Bio Pharma Dive
APRIL 23, 2021
While health officials have documented more cases of a rare blood clotting syndrome associated with J&J's vaccine, a CDC committee supported use of the shot with an added warning.
World of DTC Marketing
APRIL 23, 2021
QUICK READ: The MedAd News Manny Awards were last night. Congratulations to the winners, but the bar has been set higher if pharma is to really demonstrate they care about patients. Award winners should see their awards as a head nod and understand they have a LOT more work to do. I’m not much for pharma trade magazine awards. Too much self-promotional politics in involved but still it’s great to be recognized.
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Bio Pharma Dive
APRIL 23, 2021
A vaccine co-developed by the U.K. academic center and the Maryland biotech could be the first to meet the WHO's efficacy target for a malaria vaccine.
pharmaphorum
APRIL 23, 2021
Two years ago the use of AI in pharma and healthcare looked to be quickly heading for what Gartner’s Hype Cycle model would term the Plateau of Productivity. After the COVID-powered digital transformations of both pharma and healthcare , there can be little doubt that artificial intelligence is already having a productive time across our sector. It could even be, as consultants GlobalData predicted back in January, this year’s most disruptive technology across the pharmaceutical industry, though
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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 23, 2021
Jemperli is the seventh drug cleared by the FDA that blocks either PD-1 or PD-L1 proteins, joining Merck's Keytruda, Bristol Myers' Opdivo and others.
XTalks
APRIL 23, 2021
GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer. The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. dMMR occurs when a cell is unable to repair errors made during
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 23, 2021
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients. These are defined as patients who have elevated triglycerides and either established cardiovascular disease or diabetes and at least one additional cardiovascular ri
Scienmag
APRIL 23, 2021
Dartmouth researchers achieve better long-term control of drug-resistant breast cancer growth in mice by switching between estrogen and anti-estrogen therapies. A new clinical trial will inform which patients may benefit from this strategy Credit: Mark Washburn LEBANON, NH – Researchers at Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center (NCCC) hope to make estrogen therapy a […].
Pharma Times
APRIL 23, 2021
Construction on Leiden, Netherlands site anticipated to begin later this year
Scienmag
APRIL 23, 2021
Credit: Photograph courtesy of the MABEL team; Plots by Ke Wei As an indicator and “amplifier” of global climate change, the Arctic’s health and stability is the cornerstone of the stability of our climate system. It has far-reaching impacts on ecosystems, coastal resilience, and human settlements in the middle and high latitudes. The Arctic has […].
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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
Pharma Times
APRIL 23, 2021
Drug demonstrated a 25% relative risk reduction in the first occurrence of major adverse cardiovascular events in REDUCE-IT trial
Scienmag
APRIL 23, 2021
Credit: Jian-Yu Jiao/Sun Yat-Sen University The tree of life just got a little bigger: A team of scientists from the U.S. and China has identified an entirely new group of microbes quietly living in hot springs, geothermal systems and hydrothermal sediments around the world. The microbes appear to be playing an important role in the […].
pharmaphorum
APRIL 23, 2021
CRISPR Therapeutics is to receive a hefty $900m payment from Vertex after the companies amended a collaboration to develop, manufacture and market a gene editing therapy for sickle cell disease and beta thalassemia. Founded by Nobel prize winner Emmanuelle Charpentier, CRISPR Therapeutics has been at the forefront of gene editing technology and has refined its technology to the point where it can be used to accurately edit someone’s DNA to correct genetic conditions.
Scienmag
APRIL 23, 2021
Credit: Credit: Deng et al (2021) Geophysical Research Letters/AGU WASHINGTON– Glacial melting due to global warming is likely the cause of a shift in the movement of the poles that occurred in the 1990s. The locations of the North and South poles aren’t static, unchanging spots on our planet. The axis Earth spins around–or more […].
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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.
pharmaphorum
APRIL 23, 2021
A third US state has agreed to fund Pear Therapeutics’ digital therapeutics (DTx) to treat people with substance and opioid use disorders. . The company has been pushing for more reimbursement of its three marketed DTx products in the US following a first FDA approval in 2017. Pear said that the Ohio Department of Mental Health and Addiction Services (OhioMHAS) and RecoveryOhio are providing access to Pear’s FDA-approved DTx reSET and reSET-O, for treatment of substance use disorder and opioid u
Scienmag
APRIL 23, 2021
A new VR platform enables the display of huge amounts of data. This can be helpful in the study of rare genetic defects, among other things. Credit: Sebastian Pirch, published in Nature Communications 2021. Networks offer a powerful way to visualize and analyze complex systems. However, depending on the size and complexity of the network, […].
