Thu.Aug 06, 2020

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Biogen makes a billion-dollar bet on Parkinson's drugs

Bio Pharma Dive

In one of its biggest deals to date, Biogen plans to take an equity stake in Denali Therapeutics to gain access to new treatments for Parkinson's disease.

Drugs 267
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With Court Win, BMS and Pfizer Stave Off Generic Challengers to Eliquis – For Now

BioSpace

Investors in Bristol Myers Squibb and Pfizer are singing a happy song this morning after a federal court upheld patent claims regarding Eliquis, which blocks generic rivals from carving out a share of the market for at least six years.

Marketing 136
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Advancing cardiac care through health information technology

Bio Pharma Dive

A talk with the American College of Cardiology about how they are working with Health IT to deliver their guidance to the point-of-care.

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Clinical Course and Molecular Viral Shedding Among Patients With SARS-CoV-2 Infection

JAMA Internal Medicine

This cohort study quantitatively describes molecular viral shedding in asymptomatic and symptomatic patients with SARS-CoV-2 infection.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Bristol Myers, Pfizer fend off a key challenge to their top-selling heart drug

Bio Pharma Dive

A district court ruling likely ensures that the companies' blood thinner Eliquis won't face generic competition until at least 2026.

Drugs 260
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Restoring Cellular Power Outages: A New Drug to Treat Mitochondrial Diseases

BioSpace

A small biotech company is aiming to recharge tired cells, giving mitochondrial disease patients new hope of a disease-specific treatment.

Drugs 137

More Trending

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Denali and Biogen Ink Parkinson’s Pact Worth $2.125 Billion

BioSpace

Biogen and Denali Therapeutics inked a binding deal to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for Parkinson’s disease.

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India's role in coronavirus vaccine manufacturing grows with new deals

Bio Pharma Dive

The Serum Institute, one of the world's largest vaccine producers, licensed Novavax's experimental shot, while Wockhardt signed on with the U.K. to help make AstraZeneca's candidate.

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Could Obesity Be Contributing to Severe Cases of COVID-19?

BioSpace

Although obesity is a known risk factor for death from many conditions, such as cardiovascular disease, experts are now wondering how COVID-19 may impact those who fall into this category.

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Health Experts to F.D.A.: Make Your Vaccine Deliberations Public

NY Times

A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel when reviewing data on coronavirus trials.

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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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Novavax and SIPL to Develop 1 Billion COVID-19 Vaccine Doses for India, Other Countries

BioSpace

Novavax said the agreement will allow for the development and distribution of NVX?CoV2373, a recombinant vaccine engineered from the genetic sequence of SARS-CoV-2, in India and in low- and middle-income countries.

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A new look at Mars’ eerie, ultraviolet nighttime glow

Scienmag

Credit: LASP Every night on Mars, when the sun sets and temperatures fall to minus 80 degrees Fahrenheit and below, an eerie phenomenon spreads across much of the planet’s sky: a soft glow created by chemical reactions occurring tens of miles above the surface. An astronaut standing on Mars couldn’t see this “nightglow”–it shows up […].

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How to Prepare for the Top 10 Candidate Questions About COVID-19

BioSpace

As your organization continues with hiring efforts, interviewers will face new questions from candidates that they’ve never been asked before.

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Marshall University researcher to study renal failure-associated cardiomyopathy

Scienmag

Credit: Marshall University HUNTINGTON, W.Va. – Komal Sodhi, M.D., an associate professor of surgery and biomedical sciences at the Marshall University Joan C. Edwards School of Medicine, has been awarded a $444,000 grant from the National Institutes of Health (NIH) to further her research on cardiomyopathy associated with chronic renal failure, or uremic cardiomyopathy.

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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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Tarveda’s Phase II Miniature Drug Conjugates Deliver Better Targeting, Less Toxicity that ADCs

BioSpace

Tarveda Therapeutics is advancing its miniature drug conjugates into Phase IIa trials, using a platform that combines the best aspects of small molecules and antibody drug conjugates while addressing their deficiencies.

Drugs 94
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New science behind algae-based flip-flops

Scienmag

Biodegradable shoes meet commercial standards for products needed to help eradicate tons of plastic waste Credit: Photo courtesy of Stephen Mayfield, UC San Diego. As the world’s most popular shoe, flip-flops account for a troubling percentage of plastic waste that ends up in landfills, on seashores and in our oceans. Scientists at the University of […].

