Bio Pharma Dive
NOVEMBER 12, 2020
Coronavirus' fast accelerating spread in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results.
BioSpace
NOVEMBER 12, 2020
Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for COVID-19.
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Bio Pharma Dive
NOVEMBER 12, 2020
The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.
BioSpace
NOVEMBER 12, 2020
Sanofi was formally charged over Depakine, its epilepsy drug, for not taking action when they first discovered the fetal risks when taken by pregnant women.
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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
Bio Pharma Dive
NOVEMBER 12, 2020
With patent expirations nearing for a top-selling drug, the Belgian pharma will buy one company and partner with another to add several early-stage projects in neurological diseases.
BioSpace
NOVEMBER 12, 2020
Despite the large number of people dealing with the stinging, burning and blurring of the eye caused by the illness, there remains a significant unmet need for effective and lasting therapies.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 12, 2020
Nkarta has treated its first patient in the first-in-human Phase I clinical trial of NKX101, an investigational immunotherapy designed to treat relapsed/refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes.
Intouch Solutions
NOVEMBER 12, 2020
For years, third-party tracking cookies were the backbone of the internet. Now, marketers must develop strategies to address targeting and measurement in a world without them. Read on to get creative solutions that keep messaging personalized in a cookieless world. The post A Cookieless Future: Why All the Fuss Around Cookies? appeared first on Intouch Solutions.
BioSpace
NOVEMBER 12, 2020
There have been some concerns over the accuracy of COVID-19 rapid antigen tests—the clinical diagnostic tests that evaluate for active infections by testing for the presence of the virus’s antigens.
pharmaphorum
NOVEMBER 12, 2020
CatalYm has closed a €50 million ($59m) series B financing round to fund clinical studies of its immunotherapy targeting Growth Differentiation Factor 15 (GDF-15). The round was led by Vesalius Biocapital III, with participation from Novartis Venture Fund (NVF), Wachstumsfonds Bayern, coparion and founding investors Forbion and BioGeneration Ventures.
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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
NOVEMBER 12, 2020
Synairgen announced today that its data from the SG016 trial was published in the journal The Lancet Respiratory Medicine. The trial, which included 101 hospitalized COVID-19 patients, looked at SNG001 as a potential treatment.
pharmaphorum
NOVEMBER 12, 2020
The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% of patients. The companies said deliveries of an initial order of 200 million vaccines will be subject to approval by European regulators and are expected to start by the end of this year.
BioSpace
NOVEMBER 12, 2020
A study recently conducted at Mayo Clinic showed that dysfunctional Tissue Resident Memory (TRM) CD8 T cells are actually working against the elderly, reducing immunity and enabling residual chronic lung issues after respiratory infections such as COVID-19.
BioPharma Reporter
NOVEMBER 12, 2020
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines in preparation for the first three vaccines likely to be launched in Europe.
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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
NOVEMBER 12, 2020
A recent study found that Vitamin D deficiency may be associated with an increased COVID-19 risk.
Scienmag
NOVEMBER 12, 2020
Credit: University of Exeter Elite runners need a specific combination of physiological abilities to have any chance of running a sub-two-hour marathon, new research shows. The study is based on detailed testing of athletes who took part in Nike’s Breaking2 project – an ambitious bid to break the two-hour barrier. Professor Andrew Jones, of the […].
BioPharma Reporter
NOVEMBER 12, 2020
As vaccine development for COVID-19 continues to be successful in terms of clinical data, the next step in getting the vaccines to people is storage and distribution.
Scienmag
NOVEMBER 12, 2020
Credit: Jinan University Stroke is a leading cause of death and severe long-term disability with limited treatment available. A research team led by Prof. Gong Chen at Jinan University, Guangzhou, China recently reported the first non-human primate study demonstrating successful in vivo neural regeneration from brain internal glial cells for stroke repair.
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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.
Pharma Times
NOVEMBER 12, 2020
Interim data analysis comes from phase III clinical trials in the Russian Federation
Scienmag
NOVEMBER 12, 2020
Removing one charged molecule from a one-dimensional array causes the others to alternately turn ‘on’ or ‘off,’ paving the way for information transfer in tiny circuits Credit: Berkeley Lab Small electronic circuits power our everyday lives, from the tiny cameras in our phones to the microprocessors in our computers. To make those devices even smaller, […].
pharmaphorum
NOVEMBER 12, 2020
Swiss startup Synendos Therapeutics has raised CHF 20 million (almost $22 million) in first-round financing that will be used to develop its endocannabinoid drugs for central nervous system disorders. The Basel-based biotech – which was incubated in Switzerland’s BaseLaunch accelerator – is concentrating on developing a new class of small-molecule drugs for anxiety, mood and stress-related disorders.
Scienmag
NOVEMBER 12, 2020
Credit: Kexin CHEN Against the background of global warming, more intense and frequent heat waves have brought huge impacts on humanity. As such, the characteristics of extreme temperature changes in the future have become a key concern of the climate change community. Climate models have provided an avenue for studying the possible changes in extreme […].
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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.
Outsourcing Pharma
NOVEMBER 12, 2020
The two companies plan to work together on the creation a drug-development technology tool that helps in safety margin risk assessment prediction.
Scienmag
NOVEMBER 12, 2020
Improved medical record management means better care during COVID-19 pandemic Credit: UC San Diego Health Across the nation, top universities offer comprehensive health services to more than 20 million students in the form of primary, urgent and mental health care services. Management of medical records within student health centers is often outdated and unconnected to […].
BioSpace
NOVEMBER 12, 2020
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
NOVEMBER 12, 2020
Credit: Christopher Chambers et al, The Cryosphere, November 12, 2020. Computational models suggest that melting water originating in the deep interior of Greenland could flow the entire length of a subglacial valley and exit at Petermann Fjord, along the northern coast of the island. Updating ice sheet models with this open valley could provide additional […].
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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.
BioSpace
NOVEMBER 12, 2020
Despite the greenlight from the U.S. Food and Drug Administration as an emergency treatment, there are some questions about how effective the treatment will actually prove to be due to labeling limitations.
Scienmag
NOVEMBER 12, 2020
‘I can see it in your eyes’ Credit: Helmholtz Zentrum München Researchers at Helmholtz Zentrum München together with LMU University Eye Hospital Munich and the Technical University of Munich (TUM) created a novel deep learning method that makes automated screenings for eye diseases such as diabetic retinopathy more efficient. Reducing the amount of expensive annotated […].
BioPharma Reporter
NOVEMBER 12, 2020
Moderna has completed case accrual for the first planned interim analysis of its mRNA COVID-19 vaccine.
Scienmag
NOVEMBER 12, 2020
Credit: Feeding America URBANA, Ill. - Food insecurity in America is reaching an all-time high during the COVID-19 pandemic. But large regional differences exist in the severity of the impact. Experts project over 50 million Americans will be food insecure in 2020, including about 17 million children, says Craig Gundersen, ACES distinguished professor in the […].
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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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