Bio Pharma Dive
MAY 24, 2021
The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).
pharmaphorum
MAY 24, 2021
Germany is lagging behind other countries in the adoption of digital health, including Spain and the US, according to a new survey carried out on behalf of drugmaker Fresenius. . The three-country poll found that Spain is way out in front, with over half of people asked responding that digital is already playing a major role in the networking of healthcare facilities, diagnosing illnesses and telemedicine.
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Bio Pharma Dive
MAY 24, 2021
Pharma and biotech companies alike see potential in using bispecific antibodies for hard-to-treat cancers like leukemia, myeloma and solid tumors.
BioSpace
MAY 24, 2021
Proxalutamide, a selective high-affinity silent antagonist of the androgen receptor, is being developed by Chinese biotech, Kintor Pharmaceutical Limited (9939.HK).
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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
MAY 24, 2021
NGM Biopharmaceuticals has decided not to pursue a late-stage NASH program after its drug aldafermin became the latest in a long line of medicines to fail to help patients with the common liver condition.
Outsourcing Pharma
MAY 24, 2021
The owner of the pharmacy giant has announced plans to partner with various stakeholders in an effort to effect improvements across the trial ecosystem.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 24, 2021
Takeda has revealed long-term clinical trial results with its dengue vaccine that reinforce its safety and efficacy – and help to differentiate it from Sanofi’s challenged Dengvaxia shot. Updated results from the large-scale TIDES trial of TAK-003 show that three years after dosing it was 62% effective at warding off dengue symptoms and prevented more than 83% of hospitalisations due to the viral infection in children aged four to 16.
Bio Pharma Dive
MAY 24, 2021
The risks and challenges incurred on clinical trials logistics by the COVID-19 pandemic have significantly accelerated the adoption of DCT and DTP trials models to keep site investigators and potentially vulnerable and immunocompromised patients safe from infection.
BioSpace
MAY 24, 2021
Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
Scienmag
MAY 24, 2021
Data from ~6,000 9- and 10-year-old show positive effects on the developing ‘connectome’ Credit: Skylar Brooks, Computational Neuroscience Laboratory, Boston Children’s Hospital Regular physical activity has positive effects on children’s developing brain circuits, finds a Boston Children’s Hospital study using neuroimaging data from nearly 6,000 early adolescents.
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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
MAY 24, 2021
LION-101 is a novel recombinant AAV being developed as a one-time intravenous infusion for the treatment of adult and adolescent patients with Limb-Girdle Muscular Dystrophy Type 2I/R9.
Scienmag
MAY 24, 2021
Credit: Max Planck Florida Institute for Neuroscience Has your heart ever started to race at the thought of an upcoming deadline for work? Or has the sight of an unknown object in a dark room made you jump? Well, you can probably thank your amygdala for that. The small almond-shaped brain structure is central to […].
XTalks
MAY 24, 2021
Tea Drops, a California-based start-up, raised $5 million in a Series A funding round led by BrandProject. The company offers consumers bagless and dissolvable tea blends that eliminate traditional tea bags and reduce waste. With the help of investors Siddhi Capital — which is best known for backing Beyond Meat and Magic Spoon — AF Ventures, Cue Ball Capital and Halogen Ventures, Tea Drops will expand their reach and distribution and build a stronger online presence and develop their operational
Scienmag
MAY 24, 2021
Researchers find that a large earthquake could set off eruption of Hawaii’s Mauna Loa volcano Credit: USGS MIAMI – Scientists from the University of Miami (UM) Rosenstiel School of Marine and Atmospheric Science analyzed ground movements measured by Interferometric Synthetic Aperture Radar (InSAR) satellite data and GPS stations to precisely model where magma intruded and […].
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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
MAY 24, 2021
At six and a half years 49% of patients treated with combination therapy remained alive
Scienmag
MAY 24, 2021
Credit: Oxford Medical Illustrations at the John Radcliffe Hospital Researchers at the Karolinska Institutet, University of Oxford and University of Copenhagen have shown that elevated levels of lipids known as ceramides can be associated with a ten-fold higher risk of death from cardiovascular disease. Treatment with liraglutide could keep the ceramide levels in check, compared […].
