Thu.Oct 29, 2020

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Novartis eyes its next move in gene therapy

Bio Pharma Dive

Acquiring Vedere Bio, an Atlas Venture-backed startup, gives Novartis a technology it believes will be valuable for developing treatments for many causes of vision loss and blindness.

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Unfair balance

World of DTC Marketing

WHAT’S UP? : It’s time to admit that the FDA is completely out of touch regarding DTC advertising. Fair balance is not being read in ads or listened to on TV, and the language used in fair balance is too often complicated for online health seekers. I just finished an analysis of a pharma clients website using their analytics. Rather than just report the numbers my report “tells a story” that managers can use to justify changes to the product website.

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Gilead lifted by fast sales of COVID-19 drug Veklury. Will they last?

Bio Pharma Dive

Veklury, which was fully approved by the FDA last week, earned Gilead nearly $900 million in the third quarter, although U.S. sales seem likely to slow in the months ahead.

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Regeneron Halts Enrollment of Critically Ill Patients in COVID-19 Antibody Trial

BioSpace

The decision to halt critically ill patients was made in response to Regeneron’s independent safety board finding a potential safety signal and an unfavorable risk-benefit profile of the monoclonal antibody therapy in a subgroup of patients requiring high-flow oxygen or mechanical ventilation.

Antibody 131
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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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Fungal species naturally suppresses cyst nematodes responsible for major sugar beet losses

Scienmag

Credit: James Borneman The plant pathogenic nematode Heterodera schachtii infects more than 200 different plants, including sugar beets, and causes significant economic losses. Over the past 50 years, the primary management tool in California has been crop rotation. When the number of H. schachtii in a soil exceeds a threshold, growers are contractually required by […].

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Election Implications for the U.S. and Global COVID-19 Response

BioSpace

The U.S. – and global – response to the COVID-19 pandemic has been volatile at best. This is fair, considering that SARS-CoV-2 is a novel virus with a lethality we haven’t seen in more than a century.

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Novo Nordisk Ends Development of NN9828, Shifts Focus to Pandemic Initiatives

BioSpace

Novo Nordisk announced today that it has ended its development of the anti-IL-21 antibody NN9828 in combination with Victoza. The decision was made after analyzing Phase II clinical trial data in patients with Type 1 diabetes.

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Researcher making drones smarter, situationally aware and team-oriented

Scienmag

NSF-funded project to enable UAVs to monitor themselves and each other, taking into account different scenarios Credit: Courtesy Northern Arizona University Recent advances in artificial intelligence (AI) have opened the door for an unprecedented number of uses for unmanned autonomous vehicles (UAVs). Groups of drones now can work together in networks for purposes such as […].

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COVID-19 Vaccine Race Leaders Strive for Balance Between Safety and Urgency

BioSpace

There is an impressive amount of technological ingenuity – mRNA, monoclonal antibodies and more traditional formats – being thrown at the development of a vaccine against COVID-19.

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Archaeologists reveal human resilience in the face of climate change in ancient Turkey

Scienmag

New study fills gaps in chronological timelines of Bronze and Iron Age societies Credit: Brita Lorentzen TORONTO, ON – An examination of two documented periods of climate change in the greater Middle East, between approximately 4,500 and 3,000 years ago, reveals local evidence of resilience and even of a flourishing ancient society despite the changes […].

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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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AbCellera Enters Pact with Kodiak Sciences to Develop Eye Disease Antibodies

BioSpace

AbCellera and Kodiak Sciences have announced a new partnership to create and develop therapeutic antibodies for ophthalmologic indications. The two companies originally entered a partnership in August 2016.

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Industry impact: Wojciech Misiolek honored for materials processing advances

Scienmag

Lehigh University materials science and engineering chair, a leading expert in aluminum metal forming, wins ASM International’s prestigious William Hunt Eisenmann Award for 2020 Credit: Lehigh University Wojciech Z. Misiolek, Loewy Professor and Chair of the Department of Materials Science and Engineering in Lehigh University’s P.C. Rossin College of Engineering and Applied Science, has received […].

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Beleaguered Bellicum Slashes 79% of Workforce in Restructuring

BioSpace

Thursday afternoon, Bellicum announced it will pause the development of its BCMA GoCAR-NK program and will also discontinue discovery research and new product development.

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Autoantibody order, timing predict genetically at-risk children most likely to get T1D

Scienmag

USF Health-led TEDDY analysis focuses on development of multiple distinct autoantibodies targeting insulin-producing cells, from initial autoimmunity to symptomatic type 1 diabetes Credit: Courtesy of USF Health TAMPA, Fla. — Children with multiple islet autoantibodies – biological markers of autoimmunity — are more likely to progress to symptomatic type 1 diabetes (T1D) than those who […].

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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 is 6-Fold More Prevalent than Reported Incidents, German Study Says

BioSpace

A seroprevalance study of 15,591 children in Bavaria, published October 28th in Med, revealed a six-fold greater prevalence of the SARS-CoV-2 virus than reported cases.

