Wed.Oct 07, 2020

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Lilly, with new data, seeks emergency clearance for COVID-19 antibody drug

Bio Pharma Dive

The pharma is the first to seek emergency approval for this kind of treatment, and may quickly follow up with a second request after reporting promising data for a two-drug combination.

Antibody 334
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Romaco implements new sustainability strategy

Pharma Mirror

Romaco has appointed a Sustainability Officer and defined goals for the company’s climate-friendly development. Not only is the manufacturer seeking to enable more sustainable production by its customers; Romaco is also keen to improve its own carbon footprint. The Romaco Group has a new central corporate objective: sustainability. To enable climate protection measures to be.

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Achieving success in pharma marketing: The need for a personalized, omnichannel approach

Bio Pharma Dive

Personalized, insight-driven omnichannel marketing has never been more beneficial or important.

Marketing 312
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Regeneron Requests Emergency Use Authorization for COVID-19 Antibody Cocktail

BioSpace

Regeneron stated that under its agreement with the U.S. government for initial doses of the cocktail, if an EUA is granted the government “has committed to making these doses available to the American people at no cost and would be responsible for their distribution.

Antibody 116
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA moves to pull preterm birth drug from market

Bio Pharma Dive

AMAG Pharma, the maker of Makena, said the company disagreed with the FDA's proposal and plans to evaluate its options following a failed study.

Marketing 246
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CRISPR pioneers Doudna and Charpentier claim Nobel chemistry prize

pharmaphorum

Drs Emmanuelle Charpentier and Jennifer Doudna have won this year’s Nobel Prize for chemistry in recognition of their work on the gene-editing technology CRISPR/Cas9. Charpentier – currently at the Max Planck Unit for the Science of Pathogens in Germany – and Doudna of the University of California, Berkeley (pictured left to right), are the first two women to share the prize awarded by the Royal Swedish Academy of Sciences.

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New White Paper on Advanced Therapies Sets up Developers for Success

XTalks

“They called him ‘The Boy.’ A tiny child with a devastating genetic disease who wasn’t supposed to blow out the candles on his first birthday cake. Who wasn’t supposed to sit up. Or talk. Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. Food and Drug Administration (FDA).

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A hydrogel that could help repair damaged nerves

Scienmag

Credit: Adapted from ACS Nano 2020, DOI: 10.1021/acsnano.0c05197 Injuries to peripheral nerves — tissues that transmit bioelectrical signals from the brain to the rest of the body — often result in chronic pain, neurologic disorders, paralysis or disability. Now, researchers have developed a stretchable conductive hydrogel that could someday be used to repair these types […].

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Noodles & Company Celebrating National Noodle Day by Implementing Prices That Go Back 25 Years

XTalks

Noodles & Company kicked off their 25 th anniversary celebrations on National Noodle Day, which was on October 6 th , with throwback prices and free delivery for 25 days. The pricing applies to Noodles Rewards members, and on National Noodle Day, they will be receiving an additional 25 percent off of their orders to set the restaurant pricing back to what is was 25 years ago.

Sales 98
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MU earns $5.45 million to advance literacy efforts throughout Missouri

Scienmag

Credit: MU College of Education COLUMBIA, Mo. — Literacy serves as the foundation of education, and the ability to read and write well is critical to a child’s success in school and beyond. As part of the Show Me Literacies Collaborative, University of Missouri researchers will collaborate with the Missouri Department of Elementary and Secondary […].

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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LabCorp’s Innovative High-Speed COVID-19 Test Gets Emergency Use Authorization from the FDA

XTalks

With the need for COVID-19 testing growing amid the second wave of the pandemic, LabCorp (NYSE: LH) has received an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its high-speed COVID-19 test. The test uses innovative technology that the company says will improve efficiency and accelerate the speed at which RT-PCR tests detect the virus.

Reagent 98
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New biomarker to prevent graft-versus-host disease in stem cell transplants discovered

Scienmag

MUSC Hollings Cancer Center researchers uncover a new biomarker whose activity can be blocked to prevent graft-versus-host disease following hematopoietic stem cell transplantation Credit: Alpine Immune Sciences A recent report published in Science Translational Medicine by MUSC Hollings Cancer Center investigator Sophie Paczesny, M.D., Ph.D., sheds light on immune cell biomarkers that may reveal which […].

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Industry welcomes release of FDA COVID-19 vaccine guidance

BioPharma Reporter

On Tuesday the FDA released its guidance on Emergency Use Authorization for COVID-19 vaccines: a move welcomed by the industry as a âtried and true tradition of releasing guidance in a public and transparent wayâ.

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Presented a program capable of detecting neurodegeneration biomarkers through magnetic

Scienmag

Credit: Bellvitge Biomedical Research Institute (IDIBELL) Magnetic resonance imaging is the most sensitive and reliable technique for diagnosing and monitoring neurodegenerative diseases. Through the images obtained, we can make a complete anatomical analysis of the brain and detect atrophy in specific regions. However, the inspection of the images is usually visual, which means that certain […].

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The New Age of Decentralized Clinical Trials

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.

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People on the Move: October 2020

Outsourcing Pharma

The latest news on pharmaceutical industry hires, promotions, acquititions and other events includes Medable, Eversana, Parexel, Astellas and more.

