Bio Pharma Dive
NOVEMBER 11, 2020
The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology.
Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.
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Bio Pharma Dive
NOVEMBER 11, 2020
The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial.
World of DTC Marketing
NOVEMBER 11, 2020
SUMMARY: Social media continues to be used by online health seekers, but there is also a high level of health misinformation. Using social media for DTC can be effective if you have a story to tell in short messages. Still, DTC marketers should be aware of what’s being said around certain health conditions via social media. BMS has been running an ad for Optivio on Twitter that makes no sense because of FDA guidelines.
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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 11, 2020
Twelve trucks and 20 planes would be used each day to distribute the vaccine, should approvals follow Pfizer and partner BioNTech's positive study results.
Pharma Mirror
NOVEMBER 11, 2020
Contributing factors such as the excessive carbon dioxide in the atmosphere and burned fossil fuels wounds the earth at large. Highly dangerous pollutants from agricultural runoffs, industrial junks, and even pharmaceutical waste can decrease human life expectancy by three years. Pharmaceutical Pollution This type of pollution is practically a form of water pollution.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 11, 2020
Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment. With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare. “We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation,
BioSpace
NOVEMBER 11, 2020
Researchers from Penn Medicine have developed a new targeted approach that modifies viral vectors and inhibits toxicities in the sensory neurons of dorsal root ganglia that commonly occur following the use of gene therapy for neurological diseases.
pharmaphorum
NOVEMBER 11, 2020
In the second positive piece of COVID-19 vaccine news in a week, Russia’s Sputnik V candidate has been shown to be 92% effective at the interim point of a 40,000-patient study. The preliminary assessment is based on 20 coronavirus cases split between the vaccinated and placebo arms of the study at 21 days, according to a press statement issued this morning by the Gamaleya Institute which developed the shot and the Russian Direct Investment Fund (RDIF).
BioSpace
NOVEMBER 11, 2020
Integrating digital tools for manufacturing process development, control and data analytics brings data together in ways that enhance visibility system-wide.
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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
pharmaphorum
NOVEMBER 11, 2020
In the first episode of our Health Innovators series, Paul Tunnah speaks to David Van Sickle, CEO of Propeller Health about how digital technologies are revolutionising the field of respiratory medicine. The post Health Innovators: David Van Sickle on digital innovation in respiratory medicine appeared first on.
Scienmag
NOVEMBER 11, 2020
Credit: WSU PULLMAN, Wash. – A team of researchers for the first time has found a correlation between the levels of bacteria and fungi in the gastrointestinal tract of children and the amount of common chemicals found in their home environment. The work, published this month in Environmental Science and Technology Letters, could lead to […].
BioSpace
NOVEMBER 11, 2020
Two new companies exploded onto the scene this morning, backed by significant financing that will be used to develop treatments for a wide range of diseases.
Scienmag
NOVEMBER 11, 2020
Credit: University of Pittsburgh PITTSBURGH, Nov. 12, 2020 – In an analysis published today in the American Journal of Preventive Medicine, researchers from the University of Pittsburgh Graduate School of Public Health demonstrate positive effects of the Affordable Care Act (ACA) Medicaid expansion on rates of early cancer diagnosis. The study showed that health insurance […].
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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 11, 2020
The company said they needed 53 patients in the study to be diagnosed with COVID-19, and the trial hit that figure yesterday.
Scienmag
NOVEMBER 11, 2020
A clinical trial that evaluates the approach for medulloblastoma, the most common malignant pediatric brain tumor, is planned Credit: Rady Children’s Hospital-San Diego Scientists at Sanford Burnham Prebys Medical Discovery Institute, University of California San Diego School of Medicine and Hopp Children’s Cancer Center Heidelberg (KiTZ) have demonstrated that personalized drug screens can be used […].
BioSpace
NOVEMBER 11, 2020
BioSpace recently spoke with Dr. James Garner, CEO of Kazia Therapeutics, an oncology company that is focused on the development of cancer drugs.
