Bio Pharma Dive
FEBRUARY 24, 2021
Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.
World of DTC Marketing
FEBRUARY 24, 2021
SUMMARY: In a recent study by The Harris Poll on behalf of TIME, the overwhelming majority of Americans (78%) admitted to delaying routine medical services and health care appointments due to the coronavirus pandemic. The health care industry should invest more in patient outreach, communication and education. Via The NY Times “the coronavirus pandemic has yet to end, but we are already beginning to feel the aftershocks.
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Bio Pharma Dive
FEBRUARY 24, 2021
Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.
Camargo
FEBRUARY 24, 2021
Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to dispel incorrect preconceptions about this interactive process for board members or investors.
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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
FEBRUARY 24, 2021
The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.
BioSpace
FEBRUARY 24, 2021
The Fralin Biomedical Research Institute (FBRI) at Virginia Tech Carilion (VTC) replaced its information technology (IT) system as one of the foundational steps that, within the next few years, will allow the research center to double its research capacity with the addition of more than 25 new labs.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
FEBRUARY 24, 2021
The prosecution alleged that sometime in 2018, Holmes destroyed a database called the Laboratory Information System (LIS), which contained three years’ worth of accuracy and failure rates of Theranos tests.
Pharma Times
FEBRUARY 24, 2021
Biotech company will be dedicated to accelerating development of potential treatment
BioSpace
FEBRUARY 24, 2021
As the vaccines against COVID-19 are being rolled out worldwide, numerous studies are being conducted to evaluate how the vaccines do under less controlled situations. Here’s a look.
XTalks
FEBRUARY 24, 2021
In a bid to enter the fast-food chicken sandwich space, Taco Bell announced it is testing a new Crispy Chicken Sandwich Taco in select Nashville, Tennessee and Charlotte, North Carolina locations next month, followed by a nationwide rollout later this year. The Yum Brands Inc.-owned chain is a late and surprising entrant in the highly competitive, overly saturated chicken sandwich category.
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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
FEBRUARY 24, 2021
The U.S. Food and Drug Administration has approved AbbVie’s biologic therapy HUMIRA® (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
pharmaphorum
FEBRUARY 24, 2021
2021 will be the year when big market access changes – including the far wider use of health economic evaluation – are implemented in Spain. In the latest of a suite of features looking at the biggest markets in Europe, Leela Barham takes stock of what 2021 could bring for market access in Spain. Higher biosimilar savings. Spain, like many European countries, have seen biosimilars as a route to helping manage pressure on health care spending.
BioSpace
FEBRUARY 24, 2021
A new study published in JAMA suggests that treatment with vitamin C, in addition to thiamine and hydrocortisone, does not improve treatment outcomes in hospitalized patients with sepsis.
Pharma Times
FEBRUARY 24, 2021
Orphan designation granted for the treatment of retinitis pigmentosa and Leber Congenital amaurosis
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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
FEBRUARY 24, 2021
As scientists and vaccine manufacturers continue to test their products against the variants, researchers are seeing new variants cropping up that originated in the U.S.
pharmaphorum
FEBRUARY 24, 2021
An online consultation app developed by Livi is already available for around five million patients in the UK via NHS practices, and is now starting to roll out in the UK’s private healthcare sector. In the latest move in that direction, Livi will now be deployed by BMI Healthcare, the UK’s largest private health chain with more than 50 hospitals across the country serving millions of patients.
BioSpace
FEBRUARY 24, 2021
Bristol Myers Squibb and bluebird bio said data from the Phase II KarMMa study evaluating the safety and efficacy of ide-cel (idecabtagene vicleucel) met the primary endpoint of overall survival and the key secondary endpoint of complete response rate.
XTalks
FEBRUARY 24, 2021
The injection experience is an often-overlooked aspect in insulin administration. For many daily insulin users, the experience is an important one, as it is directly related to quality of life and medication compliance. It is inaccurate to assume that one “just gets used to” the poke of a daily needle, as more often than not, this is not the case. In fact, research suggests that 94 percent of insulin injectors experience anxiety and distress due to triggers associated with daily injections; thes
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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
FEBRUARY 24, 2021
Orna, which began as an academic query at the Massachusetts Institute of Technology (MIT), is a biotechnology company creating fully engineered circular RNA, or O-shaped RNA therapies for the treatment of cancer, autoimmune, and genetic disorders.
Outsourcing Pharma
FEBRUARY 24, 2021
A leader from Praxis explains how the firm worked with Moderna on patient recruitment strategy and other solutions in the road to launching a vaccine.
BioSpace
FEBRUARY 24, 2021
The company uses computational modeling of cell behavior to treat disease, instead of going after a molecular target, redefining drug discovery through its cell-centric approach.
pharmaphorum
FEBRUARY 24, 2021
US biotech Day One has taken ownership of a cancer drug that has been languishing in Merck KGaA’s pipeline for years, in the hope of giving it a new lease of life. . The main object of the deal is Merck’s MEK 1/2 inhibitor pimasertib, a drug it originally licensed from Santhera Pharmaceuticals more than a decade ago, bringing the drug to phase 2 in melanoma and ovarian cancer and running trials in various other solid tumours and blood cancers before shelving it in 2018.
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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
FEBRUARY 24, 2021
Scientists from Purdue University are using Doppler radar to “peek” into cells and monitor metabolic activity in real time, allowing them to test microbes, detect pathogens in different environments and identify potential treatments for antibiotic-resistant bacteria.
Scienmag
FEBRUARY 24, 2021
Credit: Mike Connelly MIAMI–Researchers have perfected the recipe for keeping sea anemone and coral cells alive in a petri dish for up to 12 days. The new study, led by scientists at the University of Miami (UM) Rosenstiel School of Marine and Atmospheric Science, has important applications to study everything from evolutionary biology to human […].
BioSpace
FEBRUARY 24, 2021
Deerfield Management-backed Jaguar Gene Therapy, and its ciliopathy-focused subsidiary Axovia Therapeutics, launched today with an undisclosed Series A.
Pharma Times
FEBRUARY 24, 2021
Over 31,000 women in London to be offered the at-home tests
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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
FEBRUARY 24, 2021
Biopharma and life sciences companies from across the globe provide updates on their business and pipelines.
Scienmag
FEBRUARY 24, 2021
WEST LAFAYETTE, Ind. – New technology from Purdue University and Indiana University School of Medicine innovators may one day help patients who suffer devastating vocal injuries from surgery on the larynx. A collaborative team consisting of Purdue biomedical engineers and clinicians from IU has tissue-engineered component tissue replacements that support reconstruction of the larynx.
BioSpace
FEBRUARY 24, 2021
Merck said the acquisition adds a pipeline of drug candidates that target a broad range of autoimmune diseases.
pharmaphorum
FEBRUARY 24, 2021
The FDA has issued guidelines allowing for faster development of updated coronavirus vaccines, based on previously approved shots that have been tweaked to combat emerging variants of the SARS-CoV-2 virus. There is evidence that some of the emerging strains, particularly one that has emerged in South Africa, could be more resistant to vaccines developed to combat earlier versions of the virus.
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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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