Seres finds the microbiome data it's been waiting for
Bio Pharma Dive
AUGUST 10, 2020
The biotech's value more than quadrupled after reporting pivotal data that, according to executives, "substantially exceeded" what's needed for approval.
Mon.Aug 10, 2020
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Sophia Genetics launches AI tool to find COVID-19 ‘unknowns’
pharmaphorum
AUGUST 10, 2020
Swiss medical data specialist Sophia Genetics has launched a platform that will sift through data generated at more than 1,000 hospitals around the world to try to work out how the COVID-19 pandemic will evolve in the coming months and years. The data mining tool will be used to try to unearth some of the many unknowns with the virus, using next-generation sequencing (NGS) to see how the genome of SARS-CoV-2 changes over time, along with patient genetic information, results of lung and CT scans,
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US puts Kodak loan on hold after stock scrutiny
Bio Pharma Dive
AUGUST 10, 2020
Lawmakers questioned the timing of stock options granted to Kodak executives a day before the planned $765 million loan was announced. An SEC investigation is reportedly underway.
Bad behaviour: why understanding human behaviour can improve outcomes
pharmaphorum
AUGUST 10, 2020
Why did I do that? A common question I often ask myself after opening the biscuit packet for the third time in an hour. Only ten minutes before I had a mental argument with myself, which I thought I had won, promising not to eat another one until tomorrow. The process that goes on inside our heads, affecting the good and bad choices we make regarding our health every day, is the focus of health psychology and the growing interest around behavioural change.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
FDA approves first liquid biopsy test that uses advanced gene sequencing
Bio Pharma Dive
AUGUST 10, 2020
The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test.
Moderna makes commercial case for COVID-19 vaccine amid price pressure
BioPharma Reporter
AUGUST 10, 2020
Moderna Therapeutics reveals it is selling its COVID-19 vaccine for up to $37 a dose, well above the amount charged by some of its rivals.
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Pfizer inks manufacturing deal with Gilead for COVID-19 med remdesivir
Pharma Times
AUGUST 10, 2020
Pfizer becomes one of multiple external manufacturing organisations supporting scale-up of treatment
Certara adds to its COVID-19 toolkit with virtual trials module
pharmaphorum
AUGUST 10, 2020
Drugmakers have been working with data specialist Certara on a new tool that they hope could speed up the development of vaccines for COVID-19. The new “biosimulation” tool is designed to make it easier for vaccine candidates across multiple patient populations through the use of virtual patients and trials, providing insights before any real-life studies have to be carried out.
UCSF Researchers Develop Synthetic Llama Antibodies Against COVID-19
BioSpace
AUGUST 10, 2020
They are approximately 25% of the size of human antibodies and from other animals, and they appear to be the most potent anti-coronavirus compound that has been tested in the laboratory so far.
Biogen’s shares surge again as FDA hurries Alzheimer’s drug review
pharmaphorum
AUGUST 10, 2020
Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. The FDA reserves these quick reviews for drugs that have the potential to improve care standards for serious diseases. There have been no new drugs approved for Alzheimer’s since 2003 and those that are on the market are only able to treat the symptoms.
The New Age of Decentralized Clinical Trials
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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
New study confirms the power of Deinosuchus and its ‘teeth the size of bananas’
Scienmag
AUGUST 10, 2020
Credit: Adam Cossette A new study, revisiting fossil specimens from the enormous crocodylian, Deinosuchus, has confirmed that the beast had teeth “the size of bananas”, capable to take down even the very largest of dinosaurs. And, it wasn’t alone! The research, published in the Journal of Vertebrate Paleontology, also reveals various kinds of “terror crocodile” […].
Russia Approves COVID-19 Vaccine Ahead of Phase III Studies
BioSpace
AUGUST 10, 2020
The government of Russia has approved a vaccine for COVID-19, marking the first preventative treatment for the novel coronavirus.
PRA: get ready for the RACE Act
Outsourcing Pharma
AUGUST 10, 2020
Experts from the CRO offers insight on preparing for the changes to the pediatric oncology research requirements, which take effect next week.
Imaging method highlights new role for cellular “skeleton” protein
Scienmag
AUGUST 10, 2020
Molecules of actin help control the division of mitochondria, with implications for disease Credit: Salk Institute/Waitt Advanced Biophotonics Center LA JOLLA–(August 10, 2020) While your skeleton helps your body to move, fine skeleton-like filaments within your cells likewise help cellular structures to move. Now, Salk researchers have developed a new imaging method that lets them […].
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
New Drug Discovery Process Could Significantly Cut Development Time
BioSpace
AUGUST 10, 2020
Simon Fraser University chemist Robert Britton and a team of international researchers believe that their findings could lead to a more efficient way of discovering drugs for newly evolved viruses as well, such as the SARS-CoV-2 (COVID-19).
NASA’s Aqua Satellite shows extent of Apple Fire’s burn scar
Scienmag
AUGUST 10, 2020
Credit: NASA Worldview On Aug. 9, 2020 NASA’s Aqua satellite imaged the Apple Fire near Big Bear Lake in California using its false-color bands in order to be able to distinguish burn scars from the surrounding area more easily. The combination of reflectance bands 7, 2, and 1 on the MODIS instrument are most useful […].
