Camargo
OCTOBER 15, 2020
As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area.
Bio Pharma Dive
OCTOBER 15, 2020
The drugmaker is acquiring Disarm Therapeutics, which was formed based on research into a specific enzyme's central role in the breakdown of axons.
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BioSpace
OCTOBER 15, 2020
Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed.
Bio Pharma Dive
OCTOBER 15, 2020
Lilly has asked the FDA for emergency clearance of the therapy, although a study safety review and an unrelated manufacturing inspection could complicate the request.
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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
World of DTC Marketing
OCTOBER 15, 2020
HEY NOW : Most companies struggled in the second quarter as the coronavirus pandemic froze the economy, but health insurers like UnitedHealth heavily benefited as people held off on going to the doctor or hospital, resulting in fewer medical claims that needed to be paid. In addition, pharma profit margins remain very high. UnitedHealth Group registered more than $6.6 billion in profits in the second quarter — by far the conglomerate’s highest quarterly profit ever, according to an ana
BioSpace
OCTOBER 15, 2020
By using naturally-derived scaffolds, human cells and other biocompatible materials, 3D bioprinting has ushered in opportunities for researchers to design, print and optimize patient personalized tissues for purposes ranging from transplantation to drug testing.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 15, 2020
This morning, the company, which was formerly known as EpiPM Therapeutics, will begin trading on the Nasdaq Global Select Market under the ticker symbol PRAX.
BioPharma Reporter
OCTOBER 15, 2020
Potential vaccines for COVID-19 should not be affected by changes in SARS-CoV-2 seen to date, nor are they likely to need to be redeveloped seasonally, according to Australian scientists.
BioSpace
OCTOBER 15, 2020
Pfizer will not seek Emergency Use Authorization for its COVID-19 vaccine until the end of November even if the readout from a Phase III study expected later this month is positive.
BioPharma Reporter
OCTOBER 15, 2020
The U.S. Food and Drug Administration (FDA) has approved Regeneronâs Inmazeb for treatment of Ebola. The antibody cocktail was developed using the same ârapid responseâ technologies as Regeneronâs investigational COVID-19 antibody combination.
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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
Scienmag
OCTOBER 15, 2020
Clinical study tested four different types of medications for efficacy, tolerability and adverse effects Credit: Justin Kelley More than 20 million people in the U.S. suffer neuropathic pain. At least 25% of those cases are classified as unexplained and considered cryptogenic sensory polyneuropathy (CSPN). There is no information to guide a physician’s drug choices to […].
BioSpace
OCTOBER 15, 2020
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
OCTOBER 15, 2020
Scientists in Cambodia have used the new IDseq tool to confirm and sequence the whole genome of the country’s first case of COVID-19 Credit: IDseq.net 15th October 2020, Hong Kong: Published today in the journal GigaScience is a new open source, cloud-based tool called IDseq that makes it possible to rapidly detect, identify, and track […].
BioSpace
OCTOBER 15, 2020
Moderna is working with international regulators to accelerate approval of the company’s COVID-19 vaccine candidate, mRNA-1273.
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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.
Scienmag
OCTOBER 15, 2020
Credit: Courtesy of Ethan Cissell TALLAHASSEE, Fla. — Researchers are learning more about the brightly colored bacterial mats threatening the ecological health of coral reefs worldwide. In new research released this month, a Florida State University team revealed that these mats are more complex than scientists previously knew, opening the door for many questions about […].
BioSpace
OCTOBER 15, 2020
The WHO’s SOLIDARITY clinical trial evaluated remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients and found that none of the drugs “substantially affected mortality” or decreased the need to ventilate patients.
Scienmag
OCTOBER 15, 2020
Credit: Mat Disney Laser technology has been used to measure the volume and biomass of giant Californian redwood trees for the first time, records a new study by UCL researchers. The technique, published in Scientific Reports, offers unprecedented insights into the 3D structure of trees, helping scientists to estimate how much carbon they absorb and […].