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AstraZeneca taps 20-plus partners to hit goal of 2bn COVID-19 vaccines

BioPharma Reporter

AstraZeneca creates âparallel supply chainsâ through partnerships to support rapid scaling up of COVID-19 vaccine capacity.

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New insight into the evolution of complex life on Earth

Scienmag

Credit: Lancaster University A novel connection between primordial organisms and complex life has been discovered, as new evidence sheds light on the evolutionary origins of the cell division process that is fundamental to complex life on Earth. The discovery was made by a cross-disciplinary team of scientists led by Professor Buzz Baum of University College […].

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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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AstraZeneca Signs First COVID-19 Vaccine Deal with China's Shenzhen Kangtai

BioSpace

AstraZeneca signed a deal with Beijing-based Shenzhen Kangtai Biological Products to manufacture AstraZeneca and the University of Oxford’s COVID-19 vaccine in mainland China.

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Study finds high levels of toxic pollutants in stranded dolphins and whales

Scienmag

Researchers examine 83 stranded dolphins and whales in North Carolina and Florida Credit: Annie Page-Karjian A study led by researchers at Florida Atlantic University’s Harbor Branch Oceanographic Institute examined toxins in tissue concentrations and pathology data from 83 stranded dolphins and whales along the southeastern coast of the United States from 2012 to 2018.

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Sanofi wins race to ship vaccines ahead of ‘record’ flu season

BioPharma Reporter

Sanofi ships first influenza vaccines to US for 2020-2021 flu season that is tipped to generate record sales.

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Metallic blue fruits use fat to produce color and signal a treat for birds

Scienmag

Credit: Rox Middleton Researchers have found that a common plant owes the dazzling blue colour of its fruit to fat in its cellular structure, the first time this type of colour production has been observed in nature. The plant, Viburnum tinus, is an evergreen shrub widespread across the UK and the rest of Europe, which […].

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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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Biopharma Update on the Novel Coronavirus: August 7

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.

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Fossil mystery solved: Super-long-necked reptiles lived in the ocean, not on land

Scienmag

Twenty-foot-long specimens described as separate species from their cousins, named after mythology’s Hydra Credit: Emma Finley-Jacob A fossil called Tanystropheus was first described in 1852, and it’s been puzzling scientists ever since. At one point, paleontologists thought it was a flying pterosaur, like a pterodactyl, and that its long, hollow bones were phalanges in the […].

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Top Tips for Bridging the Gap to the New Clinical Trial Landscape

Crucial Data Soutions

During our recent webinar, Bridging the Gap to the New Clinical Trial Landscape , Life Sciences Industry Expert, Dean Gittleman, and CDS’ Jeff Rogers and Cody Wilke explored how advanced technology, including the use of native mobile technology as an integrated data source and management tool, empowers research professionals to optimally manage not only clinical data but also the study as a whole.

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Non-invasive nerve stimulation boosts learning of foreign language sounds

Scienmag

Credit: Kenneth Probst/UCSF PITTSBURGH, Aug. 6, 2020 – New research by neuroscientists at the University of Pittsburgh and University of California San Francisco (UCSF) revealed that a simple, earbud-like device developed at UCSF that imperceptibly stimulates a key nerve leading to the brain could significantly improve the wearer’s ability to learn the sounds of a […].

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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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NICE updates guidance on chronic pain treatments

Pharma Times

Draft guidance says some commonly used drug treatments should be avoided

Drugs 110
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People who feel dizzy when they stand up may have higher risk of dementia

Scienmag

MINNEAPOLIS – Some people who feel dizzy or lightheaded when they stand up may have an increased risk of developing dementia years later, according to a new study published in Neurology®, the medical journal of the American Academy of Neurology. The condition, called orthostatic hypotension, occurs when people experience a sudden drop in blood pressure […].

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UCB’s Cimzia bags EU label extension

Pharma Times

Drug is first biologic in Europe to be approved with a dose reduction label for axSpA patients

Drugs 92
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Brain noise contains unique signature of dream sleep

Scienmag

First EEG measure of REM sleep allows scientists to distinguish dreaming from wakefulness When we dream, our brains are filled with noisy electrical activity that looks nearly identical to that of the awake brain. But University of California, Berkeley, researchers have pulled a signal out of the noise that uniquely defines dreaming, or REM sleep, […].

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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.