Thu.Dec 31, 2020

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Top 2020 Biopharma Scandals and Outrages

BioSpace

Over the course of 2020, the biopharmaceutical industry came together to rapidly address the global COVID-19 crisis. Despite that spirit of comradery and partnership, there were still a few incidents that caused some arched eyebrows, gasps of astonishment and even fits of anger.

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Desalination breakthrough could lead to cheaper water filtration

Scienmag

Credit: The University of Texas at Austin, Penn State Producing clean water at a lower cost could be on the horizon after researchers from The University of Texas at Austin and Penn State solved a complex problem that has baffled scientists for decades, until now. Desalination membranes remove salt and other chemicals from water, a […].

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Vibegron (Gemtesa) – a new drug for overactive bladder

Druggist

Vibegron (brand name: Gemtesa) is the latest drug used to treat overactive bladder that has been approved by the FDA in the USA. Gemtesa will be available in the US as prescription-only medication from April 2021. In this post, I will summarise: . Licensed use and legal status of vibegron (US). It’s a mechanism of action . The effectiveness of vibegron: summary of clinical trial . vibegron vs mirabegron: what is the difference?

Drugs 59
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Research Roundup: Different Antibody Responses to COVID-19 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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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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Clinical Research Coordinator Interview Questions

ECRG Media's Clinical Research Podcast

Clinical Research Coordinator Interview Questions 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] Clinical Rese

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Aravive Announces Board Member Transition to Advisory Role

The Pharma Data

HOUSTON, Dec. 31, 2020 (GLOBE NEWSWIRE) — Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced that Dr. Ray Tabibiazar will be stepping down from the Aravive Board of Directors but will remain an advisor to the company, effective December 31, 2020. This transition will allow Dr.

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BioSpace Movers & Shakers, Jan. 1

The Pharma Data

ImmunityBio – Fabio M. Benedetti was named chief strategy officer of California-based ImmunityBio. Benedetti will oversee life-cycle management, pipeline and commercial strategy, including medical affairs. Following the completion of ImmunityBio’s proposed merger with NantKwest, Benedetti is expected to assume the role of chief strategy officer of the combined company.

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Two University of Tennessee leaders honored by Association of Public and Land-grant Universities

Scienmag

UTIA’s Neal Schrick and Hongwei Xin recognized as FSLI Fellows Credit: Image provided by FSLI. KNOXVILLE, Tenn. — Two leaders from within the University of Tennessee Institute of Agriculture were recently honored by the Association of Public and Land-grant Universities. Neal Schrick, head of the Department of Animal Science and interim head of the Department […].

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When Popping Champagne at New Years’, Watch Out for That Cork

The Pharma Data

News. Consumer News. When Popping Champagne at New Years’, Watch Out for That Cork. THURSDAY, Dec. 31, 2020 — As 2020 comes to a close, many people plan to ring in the new year with a bit of bubbly. But that can lead to calamity when not done safely, warns the American Academy of Ophthalmology (AAO), which offers tips for keeping a Champagne toast from going wrong.

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Researchers measure, model desalination membranes to maximize flow, clean more water

Scienmag

Credit: Image by the Ganapathysubramanian research group/Iowa State University and Gregory Foss/Texas Advanced Computing Center. AMES, Iowa – Nature has figured out how to make great membranes. Biological membranes let the right stuff into cells while keeping the wrong stuff out. And, as researchers noted in a paper just published by the journal Science, they […].

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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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Vaping May Addle the Adolescent Brain

The Pharma Data

THURSDAY, Dec. 31, 2020 — Teenagers who use e-cigarettes may be at increased risk of “mental fog,” a new study suggests. The study, of thousands of U.S. teens, found that those who vaped were three times more likely than their peers to report problems with concentration, memory and decision-making. The findings mirror those of a recent study of adults by the same research team: Men and women who used e-cigarettes had more complaints about their memory and thinking skills than n

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Stretching diamond for next-generation microelectronics

Scienmag

Credit: Dang Chaoqun / City University of Hong Kong Diamond is the hardest material in nature. But out of many expectations, it also has great potential as an excellent electronic material. A joint research team led by City University of Hong Kong (CityU) has demonstrated for the first time the large, uniform tensile elastic straining […].

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Precautions Even More Important With New Coronavirus Variant: Experts

The Pharma Data

THURSDAY, Dec. 31, 2020 — A new and more infectious variant of the COVID-19 virus has shown up in separate cases in Colorado and California, weeks after it first emerged in the United Kingdom. Doctors on the pandemic’s front line say people shouldn’t panic, but should definitely adhere even more closely to proven infection control measures, like mask wearing and social distancing. “While the new strain is more transmissible — up to 70% by a recent analysis — t

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Bionic idea boosts lithium-ion extraction

Scienmag

Credit: XIN Weiwen Lithium is an energy-critical element that is considered to be a geopolitically significant resource. However, the supply of lithium may not be enough to meet continuously increasing demand. As a result, scientists are looking for new ways to extract lithium ions. Ion selective membranes have already been used extensively for water treatment […].

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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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COVID-19 Immunity Might Last at Least 8 Months: Study

The Pharma Data

THURSDAY, Dec. 31, 2020 — Folks who contract COVID-19 can expect to gain some durable immunity against future infection, according to a new study of memory cells within the immune systems of coronavirus patients. Previous studies have raised concern that COVID-19 patients might lose their immunity quickly once they recover, because the first wave of coronavirus antibodies tends to wane after the first few months.

