Wed.Sep 29, 2021

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After long wait, Editas reveals first data for CRISPR gene editing treatment

Bio Pharma Dive

Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions.

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Bayer teams up with Huma to apply AI to lung cancer diagnosis

pharmaphorum

A research project between Bayer and digital health company Huma will use artificial intelligence to detect lung cancer in CT scans – and determine which type a patient has, in order to direct treatment. AI is already being applied by a number of groups, with some studies indicating it can even be more effective than trained radiologists in detecting subtle patterns that indicate the presence of tumours.

Genome 133
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Amicus, looking for a boost, sells its gene therapy work to a SPAC

Bio Pharma Dive

The value of the biotech's growing gene therapy portfolio has been "unrecognized" by investors, said CEO John Crowley, leading to a sudden shift for an initiative that began just three years ago.

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How Has COVID-19 Changed the Way We Work in the Life Sciences?

XTalks

The world as we know it has changed because of the COVID-19 pandemic. We’ve adopted and embraced new technologies at a much faster pace in order to conform to these changes. Simple examples include the increased popularity of food delivery apps and at-home meal kits, but in the larger picture, the nature of working has changed entirely for many companies and people.

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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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AstraZeneca to buy rare disease drugmaker Caelum in small deal

Bio Pharma Dive

The British pharma inherited an option to acquire Caelum Biosciences when it bought Alexion last year. Caelum could receive as much as $500 million as a result of the planned buyout.

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Top email calamities to avoid … and how to make an impact instead

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. In this column he addresses the appropriate use of email and how to avoid nightmares in electronic communication. “My fiancée had bought me a string tanga birthday present.

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Key Takeaways from the Second Annual International Day of Awareness of Food Loss and Waste

XTalks

On December 19, 2019, the United Nations (UN) General Assembly designated September 29 as the International Day of Awareness of Food Loss and Waste (IDAFLW). Jointly led by the UN Food and Agriculture Organization (FAO) and UN Environment Programme (UNEP), the goal of the day, as its name suggests, is to raise awareness to the importance of food loss and waste and its possible solutions at all levels.

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Editas Sees Light in First Data from In Vivo CRISPR Eye Therapy

BioSpace

EDIT-101 targets a disease-causing mutation in the CEP290 gene that causes degeneration in ocular photoreceptor cells, which are critical for normal vision.

In-Vivo 106
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GSK’s ViiV Healthcare agrees new deal with Shionogi to develop promising HIV drugs

Pharma Times

ViiV Healthcare, global specialist HIV company owned by GlaxoSmithKline (GSK), has announced an exclusive collaboration with Shionogi & Co Ltd (Shionogi) to develop a third-generation HIV integrase inhibitor (INSTI), with potential for ultra-long-acting dosing intervals.

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UTA researcher studying effects of traumatic brain injury on neural cells

Scienmag

A University of Texas at Arlington researcher is studying how traumatic brain injuries (TBI) affect the ability of neural cells and surrounding cells to communicate with each other. Credit: UT Arlington A University of Texas at Arlington researcher is studying how traumatic brain injuries (TBI) affect the ability of neural cells and surrounding cells 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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Eli Lilly Doubles Down with Positive Results in T2D and Alopecia Trials

BioSpace

Indianapolis-based Eli Lilly presented data from two tirzepatide sub-studies at the 57th European Association for the Study of Diabetes (EASD) Annual Meeting.

Trials 98
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OSU research helps uncover strikingly simple means of diagnosing ecosystem health

Scienmag

Credit: Bev Law, OSU Journal Nature DOI 10.1038/s41586-021-03939-9 Method of Research Data/statistical analysis Subject of Research Not applicable Article Title The three major axes of terrestrial ecosystem function Article Publication Date 22-Sep-2021.

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Ferring Biotherapeutic Packs a Punch in C. Difficile Infection Across Five Trials

BioSpace

Ferring Pharmaceuticals today announced positive results across all five of its prospective trials for a live biotherapeutic designed to reduce recurrent C. difficile infection (rCDI).

Trials 98
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How sepsis need not be fatal

Scienmag

RIVERSIDE, Calif. — Sepsis, the body’s life-threatening response to infection affecting about 1.7 million adults in the United States each year, can lead to multisystem organ failure with a high mortality rate. Credit: RUHS. RIVERSIDE, Calif. — Sepsis, the body’s life-threatening response to infection affecting about 1.7 million adults in the United States each year, can lead to multisystem […].

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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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A Fundamentally Different View into Complex Neurological Diseases

BioSpace

Biomolecular condensates could hold the key to unlocking a number of neurological diseases that have baffled researchers the longest.

Research 103
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Researchers discover unknown childhood genetic condition and its potential cure

Scienmag

Describing a previously unknown genetic condition that affects children, researchers at University of California San Diego School of Medicine and Rady Children’s Institute for Genomic Medicine say they also found a potential method to prevent the gene mutation by administering a drug during pregnancy. Credit: Joseph Gleeson, UC San Diego Describing a previously unknown genetic […].

