Fri.Dec 11, 2020

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Viatris to lay off staff, shutter plants in major restructuring

Bio Pharma Dive

The company created by a merger of Mylan and Pfizer's Upjohn unit is dramatically cutting costs, shedding jobs and closing or divesting up to 15 plants worldwide.

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Consumers fall into three COVID-19 vaccine adoption segments

World of DTC Marketing

(Mckinsey) Much of the prevailing market research on COVID-19 vaccination frames sentiment as “likely,” “unlikely,” or “neutral.” McKinsey’s research is designed to uncover a more granular continuum of sentiments and to account for the fact that many consumers may take a “wait and see” approach to their decision about vaccination. Their research has found that consumers’ attitudes towards receiving a COVID-19 vaccine fall into three primary segments.

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In milestone, FDA clears coronavirus vaccine from Pfizer, BioNTech for emergency use

Bio Pharma Dive

Vaccinations are expected to begin within days of the historic decision, which follows early approvals in the U.K., Canada and Mexico.

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Pfizer's Covid Vaccine and Allergies: How Concerned Should You Be?

NY Times

British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who have allergies to food or bee stings.

Allergies 140
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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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Sanofi, GSK coronavirus vaccine delayed after early study results disappoint

Bio Pharma Dive

The experimental shot produced a weak immune response in adults over 49, leading the partner drugmakers to change plans and push back their development timelines.

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COVID-19 vaccine development: Setback for Sanofi and GSK candidate, University of Queensland and CSL abandon trial

BioPharma Reporter

Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.

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Does a lack of diversity in clinical trials reflect a lack of diversity among researchers?

pharmaphorum

Embedding diversity into clinical research does not start and end at trial recruitment – the community needs processes and institutions that reflect society and provide representation. Greater representation among study designers, research teams, and funding committees would lead to greater diversity among research participants and help to tackle health inequalities.

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Intouch’s Antonio Rivera Discusses Inclusion & Diversity With PharmaLive

Intouch Solutions

Intouch's associate director of inclusion and diversity recently spoke with the folks at PharmaLive about our efforts and the difference they're making in employees' work lives. The post Intouch’s Antonio Rivera Discusses Inclusion & Diversity With PharmaLive appeared first on Intouch Solutions.

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Oregon researchers find that like adults, children by age 3 prefer seeing fractal patterns

Scienmag

Study concludes that preference for common natural patterns may develop early in life Credit: Photo by Richard Taylor EUGENE, Ore. — Dec. 11, 2020 — By the time children are 3 years old they already have an adult-like preference for visual fractal patterns commonly seen in nature, according to University of Oregon researchers. That discovery […].

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Alunbrig scores NICE backing for ALK-positive lung cancer

Pharma Times

ALK inhibitor recommended in the first-line non-small cell lung cancer setting

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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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Gut microbiota plays a role in brain function and mood regulation

Scienmag

Credit: (c) Institut Pasteur / Pascal Marseaud Depression is a mental disorder that affects more than 264 million people of all ages worldwide. Understanding its mechanisms is vital for the development of effective therapeutic strategies. Scientists from the Institut Pasteur, Inserm and the CNRS recently conducted a study showing that an imbalance in the gut […].

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Sanofi, GSK face COVID-19 vaccine trial delay

Pharma Times

Potential availability of vaccine now delayed to the end of 2021

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Researchers rank various mask protection, modifications against COVID-19

Scienmag

Scientists tested consumer-grade masks and improvised face coverings to show how effective they can be at protecting individuals from airborne particles of similar size to those carrying SARS-CoV-2, the virus that causes COVID-19 Credit: UNC School of Medicine CHAPEL HILL, NC – It’s been shown that when two people wearing masks interact, the chance of […].

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Biogen Conference May Have Spread Virus to 300,000

NY Times

A February conference by the drug company Biogen was initially thought to have infected 99 people. By the end of October, it was feared that the number had grown as high as 300,000.

Drugs 83
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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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WVU, DHHR establish new COVID-19 testing laboratory in Morgantown

Scienmag

Credit: Dana Gray/WVU To address the challenges of COVID-19 testing shortages and lagging turnaround times, West Virginia University and the West Virginia Department of Health and Human Resources have teamed up to create a new testing laboratory at the Health Sciences Center thanks to funding made possible by Gov. Jim Justice. “I cannot thank Gov. […].

