Bio Pharma Dive
APRIL 30, 2021
Over three days of meetings, a group of FDA advisers discussed the tough trade-offs of accelerated immunotherapy approvals. Their decisions could escalate an already intense debate.
pharmaphorum
APRIL 30, 2021
Reports of COVID-19 vaccinations causing blood clots has caused alarm in the general population. However due to the rarity of incidences from vaccination, myGP explores the most common causes of blood clots and how we can prevent them. Over 11 million doses of COVID-19 vaccines have been given across the UK, with blood clotting observed in a small sample of patients.
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Bio Pharma Dive
APRIL 30, 2021
Five weeks after AstraZeneca reported positive trial results, the company has still not applied to the FDA for authorization, saying the size of the dataset has slowed its submission.
XTalks
APRIL 30, 2021
Cinnamon Toast Crunch has expanded their retail availability of its Cinnamon Toast Crunch Cinnadust Seasoning Blend to 4,300 stores nationwide. This seasoning blend was first introduced to the market in September 2020 and has exploded in popularity since then. Cinnamon Toast Crunch Cinnadust Seasoning Blend captures the cinnamon flavors associated with their famous cereal brand.
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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
APRIL 30, 2021
The company expects to respond within days to a long list of findings FDA officials made in a nine-day inspection of Emergent's Baltimore plant earlier this month.
Scienmag
APRIL 30, 2021
Credit: Niigata University Niigata, Japan–Researchers from Niigata University , the University of Tokyo, Osaka University and Tokyo Medical University, Japan have developed a new approach that could revolutionize the treatment, prevention, and possibly reversal of the damages caused by liver diseases. This novel strategy exploits small extracellular vesicles (sEVs) derived from interferon-?
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
APRIL 30, 2021
Credit: UTHSC Memphis, Tenn. (April 30, 2021) – The National Institute of Environmental Health Sciences has awarded Byron C. Jones, PhD, professor in the Department of Genetics, Geonomics, and Informatics at the University of Tennessee Health Science Center, $2.87 million for his continuing study of genetic alterations associated with Gulf War illness among former military […].
Pharma Times
APRIL 30, 2021
Health Secretary reveals government’s plans for UK life sciences 'transformation'
Scienmag
APRIL 30, 2021
Like Pavlov’s dog, device can be conditioned to learn by association Credit: Northwestern University Researchers have developed a brain-like computing device that is capable of learning by association. Similar to how famed physiologist Ivan Pavlov conditioned dogs to associate a bell with food, researchers at Northwestern University and the University of Hong Kong successfully conditioned […].
pharmaphorum
APRIL 30, 2021
It’s fair to say this is the most interesting time ever for market access. Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks. We take a look at all these intersecting topics in this issue – with experts from across the industry sharing their advice on how companies can navigate thes
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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
Scienmag
APRIL 30, 2021
Salk researchers and collaborators show how the protein damages cells, confirming COVID-19 as a primarily vascular disease Credit: Salk Institute LA JOLLA–(April 30, 2021) Scientists have known for a while that SARS-CoV-2’s distinctive “spike” proteins help the virus infect its host by latching on to healthy cells. Now, a major new study shows that they […].
Pharma Times
APRIL 30, 2021
Stevens will step down from the leadership role officially on 31 July
Scienmag
APRIL 30, 2021
Rice lab’s new strategy puts evolution of microscopic structures on fast track Credit: Mesoscale Materials Science Group/Rice University HOUSTON – (April 30, 2021) – The microscopic structures and properties of materials are intimately linked, and customizing them is a challenge. Rice University engineers are determined to simplify the process through machine learning.
Pharma Times
APRIL 30, 2021
Extra doses will be used for UK's planned booster vaccination programme in autumn
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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
APRIL 30, 2021
Credit: University of New Mexico Jeremy Edwards, director of the Computational Genomics and Technology (CGaT) Laboratory at The University of New Mexico, and his colleagues at Centrillion Technologies in Palo Alto, Calif. and West Virginia University, have developed a chip that provides a simpler and more rapid method of genome sequencing for viruses like COVID-19. […].
Pharma Times
APRIL 30, 2021
Report notes a ‘modest’ impact on pre-pandemic drivers of medicine use and spending from COVID-19
Scienmag
APRIL 30, 2021
Chemist from the University of Göttingen receives ERC Advanced Grant Credit: University of Göttingen Professor of Chemistry, Lutz Ackermann from Göttingen University has received an Advanced Grant from the European Research Council (ERC). The ERC will fund his project “Electrochemical Bond Functionalization (ElectroFun)” for five years with an award of around 2.5 million euros.
