Bio Pharma Dive
SEPTEMBER 25, 2020
The early study results were used to support the drugmaker's recent decision to start a large Phase 3 study that, unlike other large tests underway, will evaluate a one-shot regimen.
Pharma Mirror
SEPTEMBER 25, 2020
The Hague — Governments and other stakeholders must take urgent action to ensure equity in access to disease prevention measures, which includes greater investment in vaccines and vaccination services by community pharmacists. So said the International Pharmaceutical Federation (FIP) in a call to action made today at the start of a new FIP Digital Programme to.
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Bio Pharma Dive
SEPTEMBER 25, 2020
The Maryland-based biotech is the first developer to advance a more traditional protein-based vaccine into the final stages of clinical testing.
Drug Patent Watch
SEPTEMBER 25, 2020
Annual Drug Patent Expirations for KORLYM Korlym is a drug marketed by Corcept Therap and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph…. The post New patent for Corcept Therap drug KORLYM appeared first on DrugPatentWatch - Make Better Decisions.
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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
SEPTEMBER 25, 2020
Novavax has begun a late-stage trial of its experimental COVID-19 vaccine in the UK, which could support filings for a licence in the UK, EU and other countries. The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out. It’s one of several agreements with major vaccine makers as the UK hedges its bets over which of the shots will get okayed by regulators first.
XTalks
SEPTEMBER 25, 2020
Gardein, a Conagra Brand company, is moving from the freezer shelves to the soup aisle in supermarkets. They introduced the first-ever plant-based meat alternative soups just in time for the winter months. They are providing consumers with soups that deliver the meaty flavors they want, that are 100 percent vegan. The brand is introducing five new Gardein Soup flavors.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
SEPTEMBER 25, 2020
Nearly 200 food companies and suppliers, including some of the largest producers in the world, have pledged to halve their food waste by 2030. The companies, including Nestlé, Kellogg Co. and Campbell Soup Co., have joined the 10x20x30 initiative, a global effort to slash the staggering amount of food that is discarded every year. The announcement came Wednesday from the World Resources Institute, a global research organization that focuses on seven critical issues at the intersection of environ
Scienmag
SEPTEMBER 25, 2020
Analysis of samples taken to test for respiratory viruses over the past five years suggests that the emergence of SARS-CoV-2 was associated with a large drop in circulation of other common respiratory viruses during the first wave. The study, presented at this week’s ESCMID Conference on Coronavirus Disease (ECCVID), is by Dr Stephen Poole, BRC […].
XTalks
SEPTEMBER 25, 2020
Neurofilament light chain is a well-described biomarker that is being extensively studied for the early detection of neurodegenerative diseases. While the putative neurological biomarker is typically detected at elevated levels in the cerebrospinal fluid (CSF) and blood, researchers have now found that it can also be measured in the fluid within the eye, known as the vitreous humor.
Scienmag
SEPTEMBER 25, 2020
A multisite clinical trial, led by USF Health and Tampa General Hospital, provides the first evidence that both devices are comparable for accurate detection of COVID-19 infection Credit: © USF Health|University of South Florida TAMPA, Fla. (Sept. 25, 2020) – As COVID-19 quickly spread worldwide this spring, shortages of supplies, including the nasopharyngeal (nasal) swabs […].
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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
SEPTEMBER 25, 2020
Five-year data with Merck & Co’s Keytruda showing that it doubles survival should help the drug fend off a growing number of contenders to the first-line non-small cell lung cancer (NSCLC) market. The follow-up results from the phase 3 KEYNOTE-024 trial showed almost a third (31.9%) of patients whose tumours expressed high levels (50% or greater) of the biomarker PD-L1 who were treated with Keytruda (pembrolizumab) were still alive after five years, compared to 16.3% of the chemo group.
Scienmag
SEPTEMBER 25, 2020
Berkeley Lab scientists develop a tool that could drastically speed up the ability to design new biological systems Credit: Thor Swift/Berkeley Lab If you’ve eaten vegan burgers that taste like meat or used synthetic collagen in your beauty routine – both products that are “grown” in the lab – then you’ve benefited from synthetic biology. […].
pharmaphorum
SEPTEMBER 25, 2020
Gilead has scored a major approval for its troubled rheumatoid arthritis pill filgotinib, after regulators in Japan granted it a licence following an FDA rejection in August. The California biotech and marketing partner Eisai announced the Japanese Ministry of Health, Labour and Welfare had approved the drug under the brand name Jyseleca. The JAK1 inhibitor class drug offers a once-daily oral option for rheumatoid arthritis patients who have had an inadequate response to conventional therapies,
Scienmag
SEPTEMBER 25, 2020
Credit: ALMA (ESO/NAOJ/NRAO), Tanaka et al. Using the Atacama Large Millimeter/submillimeter Array (ALMA), astronomers spotted a pair of massive baby stars growing in salty cosmic soup. Each star is shrouded by a gaseous disk which includes molecules of sodium chloride, commonly known as table salt, and heated water vapor. Analyzing the radio emissions from the […].