BioSpace
OCTOBER 15, 2020
Galapagos NV and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet its primary endpoint in osteoarthritis knee repair.
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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 15, 2020
Credit: (Image: Chair of Molecular Infection Biology II / University of Wuerzburg / SCIGRAPHIX) More than half of the world’s population carries the bacterium Helicobacter pylori in their stomach mucosa. It often causes no problems throughout life, but sometimes it can cause inflammation, and in some cases, it can even lead to the development of […].
Pharma Times
OCTOBER 15, 2020
Drug is licensed for secondary progressive multiple sclerosis with active disease
Scienmag
OCTOBER 15, 2020
Growing populations in gateway communities cause urgent planning challenges; the GNAR initiative aims to help local officials prepare Credit: Brian Whitehead/National Park Service When COVID-19 hit the United States, small towns near ski areas such as Park City, Utah, and Sun Valley, Idaho, experienced some of the highest per capita cases; people from around the […].
BioSpace
OCTOBER 15, 2020
UCB is investing more than £1 billion over five years to expand its research and development capabilities in the U.K., which will include a transition to a newly acquired 47-acre R&D campus from Eli Lilly located in Windlesham, Surrey.
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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 15, 2020
Credit: LIU Hongji A joint research team led by Prof. WANG Hui and Prof. LIN Wenchu from the High Magnetic Field Laboratory of the Hefei Institutes of Physical Science developed a synthesis of metal-free multifunctional therapeutic reagents, called graphitic carbon nitride quantum dots embedded in carbon nanosheets (CNQD-CN), via a one-step hydrothermal treatment.
Pharma Times
OCTOBER 15, 2020
Review draws on experiences of patients and expert consensus
Scienmag
OCTOBER 15, 2020
Credit: Seth Davis/Colorado State University When southern Rocky Mountain forests are viewed from a distance these days, it may not look like much is left. Large swaths of dead, standing Engelmann spruce trees tell the tale of a severe regional spruce beetle epidemic in its waning stages. But among those dead trees, researchers have found […].
Cloudbyz
OCTOBER 15, 2020
The COVID-19 pandemic is ravaging the world in so many ways. It has affected and hit hard how clinical trials were done and managed in pre-COVID times. While the direct impact is definitely on patient recruitment and patient care, other areas like data collection, data safety, data analysis, and overall trial management are hugely impacted. While new guidance is getting issued for better management of clinical trials, it also means that sponsors need to be more vigilant and proactive in maintain
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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 15, 2020
$1.45M grants from Eric and Wendy Schmidt to support Keeling Curve, ocean pH programs, key indicators of global warming Credit: Schmidt Ocean Institute The Keeling Curve carbon dioxide measurement-the long-term atmospheric measurement that alerted the world to human-induced climate change- will receive $1 million in continuation funding from philanthropists Eric and Wendy Schmidt, Scripps Institution […].
XTalks
OCTOBER 15, 2020
October 15 is National Mushroom Day in the US, meaning all eyes are on the fungi today. Not only are mushrooms consumed because of their perceived medicinal benefits, but also their savory umami flavor. They provide easy nutrition, come in several options and are considered one of the most sustainably produced foods in the US. Among the vast array of meat substitutes, from tofu and texturized vegetable protein to tempeh and seitan, mushrooms are often forgotten in the mix.
Scienmag
OCTOBER 15, 2020
UNIVERSITY PARK, Pa. — RADAR satellites can collect massive amounts of remote sensing data that can detect ground movements — surface deformations — at volcanoes in near real time. These ground movements could signal impending volcanic activity and unrest; however, clouds and other atmospheric and instrumental disturbances can introduce significant errors in those ground movement […].
Outsourcing Pharma
OCTOBER 15, 2020
The pharmaceutical firmâs More to uS is a UK-centered campaign that shares stories of people living (and thriving) after a multiple sclerosis diagnosis.
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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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