Bio Pharma Dive
OCTOBER 22, 2021
The outcome of a high-stakes advisory panel Tuesday could open the door for millions of kids to receive Pfizer's coronavirus vaccine. Here's what we know.
Pharma Mirror
OCTOBER 22, 2021
ADELAIDE, AUS, Oct 19, 2021 – (ACN Newswire) – Agilex Biolabs, the Australian regulated bioanalytical and toxicology laboratory facilities for clinical trials is presenting a new webinar entitled “Getting it right! Considerations for Immuno-oncology and Vaccine Studies and the Bioanalytical Tools used” in partnership with Outsourcing Clinical Trials (OCT).
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Bio Pharma Dive
OCTOBER 22, 2021
Shares of Agenus fell around 25% Friday, after the company said the FDA has recommended withdrawing an approval application for its cancer immunotherapy balstilimab.
Pharma Mirror
OCTOBER 22, 2021
New Delhi, India, More than 50 per cent of the world’s hip fractures are expected to occur in the Asia Pacific by the year 2050. In a strong effort to stem the tide, and to promote quality care in osteoporosis, the Asia Pacific Consortium on Osteoporosis (APCO) has launched a world-first, interactive, educational osteoporosis resource – the APCO Health Care Professional (HCP) Peer to Peer Educational Modules – today, to mark World Osteoporosis Day (Wednesday, October 20).
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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
pharmaphorum
OCTOBER 22, 2021
The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been approved by the FDA as an alternative to traditional pen-and-paper tests with some key advantages, according to its developer.
Pharma Mirror
OCTOBER 22, 2021
TOKYO, Hitachi, Ltd. (TSE: 6501), Tohoku University and Kyoto University have become the world’s first (1) to establish technology for the highly efficient and high-quality production of actinium-225 (225Ac), a substance required for a form of radiation therapy known as targeted alpha therapy (TAT). TAT is a new cancer therapy which combines a substance that emits alpha particles which destroy cancer cells with a compound that selectively accumulates in cancer cells.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
OCTOBER 22, 2021
The US Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar for Humira (adalimumab) for the treatment of several inflammatory conditions. This means AbbVie, maker of the world’s top-selling drug Humira, could be in for some stiff competition. Boehringer Ingelheim’s Cyltezo has become the second interchangeable biosimilar approved by the FDA, and the first approved interchangeable monoclonal antibody.
pharmaphorum
OCTOBER 22, 2021
Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next year, but if that is positive expect to file for approval of Dupixent (dupilumab) in the new indication before the end of 2022.
Scienmag
OCTOBER 22, 2021
An international consortium, led by Delft University of Technology and the University of North Carolina, has for the first time succeeded in probing the molecular origins of recombination in RNA viruses. Hiccups during the copying process of viruses cause recombination to take place: the exchange of segments of viral RNA. While this can lead to […].
pharmaphorum
OCTOBER 22, 2021
Merck & Co’s Keytruda become the first cancer immunotherapy to be approved as a first-line oesophageal cancer treatment in the EU earlier this year, but will now face competition from Bristol-Myers Squibb’s Opdivo. The European Commission has given a green light to Opdivo (nivolumab) with chemotherapy for previously-untreated patients with HER2-negative oesophageal, gastric and gastroesophageal junction (GEJ) cancer whose tumours express the PDL-1 biomarker with a score of five o
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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
OCTOBER 22, 2021
Allplants, a vegan meal delivery service, has raised $52 million in Series B funding led by Draper Esprit. So now, more UK consumers can enjoy a plant-based heat-at-home meal delivered right to their doorsteps. According to Draper Esprit , this Series B funding round broke a record for the most money ever raised by a plant-based food company in Europe.
Scienmag
OCTOBER 22, 2021
A new study led by researchers at UCLA Health has found that women over the age of 50 who had breastfed their babies performed better on cognitive tests compared to women who had never breastfed. The findings, published in Evolution, Medicine and Public Health, suggest that breastfeeding may have a positive impact on postmenopausal women’s […].
