Bio Pharma Dive
MARCH 17, 2022
Biosimilar copies of Humira will arrive in the U.S. beginning early next year, testing both AbbVie and the market potential for knockoff biologic drugs.
pharmaphorum
MARCH 17, 2022
The uptake of digital health tools during the pandemic has been enormous due to improved access they provide to healthcare. In this article, Ben Hargreaves asks whether there are gaps in those utilising these solutions and what action is being taken to address this. Digital health has a tremendous capacity to transform the healthcare industry, with the ability to provide easy access to a multitude of services and new types of therapies.
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Bio Pharma Dive
MARCH 17, 2022
New study data add to evidence that checkpoint inhibitors can slow the return of lung tumors. But the results also leave some doubt over the best way to use the drugs.
Pharma Times
MARCH 17, 2022
The sub-variant combines mutations from both Omicron and Delta
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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
MARCH 17, 2022
The biotech claims the lipid nanoparticles used by Pfizer and Moderna for delivery of their coronavirus shots infringe on a key patent it holds.
pharmaphorum
MARCH 17, 2022
Researchers in Germany are have found a possible link between mild COVID-19 infection and an increased risk of type 2 diabetes, although they caution the signal needs further investigation. The team from Heinrich Heine University in Dusseldorf and healthcare data science company IQVIA identified the possible correlation after analysing health records from 8.8 million patients registered at 1,171 health practices across Germany, including almost 36,000 who had been diagnosed with mild COVID-19.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
MARCH 17, 2022
Biogen has announced new Phase 3 data showing that, after nearly 2.5 years of treatment, Aduhelm continued to reduce two key Alzheimerâs disease pathologies.
Scienmag
MARCH 17, 2022
Niigata, Japan—Monthly menstruation is a biological phenomenon in women of reproductive age that involves morphological and functional changes in the uterine endometrium followed by uterine lining shedding. The endometrial layer can regenerate after cyclic shedding in preparation for conception. The highly regenerating nature of this tissue can be a source of genetic mutations, increasing the […].
Pharma Times
MARCH 17, 2022
The NHS has not met the 18-week target for people to receive planned treatment in England since February 2016
Scienmag
MARCH 17, 2022
ROCHESTER, Minn. — New research from Mayo Clinic’s Center for Individualized Medicine finds that patients with ASXL1-mutant chronic myelomonocytic leukemia — an uncommon type of cancer of the bone marrow — have distinctive epigenetic changes that can activate harmful genes and cause the cancer to grow faster. The ASXL1 genetic mutation also can transform the disease into the more […].
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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
FDA Law Blog
MARCH 17, 2022
By Larry K. Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We blogged on the final 2016 guideline here on March 17, 2016). On February 10th, the agency published a comprehensive proposal to update the guideline. Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.
Scienmag
MARCH 17, 2022
Rochester Institute of Technology contributed to a massive study on a tiny roadside weed that shows urbanization is leading to adaptive evolution at a global scale. As part of the Global Urban Evolution Project (GLUE) project, scientists from 160 cities across six continents collected more than 110,000 samples of white clover plants in urban, suburban, […].
pharmaphorum
MARCH 17, 2022
After months of debate about the validity of its phase 3 clinical trials for Alzheimer’s therapy Aduhelm, Biogen has published the results in a peer-review journal, allowing physicians to look at the data and judge its efficacy and safety. The choice of journal looks like it could, however, add to the controversy surrounding the troubled drug, which has been used to treat only a few patients since its accelerated approval by the FDA last June.
Scienmag
MARCH 17, 2022
Providing customized training to Brazilian ranchers can not only help keep carbon in the ground, but improve their livelihoods and mitigate climate change, according to new research from the University of Colorado Boulder and the Climate Policy Initiative / PUC-Rio. Credit: Peter Newton Providing customized training to Brazilian ranchers can not only help keep carbon […].
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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.
Outsourcing Pharma
MARCH 17, 2022
The medication adherence specialist is joining IT4Anxiety, a project focused on dealing with anxiety in patients with mental disorders, via technology.
Scienmag
MARCH 17, 2022
The study, published in the journal Molecular Neurobiology led by the University’s Dr Mayo Olajide, describes how the spike protein used by the coronavirus to enter human cells can have a similar effect on the brain’s immune cells as it does with the rest of the body Credit: University of Huddersfield The study, published in […].
The Pharma Data
MARCH 17, 2022
First Phase 3 Study To Demonstrate Statistically Significant Improvement in DFS in the Adjuvant Setting for Patients With Stage IB-IIIA NSCLC Regardless of PD-L1 Expression. Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS.
Scienmag
MARCH 17, 2022
NEW YORK – Scientists have long known that learning requires the flow of calcium into and out of brain cells. But researchers at Columbia’s Zuckerman Institute have now discovered that floods of calcium originating from within neurons can also boost learning. The finding emerged from studies of how mice remember new places they explore. Credit: […].
