BioSpace
SEPTEMBER 27, 2020
BMS’s ongoing Phase III randomized, double-blind, multi-center study – named CheckMate-274 – compares Opdivo against a placebo in 709 participants deemed to be at a high risk of recurrence after radical surgery.
JAMA Internal Medicine
SEPTEMBER 27, 2020
This cross-sectional study evaluates the risk of exclusion for older adults in randomized clinical trials for treatment and vaccine interventions in coronavirus disease 2019.
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BioSpace
SEPTEMBER 27, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.
Scienmag
SEPTEMBER 27, 2020
Credit: University of Cambridge Researchers have shown that over the past two thousand years, volcanoes have played a larger role in natural temperature variability than previously thought, and their climatic effects may have contributed to past societal and economic change. The researchers, led by the University of Cambridge, used samples from more than 9000 living […].
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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
BioSpace
SEPTEMBER 27, 2020
The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
JAMA Internal Medicine
SEPTEMBER 27, 2020
This case report presents the electrocardiographic findings a woman in her 50s with COVID-19, fever, and shortness of breath, with comorbidities including morbid obesity and obstructive sleep apnea.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
SEPTEMBER 27, 2020
People with a history of positive social interactions with Chinese people were less likely to support discriminatory anti-Chinese policies as Covid-19 reached the UK – according to new research from the University of East Anglia. Researchers studied how UK residents felt towards the Chinese community as Covid-19 reached our shores, and how these feelings might […].
BioSpace
SEPTEMBER 27, 2020
On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.
JAMA Internal Medicine
SEPTEMBER 27, 2020
This essay details the services provided by primary care clinicians that are not covered by fee-for-service payments but that are more important to patients, especially near the end of life, than many expensive, unwanted tests for which fee-for-service payments are available.
BioSpace
SEPTEMBER 27, 2020
The company posted an interim analysis of its Phase I/IIa trial that showed a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants and was well-tolerated.
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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
JAMA Internal Medicine
SEPTEMBER 27, 2020
This systematic review and meta-analysis identifies and summarizes published research on the accuracy of physicians’ interpretations of electrocardiograms.
BioSpace
SEPTEMBER 27, 2020
The European Society of Medical Oncology (ESMO) Virtual Congress 2020 was last weekend and the beginning of the week, which resulted in numerous clinical trial announcements. Here’s a look.
Scienmag
SEPTEMBER 27, 2020
A routine test used to monitor patients’ breathing may be unreliable and putting them at risk, a study suggests. Incorrect results can mean clinical staff fail to spot how unwell a patient with respiratory problems is becoming, researchers say. This widely used method, which counts breaths over a 30-second period, fails to take account of […].
BioSpace
SEPTEMBER 27, 2020
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.
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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.
JAMA Internal Medicine
SEPTEMBER 27, 2020
This randomized clinical trial examines the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers.
Scienmag
SEPTEMBER 27, 2020
A new way to reduce heat penetration through building walls. Application of a phase change material and bubble injections to building walls. Credit: Korea Institue of Science and Technology(KIST) With the summer heat becoming increasingly unbearable and prolonged over the years due to climate change, the cooling load in the summertime has also been on […].
The Pharma Data
SEPTEMBER 27, 2020
A woman has described her pain at not being able to see her husband regularly at his care home during the pandemic, calling it a “torture of the heart” Jean Haste, 70, says she has only been able to see Trevor, 75, who has dementia, once a week for 30 minutes at his home in Suffolk due to visiting restrictions. She said the lack of interaction had affected her husband’s illness “grossly”, saying he hunches in his wheelchair and barely makes eye contact when she does
JAMA Internal Medicine
SEPTEMBER 27, 2020
This case series examines outcomes of in-hospital cardiac arrest among patients with COVID-19.
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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
SEPTEMBER 27, 2020
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
Scienmag
SEPTEMBER 27, 2020
Yale physician to discuss the most promising developments in estrogen therapy, including new fetal estrogens, during the 2020 NAMS Virtual Annual Meeting Pre-Meeting Symposium CLEVELAND, Ohio (September 28, 2020)–Hormone therapy remains the best proven method for managing menopause symptoms such as hot flashes. Research continues, however, in the area to identify novel approaches to estrogen […].
BioSpace
SEPTEMBER 27, 2020
Starting with just $11 million seed in 2015, investors have proven their faith in InvestiBio with their increasing financial support.
Scienmag
SEPTEMBER 27, 2020
New study based on the early versus late intervention trial with estradiol data confirms benefit of hormone therapy in reducing multiple biomarkers of inflammation CLEVELAND, Ohio (September 28, 2020)–As one of the most common treatments for effectively managing menopause symptoms, hormone therapy (HT) is also known to provide multiple health benefits, including slowing the progression […].
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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.
BioTech 365
SEPTEMBER 27, 2020
HELSINKI–(BUSINESS WIRE)–TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, announces it has dosed two patients in a phase 1 clinical trial of its dual cytokine armed oncolytic adenovirus, TILT-123, in Denmark’s Herlev hospital in Copenhagen.
Scienmag
SEPTEMBER 27, 2020
Mitochondrial biomarkers identified as having significant role in memory CLEVELAND, Ohio (September 28, 2020)–Women often complain of being more forgetful during the transition from premenopause to perimenopause to postmenopause. Such declines in memory after menopause appear independent of chronologic age. A new study sought to identify whether mitochondrial function might be a determinant of cognition […].
BioTech 365
SEPTEMBER 27, 2020
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Danish Galecto Inc. secures US$64m equity financing. from European Biotechnology – first and foremost in European biotech [link].
Scienmag
SEPTEMBER 27, 2020
Women especially affected, studies show WASHINGTON — The anxiety, stress and worry brought on by COVID-19 is not limited to daytime hours. The pandemic is affecting our dreams as well, infusing more anxiety and negative emotions into dreams and spurring dreams about the virus itself, particularly among women, according to research published by the American […].
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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.
BioTech 365
SEPTEMBER 27, 2020
– Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years – – 59% of infants were able to sit without support for at least 5 seconds – – … Continue reading →
Scienmag
SEPTEMBER 27, 2020
Louise Shelley, Professor/Director, Terrorism, Transnational Crime and Corruption Center (TraCCC), Edward Huang, Associate Professor, Systems Engineering and Operations Research, Volgenau School of Engineering, and Damon McCoy, Associate Professor of Computer Science and Engineering in New York University’s Tandon School of Engineering, are beginning a multidisciplinary project to understand, model, and disrupt drug and counterfeit illicit […].
BioTech 365
SEPTEMBER 27, 2020
Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years 59% of infants were able to sit without support for at least 5 seconds No new safety signals were … Continue reading →
Drug Patent Watch
SEPTEMBER 27, 2020
Orphan drug exclusivity is granted to drugs addressing rare ‘orphan diseases’ — those affecting fewer than 200,000 Americans. The protection granted to orphan drugs is quite strong. The FDA is…. The post Pharmaceutical companies with the most orphan drugs appeared first on DrugPatentWatch - Make Better Decisions.
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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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