Bio Pharma Dive
SEPTEMBER 23, 2020
The agency has asked Novartis to run a new study of the Zolgensma formulation that Novartis aims to bring to older patients with spinal muscular atrophy.
Pharma Mirror
SEPTEMBER 23, 2020
Pharmacists are healthcare professionals who have enough knowledge about the effective uses of medications. World Pharmacist Day is celebrated on 25th September every year since 2010 on the day FIP (International Pharmaceutical Federation) started their journey. FIP encourages pharmacists to celebrate this day to promote and support the role of the pharmacist in the whole.
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Bio Pharma Dive
SEPTEMBER 23, 2020
Negative results for the experimental drug semorinemab dents a theory that Alzheimer's disease may be caused by tangles of the protein tau in the brain.
Camargo
SEPTEMBER 23, 2020
Panel Summary from the World Orphan Drug Congress 2020. Last month, executives from leading international biopharma companies came together at the World Orphan Drug Congress 2020 to discuss how they are evaluating new opportunities in the rare disease space. The panel discussion was moderated by Camargo CEO Dan Duffy, and panelists included: Joana Granado, External Innovation Director, Actelion; Weiyong Sun, Senior Director, Specialty Medicine Search, Evaluation and Global Business Development,
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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
SEPTEMBER 23, 2020
The trial, which launched Wednesday in the U.S., South Africa and several South American countries, will enroll as many as 60,000 participants.
pharmaphorum
SEPTEMBER 23, 2020
Sixfold Bioscience and Medicines Discovery Catapult awarded Innovate UK grant to pursue ground-breaking project. Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 23, 2020
Life science companies must evolve and find new ways of working that erase the lines between industries and sub-sectors if they are to adapt to the digitalised world. That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to.
BioSpace
SEPTEMBER 23, 2020
The company allegedly used a foundation as a conduit to pay the copays of Medicare patients who were taking Letairis, Gilead’s pulmonary arterial hypertension drug.
Scienmag
SEPTEMBER 23, 2020
Credit: KAIST and IEEE Spectrum (Image usage restrictions: News organizations may use or redistribute this image, with proper attribution, as part of news coverage of this paper only.) Psychiatrists typically diagnose autism spectrum disorders (ASD) by observing a person’s behavior and by leaning on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), widely considered […].
pharmaphorum
SEPTEMBER 23, 2020
One of the less well-known symptoms of COVID-19 is inflammation and injury to blood vessels, and US biotech Aerpio Pharma thinks it has a drug that may help avert the life-threatening blood clots that can result. Ohio-based Aerpio has started a phase 2 trial of its razuprotafib drug, given as a subcutaneous injection three times a day, to hospitalised subjects with moderate to severe COVID-19, to see if it can stabilise blood vessels in their lungs and other organs.
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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
SEPTEMBER 23, 2020
Lumen Bioscience was awarded a $4 million grant by the U.S. Army Medical Research and Development Command to develop a rapid, scalable and inexpensive biologic drug cocktail to treat gastrointestinal infection in COVID-19 patients.
BioPharma Reporter
SEPTEMBER 23, 2020
Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.
XTalks
SEPTEMBER 23, 2020
Being hailed as the world’s shortest and thinnest needle for insulin injection, Droplet Micron has recently been introduced into the pen needle market by HTL (High Tech Lab)-STREFA, Inc. The new and innovative needle measures at just 34G x 3.5mm. However, despite its size, it promises to deliver a reliable, less painful and comfortable injection experience.
BioPharma Reporter
SEPTEMBER 23, 2020
Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.
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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.
Scienmag
SEPTEMBER 23, 2020
Credit: Andrew Read and Duke University. All research activities were carried out under NOAA/NMFS Scientific Research Permits 17086 and 20605 (Robin Baird); NOAA/NMFS permit 14809-03 (Doug Nowacek); and NOAA General Authorization… The blue whale might be one of the most enigmatic creatures on the planet, but the true megastars of the diving world are Cuvier’s […].
