Bio Pharma Dive
SEPTEMBER 28, 2020
A month after the FDA surprisingly rejected the rheumatoid arthritis drug, known as filgotinib, and more recently, Jyseleca, it's been cleared by regulators in Europe and Japan.
pharmaphorum
SEPTEMBER 28, 2020
The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. Housed within the agency’s Center for Devices and Radiological Health, the DHCoE is part of a wider strategy to encourage development of digital health products and therapeutics.
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Bio Pharma Dive
SEPTEMBER 28, 2020
The FDA has suspended the planned start of a late-stage trial of Inovio's experimental shot, dealing another setback to one of the most advanced DNA-based vaccine programs in development.
BioPharma Reporter
SEPTEMBER 28, 2020
Ena Respiratoryâs preventative nasal spray treatment could reach human trials within four months, following results from an animal study released today which showed the spray reduced COVID-19 replication by up to 96%.
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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 28, 2020
The results disclosed at a medical meeting on Monday show that all patients tested have seen their motor skills stabilize or improve when history suggests they wouldn't.
pharmaphorum
SEPTEMBER 28, 2020
Shares in UK biotech Valirx were up sharpy this morning after its lead drug VAL201 showed evidence of efficacy in advanced prostate cancer in its first clinical trial. The company reported results from 11 patents taking part in the phase 1/2 study which showed a 54.5% overall response rate with VAL201, with a promising safety and tolerability profile.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
SEPTEMBER 28, 2020
Clinicians and patients alike have long been hoping for liquid biopsy tests for cancer screening and diagnosis given their ease, convenience and ability to detect disease-specific mutations. LabCorp (NYSE:LH) may help lead the way with its backing of Resolution Bioscience’s new diagnostic blood test for lung cancer. The leading global life science company is set to introduce Resolution Bio’s ctDx Lung assay , a non-invasive liquid biopsy test for patients with non-small cell lung cancer (NSCLC).
pharmaphorum
SEPTEMBER 28, 2020
Clinical trial readouts continue to emerge despite countries’ lockdown policies, providing several decision-making challenges for healthcare professionals such as haematologists and oncologists – also known as haem/oncs. pharmaphorum’s Behavioural insights into haem/onc clinical decision making webinar, in association with Medscape, showed that this can negatively impact physicians’ confidence as they try and keep on top of information about an array of treatment options.
Scienmag
SEPTEMBER 28, 2020
Credit: University of Leeds A major new study has identified 2085 excess deaths in England and Wales due to heart disease and stroke during the peak of the COVID-19 pandemic. On average, that is 17 deaths each day over four months that probably could have been prevented. Excess deaths are the number of deaths above […].
Drug Patent Watch
SEPTEMBER 28, 2020
Annual Drug Patent Expirations for OZEMPIC Ozempic is a drug marketed by Novo and is included in one NDA. It is available from three suppliers. There are twenty-two patents protecting…. The post New patent for NOVO drug OZEMPIC appeared first on DrugPatentWatch - Make Better Decisions.
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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
XTalks
SEPTEMBER 28, 2020
With the worldwide population increasing steadily and acreage for agriculture shrinking, indoor farms are on their way up as a viable form of food production. Bowery Farming , founded in 2015, is growing lettuce and other greens in vertical, indoor farms located just outside of some US cities. The farms can produce crops year-round, and Bowery is using far fewer resources than traditional farms to generate less waste.
Scienmag
SEPTEMBER 28, 2020
UTA computer scientist uses machine learning for earlier detection of Alzheimer’s disease Credit: UT Arlington Won Hwa Kim, an assistant professor of computer science at The University of Texas at Arlington, is using a two-year, $175,000 grant from the National Science Foundation to use machine learning for earlier detection of Alzheimer’s disease.
Pharma Times
SEPTEMBER 28, 2020
Insights from project could potentially improve precision medicine use for paediatric AML
Scienmag
SEPTEMBER 28, 2020
CIC biomaGUNE researchers have demonstrated the restoring in vivo of the connection between neurons, yielding functional results Credit: Author: Pedro Ramos / CIC biomaGUNE Research conducted by two groups at the Center for Cooperative Research in Biomaterials CIC biomaGUNE and one at SISSA, Scuola Internazionale Superiore di Studi Avanzati (Italy), showed that functional materials based […].
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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.
