Fri.Dec 04, 2020

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Vaccine production in focus as Moderna, Pfizer await FDA decision

Bio Pharma Dive

Moncef Slaoui, a leader of Operation Warp Speed, said he expects 100 million Americans to be vaccinated by the end of February — an ambitious target even as Moderna and Pfizer ramp up manufacturing.

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Is digital the future of medicine?

World of DTC Marketing

SUMMARY: McKinsey estimates that global digital-health revenues—from telemedicine, online pharmacies, wearable devices, and so on—will rise from $350bn last year to $600bn in 2024. I’m not so sure. EHR’s have been a failure. Some 70% of American hospitals still fax and post patient records, and patients don’t have one record to share among all their doctors.

Medicine 201
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Lilly, UnitedHealth explore how to best use a COVID-19 antibody drug

Bio Pharma Dive

A new real-world study will focus on in-home testing and administration of Lilly's bamlanivimab, which was recently cleared for emergency use in certain patients infected with the coronavirus.

Antibody 141
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What Can Supplements Really Do For Health and Beauty?

Pharma Mirror

Taking a health supplement can positively impact your health and beauty if you choose the right one for your needs. According to Mayo Clinic, the benefits of supplements specifically apply to pregnant people (subject to doctor’s recommendation), over the age of 50, who have food allergies or digestive conditions or miss large food groups in their diet.

Allergies 130
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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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Is China Using CRISPR to Create Super Soldiers?

BioSpace

Has China discovered a super-soldier formula through the capabilities of genetic engineering? A U.S. government official claims this is exactly what is happening.

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Pfizer cut vaccine production targets because of raw material shortage – reports

pharmaphorum

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses. That’s enough to inoculate 25 million people as the dosing schedule involves two shots three weeks apart.

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Valneva accelerates Lyme disease vaccine R&D project with Pfizer

pharmaphorum

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age.

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Crystals may help reveal hidden Kilauea Volcano behavior

Scienmag

Credit: Image credit: USGS Scientists striving to understand how and when volcanoes might erupt face a challenge: many of the processes take place deep underground in lava tubes churning with dangerous molten Earth. Upon eruption, any subterranean markers that could have offered clues leading up to a blast are often destroyed. But by leveraging observations […].

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The urgent need for education and awareness about mitochondrial disease

pharmaphorum

Delayed diagnosis, misdiagnosis, and no cure or disease modifying treatments – children living with mitochondrial disease face all the issues often associated with rare diseases. It’s a problem that Michelle Bamber, whose two little girls both have the life-limiting condition, knows only too well. Lily was a happy, contented baby, and her parents had no cause for concern until she went for her two-year check and was put on a pathway to diagnosis.

Doctors 98
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Published Phase I Results Hint at Durability of Moderna's COVID-19 Vaccine

BioSpace

Researchers with the U.S. National Institutes of Allergy and Infectious Diseases (NIAID) published a letter in The New England Journal of Medicine describing the three-month immunogenicity levels in Moderna’s mRNA-1273 vaccine.

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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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J&J files lung cancer bispecific amivantamab for FDA approval

pharmaphorum

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease has progressed despite first-line chemotherapy.

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As Death Toll Climbs, WHO Finds No Benefit with 4 Top COVID-19 Treatments

BioSpace

The four promising treatments showed no effect on reducing mortality in ongoing Solidarity Trial.

Trials 122
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PureTech launches phase II ‘long COVID’ drug trial

Pharma Times

LYT-100 will be evaluated in patients with persistent symptoms caused by COVID-19

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Gasdermin offers insight into coral necrotic death

Scienmag

Credit: IOCAS Pyroptosis is a highly inflammatory form of programmed necrotic cell death that acts as a defense mechanism against the infection of bacterial and viral pathogens. Pyroptosis is executed by gasdermin, a family of pore-forming proteins. Gasdermin-mediated pyroptosis is characterized by rapid cell swelling, membrane disruption, and massive cytoplasmic content release.

Protein 81
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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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Pfizer & BioNTech Experience Early Vaccine Shipping and Distribution Hiccups

BioSpace

Biopharma companies who have COVID-19 vaccines in development, have astonished skeptics by the speed with which they have developed vaccines. But now comes an even more daunting challenge—scaling up manufacturing and distribution.

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Researchers adapt cell phone camera for SARS-CoV-2 detection

Scienmag

Credit: Daniel Fletcher and Melanie Ott Researchers have developed an assay that can detect the presence of SARS-CoV-2 in a nasal swab using a device attached to an ordinary smartphone, they report December 4 in the journal Cell. Although more research is needed before such a test can be rolled out, the results are promising […].

