Bio Pharma Dive
AUGUST 4, 2020
Early-stage results appear to show that Novavax's shot passed its first meaningful test, helping the Maryland biotech keep pace with larger competitors.
BioSpace
AUGUST 4, 2020
According to BioSpace research, 69% of biotech professionals feel they are on the verge of job burnout. Do you fall into that 69%? Is it time for a new job? Check out the top companies who are looking for candidates like you right now!
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Bio Pharma Dive
AUGUST 4, 2020
Early results from a trial testing Kymriah in follicular lymphoma were reportedly positive, supporting the pharma's plans to ask for another approval.
BioSpace
AUGUST 4, 2020
According to a study published in the journal Science Advances on July 24, an international team of researchers led by neuroscientists at Harvard Medical School has uncovered which olfactory cell types are most vulnerable to infection by SARS-CoV-2, which causes COVID-19.
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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
AUGUST 4, 2020
As the pandemic continues, we see teams will be recalibrating everything, especially study budgets.
BioSpace
AUGUST 4, 2020
In June, it dosed its first two patients using a novel therapeutic, AMT-130, delivered directly to the brain. Initial readouts are expected in a year’s time.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
AUGUST 4, 2020
New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Several factors make it difficult for HTA bodies often to assess orphan drugs, including a lack of robust trial data due to difficulties in finding patients, the absence of randomised controlled tri
Bio Pharma Dive
AUGUST 4, 2020
Given the long list of requirements in the FDA's rejection letter, DBV Technologies likely has years of work ahead to win approval of Viaskin Peanut.
BioSpace
AUGUST 4, 2020
The studies were run on a total of 36 rhesus macaques and 50 hamsters. The company is careful to caution that positive animal studies do not guarantee success in humans.
pharmaphorum
AUGUST 4, 2020
Sanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy drug Depakine, following the deaths of four babies whose mothers took the drug. Depakine was found to carry a high risk of birth defects if taken by pregnant women. Sanofi , which denies wrongdoing and says it warned of the risks long ago, is already being prosecuted in France following allegations it provided misleading information about the drug.
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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
AUGUST 4, 2020
New deal with Wockhardt boosts capacity at the crucial 'fill and finish' stage
Scienmag
AUGUST 4, 2020
Researchers in Spain study how disease vectors such as flying midges sense differences in gas concentration in order to locate their hosts Credit: Santiago Merino / National Museum of Natural Sciences Madrid Flying insects and parasites are often vectors for disease, but a mosquito needs to first find someone before they can bite them. In […].
Intouch Solutions
AUGUST 4, 2020
To better understand the impact of the new virtual health landscape, the DHC Group recently conducted research including thought leader roundtables, physician surveys via the SERMO network, and interviews with pharma marketers, including Intouch director of innovation, Brendon Thomas. The post Intouch Innovation Expert Weighs in on the New World of Virtual Health appeared first on Intouch Solutions.
Scienmag
AUGUST 4, 2020
Time is running out for balancing issues of safety, integrity and access Credit: RAND Corp. Many states continue to lack the policies and preparations needed to address safety concerns of holding elections in November, despite the lessons learned in recent 2020 primary elections that were disrupted by the coronavirus pandemic, according to new research from […].
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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
AUGUST 4, 2020
Startup IgGenix, Inc. emerged from stealth mode with $10 million in Series A financing and a goal to advance the company’s novel antibody therapeutics platform for the treatment of food and non-food allergies, as well as other severe allergic conditions.
Scienmag
AUGUST 4, 2020
First Canadian to be recognized by the Marconi Society’s Award in quantum photonic Credit: Piotr Roztocki The Institut National de la Recherche Scientifique (INRS) is proud to announce that PhD candidate Piotr Roztocki was selected as a 2020 Paul Baran Young Scholar by the Marconi Society, which honors the world’s most innovative young engineers in […].
Pharma Times
AUGUST 4, 2020
Therapy has been approved to treat advanced NTRK fusion-positive solid tumours
BioSpace
AUGUST 4, 2020
Two years after AbbVie and Voyager Therapeutics first forged a collaboration to develop treatments for Alzheimer’s disease, the partnership has come to an end after AbbVie terminated the agreement.
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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.
Pharma Times
AUGUST 4, 2020
Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour
Scienmag
AUGUST 4, 2020
Credit: Henry Ford Health System Findings from a research study, led by scientists at Henry Ford, published in the latest issue of Nature Communications suggest an enzyme could play an important role in the treatment of cancer and autoimmune diseases in the airway. Histone deacetylases (HDACs) are enzymes that help modulate gene expression by removing […].
BioSpace
AUGUST 4, 2020
Merck entered into an exclusive licensing deal with Hanmi Pharmaceutical for the development, manufacture and commercialization of efinopegdutide for nonalcoholic steatohepatitis (NASH).
Pharma Times
AUGUST 4, 2020
Agreement will utilise Oxford Biomedica's LentiVector platform
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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
AUGUST 4, 2020
In its CRL, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications.
Scienmag
AUGUST 4, 2020
Led by Boyce Thompson Institute’s Andrew Nelson, four partners will identify RNA modifications and develop resources that may lead to hardier crops Credit: Photo credit: Anna Nelson Dittrich ITHACA, NY, August 4, 2020 — RNA perform a variety of functions in cells, helping with everything from regulating genes to building proteins. In recent years, it […].
BioSpace
AUGUST 4, 2020
The U.S. government is seeking $11 billion in civil and criminal penalties from Purdue Pharma as the maker of OxyContin winds its way through bankruptcy.
Scienmag
AUGUST 4, 2020
In a study of 552 adults aged 70 to 93 years old, 80% of participants had at least one skin disease that required treatment, and the most common conditions were fungal skin infections, rosacea, actinic keratosis, and eczema. ? The study, which is published in the Journal of the American Geriatrics Society, also found that […].
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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.
XTalks
AUGUST 4, 2020
Upcycling is becoming a popular trend. Its growth is eye-opening and creates many prospects for food and beverage companies. So, what is upcycling? Well, it’s the opposite of downcycling, which involves converting materials and products into new materials of lesser quality. The practice of upcycling is transforming by-products, waste material and unusable or unwanted products into value-added products.
Scienmag
AUGUST 4, 2020
Researchers have examined what’s currently known about the neuroendocrine effects of grief and whether biological factors can predict complicated or prolonged grief after the death of a loved one. The findings appear in the Journal of Neuroendocrinology. The review of the 20 published studies that were deemed relevant found that most studies reported on levels […].
NY Times
AUGUST 4, 2020
Getting medication long meant seeing a licensed provider. Now a strategy for evading Covid-19 makes treatment available via the web.
Scienmag
AUGUST 4, 2020
Researchers from the Depression Grand Challenge collaborate with Apple Credit: Courtesy of Apple While the capability to diagnose cancer and heart problems has advanced by giant steps in recent years, methods to detect depression have stubbornly stayed the same for more than a century: Observe patients, and ask them how they are doing. UCLA has […].
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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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