BioPharma Reporter
SEPTEMBER 23, 2020
Catalent recently announced that it is investing US$130m in an expansion project at its viral vector manufacturing facility located in Harmans, Maryland, with five new manufacturing suites set to respond to a growing customer pipeline and market demand.
Scienmag
SEPTEMBER 23, 2020
University of Göttingen research team investigates influence on meat quality Credit: Juliane Fellner, University of Göttingen Current practices of the poultry industry have raised ethical and ecological concerns: ethical concerns include the culling of day-old male chicks of egg-laying breeds; ecological concerns include the import of large quantities of soybeans for feedstuff.
BioPharma Reporter
SEPTEMBER 23, 2020
Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.
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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.
BioSpace
SEPTEMBER 23, 2020
The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
Scienmag
SEPTEMBER 23, 2020
Credit: TMIMS Accumulation of assembled tau protein in the central nervous system is characteristic of Alzheimer’s disease and several other neurodegenerative diseases, called tauopathies. Recent studies have revealed that propagation of assembled tau is key to understanding the pathological mechanisms of these diseases. Mouse models of tau propagation are established by injecting human-derived tau seeds […].
NY Times
SEPTEMBER 23, 2020
Unlike some of its competitors, Johnson & Johnson’s vaccine does not need to be frozen and may require just one shot instead of two.
Scienmag
SEPTEMBER 23, 2020
Researchers have found a surprising effect of the stem cell-regulating growth factor R-spondin in intestinal cancer. Credit: Marianne Lähde Colorectal cancer constitute the third most common cancer in the Western world. Their incidence constantly increases as the population ages, and despite recent advances in colorectal cancer therapy, the cancer metastasizes in every third of colorectal […].
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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
SEPTEMBER 23, 2020
Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.
Scienmag
SEPTEMBER 23, 2020
In mice, the maternal gut microbiata regulates which genes are activated in the growing brain, UCLA study shows Credit: Reed Hutchinson/UCLA During pregnancy in mice, the billions of bacteria and other microbes that live in a mother’s intestines regulate key metabolites, small molecules that are important for healthy fetal brain development, UCLA biologists report Sept. […].
NY Times
SEPTEMBER 23, 2020
Benzodiazepines — commonly prescribed for anxiety, insomnia, seizures and panic disorders — are highly addictive and come with health risks, especially when combined with other drugs.
Scienmag
SEPTEMBER 23, 2020
Collaboration awarded $1.89 million Department of Energy grant to develop adaptive traffic control systems Credit: University of Tennessee-Chattanooga Center for Urban Informatics and Progress CHATTANOOGA, Tenn. (September 23, 2020) … The University of Tennessee-Chattanooga, with the University of Pittsburgh, Georgia Institute of Technology, Oak Ridge National Laboratory, and the City of Chattanooga, have been awarded […].
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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.
Pharma Times
SEPTEMBER 23, 2020
European Medicines Agency grants designation based on phase I/II data
Scienmag
SEPTEMBER 23, 2020
No other virus-eating organisms are known Credit: Ramunas Stepanauskas and coauthors Viruses occur in astronomic numbers everywhere on Earth, from the atmosphere to the deepest ocean. Surprisingly, considering the abundance and nutrient-richness of viruses, no organisms are known to use them as food. In Frontiers in Microbiology, researchers publish the first compelling evidence that two […].
BioSpace
SEPTEMBER 23, 2020
Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product.
Scienmag
SEPTEMBER 23, 2020
Credit: Credit: NASA/NRL NASA’s Terra satellite passed over post-tropical storm Paulette after it had transitioned for a second time. Using infrared imagery, Terra found no strong storms remained. Paulette has had quite a history. Paulette formed in the Central Atlantic Ocean on Sept. 6 as Tropical Depression Seventeen and became a tropical storm the next […].
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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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