Bio Pharma Dive
SEPTEMBER 17, 2020
The biotech, among the furthest along in coronavirus vaccine development, is the first developer to share the so-called study protocol of its large Phase 3 trial.
World of DTC Marketing
SEPTEMBER 17, 2020
IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcare providers is a huge reason. The adult obesity rate passed 40 percent nationally for the first time according to the 2017–2018 National Health and Nutrition Examination Survey (NHANES), a 26 percent jump from 2007–2008.
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Bio Pharma Dive
SEPTEMBER 17, 2020
Both companies believe the messenger RNA technology they're using in their coronavirus vaccines could be applied to create a better flu shot.
BioPharma Reporter
SEPTEMBER 17, 2020
Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01.
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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
SEPTEMBER 17, 2020
Predictions of results by the end of October look ambitious, as the number of COVID-19 cases needed to generate definitive data could still take months.
pharmaphorum
SEPTEMBER 17, 2020
Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. An interim analysis of the BLAZE-1 clinical trial showed a reduced rate of hospitalisation in patients treated with Lilly’s LY-CoV555, an antibody that neutralises the SARS-CoV-2 coronavirus, in a phase 2 trial.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 17, 2020
The company plans to use the funds to advance its lead candidate CP101 for recurrent C. difficile infection through the final stages of clinical development and regulatory submission.
BioPharma Reporter
SEPTEMBER 17, 2020
BioNTech will acquire Novartisâ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.
BioSpace
SEPTEMBER 17, 2020
The 2020 virtual meeting of the European Society of Medical Oncology is getting underway and companies are lining up to share information on their latest cancer treatments.
pharmaphorum
SEPTEMBER 17, 2020
US medical experts are reportedly concerned that a neurological side effect picked up in AstraZeneca’s closely-watched COVID-19 vaccine trial could compromise the whole project, as the FDA weighs whether to give the go ahead for US studies to resume. While tests of the vaccine co-developed with Oxford University have resumed in the UK, experts from the US National Institutes of Health have launched an investigation into the incident, which is still being kept under wraps by the UK pharma for pat
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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
SEPTEMBER 17, 2020
The manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational, the company said.
Scienmag
SEPTEMBER 17, 2020
When it comes to metabolic health, it’s not just what you eat, it’s when you eat it. Studies have shown that one effective means of losing weight and tackling obesity is to reduce the number of hours in the day that you eat. Time-restricted feeding – otherwise known as intermittent fasting – has also been […].
BioSpace
SEPTEMBER 17, 2020
Cidara Therapeutics is hoping that its novel approach to influenza will prevent future “twindemic” double threats like the one we may face this year.
XTalks
SEPTEMBER 17, 2020
The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. The permanent injunction was filed against the firm for violating public safety standards and comes more than two years after being sent a warning letter.
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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
SEPTEMBER 17, 2020
He also said they would be able to deliver 100 million doses to the U.S. government in the “first few months of 2021.
Triage Cancer
SEPTEMBER 17, 2020
Like many people, I thought fighting cancer was a physical battle and that recovering from surgery was the victory. Looking back now, seven years later, I see that the battle had two fronts: the physical and the emotional. I neglected the latter. For those who have received a cancer diagnosis, I strongly recommend looking for support groups to find referrals from other survivors for a counselor/therapist.
BioSpace
SEPTEMBER 17, 2020
Vaccinex, a company developing a novel approach to treat both cancer and neurodegenerative disease through the inhibition of SEMA4D, will pair its lead asset with Merck’s vaunted checkpoint inhibitor Keytruda.
XTalks
SEPTEMBER 17, 2020
In rare disease trials, it’s not always feasible to choose clinically-relevant endpoints to measure the efficacy of a new therapeutic. Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most.
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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.
Scienmag
SEPTEMBER 17, 2020
Coleen Murphy found the key to multi-generational pathogen avoidance: a small RNA called P11 Credit: Illustration by Rachel Kaletsky, Rebecca Moore and Coleen Murphy When humans see their children about to eat something they oughtn’t, we can simply tell them, “Don’t eat that. It’ll make you sick.” Those who listen to this advice are spared […].
BioSpace
SEPTEMBER 17, 2020
Exicure announced positive results from its Phase Ib trial evaluating cavrotolimod, its SNA-enabled TLR9 agonist, that is being developed for the treatment of solid tumors, in combination with pembrolizumab.
Scienmag
SEPTEMBER 17, 2020
Credit: CreativeCause.com.au TORONTO, ON – Ecologists studying the prevalence of plastic pollution in aquatic ecosystems around the world are concerned after measuring the scale of human response needed to reduce future emissions and manage what’s already floating around out there. “Unless growth in plastic production and use is halted, a fundamental transformation of the plastic […].
BioSpace
SEPTEMBER 17, 2020
85% of participants in the trial were from minority racial and ethnic groups, which are historically underrepresented in clinical studies.
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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.
Scienmag
SEPTEMBER 17, 2020
A 90-minute COVID-19 test has been shown to have over 94 per cent sensitivity, and 100% specificity in a new study Credit: Thomas Angus/Imperial College London A 90-minute COVID-19 test has been shown to have over 94 per cent sensitivity, and 100 per cent specificity in a new study. The work, published in the journal […].
pharmaphorum
SEPTEMBER 17, 2020
The US National Institutes of Health has awarded seven contracts to companies and academic institutions to develop digital health solutions to help fight the COVID-19 pandemic. According to the US-government funded NIH , the work could lead to user-friendly tools like smartphone apps, wearable devices, and software that can identify and trace contacts of infected individuals, keep track of verified COVID-19 test results, and monitor the health status of infected and potentially infected individu
Scienmag
SEPTEMBER 17, 2020
Credit: Andrew Muroyama The stem cells tasked with creating and maintaining biological tissues have a difficult job. They have to precisely divide to form new specialized cells, which are destined to different fates even though they contain identical DNA. An obvious question then is: How do the cells divide in all the right ways to […].
BioSpace
SEPTEMBER 17, 2020
Roche launched its Elecsys Anti-SARS-CoV-2 S antibody test for markets that accept the CE Mark.
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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.
Scienmag
SEPTEMBER 17, 2020
Credit: Walter Farina If you want a dog to hunt something down, it helps to let them sniff an item to pick up the scent. Now, researchers reporting in Current Biology on September 17 have found that scent training honeybees in the hive might work in a similar way–and that this approach could make bees […].
JAMA Internal Medicine
SEPTEMBER 17, 2020
Patients with acute respiratory failure due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have overwhelmed critical care capacity in some cities and countries. The mortality of patients who require critical care is high but varies widely among hospitals. Despite a rapidly increasing understanding of the pathogenesis of coronavirus disease 2019 (COVID-19), uncertainty remains about the reasons that some patients develop respiratory failure and others have no to minimal symptoms,
Scienmag
SEPTEMBER 17, 2020
Credit: Tokyo Tech Artificial light accounts for approximately 20% of the total electricity consumed globally. Considering the present environmental crisis, this makes the discovery of energy-efficient light-emitting materials particularly important, especially those that produce white light. Over the last decade, technological advances in solid-state lighting, the subfield of semiconductors research concerned with light-emitting compounds, has […].
BioSpace
SEPTEMBER 17, 2020
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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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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