Thu.Mar 04, 2021

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Biogen to spend $200M on gene therapy plant in North Carolina

Bio Pharma Dive

The planned factory is a strong sign of Biogen's interest in gene therapy, an area of research it has invested in through dealmaking over the past few years.

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The true cost of COVID-19?

World of DTC Marketing

SUMMARY: COVID-19 has killed many people worldwide, but how many really died from COVID, and how many died because they had an underlying chronic health problem as a major factor? We may never know, but we can not afford to do anything while our population becomes more obese and unhealthy. According to CNN “a team examined mortality data from Johns Hopkins University (JHU) and the World Health Organization (WHO) and found that of 2.5 million Covid-19 deaths reported by the end of February,

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Lilly says diabetes shot outperformed rival Novo drug in study

Bio Pharma Dive

The results are a boost for Lilly's drug, tirzepatide, which is being prepared for regulatory submissions later this year. But long-term heart data won't be available for some time.

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Disney characters will lend a hand to kids during MRI scans

pharmaphorum

Radiologists in Europe could soon have help keeping children calm as they have MRI scans from Disney favourites like Micky Mouse, Winnie the Pooh and the Little Mermaid. Healthcare tech company Philips has teamed up with Walt Disney Corp to develop custom ambient animations – featuring some of the most-lived characters from Disney, Marvel and Star Wars shows – that can be played to children during the procedure.

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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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Amgen, with rare buyout, pays $1.9B for cancer biotech Five Prime

Bio Pharma Dive

The acquisition marks a dramatic turnaround for Five Prime, which has in recent years struggled through setbacks, executive departures and layoffs.

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India's Covaxin Covid-19 Vaccine, Already in Use, Shows Promise in Trials

NY Times

Interim results from clinical trials suggested that Covaxin could be safe and effective, potentially removing one hurdle to New Delhi’s ambitious campaign to inoculate a vast population.

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More Trending

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One and Done: Why People Are Eager for Johnson & Johnson’s Vaccine

NY Times

Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.

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FDA lays out data modernization action plan

Bio Pharma Dive

"Even small advances in our ability to gain useful insights from data can represent significant opportunities," wrote FDA leaders Janet Woodcock and Amy Abernethy.

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Bharat’s Next-Gen COVID-19 Nasal Vaccine Moving Toward Human Testing

BioSpace

Days after vaccine-maker Bharat Biotech released interim Phase III efficacy data for a COVID-19 vaccine already in use in India, a pulmonary expert is expressing enthusiasm for the company’s next-generation intranasal vaccine on track to enter clinical testing this quarter.

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Budget 2021: Sunak focuses on vaccine development to restart economy

pharmaphorum

UK chancellor Rishi Sunak has announced a budget loaded with initiatives designed to kick-start the UK’s economy as it recovers from the coronavirus pandemic, with vaccine development, pharma and life sciences playing a key role. The ongoing fight against COVID-19 was a top-line feature of the budget announcement, with an extra £1.65bn to ensure the vaccination roll-out continues to be a success.

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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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FDA Approves First Biologic for Rare, Debilitating Lung Disease

BioSpace

The U.S. FDA approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

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Triage Cancer’s New Resources

Triage Cancer

Practical Guide to Cancer Rights and Legal & Financial Navigation Program. Navigating the legal and practical issues that may arise following a cancer diagnosis can be confusing. Triage Cancer is always developing new ways to provide information and educational resources to individuals diagnosed with cancer, caregivers, and health care professionals who treat them. .

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Halo Top is Adding Low-Calorie Frozen Fruit Pops to its Lineup

XTalks

Halo Top, the better-for-you ice cream brand, is making its first foray into frozen fruit desserts with its new line of Fruit Pops. The frozen treats are made with real fruit and fruit juice and contain up to 65 percent less sugar than other frozen fruit desserts. Fruit Pops are also low in calories, ranging from 35 to 90 calories, and are available in strawberry, coconut, lime, mango and pineapple flavors.

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Researchers Make Headway on Universal Flu Vaccine Candidate

BioSpace

A recent study published in Science Translational Medicine shows that a new flu vaccine appears to protect monkeys against influenza strains that are likely to cause a global pandemic.

