November, 2023

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Successful clinical trial for re-engineered Covid vaccine 

Drug Discovery World

The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. The pivotal proof-of-concept testing clears the way to progress the Clamp2 technology in a range of research programmes. Project leader, Associate Professor Keith Chappell, said the preliminary clinical trial results were an ‘exciting reward’ for the team’s continued dedication and the community’s wi

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Neanderthals were the world's first artists, research reveals

Science Daily: Pharmacology News

Recent research has shown that engravings in a cave in La Roche-Cotard (France), which has been sealed for thousands of years, were actually made by Neanderthals. The findings reveal that the Neanderthals were the first humans with an appreciation of art.

Research 140
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New molecular insights on medical cannabis

Drug Target Review

Autotaxin (ATX) is a 99-125 kDa lysophospholipase D involved in a large range of physiological and pathological processes. 1 This critical enzyme is part of the nucleotide pyrophosphatase/ phosphodiesterase family and is also referred to as ENPP2. Five ATX isoforms have been identified, with ATX-b expressed in most human tissues and ATX-g specific to the central nervous system.

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Social Connection and Worker Well-being

NIOSH Science Blog: Drugs

In May, the U.S. Surgeon General, Vice Admiral Vivek Murthy, MD, MBA, released Our Epidemic of Loneliness and Isolation: The U.S. Surgeon General’s Advisory on the Healing Effects of Social Connection and Community calling for a whole-of-society approach to address the epidemic of loneliness and isolation.1 Below we briefly highlight information from the Advisory and its implications for worker well-being.

Research 129
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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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What if a CRISPR cure isn’t such an easy choice?

BioPharma Drive: Drug Pricing

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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New A-Fib Ablation Therapy Benefits Women as Much as Men

Drugs.com

THURSDAY, Nov. 2, 2023 -- A procedure to treat the irregular heart rhythm condition known as atrial fibrillation (a-fib) works just as well for women as it does for men, new research shows. The technology, called pulsed field ablation (PFA), can be.

Therapies 130

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Future floods: Global warming intensifies heavy rain -- even more than expected

Science Daily: Pharmacology News

The intensity and frequency of extreme rainfall increases exponentially with global warming, a new study finds. The analysis shows that state-of-the-art climate models significantly underestimate how much extreme rainfall increases under global warming -- meaning that extreme rainfall could increase quicker than climate models suggest.

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A guide to clinical trial phases [infographic]

Antidote

Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinical trial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.

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Streamlining ERP Selection: A Business Imperative

Perficient: Drug Development

The Core of Efficiency: Choosing the Right ERP Choosing the right Enterprise Resource Planning (ERP) system is critical for ensuring optimal efficiency and future growth of your business. It is important to choose a system that seamlessly integrates with your unique processes and objectives, acting as the driving force behind your business operations.

Research 115
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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

BioPharma Drive: Drug Pricing

U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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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.

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New Antibiotic, Zoliflodacin, Seeking Approval, Tackles Drug-Resistant Gonorrhea in Trial

Drugs.com

FRIDAY, Nov. 3, 2023 -- The first new antibiotic for gonorrhea — the second most common sexually transmitted disease — has shown promise in a clinical trial. That news should come as a relief to public health experts, because gonorrhea.

Trials 126
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Stem cell therapy shows promise in advanced MS

Drug Discovery World

An international team of scientists has shown that a stem cell therapy for multiple sclerosis (MS) could prevent further damage to the brain. The early-stage clinical trial was the result of a collaboration between researchers at University of Colorado Anschutz Campus, the University of Cambridge and the University of Milano-Bicocca. “We don’t know yet whether this is the beginning of a fantastic journey or not, but the results are very strong and very consistent,” said Professor Stefano Pluchin

Therapies 264
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'Cooling glass' blasts building heat into space

Science Daily: Pharmacology News

Researchers aiming to combat rising global temperatures have developed a new 'cooling glass' that can turn down the heat indoors without electricity by drawing on the cold depths of space. The new technology, a microporous glass coating, can lower the temperature of the material beneath it by 3.5 degrees Celsius at noon, and has the potential to reduce a mid-rise apartment building's yearly carbon emissions by 10 percent.

Research 129
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A researcher's perspective: Linking scientific discovery to clinical medicine

Antidote

For Carla Greenbaum, M.D., growing up in the era of space travel and the moon landing kindled a lifelong interest in science. That interest influenced her career trajectory, and she’s now a leading investigator at Benaroya Research Institute where she has studied the natural history of type 1 diabetes (T1D) since 2000. Her work focuses on finding the cause of autoimmunity and developing targets for treatment, which she finds “incredibly exciting and inspiring—like landing on the moon!

Research 121
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Introduction to My Spring Boot Blog Series: Embarking on a Learning Journey Together

Perficient: Drug Development

Greetings, Fellow Developers, Enthusiasts, and Friends! I am thrilled to embark on a journey of exploration and learning with you as I dive into the fascinating world of Spring Boot. As I navigate this powerful framework, I’ve decided to document my experiences, insights, and newfound knowledge in a blog series. The Motivation Behind the Series: The primary motivation for initiating this blog series stems from a desire to not only solidify my understanding of Spring Boot but also to create

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Moderna adjusts to changing outlook for COVID vaccine demand

BioPharma Drive: Drug Pricing

The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.