Pharma Times
APRIL 23, 2021
Drug type could offer a new approach to treating a number of cancers with PBRM1 mutations
Scienmag
APRIL 23, 2021
Credit: Gemma Lofthouse An international team of researchers led by the University of Bergen has uncovered how organisms from crops to corals may avoid deadly DNA damage during evolution. Our cells, and those of animals, plants and fungi, contain compartments that produce chemical fuel. These compartments contain their own DNA, which stores instructions for important […].
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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.
ECRG Media's Clinical Research Podcast
APRIL 23, 2021
Possible to be a CRA Right Out of College? Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 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 S
Scienmag
APRIL 23, 2021
Credit: RUB, Marquard In the brain, more than a hundred molecular substances act as transmitters that control communication pathways between nerve cells via thousands of different receptor types. In a review article, an international research team discusses how the activation of certain nerve cell receptors affects neuronal networks in the brain. The authors from Ruhr-Universität […].
ECRG Media's Clinical Research Podcast
APRIL 23, 2021
Possible to be a CRA Right Out of College? Don't forget to Subscribe for new content! Subscribe: [link] ?Call or Text: 910-502-3732 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] ?
Scienmag
APRIL 23, 2021
Hidden structures reveal 13 million years of seafloor spreading Credit: GEOMAR It is 2,250 kilometers long, but only 355 kilometers wide at its widest point – on a world map, the Red Sea hardly resembles an ocean. But this is deceptive. A new, albeit still narrow, ocean basin is actually forming between Africa and the […].
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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.
Drug Patent Watch
APRIL 23, 2021
Annual Drug Patent Expirations for ZYDELIG Zydelig is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent expiration for Gilead Sciences drug ZYDELIG appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 23, 2021
University of Cincinnati researchers hope to advance the understanding of skeletal muscular disorders Credit: Colleen Kelley/University of Cincinnati Researchers at the University of Cincinnati say a regulatory protein found in skeletal muscle fiber may play an important role in the body’s fight or flight response when encountering stressful situations.
Drug Patent Watch
APRIL 23, 2021
Annual Drug Patent Expirations for AUVI-Q Auvi-q is a drug marketed by Kaleo Inc and is included in one NDA. It is available from two suppliers. There are twenty-nine patents…. The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 23, 2021
Researchers at Osaka University and JOANNEUM RESEARCH develop ultrathin self-powered e-health patches that can monitor a user’s pulse and blood pressure, which may lead to new flexible motion-based energy harvesting devices Credit: Osaka University Osaka, Japan – Scientists at Osaka University, in cooperation with JOANNEUM RESEARCH (Weiz, Austria), introduced wireless health monitoring patches that use […].
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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.
Drug Patent Watch
APRIL 23, 2021
Annual Drug Patent Expirations for EVZIO Evzio is a drug marketed by Kaleo Inc and is included in two NDAs. There are thirty-two patents protecting this drug. Drug patent litigation…. The post New patent for Kaleo Inc drug EVZIO appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 23, 2021
Goethe University researchers investigate oxidative stress in mice FRANKFURT. Originally, oxygen radicals – reactive oxygen species, or ROS for short – were considered to be exclusively harmful in the body. They are produced, for example, by smoking or UV radiation. Because of their high reactivity, they can damage many important molecules in cells, including the […].
Drug Patent Watch
APRIL 23, 2021
Annual Drug Patent Expirations for EVZIO+%28AUTOINJECTOR%29 Evzio (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. It is available from two suppliers. There are thirty-one…. The post New patent for Kaleo Inc drug EVZIO (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 23, 2021
Patients with age-related muscle loss and poor walking abilities have worse prognoses after lung cancer surgery, new study finds Lung cancer is a major global cause of mortality, reportedly accounting for 1.7 million deaths each year. The most common form of lung cancer is non-small-cell lung cancer (NSCLC), and early-stage NSCLCs can often be surgically […].
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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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