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Analyzing the Emerging Demand for the Probiotics

Delveinsight

Probiotics are a type of beneficial or live bacteria that provides various valuable benefits such as boosting the immune system and maintaining digestive health. Due to their beneficial properties, the demand is growing at a significant rate. Probiotics are available as dietary supplements. In the food supplement, they either occur naturally or are added externally.

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USAID awards UC Davis $15 Million for Global Horticulture Research Program

Scienmag

The U.S. Agency for International Development will provide a base $15 million investment over the next five years, with up to $34.5 million total funding possible, to support a global research program led by the University of California, Davis, that advances fruit and vegetable production, handling, and consumption. Credit: UC Davis The U.S. Agency for […].

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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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Opioid Fight Clocks Another Win as Drug Distributors Reach Settlements

BioSpace

Teva Pharmaceuticals reached a $15 million agreement with the state of Louisiana to settle claims against the company over its marketing of opioid products.

Drugs 102
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Clover growth in Mars-like soils boosted by bacterial symbiosis

Scienmag

Clover plants grown in Mars-like soils experience significantly more growth when inoculated with symbiotic nitrogen-fixing bacteria than when left uninoculated. Franklin Harris of Colorado State University, U.S., and colleagues present these findings in the open-access journal PLOS ONE on September 29, 2021. Credit: Harris et al., 2021, PLOS ONE, CC-BY 4.0 ([link] Clover plants grown […].

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Merck Cements Dedication to Cardiovascular Disease with $11.5 Acceleron Acquisition

BioSpace

Merck will acquire Acceleron for the expected $180 per share in cash for an approximate total equity value of $11.5 billion.

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Scientists behind RNA-repairing strategy recognized with American Chemical Society’s Nobel Signature award

Scienmag

JUPITER, FL – The American Chemical Society announced that its prestigious 2022 Nobel Laureate Signature Award for Graduate Education in Chemistry honors a student from the Skaggs Graduate School of Chemical and Biological Sciences at Scripps Research and her faculty advisor, for their pioneering work developing RNA-targeting medications for genetic diseases, including a form of […].

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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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Big Bank Analyst Charged by SEC for Insider Trading Ahead of Biopharma Deals

BioSpace

Jose Luis Casero Sanchez took advantage of his position in Goldman Sachs’ “control room” to gain insider knowledge of upcoming transactions, including those for several biopharma companies.

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ECMO life support offers sickest COVID-19 patients a chance to survive, but a slimmer one than once thought

Scienmag

The life-support system called ECMO can rescue COVID-19 patients from the brink of death, but not at the rates seen early in the pandemic, a new international study finds. Credit: Michigan Medicine The life-support system called ECMO can rescue COVID-19 patients from the brink of death, but not at the rates seen early in the […].

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Otsuka and Sunovion Ink Neuropsychiatric Medicine Deal Worth Nearly $1 Billion

BioSpace

The companies said the collaboration recognizes a “great need for novel treatments in the area of neuropsychiatric medicine development.

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Weight or energy: Undergraduate student’s research finds ACL recovery results and implications for returning to sport

Scienmag

According to 2021 research in the Orthopaedic Journal of Sports Medicine, 35 percent of athletes who have recovered from anterior cruciate ligament (ACL) injuries will re-injure it after returning to their sport. Credit: Virginia Tech According to 2021 research in the Orthopaedic Journal of Sports Medicine, 35 percent of athletes who have recovered from anterior […].

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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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Mirum Snags First Drug Approval for Rare, Genetic Liver Disorder

BioSpace

?LIVMARLI is indicated for ages one year and older and will now be accessible to patients with a prescription through Mirum Access Plus.

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Scientists to reveal results from major study into male suicide and depression

Scienmag

RESULTS of a major research project addressing increasing rates of male suicide and depression in the UK and Europe are to be announced next week. Credit: University of Chichester Findings from Step-by-Step study to reveal how men facing issues including depression and social isolation benefit from newly-created community Men’s Shed model Project launched in 2017 […].

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UK’s clinical research recovering slower than Euro peers, says ABPI

pharmaphorum

The pandemic had a negative effect on clinical research across all countries, but the UK seems to be taking longer than others to recover, according to a report from the Association of the British Pharmaceutical Industry (ABPI). The industry body maintains however that the UK can bounce back strongly if it adopts the innovative approaches taken to fighting COVID-19 – including regulatory flexibilities, digital and remote approaches, and innovative design and delivery models – and make sure clini

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Curriculum grant fosters novel approach to teaching art history

Scienmag

Which artists are represented in the canon of modern art history? Has the art world fostered an incomplete view of the history of art and its makers? Annie Ronan, assistant professor of Art History, has been awarded a grant from the College of Architecture and Urban Studies to explore these questions as she revises the curriculum for […].

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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.