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Albireo submits rare liver disease med odevixibat to FDA and EMA

Pharma Times

If approved, drug will become first treatment for PFIC patients in the US and EU

Drugs 96
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OHSU physician honored for co-invention of eye-imaging technology

Scienmag

David Huang, M.D., Ph.D., recognized by Sanford and Susan Greenberg Prize to End Blindness Credit: OHSU/John Valls An ophthalmologist and researcher at Oregon Health & Science University Casey Eye Institute is being honored for co-inventing an eye imaging technology that is widely used to diagnose and guide treatment for people with the leading causes of […].

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CRUK researchers develop new early-stage rectal cancer treatment

Pharma Times

New treatment could prevent debilitating side effects of standard major surgery

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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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The pressure sensor of the venus flytrap

Scienmag

Credit: (Picture: Ines Kreuzer, Soenke Scherzer / University of Wuerzburg) All plant cells can be made to react by touch or injury. The carnivorous Venus flytrap (Dionaea muscipula) has highly sensitive organs for this purpose: sensory hairs that register even the weakest mechanical stimuli, amplify them and convert them into electrical signals that then spread […].

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ERT to merge with clinical imaging firm Bioclinica

pharmaphorum

ERT, a clinical services firm with expertise in digital technology is to merge with clinical imaging firm Bioclinica. The companies said that the combination will strengthen their offering to pharmaceutical and biotech companies. The transaction will integrate Bioclinica’s expertise in imaging with ERT’s expertise in electronic clinical outcome assessment, cardiac safety, respiratory and wearables.

Trials 60
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School of Education assistant professor revolutionizing the older adult wellness narrative

Scienmag

Credit: Ana M. Amoregui for iStock When a society only focuses on the physical effects of aging, it casts a wide shadow over other important aspects of growing older. Matthew Fullen is determined to shine a spotlight. The assistant professor of counselor education in the Virginia Tech School of Education earned a $100,000 grant from […].

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Sanofi/GSK trial woes delay a billion COVID-19 shots by nine months

pharmaphorum

Sanofi and GlaxoSmithKline have said their COVID-19 vaccine has hit a snag in clinical development, prompting analysts to note this could delay delivery of potentially more than a billion shots globally by up to nine months. Interim results from a phase 1/2 clinical trial show the immune response from Sanofi/GSK’s vaccine produced a lower immune response in older adults.

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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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Novel cathode design significantly improves performance of next-generation battery

Scienmag

Credit: HKUST A team led by Cheong Ying Chan Professor of Engineering and Environment Prof. ZHAO Tianshou, Chair Professor of Mechanical and Aerospace Engineering and Director of HKUST Energy Institute, has proposed a novel cathode design concept for lithium-sulfur (Li-S) battery that substantially improves the performance of this kind of promising next-generation battery.

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FDA decision on US authorization of Pfizer COVID-19 vaccine expected within days

BioPharma Reporter

The FDA is set to make a decision on Emergency Use Authorization (EUA) in the coming days for the mRNA COVID-19 vaccine candidate, BNT162b2, from drug makers, Pfizer and BioNTech.

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Fan mussel larval dispersal for the future of an endangered species

Scienmag

Science to protect an emblematic species in the Mediterranean Credit: Diego Kersting (UB-IRBio) Fan mussel populations -the biggest bivalve mussel in the Mediterranean- are endangered due to the severe parasitosis caused by the protozoan Haplospridium pinnae since 2016. Now, a study published in the journal Frontiers in Marine Science reveals the fan mussel would express […].

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How Men Should Dress For The Interview

ECRG Media's Clinical Research Podcast

How Men Should Dress For The Interview Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 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 » Education Send in a voi

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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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Potential extreme condition history detector – recoverable PL achieved in pyrochlore

Scienmag

Credit: Yongsheng Zhao Photoluminescence (PL) is light emission from a substance after the absorption of photons stimulated by temperature, electricity, pressure, or chemistry doping. An international team of scientists led by Dr. Wenge Yang from Center for High Pressure Science &Technology Advanced Research (HPSTAR) presents a strong tricolor PL achieved in non-PL pyrochlore Ho2Sn2O7 through high pressure treatment.

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How Men Should Dress For The Interview

ECRG Media's Clinical Research Podcast

How Men Should Dress For The Interview. Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 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 » Education.

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Vanderbilt researchers discover strong correlation between partisanship and social mobility during COVID-19 pandemic

Scienmag

According to many medical experts, reduced social mobility – defined here as social contact and travel within and among communities – is a necessary factor to contain the spread of COVID-19. Joshua Clinton, professor of political science at Vanderbilt University, led a team of researchers to analyze data from more than one million US adults, […].

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Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

Friday, December 11, 2020. U.S. FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. immediately. Pfizer and BioNTech previously announced an agreement with the U.S. Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. Histori

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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.