Bio Pharma Dive
OCTOBER 6, 2020
The review criteria outlined in the document, which the White House had held up for weeks, make the early approval of a coronavirus shot before the Nov. 3 election less likely.
World of DTC Marketing
OCTOBER 6, 2020
WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. But as hospitals brace for an onslaught of critically ill patients and laboratories worldwide are disrupted, researchers have had to shelve clinical trials of therapies for other illnesses. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.
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Bio Pharma Dive
OCTOBER 6, 2020
Blocked by the White House from issuing new vaccine guidelines, the FDA made its criteria for an emergency authorization clear anyway, publishing requirements it had previously communicated to drugmakers.
Pharma Mirror
OCTOBER 6, 2020
One of the biggest medical advancements of recent times is the invention of the cell isolation method. Also known as cell sorting or cell separation, the cell isolation method has rapidly become an integral component of modern biological and medical research. In this method, a one-cell population or multiple cell types are isolated from a. The post How is Cell Isolation Revolutionizing Medical Industry?
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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
OCTOBER 6, 2020
The decision by European regulators to start speedy, "rolling" reviews of two vaccine candidates comes as the FDA and White House have reportedly been unable to agree on early approval standards.
Pharma Mirror
OCTOBER 6, 2020
Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the market release of SeptiCyte® RAPID on Idylla™ as a CE-marked IVD test. SeptiCyte® RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 6, 2020
An Excel spreadsheet was behind IT glitch that caused thousands of positive COVID-19 tests to be omitted from the UK’s official records, according to press reports. The issue that left almost 16,000 positive results going unreported has been blamed on the way Public Health England tracks results from mainly private labs that have been hired to add extra testing capacity.
Drug Patent Watch
OCTOBER 6, 2020
Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
OCTOBER 6, 2020
The UKâs Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's Oxbox centre.
BioSpace
OCTOBER 6, 2020
The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization.
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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
BioPharma Reporter
OCTOBER 6, 2020
Vaxxas has received a $22m US Government award to conduct a Phase 1 clinical study for its novel skin-patch vaccination platform. While the trial will use a pandemic influenza vaccine, Vaxxas is also investigating opportunities to use the technology against COVID-19.
BioSpace
OCTOBER 6, 2020
This morning, the Swiss pharma giant acquired a portfolio of experimental cystic fibrosis therapies, including a candidate that has the potential to treat all patients with this disease.
Scienmag
OCTOBER 6, 2020
Credit: Andy Radford [meerkat photograph]; Michalis Mantelos [red-ruffed lemur photograph] From ants to primates, ‘Napoleonic’ intelligence has evolved to help animals contend with the myriad cognitive challenges arising from interactions with rival outsiders, suggest researchers at the University of Bristol in a paper published in Nature Communications today [Tuesday 6 October].
BioSpace
OCTOBER 6, 2020
Eli Lilly is seeking Emergency Use Authorization for its antibody therapy, LY-CoV555, for the treatment of high-risk patients with recently diagnosed mild-to-moderate coronavirus disease 2019 (COVID-19).
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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.
BioPharma Reporter
OCTOBER 6, 2020
Contract development and manufacturing organization (CDMO), Cobra Biologics, has been selected to manufacture plasmids for a Phase I clinical trial of a COVID-19 vaccine being developed by UK company, Scancell.
BioSpace
OCTOBER 6, 2020
Michael Haas, Medasource’s Pharmaceutical & Life Sciences Vertical Director, describes the company as a “national healthcare consulting and project services company.
Scienmag
OCTOBER 6, 2020
Credit: UCLouvain Since 2004, Claude Knauf (INSERM) and Patrice Cani (UCLouvain) have been collaborating on molecular and cellular mechanisms in order to understand the causes of the development of type 2 diabetes and above all to identify new therapeutic targets. In 2013, they created an international laboratory, ‘NeuroMicrobiota Lab’ (INSERM-UCLouvain), to identify links between the […].
BioSpace
OCTOBER 6, 2020
Bristol Myers Squibb announced today that its Phase III CheckMate -816 trial met its primary endpoint of pathologic complete response (pCR) in patients with resectable non-small cell lung cancer.
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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
OCTOBER 6, 2020
Credit: Adam Malin/ORNL, U.S. Dept. of Energy Census – Remote population counting Oak Ridge National Laboratory scientists helped count the population of Nigeria – all without leaving the lab. Medical teams with the Bill and Melinda Gates Foundation needed help finding patients while vaccinating for polio in Nigeria, a nation of roughly 190 million people. […].
Pharma Times
OCTOBER 6, 2020
Two-drug regimen continues to offer non-inferior efficacy compared to a three-drug regimen
Scienmag
OCTOBER 6, 2020
New study by a team of Harvard-led researchers rebuts 75-year-old belief in reptile evolution Credit: Tiago R. Simões Challenging a 75-year-old notion about how and when reptiles evolved during the past 300 million-plus years involves a lot of camerawork, loads of CT scanning, and, most of all, thousands of miles of travel. Just check the […].
Outsourcing Pharma
OCTOBER 6, 2020
A leader from the CRO shares insights as to what strategies and philosophies work best when working to craft a successful drug development program.
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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
OCTOBER 6, 2020
Credit: Gemma Aragay/ICIQ The transport of amino acids and other molecules across the cell’s membrane plays a crucial role in the metabolism of cells and, therefore, in human health. Current research hints that cancer, cystic fibrosis, aminoacidurias and neurodegenerative diseases may stem from missing or defective amino acid transport at the cell membrane.
Pharma Times
OCTOBER 6, 2020
Research tool will predict disease severity and therapeutic response
Scienmag
OCTOBER 6, 2020
Credit: UZH, Rie Shimizu-Inatsugi A new plant species named Cardamine insueta appeared in the region of Urnerboden in the Swiss alps, after the land has changed from forest to grassland over the last 150 years. The inheritance of two key traits from its parent plants enabled the newly emerged species to grow in a distinct […].
Forte Research Systems®
OCTOBER 6, 2020
Learn how sites can quantify protocol complexity and anticipate resources to ensure more efficient clinical trial processes.
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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
OCTOBER 6, 2020
Credit: University of Birmingham Using dried blood spot samples (DBS) is an accurate alternative to venous blood in detecting SARS-CoV-2 antibody tests, a new study by immunology experts at the University of Birmingham has found. Currently antibody testing for COVID-19 uses serum or plasma, which requires a full intravenous blood sample, collected by a trained […].
BioSpace
OCTOBER 6, 2020
A new, nanoparticle tool mimics the way the SARS-CoV-2 virus infects a cell, letting scientists perform vital COVID-19 research without the risk of becoming infected themselves.
Scienmag
OCTOBER 6, 2020
Versatile and highly scalable technology simultaneously targets multiple differences and activates multiple immune system responses Credit: Yale Cancer Center With a $500,000 Research Grant from Alliance for Cancer Gene Therapy (ACGT), Sidi Chen, PhD, assistant professor in the Department of Genetics and Systems Biology Institute at Yale School of Medicine and member of Yale Cancer […].
pharmaphorum
OCTOBER 6, 2020
The FDA has rejected Mesoblast’s Ryoncil cell therapy for children with graft versus host disease, despite a recommendation to approve from a panel of expert advisers. In August the FDA’s Oncology Drugs Advisory Committee voted nine to one in favour of approving Ryoncil (remestemcel-L), making approval likely as the regulator usually follows the advice of such committees.
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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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