Ligand Buys Pfenex in $516 Million Deal to Access Protein Production Platform
BioSpace
AUGUST 10, 2020
Pfenex’ proprietary protein production platform, Pfenex Expression Technology, is used to improve existing treatments and create novel therapies.
Discovery transforms understanding of hydrogen depletion at the seafloor
Scienmag
AUGUST 10, 2020
Scientists analyzing hydrothermal fluid from Piccard vents at Mid-Cayman Rise find non-biological processes deplete hydrogen that was thought to be readily available to subseafloor microbial communities; discovery could impact global hydrogen budget Credit: Image Credit: Jill McDermott The discovery of hydrothermal vents – where volcanoes at the seafloor produce hot fluid exceeding 350 degrees Celsius, […].
The New Age of Decentralized Clinical Trials
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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.
Reata Pharmaceuticals Sees Hiccup in Filing for Approval of FA Drug
BioSpace
AUGUST 10, 2020
Texas-based Reata Pharmaceuticals announced the potential delay Monday when it released its 2nd quarter financial report.
COVID-19 Prevention Network launches two research studies evaluating monoclonal antibodies
Scienmag
AUGUST 10, 2020
Credit: CoVPN DURHAM, N.C. – The COVID-19 Prevention Network (CoVPN) today announced two Phase 3 trials to determine whether monoclonal antibodies (mAbs) can prevent SARS-CoV-2, the virus that causes COVID-19. The first trial, CoVPN 3501, will evaluate LY-CoV555, an Eli Lilly and Company mAb to see whether it can prevent SARS-CoV-2 infection among people living […].
Industry Group Will Create New Standards to Protect Ad Practices and Consumers
Intouch Solutions
AUGUST 10, 2020
As the demand for more privacy protections continues, the ad industry moves to create new standards that protect digital advertising practices, including targeting and messaging, while also maintaining consumer privacy. The post Industry Group Will Create New Standards to Protect Ad Practices <i>and</i> Consumers appeared first on Intouch Solutions.
New machine learning tool predicts devastating intestinal disease in premature infants
Scienmag
AUGUST 10, 2020
Researchers develop new machine learning approach that shows promise in predicting necrotizing enterocolitis; could lead to improved medical decision-making in neonatal ICUs Credit: Sharon McCutcheon/Unsplash New York, NY–August 7, 2020–Necrotizing enterocolitis (NEC) is a life-threatening intestinal disease of prematurity. Characterized by sudden and progressive intestinal inflammation and tissue death, it affects up to 11,000 premature […].
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Filtration Efficiency, Effectiveness, and Availability of N95 Face Masks for COVID-19 Prevention
JAMA Internal Medicine
AUGUST 10, 2020
In March 2020, the soaring number of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections resulted in an unprecedented shortage of personal protective equipment (PPE) for clinicians and essential health care workers. The shortage was most profound among N95 masks. N95 respirators, named for their ability to filter 95% or more of tiny 0.3-?
Air pollution impacts the health of wild pollinators
Scienmag
AUGUST 10, 2020
Through a series of experiments, scientists have found that Giant Asian honey bees from more polluted areas of the megacity of Bangalore exhibited lower flower visitation rates than in less polluted areas Credit: Micrograph obtained by Geetha Thimmegowda with a Zeiss merlin compact VP microscope at 1 kV EHT and 460X magnification. Our air is […].
Gilead files COVID-19 drug remdesivir with FDA
pharmaphorum
AUGUST 10, 2020
Gilead has filed its COVID-19 drug remdesivir with the FDA, to treat patients with severe disease, under the brand name Veklury. The drug is currently available to US patients under an Emergency Use Authorisation for treatment of hospitalised patients with severe COVID-19. This filing is the last part of a rolling submission with the FDA that the company began in early April and could lead to a full licence for the drug, which was the first to show significant improvements in recovery time in pa
Personal connections key to climate adaptation
Scienmag
AUGUST 10, 2020
Credit: Dean Miller. Connections with friends and family are key to helping communities adapt to the devastating impact of climate change on their homes and livelihoods, a new study shows. The research found people are more empowered to respond when they see others doing the same. Scientists analysed how an island community in Papua New […].
How Machine Learning Drives Clinical Trial Efficiency
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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.
Bristol Myers Squibb’s Opdivo Hits Mark in Two Phase III Studies
BioSpace
AUGUST 10, 2020
Bristol Myers Squibb announced positive data from two separate Phase III clinical trials of its checkpoint inhibitor Opdivo (nivolumab).
Space invaders as MOFs act as liquids
Scienmag
AUGUST 10, 2020
Credit: © 2020 KAUST Innovative materials called metal organic frameworks (MOFs) could become much more versatile following research that shows that they can be manipulated as liquids. MOFs are highly porous crystalline solids with metal ions or metal clusters joined by organic (carbon-based) linker groups. Varying these parts can create a huge variety of solids […].
Roche post mixed results for etrolizumab in ulcerative colitis
Pharma Times
AUGUST 10, 2020
Phase III study of drug in Crohn's disease is ongoing
Biogen to Run Phase IV SMA Trial: “I Want to Optimize Their Life.”
BioSpace
AUGUST 10, 2020
Biogen recently announced plans to initiate a Phase IV clinical trial to determine the benefit of Spinraza in patients who received Zolgensma. The two therapies have markedly different ways of treating the disease.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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