Bio Pharma Dive
DECEMBER 2, 2020
The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days.
World of DTC Marketing
DECEMBER 2, 2020
SUMMARY: Both emergency room visits and doctors’ visits are down by about half because people are putting off treatment for medical emergencies due to fears of contracting COVID-19. How is pharma going to get patients back into to ask their doctor about branded medications? Year-to-date spending on health services is down about 2% from last year.
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Bio Pharma Dive
DECEMBER 2, 2020
The pharma licensed a treatment for a severe type of age-related vision loss, building on past deals that gave it a foothold in gene therapy.
pharmaphorum
DECEMBER 2, 2020
Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest drugmakers in the world. Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and Charles Erhart. Both in their mid-twenties, the two men set up what was initially a fine chemicals business in a Brooklyn factory, using a loan from Pfizer’s father as capital.
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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
DECEMBER 2, 2020
A quest by former Teva and Bristol Myers executive Jeremy Levin to develop an old drug for Angelman's syndrome fell short in a late-stage clinical trial.
BioSpace
DECEMBER 2, 2020
Auris Medical rose by as much as 480% yesterday after it announced lab test results, which appeared to show that its nasal spray could potentially protect users against COVID-19.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
DECEMBER 2, 2020
The United Kingdom’s Medicines & Healthcare Products Regulatory Agency granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.
XTalks
DECEMBER 2, 2020
British officials have granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine, making it the first approved vaccine in the world for the novel coronavirus. The British population will also become the first in the world to be vaccinated against the SARS-CoV-2 virus that causes COVID-19, as the vaccine will be rolled out as early as next week.
Pharma Times
DECEMBER 2, 2020
First doses for emergency use will be delivered 'immediately'
Scienmag
DECEMBER 2, 2020
Credit: Katrina Kenny Ancient deep sea creatures called radiodonts had incredible vision that likely drove an evolutionary arms race according to new research published today. The international study, led by Professor John Paterson from the University of New England’s Palaeoscience Research Centre, in collaboration with the University of Adelaide, the South Australian Museum and The […].
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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
DECEMBER 2, 2020
This morning, Bayer said the launch of the new platform is a “deeply transformative” move for its business.
Pharma Times
DECEMBER 2, 2020
Agreement will aim to develop a platform to support radiologists' decision-making
BioSpace
DECEMBER 2, 2020
The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
Scienmag
DECEMBER 2, 2020
Credit: Sean Mullen Researchers at the University of Illinois Urbana-Champaign have found that a combination of exercise and mindfulness training can help reduce fatigue in breast cancer survivors. The results from their preliminary trials might be useful in designing interventions for other cancer patients. The study “Acute effects of aerobic exercise and relaxation training on […].
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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
DECEMBER 2, 2020
Earlier theories of memory could only hypothesize that such recollections were stored by time cells, or "neurons in the hippocampus and entorhinal cortex that fire at specific moments within a cognitive task or experience".
pharmaphorum
DECEMBER 2, 2020
French tech company Kayentis has raised €7 million in private funding that will be invested in its digital platform for clinical trials. The Grenoble-based company operates in the electronic Clinical Outcome Assessment (eCOA) market, which covers areas like patient and clinician reported outcomes, automatic remote testing, and patient diaries through a combination of web and mobile tools.
Scienmag
DECEMBER 2, 2020
A researcher at Osaka University uncovered a simple mechanism underlying the intricate skin patterns of animals through comprehensive analyses of the diversity of fish colorations Credit: Seita Miyazawa Why do leopards have spots and zebras have stripes? Many biologists have tried to answer these questions and have provided interesting hypotheses, including camouflage, thermoregulation, and insect […].
pharmaphorum
DECEMBER 2, 2020
Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world to approve it. As predicted by pharmaphorum, the regulator was able to move faster than its counterparts from the European Medicines Agency, who are also conducting a separate review of the data. Pfizer and BioNTech have an agreement to supply the UK with 40 million doses of the vaccine, which is called BNT162b2 and was shown to be 95% effectiv
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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.
Scienmag
DECEMBER 2, 2020
Credit: Charles Ray, Penn State Shipping pallets — often used as display platforms in retail settings or seen as raw material for household projects — were responsible for sending more than 30,000 people to the emergency rooms of U.S. hospitals over a recent five-year period, according to a new study. With approximately 400 million new […].
NY Times
DECEMBER 2, 2020
The company said the trial would involve children ages 12 through 17.
Scienmag
DECEMBER 2, 2020
Credit: RUDN University Many substances with different chemical and physical properties, from diamonds to graphite, are made up of carbon atoms. Amorphous forms of solid carbon do not have a fixed crystal structure and consist of structural units–nanosized graphene particles. A team of physicists from RUDN University studied the structure of amorphous carbon and suggested […].
pharmaphorum
DECEMBER 2, 2020
Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche. The company is developing four phase 2 drugs brought in from Roche after the big Swiss pharma decided somebody else should take the risk of developing them. Roche, which decided the products were surplus to requirements in an already-packed pipeline, also received a shareholding in Noema, in exchange for rights to the four clinical-stage product-candidates.
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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
DECEMBER 2, 2020
Credit: Amandine Aftalion Article Title: “Optimal speed in Thoroughbred horse racing” Funding: QM funder: LabEx AMIES (ANR-10-LABX-0002-01) of Université Grenoble Alpes no grant number, program PEPS [link] The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Competing Interests: The authors have declared that no […].
BioSpace
DECEMBER 2, 2020
Children, who have not been widely tested in clinical trials for the vaccine, are typically less severely affected and are much further down the priority list for receiving the vaccines. But the vaccine has not been tested at all in younger children.
Scienmag
DECEMBER 2, 2020
Physicists report accelerated electrons linked with cosmic rays Credit: NASA/JPL More than 40 years since they launched, the Voyager spacecraft are still making discoveries. In a new study, a team of physicists led by the University of Iowa report the first detection of bursts of cosmic ray electrons accelerated by shock waves originating from major […].
pharmaphorum
DECEMBER 2, 2020
The FDA has cleared Roche and Blueprint Medicine’s Gavreto for a new use in RET-mutated thyroid cancer, putting it on a level playing field with Eli Lilly’s rival therapy Retevmo. The US regulator says Gavreto (pralsetinib) can be used to treat patient aged over 12 with advanced or metastatic RET-mutant thyroid tumours, adding to its earlier approval for adults with metastatic RET-positive non-small-cell lung cancer (NSCLC) in September.
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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
DECEMBER 2, 2020
Norepinephrine release to cells is diminished, causing cascade of effects Credit: UT Health San Antonio SAN ANTONIO, Texas, USA – In a new paper, researchers from The University of Texas Health Science Center at San Antonio (UT Health San Antonio) report brain chemistry that may contribute to why drinkers have difficulty paying attention while under […].
NY Times
DECEMBER 2, 2020
China, which has been expanding its presence in the region, is likely to beat the United States in its own backyard with vaccine diplomacy as Washington looks “at taking care of the U.S. first.”.
Scienmag
DECEMBER 2, 2020
Scientists discover a neuropeptide that reflects the current state of a fish’s social environment Credit: Max Planck Institute for Brain Research / J. Kuhl Have you recently wondered how social-distancing and self-isolation may be affecting your brain? An international research team led by Erin Schuman from the Max Planck Institute for Brain Research discovered a […].
BioSpace
DECEMBER 2, 2020
On Tuesday, the CDC Advisory Committee on Immunization Practices voted 13-1 in support of this recommendation.
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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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