Bio Pharma Dive
APRIL 26, 2021
The French pharma has agreed to "fill and finish" up to 200 million vials of Moderna's shot at its New Jersey plant, the third such manufacturing deal it struck with other vaccine developers.
pharmaphorum
APRIL 26, 2021
Technology firm Jolly Good and Teijin Pharma have begun a partnership to develop virtual reality digital therapeutics (VR DTx) for major depressive disorder. The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). Jolly Good has already won a “Home Healthcare Award” in a programme held by Teijin in December last year.
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Bio Pharma Dive
APRIL 26, 2021
VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain.
BioPharma Reporter
APRIL 26, 2021
A Phase 2b trial for the University of Oxfordâs malaria vaccine candidate showed 77% efficacy in children, according to a study published in The Lancet. âWe believe this vaccine could have a major public health impactâ, say researchers.
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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
APRIL 26, 2021
An investigation by UniQure determined the company's hemophilia gene therapy was "highly unlikely" to have caused a study volunteer's liver cancer, clearing the way for the FDA's green light.
XTalks
APRIL 26, 2021
After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. The results come from a Phase II trial of the vaccine, called R21/Matrix-M (MM), which have been published in a pre-print study in the journal The Lancet.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
APRIL 26, 2021
In phase one of the two-part program, access to tofersen will be granted on an individual basis to SOD1-ALS patients with an ALS Functional Rating Scale - Revised (ALSFRS-R) slope decline greater than or equal to 2 points per month.
Scienmag
APRIL 26, 2021
Simulation led by UChicago geoscientist finds missing piece to Martian climate puzzle Credit: NASA and JPL-Caltech. One of the great mysteries of modern space science is neatly summed up by the view from NASA’s Perseverance, which just landed on Mars: Today it’s a desert planet, and yet the rover is sitting right next to an […].
BioSpace
APRIL 26, 2021
Galectin Therapeutics takes its role seriously, as perhaps the only company developing a therapy for non-alcoholic steatohepatitis (NASH) cirrhosis, an advanced form of NASH. Along with its Phase IIb/III clinical trial, it recently launched NAVIGATEnash.com.
Scienmag
APRIL 26, 2021
Credit: Control room photo courtesy of KSTAR; collage and right-hand photo by Elle Starkman/PPPL Office of Communications. The process designed to harvest on Earth the fusion energy that powers the sun and stars can sometimes be tricked. Researchers at the U.S. Department of Energy’s (DOE) Princeton Plasma Physics laboratory have derived and demonstrated a bit […].
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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
Pharma Times
APRIL 26, 2021
Monoclonal antibody reduced lower respiratory tract infections due to RSV in healthy infants
Scienmag
APRIL 26, 2021
Credit: UK HealthCare Marketing LEXINGTON, Ky. (April 26, 2021) — From Kentucky farms to University of Kentucky labs and now to Kentucky patients, the UK Markey Cancer Center has officially launched a unique new clinical trial to test whether Artemisia annua extract can prevent ovarian cancer recurrence. Markey will be the first site worldwide to […].
BioSpace
APRIL 26, 2021
A multi-day conference hosted by Biogen during the early days of the COVID-19 pandemic has been determined to be a super-spreader event, with more than 300,000 infections linked to the conference.
Scienmag
APRIL 26, 2021
Credit: Daniel Keppeler, UMG Understanding spoken words, developing normal speech – cochlear implants enable people with profound hearing impairment to gain a great deal in terms of quality of life. However, background noises are problematic, they significantly compromise the comprehension of speech of people with cochlear implants. The team led by Tobias Moser from the […].
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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.
NY Times
APRIL 26, 2021
President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a four-alarm fire.”.
