Wed.Jan 27, 2021

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Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others

Bio Pharma Dive

A large safety study found that patients given Pfizer's Xeljanz had health issues like major heart complications and cancer at a higher rate than those who got a different kind of anti-inflammation drug.

Drugs 343
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10 Essential pharma content strategy must-haves

World of DTC Marketing

SUMMARY: Pharma has not embraced a content strategy when the number of online health seekers is climbing. A content management strategy can lead to a better brand-patient relationship and turn customers into brand ambassadors. I’m not a huge believer in content strategy for CPGs. I feel that there is so much content already out there that people don’t have the time to read it all.

Branding 202
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Lilly allies with Vir, GSK as coronavirus variants raise worries about antibody drugs

Bio Pharma Dive

The emergence of new variants has made antibody drug combinations, which are harder for the virus to evade, more important and led to a unique partnership between a trio of drugmakers.

Antibody 161
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FDA Designations for Rare Disease Products, Part 1

Camargo

Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations. The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation.

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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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US to order 200M more doses of Pfizer, Moderna coronavirus vaccines

Bio Pharma Dive

As coronavirus variants spread, the White House aims to up U.S. vaccine supply by exercising purchase options in contracts with Pfizer and Moderna.

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Colorado RFP on Drug Importation Accounts for Canada’s Order Protecting Against Shortages

Pharmacy Checkers

This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule. Colorado’s proposal request is chock full of details, with many regulatory and legal issues addressed, quite ably predicting pushback from drug companies who virulently oppose impo

Drugs 125

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Setting up a virtual clinical trial: Things to consider

Cloudbyz

+1 (312)-763-8040. Follow us to get daily updates : Linkedin. Twitter. Products. Enterprise IT. Project Portfolio Management (PPM). Resource Management. Agile Portfolio Management. IT Business Management (ITBM). Healthcare & Lifesciences. Clinical Trial Management (CTMS). R&D Portfolio Management. Clinical Trial Budget Management. Study Start-up.

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Bomb scare sparks evacuation of plant making AZ COVID-19 vaccine

pharmaphorum

A plant in Wales manufacturing the AstraZeneca COVID-19 vaccine was evacuated on the advice of the authorities today after it was sent a suspicious package. Bomb disposal experts were called in to investigate the parcel at the fill and finish facility in Wrexham, operated by Wockhardt UK, which has the capacity to produce around 300 million doses of the vaccine per year.

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Researchers use car collisions with deer to study mysterious animal-population phenomena

Scienmag

Credit: U.S. Fish and Wildlife Service LAWRENCE — For at least a century, ecologists have wondered at the tendency for populations of different species to cycle up and down in steady, rhythmic patterns. “These cycles can be really exaggerated — really huge booms and huge busts — and quite regular,” said Daniel Reuman, professor of […].

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PMN WEBINAR: Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience

Pharma Marketing Network

2020 was a year defined by unexpected challenges – and related opportunity – for pharmaceutical marketers. Some Key Discussion Topics Include: What have we learned about how to create connection within this new paradigm? Which recent innovations are poised to become the best practices that will create measurable impact in 2021? Tune in to listen to the Pharma Marketing Network and leading experts from GSK, Otsuka & Bayer as we navigate these trends and discuss what you need to know to

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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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Putting bugs on the menu, safely

Scienmag

The thought of eating insects is stomach turning for many, but new Edith Cowan University (ECU) research is shedding light on allergy causing proteins which could pose serious health risks for those suffering from shellfish allergy Credit: Edith Cowan University The thought of eating insects is stomach turning for many, but new Edith Cowan University […].

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NICE recommends Revlimid for newly diagnosed multiple myeloma patients

Pharma Times

Cost-effectiveness agency initially turned down the drug in this setting

Drugs 131
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New NCAR-Wyoming supercomputer to accelerate scientific discovery

Scienmag

New system will advance nation’s understanding of geosciences Credit: Image by Matthias Rempel, ©University Corporation for Atmospheric Research The National Center for Atmospheric Research (NCAR) announced today that it has selected its next supercomputer for advancing the Earth system sciences, following a competitive open procurement process.

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NeuraMetrix joins with bioaccess to market brain health tool in Latin America

pharmaphorum

San Francisco’s NeuraMetrix has joined with US contract research organisation (CRO) bioaccess to research and market a brain health monitoring tool based on typing cadence in Latin America. This latest announcement builds on a partnership announced in summer 2019 with N-Strategy Consulting Services to expand the test in the Asia-Pacific region. NeuraMetrix said will work with Orlando-based bioaccess to research and market the tool in Latin America, where the CRO already has a presence. bioaccess

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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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Using wearable tech to keep babies, pregnant women healthy

Scienmag

Credit: Brian Persinger/West Virginia University If a weightlifter is pregnant, she may get conflicting medical advice about how much she can safely lift at the gym. One doctor might say she shouldn’t exceed 90 pounds. Another might draw the line at 25. Still another might suggest that she suspend her workouts entirely. Doctors’ opinions vary […].