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Migraine? Reach for Prescription Meds, Not Ibuprofen

Drugs.com

THURSDAY, Nov. 30, 2023 -- Migraine sufferers would do better to talk to their doctor about a prescription drug than reaching for a bottle of ibuprofen, a new study finds.Drugs like triptans, ergots and anti-emetics can be two to five times more.

Doctors 119
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Research proves synthetic molecule can mitigate heart failure

Drug Discovery World

Researchers at the University of São Paulo (USP) in Brazil and Foresee Pharmaceuticals have tested a synthetic molecule which could increase heart function in patients with heart failure. Heart failure is a condition in which the heart cannot pump enough blood to meet the body’s needs for blood and oxygen. A number of drugs can slow its progression but currently no treatment exists that can reverse it.

Research 264
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Brittle stars can learn just fine -- even without a brain

Science Daily: Pharmacology News

We humans are fixated on big brains as a proxy for smarts. But headless animals called brittle stars have no brains at all and still manage to learn through experience, new research reveals. These shy marine creatures have no brain to speak of -- just nerve cords running down each of their five wiggly arms. But that seems to be enough to learn by association, researchers report.

Research 127
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Patient perspectives: Clinical trials and Diabetes Awareness Month

Antidote

Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — In October 2021, FDA and MHRA (United Kingdom’s Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles for the development of Good Machine Learning Practice (GMLP) with the goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies.

FDA 115
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Roche’s Genentech partners with Nvidia in AI drug deal

BioPharma Drive: Drug Pricing

The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.

Drugs 128
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Early Promise for Stem Cell Therapy to Curb MS

Drugs.com

TUESDAY, Nov. 28, 2023 -- Stem cells injected into the brains of multiple sclerosis patients appear to protect them against further damage from the degenerative disease, a new study shows.MS occurs when the body’s own immune system attacks and.

Therapies 119
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Drug halves alcohol consumption to aid alcohol dependence

Drug Discovery World

Kinnov Therapeutics’ Phase II study for its lead compound KT-110 has shown that the treatment can halve alcohol consumption amongst heavy drinkers in three months. The trial showed that KT-110 has superior efficacy in significantly reducing alcohol consumption in heavy drinkers by 26 to 30 grams (2.6-3 drinks) per day compared to the placebo. This increased to 50 grams (five drinks) per day compared to the baseline measure at the start of treatment.

Drugs 264
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Scientists build tiny biological robots from human cells

Science Daily: Pharmacology News

Scientists have created tiny moving biological robots from human tracheal cells that can encourage the growth of neurons across artificial 'wounds' in the lab. Using patients' own cells could permit growth of Anthrobots that assist healing and regeneration in the future with no nead for immune suppression.

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What to know about colon cancer stages

Antidote

Despite the fact that colorectal cancer cases have been declining in the United States since the mid-1980s, it is still the third most common cancer diagnosed each year excluding skin cancer. Often shortened to colon cancer, colorectal cancer occurs when cells in the colon and/or the rectum begin to grow uncontrollably and eventually spread to other parts of the body.

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Why Content Is the Key to Opening Healthcare’s Digital Front Door – Part 3: Medical Devices

Perficient: Drug Development

This is the third and final part of our series in which we’re discussing healthcare’s digital front door — the technologies and strategies you use to engage with consumers throughout their journeys. By now, you are getting the idea that a cohesive content strategy is the key for consumers to open your digital front door and engage with your organization regardless of where you sit in the healthcare ecosystem.

Doctors 116
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FDA investigating cancer risk linked to CAR-T cell therapy

BioPharma Drive: Drug Pricing

The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.

Therapies 117
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Many Primary Care Docs Unaware of Biologic Asthma Meds

Drugs.com

TUESDAY, Nov. 21, 2023 -- Biologic drugs to treat asthma have been around for two decades, but a surprising number of family doctors still aren’t prescribing them to kids and adults. A new survey found that more than two in five primary care.

Doctors 119
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Alternate origin discovered for brain mosaicism and focal epilepsy

Drug Target Review

Most people have the same genetic information in every cell of their body. However, usually during foetal development, people can develop two or more genetically diverse set of cells. Known as mosaicism, occasionally one of those groups of cells has genetic changes that may cause disorders or diseases. Previous research has shown that mosaicism in the brain is an important contributor to epilepsy, so neurologists, neurosurgeons and genomic experts have collaborated to assess mosaicism in brain t

Hospitals 115
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Lost brain function restored in mice after stroke

Science Daily: Pharmacology News

Researchers have succeeded in restoring lost brain function in mouse models of stroke using small molecules that in the future could potentially be developed into a stroke recovery therapy.

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What’s a corneal epithelial defect?

Antidote

The cornea is the outermost layer of the human eye, serving both as a protective covering and allowing light into the retina. To perform this function, the cornea is made up of several layers, the outermost of which is known as the epithelium.

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Establishing a Composable Roadmap

Perficient: Drug Development

It’s no secret: the digital world is moving to composable. Moving from the traditional monolithic CMS model to composable does allow you to pick and choose “best in breed” products, but it can lead to confusion and uncertainty. How do you determine what the ideal mix is? When do you start to migrate to these tools? Here are three steps to establish a composable roadmap in your organization.

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FDA names chief scientist Bumpus as Woodcock’s successor

BioPharma Drive: Drug Pricing

Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.

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