Scienmag
APRIL 26, 2021
Innovative platform pairs mass spectrometry with machine learning Credit: UC Davis Health A partnership between UC Davis and Maurice J. Gallagher, Jr., chairman and CEO of Allegiant Travel Company, has led to a new rapid COVID-19 test. A recent study published Nature Scientific Reports shows the novel method to be 98.3% accurate for positive COVID-19 […].
BioSpace
APRIL 26, 2021
As vaccinations against COVID-19 continue across the U.S., there appears to be an increase in cases in younger populations.
Scienmag
APRIL 26, 2021
Nationwide survey, led by BU researcher, indicates colleges and universities need to invest in more resources for faculty “gatekeepers” of mental health Credit: Photo by RichLegg/iStock Nearly 80 percent of higher education faculty report dealing with student mental health issues–issues that more than 90 percent of faculty believe have worsened or significantly worsened during the […].
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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.
Outsourcing Pharma
APRIL 26, 2021
Published by Tabula Rasa Healthcare, the report looks at the MedWise Risk Score, technology designed to determine ADE risk rising from medication regimens.
Scienmag
APRIL 26, 2021
Credit: Augusta University The COVID pandemic appears to have triggered about a 44% increase in insomnia disorder among health care workers at a medical-school affiliated health system, with the highest rates surprisingly among those who spent less time in direct patient care, investigators say. Another surprise was that about 10% of the group of 678 […].
BioSpace
APRIL 26, 2021
Top-line results from the Phase III INVIGORATE trial show Aldeyra Therapeutics’, reproxalap, significantly reduced ocular itching in patients with allergic conjunctivitis.
Scienmag
APRIL 26, 2021
Credit: VCU Massey Cancer Center The hormone prolactin has long been understood to play a vital role in breast growth and development and the production of milk during pregnancy. But a pair of recent studies conducted at VCU Massey Cancer Center finds strong evidence that prolactin also acts as a major contributor to breast cancer […].
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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
APRIL 26, 2021
There are several experimental treatments undergoing study for types of melanoma. BioSpace rounds up some of the most recent clinical news in this space.
Scienmag
APRIL 26, 2021
The winning entry of the Open Research Challenge (ORC) offers a solution for cleaning paleontological data Credit: Picture: Joe Flannery Sutherland The Open Research Challenge 2020, organised by Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), invited young researchers from around the world to submit innovative and creative ideas to remove incorrect and outdated entries in the largest database used […].
Pharma Times
APRIL 26, 2021
CHMP adopted positive opinions for eight new medicines in its April meeting
Scienmag
APRIL 26, 2021
Francisco Serrano, from University of Malaga, refutes this conclusion published in 2020 in the absence of scientific evidence Credit: F.J. Serrano. University of Malaga Powered flight in animals -that uses flapping wings to generate thrust- is a very energetically demanding mode of locomotion that requires many anatomical and physiological adaptations.
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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.
NY Times
APRIL 26, 2021
Many think the abdominal disorder starts in childhood, but it can occur at any age and is becoming more prevalent throughout the world.
Scienmag
APRIL 26, 2021
Susan Landau’s ‘People Count’ Credit: The MIT PRESS, 2021. How do you stop a pandemic before a vaccine arrives? Contact tracing is key, the first step in a process that has proven effective: trace, test, and isolate. Smartphones can collect some of the information required by contact tracers–not just where you’ve been but also who’s […].
XTalks
APRIL 26, 2021
The Upcycled Food Association (UFA) recently introduced its certification marker to provide consumers with guidance about the presence of upcycled foods in a wide range of products. The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. But will an upcycled certification marker gain consumers’ attention enough to influence their purchasing decisions?
Scienmag
APRIL 26, 2021
Credit: Aimee Obidzinski PITTSBURGH (April 26, 2021) … Anna C. Balazs, an award-winning University of Pittsburgh Distinguished Professor in the Swanson School of Engineering, has added one of the nation’s top honors to her portfolio. The National Academy of Sciences announced today that Balazs is among its 120 newly elected members, recognizing distinguished and continuing […].
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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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