Scienmag
NOVEMBER 11, 2020
Credit: Indiana University Bramsh Chandio, a Ph.D. candidate in intelligent systems engineering, advised by Assistant Professor of Intelligent Systems Engineering Eleftherios Garyfallidis, published a paper in Nature Scientific Reports that lays out a large medical analytics framework that can be used in neuroscience and neurology to study brain connectivity in living organisms.
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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
NOVEMBER 11, 2020
If you’re contemplating changing careers in the midst of the COVID-19 pandemic, the reality is that if it’s time to make a change, there’s no time like the present.
Scienmag
NOVEMBER 11, 2020
Credit: Masato Kanemaki Researchers can now more accurately and precisely target specific proteins in yeast, mammalian cells and mice to study how knocking down specific protein traits can influence physical manifestation in a cell or organism. The Japan-based team published their results on November 11th in Nature Communications. “Conditional gene knockout and small interfering RNA […].
BioSpace
NOVEMBER 11, 2020
Five Prime Therapeutics Inc., in collaboration Zai Lab Limited on the development bemarituzumab, a novel therapy for front-line advanced non HER2+ gastric or gastroesophageal junction (GEJ) cancer, on Wednesday announced groundbreaking positive topline Phase II results.
Scienmag
NOVEMBER 11, 2020
Credit: Beau Barber/RIPE project Carbon dioxide fuels photosynthesis, the process by which plants generate their food in the form of carbohydrates. The atmosphere’s carbon dioxide levels are rapidly increasing, but there is uncertainty about whether plants can turn these extra resources into higher yields while retaining nutritional quality. A team from the University of Illinois […].
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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
NOVEMBER 11, 2020
AstraZeneca reported that the CALAVI Phase II trials of Calquence (acalabrutinib) in hospitalized patients with respiratory symptoms of COVID-19 failed to meet the trials’ primary efficacy endpoint.
Scienmag
NOVEMBER 11, 2020
Cedars-Sinai study suggests genomic medicine could help lower the threat of thromboembolism associated with inflammatory bowel disease Credit: Photo by Cedars-Sinai LOS ANGELES (Nov. 11, 2020) — Blood clots are the biggest cause of death in patients with inflammatory bowel disease (IBD) — ulcerative colitis or Crohn’s disease. In a retrospective study recently published in […].
Pharma Times
NOVEMBER 11, 2020
Detailed results are due to be presented at forthcoming medical meeting
Scienmag
NOVEMBER 11, 2020
Slinky-like sensor is ultra-sensitive and resilient Credit: (Image courtesy of Oluwaseun Araromi/Harvard SEAS) Think about your favorite t-shirt, the one you’ve worn a hundred times, and all the abuse you’ve put it through. You’ve washed it more times than you can remember, spilled on it, stretched it, crumbled it up, maybe even singed it leaning […].
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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.
JAMA Internal Medicine
NOVEMBER 11, 2020
Among patients who have recovered from COVID-19, repeated testing for SARS-CoV-2 may be done weeks or months after infection either as part of routine screening (eg, screening nursing home personnel on a weekly basis to prevent transmission of infections to patients) or because of the development of symptoms that are worrisome for reinfection. Unfortunately, the interpretation of positive test results in patients who have previously recovered from COVID-19 is fraught.
Scienmag
NOVEMBER 11, 2020
Familiarity with self-power generation devices Credit: Nagoya University The Japanese research team elucidated the microscopic mechanism in which amorphous silica(1) becomes negatively charged as a vibrational energy harvester(2), which is anticipated to achieve self-power generation without charging, as it is needed for IoT that is garnering attention in recent years with its “trillion sensors” that […].
JAMA Internal Medicine
NOVEMBER 11, 2020
This study examines positive real-time polymerase chain reaction nasal-oropharyngeal swab results from patients who recovered from COVID-19 with prior negative results.
Scienmag
NOVEMBER 11, 2020
Credit: Zhengmao Lu and Ningxin Chen Scientists have developed a bilayer passive cooling technology inspired by the way camels stay cool in the hot desert sun. The technology’s bottom hydrogel layer acts like a camel’s sweat glands, lowering the temperature through evaporating water, whereas the top aerogel layer functions like fur, insulating against outside heat […].
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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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