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RPS in discussions with government to improve patient access to medicines

Pharma Times

Follows joint letter calling for pharmacists to be able make minor prescription changes

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Manchester group help fine tune ‘twistronics’

Scienmag

Novel method to fine tune the angle – “twist” – between 2D materials in van der Waals heterostructures to help accelerate the next generation of electronics Credit: Artem Mishchenko/The University of Manchester A group of international researchers at The University of Manchester have revealed a novel method that could fine tune the angle – “twist” […].

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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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Advancements in Neuromodulation

Delveinsight

According to the International Neuromodulation Society, neuromodulation is “ the alteration—or modulation—of nerve activity by delivering electrical or pharmaceutical agents directly to a target area “ The neuromodulation space is witnessing one of the fastest-growing medical device markets in the healthcare industry. Several big industry players such as Abbott , Boston Scientific , and Medtronic have developed life-changing Neuromodulation devices for many indications ranging from c

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UAB startup company receives FDA clearance for liver imaging software

Scienmag

A Birmingham, Alabama, early-stage startup has been approved for low-cost, low-risk, non-invasive procedures for patients with chronic liver disease. Credit: UAB BIRMINGHAM, Ala. – AI Metrics, LLC, a medical imaging startup focused on leveraging artificial intelligence to improve patient care, has received United States Food and Drug Administration 510(k) clearance and CE mark clearance for […].

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Research Roundup: New Abnormal Tau Protein IDed in Alzheimer’s Disease and More

BioSpace

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

Protein 70
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Research reveals how airflow inside a car may affect COVID-19 transmission risk

Scienmag

Credit: Breuer lab / Brown University PROVIDENCE, R.I. [Brown University] — A new study of airflow patterns inside a car’s passenger cabin offers some suggestions for potentially reducing the risk of COVID-19 transmission while sharing rides with others. The study, by a team of Brown University researchers, used computer models to simulate the airflow inside […].

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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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Is This a Good Entry Level Job Into Clinical Research?

ECRG Media's Clinical Research Podcast

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 voice message: [link] Don't forget to Subs

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Iron deficiency can be managed better

Scienmag

Credit: WEHI, Australia Australian and European researchers have released updated, evidence-based guidance for managing iron deficiency, a serious worldwide health problem. Iron deficiency is a major cause of anaemia, a lack of oxygen-carrying red blood cells or haemoglobin, which is experienced by two billion people worldwide – including almost one in 20 Australian adults.

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Is This a Good Entry Level Job Into Clinical Research?

ECRG Media's Clinical Research Podcast

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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Electrical spin filtering the key to ultra-fast, energy-efficient spintronics

Scienmag

Electrical spin filtering avoids energy-costs of magnetic field Credit: FLEET Spin-filtering could be the key to faster, more energy-efficient switching in future spintronic technology, allowing the detection of spin by electrical rather than magnetic means. A UNSW paper published last month demonstrates spin detection using a spin filter to separate spin orientation according to their […].

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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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Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for Use with Home-Collected Samples

The Pharma Data

. SILVER SPRING, Md. , Dec. 4, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration (FDA) authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19

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Green energy transition: Early and steady wins the race

Scienmag

Researchers from Aarhus University have modelled the decarbonisation of the sector-coupled European energy system using very high-resolution data. The results are clear: To reach climate-neutrality by 2050 we need solar energy; and lots of it Credit: Ida Jensen, AU Photo Researchers from Aarhus University have modelled the decarbonisation of the sector-coupled European energy system using […].

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Impact of Medicaid Expansion on Diabetes Outcomes Limited

The Pharma Data

News. Professional. Impact of Medicaid Expansion on Diabetes Outcomes Limited. FRIDAY, Dec. 4, 2020 — Medicaid expansion alone has not been enough to improve outcomes for patients with diabetes , according to a study published online Nov. 11 in the American Journal of Preventive Medicine. Lily D. Yan, M.D., from the Boston Medical Center, and colleagues used data from the Behavioral Risk Factor Surveillance System (2008 to 2018) to assess the impact of Medicaid expansion on linkage to care

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No strings attached: maximizing wireless charging efficiency with multiple transmitters

Scienmag

New control strategy dynamically changes transmitter currents for optimal wireless charging in moving devices, such as robots and electric cars Credit: Unsplash Wireless power transfer has proven to be quite useful in electronic devices such as medical implants and smartphones. In most cases, this is done by aligning or “coupling” two separate coils of wire […].

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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.