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Study: in social media safety messages, the pictures should match the words

Scienmag

Effective posts led to better understanding among new parents Credit: The Ohio State University COLUMBUS, Ohio — When using social media to nudge people toward safe and healthy behaviors, it’s critical to make sure the words match the pictures, according to a new study. After looking at social media posts, parents of young children were […].

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WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access

The Pharma Data

The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago. The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.

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Scientists find the error source of a sea-ice model varies with the season

Scienmag

Credit: Yue Sun Arctic sea ice has been rapidly declining in recent decades, and changes in arctic sea ice can have a significant impact on global weather and climate through interactions with the atmosphere and oceans. In addition, the Arctic shipping routes are a shortcut to connect the major countries in the Northern Hemisphere. The […].

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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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Scans Reveal How COVID-19 Can Harm the Brain

The Pharma Data

THURSDAY, Dec. 31, 2020 — Blood vessel damage and inflammation in the brains of deceased COVID-19 patients suggest the damage is not caused by the virus, but the body’s immune response to it. Researchers from the U.S. National Institutes of Health (NIH) consistently found signs of damage caused by thinning and leaky brain blood vessels in tissue samples from patients who died shortly after getting COVID-19.

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AstraZeneca/Oxford’s COVID-19 Vaccine Receives Authorization for Emergency Use in the UK

XTalks

AstraZeneca and The University of Oxford’s jointly developed COVID-19 vaccine has received authorization for emergency supply in the UK. Vaccinations will begin early in the new year according to officials. The UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized the vaccine (known formerly as AZD1222) for emergency supply for the immunization of individuals 18 years or older.

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Health Highlights: Dec. 31, 2020

The Pharma Data

Below are newsworthy items compiled by HealthDay staff: Pet Food Recalled for Deadly Levels of Aflatoxin: FDA. The U.S. Food and Drug Administration is recalling Sportmix pet food products made by Midwestern Pet Foods, Inc. that may contain fatal levels of aflatoxin. “Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal.

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Improving cancer immunotherapy; Senseonics’ Eversense delayed; FDA acknowledges Alkermes’ Resubmission; 3D breast ultrasound improves diagnosis

Delveinsight

Improving cancer immunotherapy by recovering a warning system. Cancer cells, most of the time, develop tactics to elude the immune system. A research team that is led by scientists at Memorial Sloan Kettering Cancer Center has recognized one such mechanism, and it believes aiming it with drugs could potentially enhance responses to immuno-oncology treatments.

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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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Even Rich Americans Don’t Get World-Class Health Care: Study

The Pharma Data

THURSDAY, Dec. 31, 2020 — Even the most privileged people in the United States with the best access to health care are sicker and more likely to die than average folks in other developed nations, a new study finds. People living in the highest-income counties in the United States are, on average, more likely to die from a heart attack or cancer, during childbirth, or to lose an infant than people in 12 other industrialized countries, according to findings published online Dec. 28 in JAMA I

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PureK Holdings Corp. to Acquire No B.S. Skincare, a Clean Ingredient Skincare Company

BioTech 365

PureK Holdings Corp. to Acquire No B.S. Skincare, a Clean Ingredient Skincare Company PureK Holdings Corp. to Acquire No B.S. Skincare, a Clean Ingredient Skincare Company No B.S.

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Biom Therapeutics Files Orphan Drug Designation For BIO017 With The FDA

The Pharma Data

With our compelling preclinical data, BIO017 will treat Angelman Syndrome patients because they have a huge unmet medical need,” said Bobban Subhadra, CEO at Biom Therapeutics. SARASOTA, FL, December 31, 2020 /24-7PressRelease/ — Biom Therapeutics announced today that it has applied for an orphan drug designation for its lead drug candidate, BIO017.

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Calithera Biosciences Announces New Employment Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

BioTech 365

Calithera Biosciences Announces New Employment Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) Calithera Biosciences Announces New Employment Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) SOUTH SAN FRANCISCO, Calif., Dec. 31, 2020 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc.

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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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New proposal for how aerosols drive increased atmospheric convection in thunderstorm clouds

Scienmag

High in the clouds, atmospheric aerosols, including anthropogenic air pollutants, increase updraft speeds in storm clouds by making the surrounding air more humid, a new study finds. The results offer a new mechanism explaining the widely observed – but poorly understood – atmospheric phenomenon and provide a physical basis for predicting increasing thunderstorm intensity, particularly […].

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Jeff Yauck Announces Filing of Early Warning Report Related to Disposition of Common Shares of PureK Holdings Corp.

BioTech 365

Jeff Yauck Announces Filing of Early Warning Report Related to Disposition of Common Shares of PureK Holdings Corp. Jeff Yauck Announces Filing of Early Warning Report Related to Disposition of Common Shares of PureK Holdings Corp. VANCOUVER, British Columbia, Dec.

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BioSpace Movers & Shakers, Jan. 1

BioSpace

Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.

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Aravive Announces Board Member Transition to Advisory Role

BioTech 365

Aravive Announces Board Member Transition to Advisory Role Aravive Announces Board Member Transition to Advisory Role HOUSTON, Dec. 31, 2020 (GLOBE NEWSWIRE) — Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced that Dr.

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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.