XTalks
OCTOBER 22, 2021
The Plant-Based Food Alliance , a coalition of companies, civil groups and charities, recently launched in the UK with founding members Oatly, Upfield, Alpro, ProVeg UK and The Vegan Society. The aim of the alliance is to provide a voice for the growing plant-based sector and help make the UK a leader in the space. . The Alliance will be creating a Food Charter to outline how businesses and the UK government can collaborate to support the uptake in plant-based diets.
NY Times
OCTOBER 22, 2021
The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps next week, a long-awaited development that would affect 28 million children.
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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.
Scienmag
OCTOBER 22, 2021
One of the youngest planets ever found around a distant infant star has been discovered by an international team of scientists led by University of Hawai?i at M?noa faculty, students, and alumni. Credit: Subaru Telescope and Gaidos, et al. (2021) One of the youngest planets ever found around a distant infant star has been discovered […].
NY Times
OCTOBER 22, 2021
Pfizer and Moderna are skeptical, but we found 10 companies in Africa, Asia and South America well-positioned to produce the gold-standard mRNA shots.
Scienmag
OCTOBER 22, 2021
Tokyo, Japan – Researchers from Tokyo Metropolitan University have found new ways of controlling how heat flows through thin materials by stacking atomically thin layers of atoms into van der Waals heterostructures. By comparing different stacks of different materials, or even the same material after heat treatment, they found that weak coupling and mismatch between […].
Pharma Times
OCTOBER 22, 2021
The British Medical Association (BMA) has accused the Health Secretary of being “willfully negligent”
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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
OCTOBER 22, 2021
Tom Sanchez, professor of urban affairs and planning, and Chris North, professor of computer science and associate director of the Sanghani Center for Artificial Intelligence and Data Analytics, have been awarded a planning grant from the National Science Foundation’s Smart and Connected Communities program. Credit: Virginia Tech Tom Sanchez, professor of urban affairs and planning, and Chris North, professor of computer […].
Pharma Times
OCTOBER 22, 2021
Dupixent significantly reduced itch and skin lesions compared to placebo in the investigational trial setting
Scienmag
OCTOBER 22, 2021
Agriculture and the change in soil use produce 23% of the total emissions of greenhouse gases of anthropogenic origin. Moreover, the expansion and intensification of agriculture are considered determining factors in soil loss and degradation by accelerating erosion rates and favouring the loss of organic matter and nutrients.The most commonly used sustainable farming practices to […].
BioSpace
OCTOBER 22, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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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
OCTOBER 22, 2021
Galli is recognized for her contributions to the fields of computational condensed matter, materials science and nanoscience. Credit: (Image by Argonne National Laboratory.) Galli is recognized for her contributions to the fields of computational condensed matter, materials science and nanoscience. Giulia Galli, a senior scientist at the U.S. Department of Energy’s (DOE) Argonne National Laboratory, […].
BioSpace
OCTOBER 22, 2021
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
Scienmag
OCTOBER 22, 2021
Anyone traveling from the German city of Brandenburg via Berlin to Frankfurt an der Oder at the Polish-German border does so along an ancient route that reaches far into Poland. German and Polish researchers have now documented the influence of this East-West connection on the history of the landscape by examining the sediments of Lake […].
Pharma Times
OCTOBER 22, 2021
EUA amendments 'based on the available data and information'
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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
OCTOBER 22, 2021
A newly developed coating that allows for certain liquids to move across surfaces without fluid loss could usher in new advances in a range of fields, including medical testing. Credit: Mohammad Soltani / University of Toronto Engineering A newly developed coating that allows for certain liquids to move across surfaces without fluid loss could usher […].
BioSpace
OCTOBER 22, 2021
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
Scienmag
OCTOBER 22, 2021
Sure, you could attach two screens with a hinge and call a cell phone “foldable,” but what if you could roll it up and put it in your wallet? Or stretch it around your wrist to wear it as a watch? Credit: Wustl/Wang Lab Sure, you could attach two screens with a hinge and call […].
BioSpace
OCTOBER 22, 2021
Earlier this month, Catalent announced plans to add 500–600 jobs in Bloomington, Ind., one of its Moderna and Johnson & Johnson COVID-19 vaccine manufacturing sites.
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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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