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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.
The Pharma Data
MARCH 17, 2022
The Better Life Farming Alliance (BLF) supports smallholder farmers to improve their livelihoods / Bayer is a part of the BLF global alliance along with the International Finance Corporation (IFC) – a member of the World Bank Group –, Netafim – a global irrigation specialist, and more than 30 local partners / Opening of first BLF Center in Mexico. The Better Life Farming (BLF) Alliance has been launched in Latin America starting with the opening of the first BLF Center in Córdoba, Mexico in Febr
Scienmag
MARCH 17, 2022
COVID-19 has put a spotlight on the pulmonary and nervous systems, but there is still much to learn about how they interact. Researchers at University of California San Diego School of Medicine recently explored this relationship in the context of a childhood lung disease, but their findings may also apply to COVID-19 symptoms. Credit: UC […].
Pharma in Brief
MARCH 17, 2022
In a recently released decision , the Federal Court ( FC ) considered what happens when a patent infringement plaintiff agrees to resolve a dispute in a foreign jurisdiction, but continues to press parallel litigation against the same defendant in Canada. In this case, the defendant sought summary judgment based on the terms of a voluntary dismissal between the parties in the United States.
Scienmag
MARCH 17, 2022
Monarch butterflies, one of the most iconic insects of North America, are increasingly plagued by a debilitating parasite, a major new analysis shows. The Journal of Animal Ecology published the findings, led by scientists at Emory University. Credit: Photo by Jaap de Roode Monarch butterflies, one of the most iconic insects of North America, are […].
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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.
Intouch Solutions
MARCH 17, 2022
In our first blog recapping SXSW 2022, we talked about the metaverse; about our purpose as pharma marketers to champion science and equity; about the importance of refueling to prevent burnout; and about connection and creativity in the face of isolation and loneliness. In the second half of our recap, let’s cover the other three big insights that we gleaned from SXSW this year: Why “re-perception” might need to be your word of the year Why duality is such an important concept right now Why ou
Scienmag
MARCH 17, 2022
WASHINGTON—Marine cold spells are cold versions of heat waves: periods of exceptionally cold water, able to hurt or help the ecosystems they hit. As the atmosphere and oceans warm, marine cold spells are becoming less intense and less frequent overall, according to a new study. Credit: Fengyou Wan/Unsplash WASHINGTON—Marine cold spells are cold versions of […].
pharmaphorum
MARCH 17, 2022
Alnylam claims it is owed a slice of the massive revenues booked by Pfizer and Moderna for their mRNA-based COVID-19 vaccines, because they are both infringing patents its holds on a delivery technology. The US biotech has filed a pair of lawsuits in Delaware alleging infringement of US Patent No 11,246,933, which covers lipid nanoparticles (LNPs) made from cationic and PEG lipids that can be used to deliver active agents “such as a nucleic acid.” In an SEC filing, Alnylam said it is
Scienmag
MARCH 17, 2022
The top of the atmosphere is the agreed-upon border between Earth’s atmosphere and outer space. Satellites traverse this space, facilitating global communications and imaging the planet, measuring changing ice coverage heights and land mass shifts. While the satellite technology is incredibly advanced, it is a long-standing challenge to produce accurate depth of water for every […].
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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.
pharmaphorum
MARCH 17, 2022
The global market for life sciences is changing rapidly. Fuelled by technological advancements and a global pandemic, there are more opportunities than ever for companies to get innovative and life-saving therapies to the patients that need them. But when it comes to marketing new therapies, the seemingly complex nature of global markets can be intimidating, with regulatory, cultural and language insight required to commercialise a brand image across different markets.
Scienmag
MARCH 17, 2022
A COLLABORATIVE research project led by the University of Huddersfield’s Global Disaster Resilience Centre and entitled REGARD (REbuildinG AfteR Displacement), set out to investigate the role of built environment in the context of displacement. Now, a final project report has been published and presents a summary of the findings from this international project.
Cloudbyz
MARCH 17, 2022
Companies on the 2022 Inc. 5000 Regionals Midwest list had an average growth rate of 147% percent. NAPERVILLE, Ill. , March 17, 2022 /PRNewswire/ – Inc. magazine today revealed that Cloudbyz is No. 30 on its third annual Inc. 5000 Regionals Midwest list, the most prestigious ranking of the fastest-growing private companies based in Iowa , Illinois , Indiana , Kansas , Michigan , Minnesota , Missouri , North Dakota , Nebraska , Ohio , South Dakota , and Wisconsin.
Scienmag
MARCH 17, 2022
Fast radio bursts (FRBs) are the brightest millisecond-duration astronomical transients in radio bands with yet unknown origin. Credit: NAOC Fast radio bursts (FRBs) are the brightest millisecond-duration astronomical transients in radio bands with yet unknown origin. The polarization of FRBs contains crucial information about their environments. High-fidelity polarization measurements of FRBs are thus crucial to […].
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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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