Bio Pharma Dive
JUNE 22, 2022
The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants.
World of DTC Marketing
JUNE 22, 2022
Advanced economies typically spend about 10% of GDP on keeping their citizens in good health, a share that is rising as populations age. America’s profit-riddled healthcare-industrial complex consumes 17% of GDP, equivalent to $3.6trn a year. That is unsustainable. However, changes are slowly being implemented that could lower healthcare costs.
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Bio Pharma Dive
JUNE 22, 2022
The pharma will pay $75 million to access Precision’s gene editing technology, adding another program to the lengthening list of drug development efforts targeting the inherited blood condition.
Pharmaceutical Technology
JUNE 22, 2022
BioMarin Pharmaceutical has obtained Japan’s Ministry of Health, Labor and Welfare (MHLW) approval of the registration for its Voxzogo (vosoritide) for injection to treat achondroplasia in children whose growth plates are not closed. A modified C-type natriuretic peptide (CNP), Voxzogo acts on achondroplasia’s underlying pathophysiology. It works by down-regulating fibroblast growth factor receptor 3 (FGFR3) signalling and subsequently boosting endochondral bone formation.
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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
JUNE 22, 2022
The Belgian drugmaker will spend more than $100 million to acquire two companies, CellPoint and AboundBio, in a move meant to “disrupt” CAR-T treatment.
pharmaphorum
JUNE 22, 2022
The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. Ben Hargreaves finds out how the issue of foreign manufacturing has become a major US political talking point and how this could influence the pressures facing the industry. In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 22, 2022
Pfizer has harnessed the expertise of health data specialist Truveta to provide close monitoring of safety and other signals for its products, including COVID-19 vaccine Comirnaty, almost in real-time. Truveta’s platform is based on electronic medical record data – updated daily – for more than 50 million people in the US, harvesting anonymised patient care information from tens of thousands of clinical care sites across 42 states.
Pharma Times
JUNE 22, 2022
Novartis receives approval from the European Commission for Tabrecta for the treatment of non-small cell lung cancer
BioSpace
JUNE 22, 2022
According to a recent report, the New York City Metro area is home to 7% of the U.S. population but contains 10% of all U.S. biochemists and biophysicists and 12% of U.S. chemists.
Scienmag
JUNE 22, 2022
An important East Coast shellfish industry is projected to suffer revenue losses as offshore wind energy develops along the U.S. Northeast and Mid-Atlantic coasts, according to two Rutgers studies. Credit: © The Author(s) 2022. Published by Oxford University Press on behalf of International Council for the Exploration of the Sea. An important East Coast shellfish […].
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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
JUNE 22, 2022
The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.
Scienmag
JUNE 22, 2022
Researchers at the National Institute of Standards and Technology (NIST) have developed a new statistical tool that they have used to predict protein function. Not only could it help with the difficult job of altering proteins in practically useful ways, but it also works by methods that are fully interpretable — an advantage over the […].
BioSpace
JUNE 22, 2022
Although COVID-19 appears to be on the run in the U.S., there is still a threat of resurgence. Here’s a look at some of the most recent COVID-19 stories and research.
Scienmag
JUNE 22, 2022
Doctors at the UCLA Gender Health Program have developed a technique to reduce an Adam’s apple bump without leaving a scar on the patient’s neck. Credit: UCLA Gender Health Program Doctors at the UCLA Gender Health Program have developed a technique to reduce an Adam’s apple bump without leaving a scar on the patient’s neck. The advance could be […].
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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
JUNE 22, 2022
An experimental AstraZeneca drug for Wilson disease hit the mark in a Phase III study in which the drug, ALXN1840, was able to mobilize copper three times greater than standard-of-care.
Scienmag
JUNE 22, 2022
Anew study by the Neuronal Dynamics Research Group at UPF has elucidated the cellular and molecular mechanisms that regulate the balance between the differentiation of neurons and the maintenance of progenitor cells during the construction of the embryonic brain. The study, conducted in the zebrafish model, has been published in the journal Cell Reports.
BioSpace
JUNE 22, 2022
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.
Outsourcing Pharma
JUNE 22, 2022
The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.
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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
JUNE 22, 2022
In addition to patent cases, partnerships and pledging money to global tropical disease efforts, Novartis scored a win on a combo-treatment for solid tumors.
Scienmag
JUNE 22, 2022
Trees play an important role for natural ecosystems, for our climate and for societies across the world. However, recent research shows that many tree species are rare, and are at risk of disappearing. Credit: Wen-Yong Guo In a new global study of more than 46,000 species of trees, an international team of researchers has shown […].
BioSpace
JUNE 22, 2022
PhaseBio is working toward mitigating the surgical risks for cardiac patients taking antiplatelet therapies with bentracimab, which is currently in Phase III development.
Scienmag
JUNE 22, 2022
On June 16, 1995, when the World Wide Web was young, two gamma-ray astronomers at NASA’s Goddard Space Flight Center in Greenbelt, Maryland, launched a website with a simple aim – to post a daily astronomical image along with a brief, easily understood explanation. Credit: IAU On June 16, 1995, when the World Wide Web […].
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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
JUNE 22, 2022
Female scientists are now quantitatively not getting the credit they deserve, according to a new study published in the scientific journal Nature.
Scienmag
JUNE 22, 2022
Mangrove forests play a vital role in the health of our planet. The trees and shrubs absorb a substantial amount of greenhouse gas emissions, help protect communities from rising sea levels, and act as nurseries for baby fish. Credit: Dr Ian Hendy, University of Portsmouth Mangrove forests play a vital role in the health of […].
BioSpace
JUNE 22, 2022
Olink said the measurement of proteins at "population scale" provides the ability to improve the understanding of underlying mechanisms of diseases.
Scienmag
JUNE 22, 2022
HOUSTON – (June 22, 2022) – Inspired by your liver and activated by light, a chemical process developed in labs at Rice University and in China shows promise for drug design and the development of unique materials. Credit: Rice University HOUSTON – (June 22, 2022) – Inspired by your liver and activated by light, a chemical process […].
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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
JUNE 22, 2022
Regeneron has broken ground on a $1.8 billion expansion of its Tarrytown, NY facilities that will add at least 1,000 new full-time jobs.
Scienmag
JUNE 22, 2022
The number of elderly suffering from Alzheimer’s Disease has been rapidly rising over the past decades. For a long time, scientists believed that misfolded aggregates of amyloid-beta protein accumulate and form plaques in the brain, leading to memory loss and neuronal death. However, the recent failures of the clinical trials indicate the pressing need to […].
BioSpace
JUNE 22, 2022
In an overwhelming vote of support, the U.S. House of Representatives approved the creation of a new department within the National Institutes of Health that is focused on biomedical innovation.
Scienmag
JUNE 22, 2022
For a few years now, spent grain, the cereal residue from breweries, has been reused in animal feed. From now on, this material could also be used in nanotechnology! Professor Federico Rosei’s team at the Institut national de la recherche scientifique (INRS) has shown that microbrewery waste can be used as a carbon source 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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