Bio Pharma Dive
NOVEMBER 5, 2020
Requests for more data on manufacturing, clinical holds and a surprise rejection have led to questions of a tougher standard at the agency. Officials, however, point to a large and fast-advancing pipeline.
Intouch Solutions
NOVEMBER 5, 2020
What’s the best approach for investments in AI-based implementations? At this year's Frontiers Health conference, Intouch experts will discuss the 'what' and 'how'; we'll also hear a case study on creating an augmented-reality tool to help oncology HCPs empathize with patients undergoing chemotherapy, developed together with Athenex Oncology. The post Intouch & Athenex Oncology Talk AI at Frontiers Health Global Hybrid Conference appeared first on Intouch Solutions.
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Bio Pharma Dive
NOVEMBER 5, 2020
Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields.
pharmaphorum
NOVEMBER 5, 2020
After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use. The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the patient voice is “in the room” when pharma companies make decisions.
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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
NOVEMBER 5, 2020
Buying VelosBio is Merck's second investment in so-called antibody-drug conjugates since September, reflecting the drug class' fast turnaround.
BioPharma Reporter
NOVEMBER 5, 2020
The Australian Government has inked an agreement with Novavax for 40 million COVID-19 vaccine doses; and with Pfizer/BioNTech for 10 million doses.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 5, 2020
An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck
Bio Pharma Dive
NOVEMBER 5, 2020
The setback for Bluebird's LentiGlobin comes amid a string of manufacturing-related delays for gene therapy developers.
BioSpace
NOVEMBER 5, 2020
A multi-institutional research team has developed a nasal spray that effectively blocks absorption of the SARS-CoV-2 virus in ferrets with direct contact to infected animals.
Scienmag
NOVEMBER 5, 2020
Credit: Cedric Guigand NEWPORT, Ore. – Small shifts in ocean temperature can have significant effects on the eating habits of blackfin tuna during the larval stage of development, when finding food and growing quickly are critical to long-term survival, a new study from Oregon State University researchers has found. In a year of warmer water […].
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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
NOVEMBER 5, 2020
NHS Confederation chief exec calls on public to support non-COVID services
Scienmag
NOVEMBER 5, 2020
Australian-led GALAH project releases chemical information for 600,000 stars Credit: Dr Ángel R. López-Sánchez/Australian Astronomical Optics/Macquarie University/ASTRO 3D How do stars destroy lithium? Was a drastic change in the shape of the Milky Way caused by the sudden arrival of millions of stellar stowaways? These are just a couple of the astronomical questions likely to […].
BioSpace
NOVEMBER 5, 2020
This morning, the Swiss pharma giant announced Ilaris plus standard of care did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus the standard of care.
Scienmag
NOVEMBER 5, 2020
Professor Barbara Hammer and three European colleagues receive ERC Synergy Grant Credit: Photo: Bielefeld University/S. Jonek Secure the supply of drinking water in the face of urban growth: Dr Barbara Hammer, professor of computer science from Bielefeld University, and three other European scientists will be exploring new technologies for this purpose.
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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.
Pharma Times
NOVEMBER 5, 2020
SGLT2 inhibitor approved for heart failure with reduced ejection fraction
Scienmag
NOVEMBER 5, 2020
Cedars-Sinai study suggests ACE2, which helps coronavirus invade cells, may be a double-edged sword Credit: Courtesy of the National Institutes of Health LOS ANGELES (Nov. 5, 2020) — An enzyme that helps COVID-19 (coronavirus) infect the body also plays a role in inflammation and patient outcomes in inflammatory bowel disease (IBD), according to a new […].
BioSpace
NOVEMBER 5, 2020
Denmark’s Novo Nordisk is acquiring New Jersey-based Emisphere Technologies in a deal worth about $1.8 billion. Novo Nordisk and Emisphere have been partnered since 2007.
Scienmag
NOVEMBER 5, 2020
Study shows music volume has a major impact on how the listener experiences the acoustics of a concert hall Credit: Photo: Jukka Patynen The volume and timbre of music have a significant impact on how people perceive the acoustics in a concert hall, according to two recent studies carried out by the research group of […].
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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.
BioTech 365
NOVEMBER 5, 2020
Translate Bio Announces Third Quarter 2020 Financial Results and Reviews Recent Progress Translate Bio Announces Third Quarter 2020 Financial Results and Reviews Recent Progress — Advances Phase 1/2 clinical trial of MRT5005 for the treatment of cystic fibrosis (CF) with … Continue reading →
Scienmag
NOVEMBER 5, 2020
Credit: Michael Adams Bonfire Night celebrations contaminate our air with hugely elevated amounts of soot, scientists have found. Researchers from the University of Leeds were monitoring air quality to determine whether soot created by fires and fireworks, known as black carbon, could help to create ice in clouds. They found soot in the atmosphere around […].
BioSpace
NOVEMBER 5, 2020
The latest approval for Brilinta is based on the Phase III THALES trial that showed aspirin plus 90 mg of Brilinta significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA.
Scienmag
NOVEMBER 5, 2020
Children who received intervention experienced significant improvements in behavioral regulation and liking of fruits and vegetables, according to a new study in the Journal of Nutrition Education and Behavior Credit: Journal of Nutrition Education and Behavior Philadelphia, November 6, 2020 – Mindfulness training and engaging in classroom-based games can influence self-regulation and food liking when […].
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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
NOVEMBER 5, 2020
Assembly Biosciences, Inc. provided an update on Nov. 5 of its ongoing Phase 2 extension study, Study 211, examining vebicorvir (VBR, or ABI-H0731) in patients with hepatitis B virus infection.
Scienmag
NOVEMBER 5, 2020
What The Study Did: Changes in rates and risk factors over more than a decade in the U.S. for hospitalizations for a vision-threatening eye infection related to intravenous (IV) drug use were investigated in this study. Authors: David M. Hinkle, M.D., of the West Virginia University School of Medicine in Morgantown, is the corresponding author. […].
BioSpace
NOVEMBER 5, 2020
Harvard immunology experts comment on studies regarding antibodies in COVID-19 patients diminishing over time.
Scienmag
NOVEMBER 5, 2020
TUCSON, Ariz., November 5, 2020 — The Pediatric IBD Foundation, ImproveCareNow, and the Critical Path Institute (C-Path) are proud to announce a collaboration establishing the Children’s Registry for the Advancement of Therapeutics (CREATE™). CREATE™ is a drug-agnostic safety registry designed to support the completion of global post-marketing safety requirements, as well as collect safety information […].
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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
NOVEMBER 5, 2020
Three hemophilia organizations issued a joint statement reporting that Sanofi Genzyme had placed a global dosing hold on its full clinical development program.
Scienmag
NOVEMBER 5, 2020
People who experience strokes while infected with COVID-19 appear to be left with greater disability after the stroke, according a study led by UCL and UCLH researchers. Having COVID-19 at stroke onset was also associated with more than double the mortality rate of other stroke patients, according to the findings published in the Journal of […].
BioSpace
NOVEMBER 5, 2020
Setbacks and delays caused by COVID-19 are making everyone, in every facet of life, nervous. This week, that includes legacy Celgene CVR investors who are staging a mass exodus as two drugs under the agreement near the deadline and one, Liso-cel, faces inspection delays.
Scienmag
NOVEMBER 5, 2020
Some of the more than 100 scientists who contributed to the UN-FAO Report, “State of Knowledge of Soil Biodiversity: Status, Challenges, and Potentialities” will discuss the importance of including science in policymaking. The scientists will also talk about the importance of this report for the future of research and policy. ### Media ContactMary Guidenmary.guiden@colostate.edu[link].
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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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