) shortages brought about by the COVID-19 pandemic proved to be an opportunity for a Virginia health system to not only address supply chain issues, but also to improve their environmental footprint. By designing and producing a custom, reusable isolation gown, Inova […].
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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