Pharma Times
MAY 24, 2021
First targeted treatment authorised in the US for NSCLC patients with EGFR exon 20 insertion mutations
Scienmag
MAY 24, 2021
The distinctive white stripes in clownfish form at different rates depending on their sea anemone hosts, a PNAS study finds Credit: Tane Sinclair-Taylor Clownfish species develop their characteristic white stripes, or bars, during the process of metamorphosis Researchers have now discovered that the white bars form at different speeds depending on the sea anemone 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.
Pharma Times
MAY 24, 2021
Collaboration will aim to address challenge of timely and costly AAV-based vector manufacturing
BioSpace
MAY 24, 2021
Gene therapy is still very much cutting-edge with the potential to cure incurable genetic diseases. Here’s some recent news in the space.
Pharma Times
MAY 24, 2021
First one-time gene therapy for CALD among latest recommendations
BioSpace
MAY 24, 2021
The clinical trial, which will be conducted by Xilio, will assess XTX101's safety and efficacy as a monotherapy, as well as in combination with Keytruda, in solid tumors.
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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.
Scienmag
MAY 24, 2021
News from the Journal of Marketing Researchers from University of Sydney, University of Florida, and Rutgers University published a new paper in the Journal of Marketing that examines the role of serendipity in customer satisfaction and how marketers can provide it. The study, forthcoming in the Journal of Marketing, is titled “Serendipity: Chance Encounters in […].
pharmaphorum
MAY 24, 2021
Shares in NGM Biopharma have plummeted after the US biotech said it would abandon development of aldafermin in non-alcoholic steatohepatitis (NASH), adding to a lengthening list of failed candidates for the fatty liver disease. . The decision was taken after a phase 2b trial of NGM’s lead drug candidate missed its primary target of showing an improvement over placebo in liver fibrosis with no worsening in stage 2 or 3 NASH at 24 weeks.
Scienmag
MAY 24, 2021
FAU Harbor Branch unique historical baseline (1983-2019) reveals dramatic changes in composition of sargassum Credit: Brian Lapointe, Ph.D. For centuries, pelagic Sargassum, floating brown seaweed, have grown in low nutrient waters of the North Atlantic Ocean, supported by natural nutrient sources like excretions from fishes and invertebrates, upwelling and nitrogen fixation.
BioPharma Reporter
MAY 24, 2021
Samsung Biologics will provide large-scale fill-finish manufacturing for Modernaâs COVID-19 vaccine from its facilities in South Korea.
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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.
Scienmag
MAY 24, 2021
Credit: Ben Long || The Australian National University Rubisco is arguably the most abundant–and most important–protein on Earth. This enzyme drives photosynthesis, the process that plants use to convert sunlight into energy to fuel crop growth and yield. Rubisco’s role is to capture and fix carbon dioxide (CO2) into sugar that fuels the plant’s activities. […].
pharmaphorum
MAY 24, 2021
Indian digital health company Qure.ai is making an artificial intelligence-driven diagnostic app available to doctors scrambling to cope with escalating COVID-19 cases and deaths. With the help of health-focused non-governmental organisation (NGO) PATH, Qure is providing its AI bot for interpreting chest X-rays to physicians across India on the Telegram messaging app.
Scienmag
MAY 24, 2021
Ancient Judeans commonly ate non-kosher fish surrounding the time that such food was prohibited in the Bible, suggests a study published in the peer-reviewed journal Tel Aviv. This finding sheds new light on the origin of Old Testament dietary laws that are still observed by many Jews today. Among these rules is a ban on […].
BioPharma Reporter
MAY 24, 2021
Vaccine effectiveness against symptomatic disease from the B.1.617.2 (âIndiaâ) variant is similar to that found against the B.1.1.7 ('UK') variant, according to a new study.
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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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