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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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Why AI equity is the next step for transformational pharma

pharmaphorum

AI can be transformative for all areas of healthcare, but often these systems are built off biased datasets that don’t reflect the true diversity of the general public – leading to approaches that only work for specific populations. Intouch Group’s Abid Rahman explains this concept of AI equity and gives some practical tips for how companies can work towards it.

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An unstable working life affects the future mental health of young people

Scienmag

This study evaluates the relationship between the various possible pathways at the start of working life with future absenteeism due to mental disorders in a sample of salaried workers Credit: Adapted from The Noun Project A new study reveals that a precarious, unstable initiation by young people to working life is associated with poorer future […].

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New patent for Horizon Pharma drug PROCYSBI

Drug Patent Watch

Annual Drug Patent Expirations for PROCYSBI Procysbi is a drug marketed by Horizon Pharma Usa and is included in two NDAs. There are sixteen patents protecting this drug. Drug patent…. The post New patent for Horizon Pharma drug PROCYSBI appeared first on DrugPatentWatch - Make Better Decisions.

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Protein discovery could help enable eco-friendly fungicides

Scienmag

Findings explain how plants use RNA to defend against fungal invaders Credit: Nicole Ward Gauthier/University of Kentucky New research reveals an essential step in scientists’ quest to create targeted, more eco-friendly fungicides that protect food crops. Scientists have known for decades that biological cells manufacture tiny, round structures called extracellular vesicles.

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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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US Army taps PPD to conduct PTSD treatment research

Outsourcing Pharma

The CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options.

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Newly discovered millipede, Nannaria hokie, lives at Virginia Tech

Scienmag

Credit: Virginia Tech Hearing the words “new species discovered” may conjure images of deep caves, uncharted rainforests, or hidden oases in the desert. But the reality is that thousands of new species are discovered each year by enterprising scientists all over the world. Many of these new species do come from exotic locations, but more […].

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After Outcry Over Rejected ALS Therapy, FDA Explains Itself

BioSpace

Advocates from the ALS community flooded the FDA with letters, Tweets, emails, videos and other comments expressing their anger over the rejection and the frustration that there are few therapeutics for a disease that is a delayed death sentence.

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EMA launches rolling review of Russia’s Sputnik V COVID-19 vaccine

Pharma Times

Rolling review begins based on lab and clinical studies in adults

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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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Proteomics Approach Finds Aggressive Cancer Drivers and Identifies Treatments

BioSpace

Baylor College of Medicine researchers suggest that the analysis of all protein data from aggressive human cancers could help identify novel treatment targets.

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ConserV Bio partners with eTheRNA on mRNA vaccine development

Pharma Times

Collaboration will focus on vaccines for infectious diseases

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Research Roundup: Putting a Number to COVID-19’s Transmissibility and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

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Int’l Women’s Day: Fathima Wakeel to present at Women in Data Science Conference

Scienmag

Wakeel, from Lehigh University’s College of Health, will discuss how to frame population health disparities during the COVID-19 pandemic using maternal and child health epidemiological approaches at the ‘Data Science for Social Good’ Panel Credit: Lehigh University College of Health Lehigh University College of Health faculty member, Fathima Wakeel, will present at the virtual Women […].

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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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NICE rejects rare blood cancer treatment Poteligeo in final appraisal

Pharma Times

Final appraisal document said that clinical trial evidence for Poteligeo is ‘very uncertain’

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ABclonal Uses Fresh Funds to Buy Antibody CRO

BioSpace

Boston-based ABclonal Biotechnology acquired contract research organization (CRO) Yurogen Biosystems.

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Walking pace among cancer survivors may be important for survival

Scienmag

Surveillance methods and interventions to improve cancer survivors’ walking pace should be investigated A new study led by Washington University School of Medicine in St. Louis and the National Cancer Institute (NCI) has identified an association between slow walking pace and an increased risk of death among cancer survivors. While the study does not establish […].

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Failed Studies Shut Down COVID-19 Programs

BioSpace

Apellis Pharmaceuticals terminated its investigational COVID-19 asset after study data showed the therapeutic failed to reduce mortality rate in patients compared to standard of care.

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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.