Pharma Times
SEPTEMBER 28, 2020
Treatment is indicated for use in adults with moderate-to-severe active rheumatoid arthritis
Scienmag
SEPTEMBER 28, 2020
A team of researchers led by Osaka University unravel a tangle of pathways involving calcium, lipids, and the degradation of damaged lysosomes that is essential for preventing crystal-induced kidney injury Credit: Osaka University Osaka, Japan – Human cells need to work like well-oiled machines to keep our bodies running as they should. Waste products such […].
Pharma Times
SEPTEMBER 28, 2020
Drug is being investigated in up to 800 hospitalised patients nationwide
Triage Cancer
SEPTEMBER 28, 2020
The passing of Justice Ruth Bader Ginsburg has left a vacancy on the Supreme Court of the United States. On November 10, just a few days after the election, the Supreme Court is scheduled to hear oral arguments on a case that challenges the constitutionality of the Patient Protection and Affordable Care Act (ACA/Obamacare), and argues that the entire law should be struck down.
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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 28, 2020
The importance of diversity of patients in clinical studies cannot be overlooked, nor can the importance of diversity at the C-suite level. But, it’s equally important to have a diverse clinical research team as well.
Scienmag
SEPTEMBER 28, 2020
Combining light and sound adds depth information that boosts security of biometric authentication Credit: Jun Xia, University at Buffalo, The State University of New York WASHINGTON — Biometric authentication, which uses unique anatomical features such as fingerprints or facial features to verify a person’s identity, is increasingly replacing traditional passwords for accessing everything from smartphones […].
BioPharma Reporter
SEPTEMBER 28, 2020
Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results for its candidate.
BioSpace
SEPTEMBER 28, 2020
More than one month after the government of Russia announced it approved the world’s first vaccine for COVID-19, it announced it will share preliminary data from the first six weeks of the ongoing Phase III study.
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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 28, 2020
Credit: West Virginia University While debate over COVID-19 guidelines and vaccine development has raised skeptics’ eyebrows and undermined confidence, a West Virginia University associate professor says that communication is essential for the science community to gain the American public’s trust. According to Geah Pressgrove, scientists and communications professionals need to rethink how they communicate through […].
BioSpace
SEPTEMBER 28, 2020
At a recent Demy-Colton Virtual Salon, Michael Gaito, head of healthcare investment banking at J.P. Morgan, discussed the strength of capital raises despite COVID-19 and the resilient state of the biotech sector in the run-up to the Presidential election in November and the virtual J.P. Morgan H.
Scienmag
SEPTEMBER 28, 2020
Credit: ©Science China Press It is usually believed that ferroelectricity can appear in insulating or semiconducting materials rather than in metals, because conducting electrons of metals always screen out the internal static electric field arising from the dipole moments. In 1965, Anderson and Blount proposed the concept of ‘ferroelectric metal’, pointing out that the electric […].
Drug Patent Watch
SEPTEMBER 28, 2020
Annual Drug Patent Expirations for ARIKAYCE+KIT Arikayce Kit is a drug marketed by Insmed Inc and is included in one NDA. There are ten patents protecting this drug. This drug…. The post New patent for Insmed Inc drug ARIKAYCE KIT appeared first on DrugPatentWatch - Make Better Decisions.
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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 28, 2020
The National Comprehensive Cancer Network publishes free treatment recommendations for pediatric Hodgkin lymphoma, adding to growing library of pediatric cancer guidelines Credit: NCCN PLYMOUTH MEETING, PA [September 28, 2020] — The National Comprehensive Cancer Network® (NCCN®) today announced the publication of new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Hodgkin Lymphoma.
BioSpace
SEPTEMBER 28, 2020
XtalPi Inc., an AI-based pharmaceutical technology company with an AI-powered platform that twins with existing R&D pipelines, now has $318.8 million more to bring drug development into the future.
Scienmag
SEPTEMBER 28, 2020
First study of its kind reveals the benefits of droplets on leaves Credit: Pablo Urbaneja-Bernat Small watery droplets on the edges of blueberry bush leaves are loaded with nutrients for many insects, including bees, wasps and flies, according to a Rutgers-led study, the first of its kind. The study, published in the journal Proceedings of […].
pharmaphorum
SEPTEMBER 28, 2020
NHS England has recommended that patients with von Willebrand disease (VWD) be treated with Takeda’s Veyvondi, making it the first and only medicine backed for what is the most common inherited bleeding disorder in the UK. The decision was taken by the Clinical Priorities Advisory Group (CPAG), which advises NHS England on commissioning services, treatments and new technologies.
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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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