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Aerodynamicists reveal link between fish scales and aircraft drag

Scienmag

City, University of London’s Professor Christoph Bruecker and his team have transferred the idea of fish scales to arrays of bio-inspired scales which are capable of producing a streaky flow that could reduce skin friction drag by more than 25 percent. Credit: City, University of London The team’s findings have been published in Nature: Scientific […].

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EMA accepts filing for Biogen/Samsung Bioepis’ Lucentis biosimilar

Pharma Times

Biosimilar is an anti-VEGF therapy for retinal vascular disorders

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First relatives of rubella virus discovered in bats in Uganda and mice in Germany

Scienmag

Credit: Emily Julka MADISON, Wis. — At night in a Ugandan forest, a team of American and African scientists take oral swabs from insect-eating cyclops leaf-nosed bats. In a necropsy room near the Baltic Sea, researchers try to determine what killed a donkey, a Bennett’s tree-kangaroo and a capybara at a German zoo — all […].

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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Merck KGaA out-licenses osteoarthritis programme to Novartis

Pharma Times

Potential disease modifying osteoarthritis candidate is phase II ready

Licensing 123
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Broken promises: Almost 80% of threatened species lack sufficient protection

Scienmag

Credit: TJ Watt A failure by governments to deliver on commitments under a global nature conservation treaty, the Convention on Biological Diversity, could have devastating effects. The warning comes after a consortium of scientists, led by Dr Sean Maxwell and Professor James Watson from The University of Queensland, reviewed national area-based conservation efforts, including protected […].

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Pfizer-Lilly Endeavor Shows NGF Inhibitor Tanezumab Lowers Osteoarthritic Pain

BioSpace

Results from multiple Phase III trials show consistent improvements in pain relief and physical function.

Trials 114
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Paleontologists identify new species of mosasaur

Scienmag

Ancient lizard’s long, crocodile-like snout suggests it carved out a niche in a competitive marine ecosystem. Credit: Tatsuya Shinmura) A new species of an ancient marine reptile evolved to strike terror into the hearts of the normally safe, fast-swimming fish has been identified by a team of University of Alberta researchers, shedding light on what […].

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How Machine Learning Drives Clinical Trial Efficiency

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.

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NEJM Calls for Change in U.S. Leadership Over 'COVID-19 Failings'

BioSpace

As COVID-19 cases continue to rise in the United States, the editors of the prestigious New England Journal of Medicine have taken an unprecedented political stance and called for a change in political leadership this country.

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Jennifer Doudna wins 2020 Nobel Prize in Chemistry

Scienmag

Credit: UC Berkeley Biochemist Jennifer Doudna, a professor at UC Berkeley and faculty scientist at the Department of Energy’s Lawrence Berkeley National Laboratory (Berkeley Lab), is co-winner of the 2020 Nobel Prize in Chemistry for “the development of a method for genome editing.” She shares the Nobel Prize with co-discoverer Emmanuelle Charpentier, who currently serves […].

Genome 89
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Pfizer and OPKO's Growth Hormone Drug Effective in Late-Stage Trial

BioSpace

Pfizer and Opko Health reported their Phase III clinical trial of somatrogan met the primary endpoint compared to Genotropin (somatropin) for treating children 3 to 18 years of age with growth hormone deficiency.

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Sea-level rise projections can improve with state-of-the-art model

Scienmag

New ice-sheet ’emulator’ focuses on Antarctica, Rutgers research shows Credit: Ted Scambos/NSIDC Projections of potentially dramatic sea-level rise from ice-sheet melting in Antarctica have been wide-ranging, but a Rutgers-led team has created a model that enables improved projections and could help better address climate change threats.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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Responding to dynamic shifts in value communications

pharmaphorum

OPEN Health’s Beth Lesher and Annemarie Clegg examine what the convergence of medical communications and market access means for pharmaceutical companies. Value in healthcare is a continually changing concept. As the needs of different stakeholders evolve and gain in prominence, pharmaceutical companies must be prepared to address value from various viewpoints using a variety of different metrics.

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Study finds older adults using cannabis to treat common health conditions

Scienmag

Data indicates 61 percent of patients who used cannabis began after age 60 Credit: UC San Diego Health Sciences With growing interest in its potential health benefits and new legislation favoring legalization in more states, cannabis use is becoming more common among older adults. University of California San Diego School of Medicine researchers report that […].

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Retired NFL Linebacker Overcomes ADHD, Invests in Mental Health Platform Done

pharmaphorum

October is ADHD Awareness Month, and retired NFL linebacker J.T. Thomas wants people to know that it is okay to get help for the treatment of attention deficit hyperactivity disorder (ADHD). As a person with ADHD, J.T. Thomas knows how important getting help is, and why overcoming obstacles such as stigma, access to care and improper diagnosis are so important.

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Musical training can improve attention and working memory in children – study

Scienmag

Cognitive benefits could last a lifetime Credit: L. Kausel and coauthors Neuroscientists have found new evidence that learning to play an instrument may be good for the brain. Musically trained children perform better at attention and memory recall and have greater activation in brain regions related to attention control and auditory encoding, executive functions known […].

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.