Bio Pharma Dive
OCTOBER 31, 2021
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
BioSpace
OCTOBER 31, 2021
?Under the agreement, Merck can use Synthekine's surrogate cytokine agonist platform to discover, develop, and sell new cytokine-based treatments for up to two cytokine targets.
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JAMA Internal Medicine
OCTOBER 31, 2021
This case series cohort study examines the association of onset of Guillain-Barré Syndrome following vaccination with the recombinant zoster vaccine in Medicare beneficiaries.
BioSpace
OCTOBER 31, 2021
The FDA informed Moderna that it would need more time to evaluate the company’s Emergency Use Authorization (EUA) submission for its COVID-19 vaccine for adolescents 12 to 17 years of age.
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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
Scienmag
OCTOBER 31, 2021
Anyone waiting for the results of a medical test knows the anxious question:’Will my life change completely when I know?’ And the relief if you test negative. Credit: Graphic design by Therese van Wyk, University of Johannesburg. Based on Pixabay images. Telling sick people that they’re healthy, can happen when a human doctor sees a […].
BioSpace
OCTOBER 31, 2021
One year after snagging $310 million in a financing round, LianBio raised $325M in its initial public offering. Its stock begins selling today on Nasdaq under the ticker symbol “LIAN.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 31, 2021
This lipid-based system is able to tightly target antigen-presenting cells and thus trigger a rapid, persistent and robust T cell response against various cancers.
Scienmag
OCTOBER 31, 2021
AUGUSTA, Ga. (Nov. 1, 2021) – With mask wearing and social distancing on the decline and the cold and flu season upon us, researchers have developed a viral panel that enables the simultaneous testing for SARS-CoV-2 along with numerous common respiratory viruses, that tells us whether other viruses also are at play in patients hard hit […].
BioSpace
OCTOBER 31, 2021
GlaxoSmithKline denied reports that they were interested in acquiring Canada’s Aurinia Pharmaceuticals, although some reports claim they are preparing to bid.
Scienmag
OCTOBER 31, 2021
Asia-Pacific Climate Change Adaptation Information Platform (AP-PLAT) website is accessible at [link] Credit: CCCA, NIES Asia-Pacific Climate Change Adaptation Information Platform (AP-PLAT) website is accessible at [link] 1. Background of the website The Climate Change Adaptation Centre is responsible for developing an international information sharing system on climate change and other related issues, as […].
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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
BioSpace
OCTOBER 31, 2021
As the world marks a grim milestone of 5 million COVID-19 deaths, public health officials are keeping a close watch on a substrain of the Delta variant.
Scienmag
OCTOBER 31, 2021
Languages and Modalities, a new peer-reviewed international journal published by the Moscow State Linguistic University, now uses a high-end publishing infrastructure after moving to the technologically advanced ARPHA Platform and signing with scholarly publisher and technology provider Pensoft. Credit: Pensoft Publishers Languages and Modalities, a new peer-reviewed international journal published by the Moscow State Linguistic […].
BioSpace
OCTOBER 31, 2021
The National Institutes of Health has removed a notice aimed at encouraging grant proposals from minority scientists from three separate institutes.
Scienmag
OCTOBER 31, 2021
Coral restoration could become easier and quicker with the use of 3D printing. As the technology matures, it could be used to rapidly and reliably create support structures for corals to grow on. Credit: © 2021 KAUST; Anastasia Serin. Coral restoration could become easier and quicker with the use of 3D printing. As the technology […].
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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.
BioSpace
OCTOBER 31, 2021
Inovio shares are down about 2% in premarket trading after cancellation reports of a DNA cancer vaccine collab with AstraZeneca.
Scienmag
OCTOBER 31, 2021
The UN Environment Programme (UNEP), with support from the European Union, today launched a new Observatory to drive action on reducing methane emissions – a powerful greenhouse gas responsible for at least a quarter of the current climate warming. Credit: UNEP The UN Environment Programme (UNEP), with support from the European Union, today launched a […].
BioSpace
OCTOBER 31, 2021
The decision came after Avoro Capital Advisors, which owns a 7% stake in Acceleron, posted its objections to the deal.
ECRG Media's Clinical Research Podcast
OCTOBER 31, 2021
Senior CRA Discusses His Favorite Parts of Being A CRA Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] 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 short is a c
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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.
BioSpace
OCTOBER 31, 2021
The decision made VUITY the very first and only eye drop to be approved for the condition.
ECRG Media's Clinical Research Podcast
OCTOBER 31, 2021
Senior CRA Discusses His Favorite Parts of Being A CRA. Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] 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.
BioSpace
OCTOBER 31, 2021
?Scemblix is the first-in-class FDA-approved treatment for adult patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia.
FDA Law Blog
OCTOBER 31, 2021
By Karin F.R. Moore & Riëtte van Laack — On October 5, 2021, California signed SB 343 “Truth in Labeling for Recyclable Materials” into law, amending the state’s law relating to environmental advertising. The result is a California law that is significantly more narrow than the Federal Trade Commission Guides for the Use of Environmental Marketing Claims (“ Green Guides ”), In addition to significantly narrowing the categories and types of items that may be labeled as recyclable, the new l
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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.
BioSpace
OCTOBER 31, 2021
?Researchers found that those who took either the once-a-month or once-every-two-month doses experienced longer periods before relapsing.
Scienmag
OCTOBER 31, 2021
Today the world’s largest study of the impact of temperature changes and kidney disease reveals that 7.4 per cent of all hospitalisations for renal disease can be attributed to an increase in temperature. In Brazil – where the study was focused – this equated to more than 202,000 cases of kidney disease from 2000-2015. Credit: […].
BioSpace
OCTOBER 31, 2021
Yet another busy week for clinical trial news. Here’s a look.
BioTech 365
OCTOBER 31, 2021
HUTCHMED and AstraZeneca Initiate SAMETA Global Phase III Trial of Savolitinib in Combination with PD-L1 Inhibitor IMFINZI® in Patients with MET-Driven Advanced Papillary Renal Cell Carcinoma HUTCHMED and AstraZeneca Initiate SAMETA Global Phase III Trial of Savolitinib in Combination with … Continue reading →
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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.
BioSpace
OCTOBER 31, 2021
The acquisition of the medicines – which netted AstraZeneca $143 million in the geographies covered under the agreement – provides a significant boost to Covis’s respiratory portfolio.
BioTech 365
OCTOBER 31, 2021
DGAP-News: Vivoryon Therapeutics N.V. / Key word(s): Miscellaneous 01.11.2021 / 07:00 The issuer is solely responsible for the content of this announcement. Vivoryon Therapeutics N.V.
Drug Patent Watch
OCTOBER 31, 2021
This chart shows the pharmaceutical companies with the most patents in Malaysia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Malaysia? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
OCTOBER 31, 2021
Vernalis Research – a Fully Owned Subsidiary of HitGen Inc – and Hannibal Innovation Announce the Creation of Dania Therapeutics ApS Vernalis Research – a Fully Owned Subsidiary of HitGen Inc – and Hannibal Innovation Announce the Creation of Dania … Continue reading →
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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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