Fri.Aug 21, 2020

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Americans continue to neglect their health

World of DTC Marketing

As the NY Times recently reported , obesity is the leading cause of mortality in the United States. Obesity costs the nation $1.72 trillion every year. In the United States, where at least 4.6 million people have been infected and over 165,000 have died, the promise of a vaccine is hampered by a vexing epidemic that long preceded Covid-19: obesity.

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Pilot study backs Kaia Health app for back pain relief

pharmaphorum

An app developed by Kaia Health to help people suffering from back pain who may not want to take painkillers has shown its worth again in a study conducted with a health benefit plan in the US. The pilot study of the app – which combines physical therapy, relaxation exercises and medical information to help back pain sufferers manage their condition – showed it was able to reduce self-reported pain and sleep quality.

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Could Smartphone and Blockchain Technology Fight Against Food Fraud?

XTalks

Food fraudsters have found countless ways to trick shoppers – from cheap horsemeat sold as beef to conventional apples labeled as organic. But new rapid testing and tracing technologies may help turn the tables on food crime. The stakes are high for producers of expensive foods, which are particularly vulnerable to fraud. These include extra virgin olive oil, saffron and organic produce.

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Pfizer/BioNTech say COVID-19 jab on track for approval by year-end

pharmaphorum

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp.

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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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Researchers link end of Green Sahara with SE Asia megadrought

Scienmag

Previously unknown mid-Holocene event led to major changes in human settlement Credit: Amy Ellsworth Irvine, Calif., – Physical evidence found in caves in Laos helps tell a story about a connection between the end of the Green Sahara – when once heavily vegetated Northern Africa became a hyper-arid landscape – and a previously unknown megadrought […].

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Mission successful for Novartis after FDA approves ofatumumab in MS

pharmaphorum

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis. Kesimpta will have a list price of around $83,000 a year, which the company argues will make it one of the lowest-cost branded options in a highly competitive market where drugs like Sanofi’s Aubagio and Roche’s

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Coronavirus pharma news round-up 21/08/20

pharmaphorum

New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues. Here we highlight the biggest R&D, market access and digital coronavirus news of the past week. Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage

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The age of the Earth’s inner core revised

Scienmag

Credit: NASA/ Gary A.Glatzmaier By creating conditions akin to the center of the Earth inside a laboratory chamber, researchers have improved the estimate of the age of our planet’s solid inner core, putting it at 1 billion to 1.3 billion years old. The results place the core at the younger end of an age spectrum […].

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Patient Partnership Index virtual conference to take place October 7

Pharma Times

The free event will discuss key insights into achieving impactful patient partnerships and advocacy

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Genomic analysis reveals many animal species may be vulnerable to SARS-CoV-2 infection

Scienmag

Credit: Matt Verdolivo/UC Davis Humans are not the only species facing a potential threat from SARS-CoV-2, the novel coronavirus that causes COVID-19, according to a new study from the University of California, Davis. An international team of scientists used genomic analysis to compare the main cellular receptor for the virus in humans — angiotensin converting […].

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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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UK doctors call for tighter rules on coronavirus antibody tests

pharmaphorum

Doctors have called for rules to be tightened on coronavirus antibody tests in the UK amid fears that false readings could put the public at risk. It’s not even known for sure that having antibodies against the SARS-CoV-2 coronavirus confers immunity. But with many other diseases the presence of specific antibodies indicates that the body can quickly fight off an infection in healthy individuals.

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Anthropogenic CO2 increase is unprecedented

Scienmag

Credit: © Thibaut Vergoz, Institut polaire français. a A new measurement technology developed at the University of Bern provides unique insights into the climate of the past. Previous CO2 concentrations in the atmosphere could be reconstructed more accurately than ever before, thanks to high-resolution measurements made on an Antarctic ice core. The study, which analyzed […].

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Qualitative KOL Mapping

pharmaphorum

If you were trying to identify the most influential people within a large and active Facebook group, would you restrict yourself to analysing “number of posts” and other quantitative metrics only? In such situations, adding a variety of qualitative inputs – to balance the objective with the subjective – can uncover and yield additional insights about influence and impact.

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NASA’s Terra satellite analyzes Caribbean’s Tropical Depression 14

Scienmag

Credit: Credit: NASA/NRL NASA’s Terra satellite gathered infrared data on Tropical Depression 14 as it moves through the Caribbean Sea. Infrared data was used to find the location of the strongest storms. NASA’s Terra satellite uses infrared light to analyze the strength of storms by providing temperature information about the system’s clouds.

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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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NICE recommends combination treatment from Roche for certain lymphoma patients

The Pharma Data

NICE has moved to recommend Roche’s Polivy (polatuzumab vedotin), when combined with rituximab and bendamustine, for the treatment of diffuse large B-cell lymphoma (DLBCL) in adult patients whose disease has relapsed or have not responded to primary treatment and are not eligible for a haematopoietic stem cell transplant. This means that, out of the 4,800 people in England who suffer with the condition, 530 will now be eligible for the treatment.

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Self-collected saliva and deep nasal swabs are equally effective for diagnosing COVID-19

Scienmag

SALT LAKE CITY — Self-collected saliva and deep nasal swabs collected by healthcare providers are equally effective for detecting SARS-CoV-2, the virus that causes COVID-19, according to a new study conducted by ARUP Laboratories and University of Utah (U of U) Health. The study, published in the Journal of Clinical Microbiology, represents one of the […].

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FDA approves Novartis’ MS drug Kesimpta for treating relapsed forms of the disease

The Pharma Data

The FDA has authorised Novartis’ Kesimpta (ofatumumab) for treating patients with relapsing forms of multiple sclerosis (MS), it has been revealed. . The injectable treatment also covers other forms of MS including clinically isolated syndrome and active secondary progressive disease. Kesimpta targets and delivers B-cell therapy and has shown to have superior efficacy and safety profile compared to similar treatments.