Doctors 96
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Keytruda scores new EU approval in colorectal cancer

Pharma Times

First checkpoint inhibitor to be approved in the EU to treat MSI-H or dMMR colorectal cancer

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Global analysis suggests COVID-19 is seasonal

Scienmag

Credit: L. Brian Stauffer, University of Illinois URBANA, Ill. – With cities around the globe locking down yet again amid soaring COVID-19 numbers, could seasonality be partially to blame? New research from the University of Illinois says yes. In a paper published in Evolutionary Bioinformatics, Illinois researchers show COVID-19 cases and mortality rates, among other […].

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Sanofi steps in to boost supplies of Pfizer/BioNTech’s COVID shot

pharmaphorum

Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The French pharma will use its production infrastructure to boost supplies of the vaccine and perform late-stage manufacturing to supply over 125 million doses to the EU. In a statement Sanofi said that the production capacity will be at its Frankfurt plant.

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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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In Brazil, many smaller dams disrupt fish more than large hydropower projects

Scienmag

Credit: Victor Baptista The development of small hydropower dams is widespread throughout Brazil and elsewhere in the world, vastly overshadowing large hydropower projects. The proliferation of these smaller dams is a response to growing energy and security needs. Their expansion, however, threatens many of the remaining free-flowing rivers and biodiverse tropical regions of the world […].

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Boosting supply: Sanofi to support BioNTech/Pfizer on COVID-19 vaccine production

BioPharma Reporter

French company, Sanofi, says it will the support manufacturing and supply of BioNTechâs COVID-19 vaccine, which is being co-developed with Pfizer, in a pledge to increase vaccine accessibility.

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Scientists publish a blueprint to apply artificial intelligence to extend human longevity

Scienmag

The international team of artificial intelligence experts and medical doctors propose a framework for the application of next-generation AI to extend human longevity Credit: Deep Longevity Limited 27th of January, Wednesday, Hong Kong – Deep Longevity, a fully-owned subsidiary of Regent Pacific (HKEX: 0575), specializing in the development and the application of next-generation artificial intelligence […].

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Vaccine Shortages Hit E.U. in a Setback for Its Immunization Race

NY Times

Spain has suspended vaccinations in Madrid because of a shortfall of doses, as the European Union locks horns with the drugmaker AstraZeneca over vaccine delivery cuts.

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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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Carbon-chomping soil bacteria may pose hidden climate risk

Scienmag

Credit: Judy Q. Yang Much of the earth’s carbon is trapped in soil, and scientists have assumed that potential climate-warming compounds would safely stay there for centuries. But new research from Princeton University shows that carbon molecules can potentially escape the soil much faster than previously thought. The findings suggest a key role for some […].

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New NHS Medtech Funding Mandate welcomed by BIVDA

Pharma Times

System will allow ‘in vitro diagnostics devices a faster and easier route to market’

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Mira’s last journey: Exploring the dark universe

Scienmag

Credit: (Image by Argonne National Laboratory.) A massive simulation of the cosmos and a nod to the next generation of computing A team of physicists and computer scientists from the U.S. Department of Energy’s (DOE) Argonne National Laboratory performed one of the five largest cosmological simulations ever. Data from the simulation will inform sky maps […].

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Regeneron and Lilly post new data backing COVID antibody cocktails

pharmaphorum

Regeneron is considering an emergency filing for its antibody cocktail REGEN-COV to protect people against COVID-19 after early trial results showed it conferred 100% protection against symptomatic infection. The announcement came after Eli Lilly posted results from its rival antibody cocktail, showing hospitalisations were reduced by 70% in high-risk patients.

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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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Pitt researcher receives ARPA-E grant to ‘innervate’ pipelines

Scienmag

Credit: Paul Ohodnicki When you stub your toe, a chain of nerves sends a signal from your toe to your brain–ouch!–to let you know that there might be damage. The human body is great at monitoring its own condition. Why not apply that same system to critical infrastructure that requires nonstop monitoring? Research led by […].

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Research finds decrease in radiotherapy treatments due to COVID-19

Pharma Times

Study also discovered a rapid change in practise for breast cancer treatments

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Ultra-absorptive nanofiber swabs could improve SARS-CoV-2 test sensitivity

Scienmag

Credit: Adapted from Nano Letters 2021, DOI: 10.1021/acs.nanolett.0c04956 Rapid, sensitive diagnosis of COVID-19 is essential for early treatment, contact tracing and reducing viral spread. However, some people infected with SARS-CoV-2 receive false-negative test results, which might put their and others’ health at risk. Now, researchers reporting in ACS’ Nano Letters have developed ultra-absorptive nanofiber swabs […].

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Why CRC's Should Be Available For Monitoring Visits

ECRG Media's Clinical Research Podcast

Why CRC's should be available during Monitoring Visits Don't forget to Subscribe for new content! Check Out Our Merch: [link] Subscribe: [link] Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Educat

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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.