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COVID-19 testing will remain key even as vaccines enter into the fray, says Cytiva as it invests in diagnostic inventory and service labs

BioPharma Reporter

A lot of new companies have been entering the diagnostics field this year to address the challenges of the COVID-19 pandemic. Cytiva, as a diagnostic component provider, has been investing in new and existing sites and services to support that surge in capacity.

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Regeneron’s REGN-COV2 Cocktail Meets Clinical Endpoints in Phase II/III Trial

BioSpace

The positive findings were shared as part of the company’s Emergency Use Authorization submission for its investigational COVID-19 therapy.

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Salt wars: The battle over the biggest killer in the American diet by Michael F. Jacobson

Scienmag

Available now from The MIT Press Credit: The MIT Press A high-sodium diet is deadly; studies have linked it to high blood pressure, strokes, and heart attacks. It’s been estimated that excess sodium in the American diet causes as many as 100,000 deaths and many billions of dollars in avoidable health-care costs each year. And […].

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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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Stirling going the extra mile to ensure cold-storage capacity for final leg in COVID-19 vaccine distribution

BioPharma Reporter

To support COVID-19 global preparedness, Stirling Ultracold is engaging directly with several pharmaceutical companies currently involved in COVID-19 vaccine development, with the idea of building a fleet of ULT freezers capable of storing their approved vaccines, once available.

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Two-hour sepsis test in development at Penn State and Stanford University

Scienmag

A National Institutes of Health grant will fund a precise and quick test to help treat one of the largest causes of death due to infection in the United States Credit: Pak Kin Wong, Penn State One in three people who die in U.S. hospitals have sepsis, the body’s extreme response to infection that can […].

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Fauci Predicts First COVID-19 Vaccine by Late December for High-Risk Americans

BioSpace

Fauci said the first COVID-19 vaccines could ship late December or early January.

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Study reveals impact of COVID-19 on oncology staff and their work

Scienmag

The results of a survey of 1038 doctors, nurses, pharmacists, administrators and allied health professionals (such dieticians and physiotherapists) working in oncology in the UK National Health Service (NHS) during the spring wave of COVID-19 will be presented at the NCRI Virtual Showcase. The results of the COVID-NOW study show that 69% of oncology staff […].

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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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Sleepless Nights, Hair Loss and Cracked Teeth: Pandemic Stress Takes Its Toll

Triage Cancer

by Aneri Pattani, Kaiser Family Foundation. In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache. “The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island. She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through — a constant drumbea

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Study finds 5 distinct dog types from 11,000 years ago

Scienmag

Texas A&M Professor Anna Linderholm and a team of researchers examined dog DNA to learn about movement and patterns of ancient dogs and their relationship with humans An international team of researchers that includes a Texas A&M University professor has studied the lineage of dogs and found that there were at least five different types […].

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Novartis acquires Vedere Bio: ‘This enhances our position as an AAV-based gene therapy powerhouse'

BioPharma Reporter

Novartis has acquired Vedere Bio, giving the company a new platform for AAV-based delivery of gene therapies and an optogenetics program for the treatment and prevention of vision loss and blindness.

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Lung scans for stroke patients could provide earlier COVID-19 detection

Scienmag

Stroke Journal Report Embargoed until 4 a.m. CT/5 a.m. ET Thursday, Oct. 29, 2020 DALLAS, Oct. 29, 2020 — Computed tomography angiogram (CTA) scans may offer fast and early detection of COVID-19 in acute ischemic stroke (AIS) patients, according to new research published today in Stroke, a journal of the American Stroke Association, a division […].

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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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Q32 Stays Busy with $60 Million Series B and First Dose in Phase I Trial

BioSpace

Q32 Bio rakes in $60 million Series B as they dose their first patient in IL-7R antibody trial.

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New research shows SARS-CoV-2 spike proteins disrupt the blood-brain barrier

Scienmag

First study to show SARS-CoV-2 spike proteins disrupt the blood-brain barrier, potentially raising risk of neurological damage in COVID-19 patients Credit: Lewis Katz School of Medicine at Temple University (Philadelphia, PA) – Like a key, SARS-CoV-2 – the virus that causes coronavirus disease 2019 (COVID-19) – attaches to specific molecules on the host cell surface, […].

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Gilead’s Covid-19 Drug is Mediocre. It Will Be a Blockbuster Anyway.

NY Times

Gilead Sciences said Wednesday that remdesivir, which has been authorized for emergency use since the spring, brought in $873 million in revenues so far this year.

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Study reveals robust performance in aged detonator explosive

Scienmag

PETN explosive is used extensively in commercial detonators and in the nuclear stockpile Credit: Los Alamos National Laboratory LOS ALAMOS, N.M., October 28, 2020 — In a large, statistically significant, one-of-a-kind study, researchers at Los Alamos National Laboratory have confirmed that the explosive called PETN (Pentaerythritol tetranitrate), stabilized with a polysaccharide coating, is resistant to […].

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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.