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UCF researchers generate attosecond light from industrial laser

Scienmag

The ultrafast measurement of the motion of electrons inside atoms, molecules and solids at their natural time scale is known as attosecond science and could have important implications in power generation, chemical- and biological-weapon detection, and me ORLANDO, August 21, 2020 – University of Central Florida researchers are making the cutting-edge field of attosecond science […].

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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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Janssen granted US approval for multiple myeloma drug combination

The Pharma Data

Photo by Janssen Cilag. The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined with carfilzomib and dexamethasone, in patients who have previously received between one and three lines of therapy. Janssen acquired the worldwide license to develop, manufacture and commercialise the drug through an agreement with Genmab in 2012.

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Gaps in early surveillance of coronavirus led to record-breaking US trajectory

Scienmag

As the United States exceeds 5 million reported coronavirus cases — the world’s first country to do so — epidemiologists have pinpointed what helped to set the country on this path. Research from the University of Notre Dame estimates that more than 100,000 people were already infected with COVID-19 by early March — when only […].

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Building collaborations to fight a pandemic

The Pharma Data

As an expert in infectious diseases, Jennifer Leeds could see the storm brewing. When COVID-19 began to emerge – first in Asia, then in Europe – she could see that its relative ease transmitting from person to person, along with the lack of tests and preventions or treatments for infection, made the virus a credible threat to humanity. Knowing that a pandemic was likely coming made watching the crisis unfold no less heartbreaking.

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Scientists discover a social cue of safety

Scienmag

From schools of fish, to herds of antelope and even human societies, one of the group’s many advantages is its inherent safety. Surrounded by their peers, individuals can lower their vigilance and calmly engage in other activities, such as foraging, or watching youtube videos. But the Safety in Numbers rule has more to it than […].

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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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With 6 rivals in the U.S., why would Lilly shell out up to $1B for Innovent's PD-1 med Tyvyt?

The Pharma Data

Eli Lilly, on the heels of detailing a clinical win in China for PD-1 inhibitor Tyvyt, has decided to take a bigger stake in the drug developed by partner Innovent Biologics in an expanded deal that could vault it into the lucrative—yet ultra-competitive—U.S. lung cancer market. Lilly’s shelling out $200 million up front and committing up to $825 million in milestones, plus double-digit royalties, to gain exclusive rights to Tyvyt (sintilimab) outside China.

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Psychological disease avoidance linked to preventative behavior, study finds

Scienmag

Creeped out by cooties? Grossed out by germs? Squeamish about sickness? If so, then you might also find yourself engaging in more preventative health behaviors, like frequent handwashing and disinfecting your living environment, during the ongoing coronavirus pandemic. More than other factors, strong feelings of germ aversion and pathogen disgust are significantly associated with concern […].

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Patient Partnership Index virtual conference to take place October 7

The Pharma Data

The free event will discuss key insights into achieving impactful patient partnerships and advocacy. Senior leaders in pharma and patient groups will be offering key insights into impactful patient centricity and advocacy at the Patient Partnership Index virtual conference on October 7. The free event, hosted by OVID Health, follows the success of the inaugural Patient Partnership Index, which saw four pharma companies achieve GOLD standard for their entries.

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NASA nighttime imagery finds Tropical Storm Laura developing  

Scienmag

Credit: Credit: NASA Worldview, Earth Observing System Data and Information System (EOSDIS) NASA-NOAA’s Suomi NPP satellite provided forecasters with a nighttime view of Tropical Depression 13 early on Aug. 21. By 11 a.m. EDT, it had strengthened into Tropical Storm Laura. NASA’s Night-Time View of Tropical Depression 13 The Visible Infrared Imaging Radiometer Suite (VIIRS) […].

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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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AstraZeneca scores Japanese approval for Imfinzi combo in extensive-stage small cell lung cancer

The Pharma Data

AstraZeneca’s Imfinzi (durvalumab) has secured approval in Japan for the treatment of extensive-stage small cell lung cancer when combined with etoposide and either carboplatin or cisplatin platinum chemotherapy, it has emerged. The Japanese Ministry of Health, Labour and Welfare awarded the authorisation based on Phase 3 data which showed that Imfinzi generated “statistically significant and clinically meaningful improvement” in overall survival (OS), meeting its primary endpoint back in

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Surface deep: Light-responsive top layer of plastic film induces movement

Scienmag

Scientists show that azobenzene-containing film, important for many industries, does not need to be made entirely of light-sensitive material to function. Credit: Issei Kitamura / Springer Nature Azobenzene-containing plastic film is a peculiar material; its surface can change shape when exposed to light, making it a valuable component in modern technologies/devices like TV screens and […].

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Keeping tabs on Covid-19: Roche and Regeneron join forces to boost vaccine suppl…

The Pharma Data

As the pharma community continue to research and develop hundreds of potential therapies to combat the Covid-19 pandemic, very few initiatives are yet to cross the finishing line into the commercial market. However, in this week’s round up, Pharma IQ shares promising news of a Covid-19 candidate collaboration between Roche and Regeneron that looks to boost manufacturing and delivery efforts to patients in need of a cure.

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Nasal vaccine against COVID-19 prevents infection in mice

Scienmag

Nasal delivery produces more widespread immune response than intramuscular injection Credit: Hassan et al. Scientists at Washington University School of Medicine in St. Louis have developed a vaccine that targets the SARS-CoV-2 virus, can be given in one dose via the nose and is effective in preventing infection in mice susceptible to the novel coronavirus. […].

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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.