XTalks
APRIL 30, 2021
The food website Epicurious recently announced it would ditching be beef recipes in an effort to encourage more sustainable consumption among its readers. Beef production has long been cited as one of the world’s largest greenhouse gas (GHG) emitters, but will the move to eliminate beef recipes from the site actually make a difference in combatting climate change?
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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
APRIL 30, 2021
Humans have significantly altered biodiversity in all climate zones of the Earth. This has been shown by a study published in “Science” Credit: © Manuel Steinbauer. Humans have significantly altered biodiversity in all climate zones of the Earth. This has been shown by a study now published in Science. Led by Prof. Dr. Manuel Steinbauer […].
pharmaphorum
APRIL 30, 2021
AstraZeneca’s not-for-profit coronavirus vaccine has bit into margins in Q1, although revenues were ahead of expectations as the company heads towards completion of its $39bn acquisition of Alexion. . The company posted Q1 product sales of $7.26bn, ahead of consensus forecasts of around $6.84 billion, with total revenues up 15% compared with last year’s Q1 to $7.3bn.
Scienmag
APRIL 30, 2021
Credit: The Astrophysical Journal DALLAS (SMU) – NASA has a long tradition of unexpected discoveries, and the space program’s TESS mission is no different. SMU astrophysicist and her team have discovered a particularly bright gamma-ray burst using a NASA telescope designed to find exoplanets – those occurring outside our solar system – particularly those that […].
pharmaphorum
APRIL 30, 2021
The NHS app could be used a kind of vaccine passport, according to UK government sources, although it is unclear how far the project has progressed. . NHS England’s app is connected to GP services in England and linked to personal health data and as such could be used to show a person’s vaccine status before travelling. People can already use the app to request repeat subscriptions, message their doctor and organise online consultations.
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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
APRIL 30, 2021
MUSC Hollings Cancer Center researchers to evaluate impact of proactive opt-out approach to smoking cessation interventions Credit: Sarah Pack/MUSC Researchers at MUSC Hollings Cancer Center have received more than $2 million from the National Cancer Institute (NCI) to evaluate the impact of a proactive opt-out approach to smoking cessation on the health outcomes of people […].
pharmaphorum
APRIL 30, 2021
Ken Frazier’s final appearance on Merck & Co’s financial results call as chief executive was a muted affair, as the company reported lower-than-expected revenues dragged down as the pandemic continued to restrict patient access to healthcare. . Pharmaceutical sales were flat on the same period of 2020 at $10.7 billion, with vaccines sales falling nearly 19% to $1.8 billion and cancer behemoth Keytruda (pembrolizumab) missing its growth projections – due to a delay in new patients
Scienmag
APRIL 30, 2021
Blackmond’s discoveries have propelled drug development and shed new light on complex chemistry that exists in the natural world Credit: Scripps Research LA JOLLA, CA–Donna Blackmond, PhD, a renowned Scripps Research professor who has expanded the world’s understanding of the chemistry of life, has been elected to the National Academy of Sciences in recognition of […].
pharmaphorum
APRIL 30, 2021
Langland has appointed Mike Brightley as creative director for its advertising section. Brightley has more than 14 years of healthcare advertising experience and has worked for companies including Ogilvy Healthworld, PAN and was most recently associate creative director at TBWA/WorldHealth. Brightley has worked on several insightful campaigns including applied emotion-recognition technology for adaptive storytelling.
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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
APRIL 30, 2021
A new approach to immunotherapy arrests solid tumor growth for a variety of cancers and squashes the spread of cancer to other tissues, in mice. Credit: Shawn Wang, Ph.D. Through T cell engineering, researchers at Virginia Commonwealth University Massey Cancer Center show that it’s possible to arrest tumor growth for a variety of cancers and […].
pharmaphorum
APRIL 30, 2021
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients. . The panel voted 6 to 2 that Keytruda (pembrolizumab) should not stay on the market for PD-L1–positive gastric or GEJ adenocarcinoma in patients who have received two or more earlier lines of therapy.
Scienmag
APRIL 30, 2021
Researchers have identified a vulnerability in some cases of acute myeloid leukaemia that could be harnessed for targeted treatment of these poor-prognosis cancers Targeting a pathway that is essential for the survival of certain types of acute myeloid leukaemia could provide a new therapy avenue for patients, the latest research has found. Researchers from the […].
ECRG Media's Clinical Research Podcast
APRIL 30, 2021
Who Will Work as A Central Monitor? Don't forget to Subscribe for new content! Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for s
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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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