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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 25, 2020
Trial is being conducted in partnership with UK government's Vaccines Taskforce
Scienmag
SEPTEMBER 25, 2020
Credit: Universidad de Córdoba Consumers always look for good quality products, above all in fresh food like vegetables. But how do we measure the quality of fresh spinach before it gets on the market nowadays? The most commonly used methods to analyze vegetable quality are slow, costly and destructive. They require choosing several samples from […].
Pharma Times
SEPTEMBER 25, 2020
Zercepac will be available for HER2-positive breast and gastric cancers
Scienmag
SEPTEMBER 25, 2020
This article by Dr. Bimal Krishna Banik and colleagues is published in Current Organocatalysis, 2020 One of the important objectives of green chemistry is the use of eco-friendly solvents and catalysts to perform chemical reactions. Catalysts such as organocatalysts, enzymes, and ionic liquids have shown very assuring results in synthesis by reducing the number of […].
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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.
pharmaphorum
SEPTEMBER 25, 2020
Leap Therapeutics will get a swift FDA review for its lead drug DKN-01 for a form of gastric and gastroesophageal junction (G/GEJ) cancer after being awarded fast-track status by the regulator. DKN-01 is an antibody drug targeting the Dickkopf-1 (DKK1) protein, which is overexpressed in some forms of G/GEJ adenocarcinoma and is thought to be involved in tumour growth as well as dampening down the immune response against the cancer.
Scienmag
SEPTEMBER 25, 2020
Credit: UNSW Sydney Escherichia coli, known as E. coli, are bacteria which many people associate with causing mild food poisoning, but some types of E. coli can be fatal. UNSW Science microbiologists studied an E. coli strain that causes a severe intestinal infection in humans: enterohemorrhagic E. coli (EHEC). Their findings were published this week […].
BioPharma Reporter
SEPTEMBER 25, 2020
Novavax has initiated its first Phase 3 trial to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate.
Scienmag
SEPTEMBER 25, 2020
Researchers from the University of Seville analyse two human skulls and the remains of a goat found in the Cueva de la Dehesilla (Cádiz, Spain) Credit: Universidad de Sevilla Experts from the Department of Prehistory and Archaeology of the University of Seville have just published a study in the prestigious journal PLOS ONE on an […].
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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.
The Pharma Data
SEPTEMBER 25, 2020
Image copyright. Getty Images. Demand for coronavirus tests has almost trebled among young children in England this month – but only 1% were found to have the virus, figures show. In the first two weeks of September, more than 200,000 under-nines were tested, according to government’s test-and-trace programme. That is nearly three times as many as in the previous fortnight.
Scienmag
SEPTEMBER 25, 2020
Credit: Illustration by Jian Wu/Iowa State University. Galaxy image from the Sloan Digital Sky Survey. AMES, Iowa – Computer simulations are showing astrophysicists how massive clumps of gas within galaxies scatter some stars from their orbits, eventually creating the smooth, exponential fade in the brightness of many galaxy disks. Researchers from Iowa State University, the […].
The Pharma Data
SEPTEMBER 25, 2020
British consumers have increasingly turned to community pharmacies during the coronavirus pandemic, according to a new study. Research conducted by Ipsos Mori and commissioned by Johnson & Johnson Consumer Health EMEA surveyed between 6,000 people between 16 and 75. It found 57% of UK consumers are looking to community pharmacists to provide advice about over-the-counter healthcare products.
Scienmag
SEPTEMBER 25, 2020
Peer reviewed — survey — humans People with bone, joint and muscle pain saw their symptoms worsen during lockdown – according to new research from the University of East Anglia. A new study published today shows that the majority of people with musculoskeletal pain reported increased symptoms – as the nation adhered to new government […].
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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.
The Pharma Data
SEPTEMBER 25, 2020
Image copyright. PA Media. Image caption. Boris Johnson revealed his plan earlier this week. After dangling the possibility of a mini-lockdown to break coronavirus’s chain of transmission, Boris Johnson has opted for a much softer strategy. The new Covid restrictions for England – which allow pubs and restaurants to remain open and households to continue mixing – have been met by scientists with responses ranging from praise to despair.
Scienmag
SEPTEMBER 25, 2020
Credit: Institute of Industrial Science, the University of Tokyo Tokyo, Japan – Researchers led by The University of Tokyo employed a new computer model to simulate the networks of force-carrying particles that give amorphous solids their strength even though they lack long range order. This work may lead to new advances in high-strength glass, which […].
Drug Patent Watch
SEPTEMBER 25, 2020
Annual Drug Patent Expirations for EPANED Epaned is a drug marketed by Azurity and Silvergate Pharms and is included in two NDAs. It is available from one supplier. There are…. The post New patent for Azurity drug EPANED appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
SEPTEMBER 25, 2020
Business model would share sensor data Credit: UT Arlington Sensors are everywhere, collecting data in nearly every part of society and growing continuously as individuals, companies and agencies add more. A pair of computer scientists at The University of Texas at Arlington is working to create a framework for businesses that would encourage the owners […].
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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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