Sat.Nov 25, 2023 - Fri.Dec 01, 2023

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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 265
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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 128
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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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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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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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Meet the Researcher: Jennifer Cann, Director of Pathology, Virscio 

Drug Discovery World

DDW’s Megan Thomas speaks to Jennifer Cann, Director of Pathology at Virscio, a company solving human health challenges through biomedical research. MT: Can you provide a top line summary of your research? JC: As Virscio’s Director of Pathology, I provide exploratory and translational pathology support for drug development research at all stages of the pipeline from pre-clinical through life cycle management, including clinical trial biopsy analysis to demonstrate pharmacodynamic effects wit

Research 174
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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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FDA investigates safety of CAR-T cell immunotherapies

Drug Discovery World

The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients. The reports were received from clinical trials and postmarketing adverse event (AE) data sources.

FDA 163
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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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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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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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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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Scleroderma drug trial shows up to 60% improvement

Drug Discovery World

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. The results were presented at ACR Convergence 2023, the annual scientific meeting of the American College of Rheumatology in San Diego, California (10-15 November 2023). Treatment with FT011 for 12 weeks resulted in a clinically meaningful improvement in 60% of patients treated with FT011 400mg and 20% of patients in the FT011 200mg group compared with 10% in the pl

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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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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.

FDA 117
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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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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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New podcast: Outside the box thinking for drug discovery success

Drug Discovery World

This is the latest episode of the free DDW narrated podcast, “Outside the box thinking for drug discovery success”, which covers three written for Volume 23 – Issue 4, Fall 2022 of DDW. They are called: Stanford researchers construct the most complete synthetic microbiome , Highs and lows of drug repurposing , and Unlocking the potential of mucoadhesive drug delivery.

Drugs 148
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Human behavior guided by fast changes in dopamine levels

Science Daily: Pharmacology News

A new study shows that dopamine release in the human brain plays a crucial role in encoding both reward and punishment prediction errors. This means that dopamine is involved in the process of learning from both positive and negative experiences, allowing the brain to adjust and adapt its behavior based on the outcomes of these experiences.

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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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GSK cancer drug Blenrep gets surprise trial win

BioPharma Drive: Drug Pricing

One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.

Trials 113
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CRISPR gene editing ‘cancer shredding’ technique destroys brain tumours

Drug Discovery World

Scientists have used CRISPR gene editing to target and rapidly destroy glioblastoma cells in an approach that could apply to other highly mutated cancers. Using a technique they’ve dubbed “cancer shredding,” the researchers at Gladstone Institutes programmed CRISPR to zero-in on repeating DNA sequences present only in recurrent tumour cells – and then obliterate those cells by snipping away at them.

DNA 148
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One of the largest magnetic storms in history quantified: Aurorae covered much of the night sky from the Tropics to the Polar Regions

Science Daily: Pharmacology News

An international multidisciplinary team consisting of solar physicists, geophysicists, and historians from nine countries analysed observations of an extreme solar-terrestrial storm reported in historical records from February 1872. Their findings confirm that a moderate sunspot group triggered one of the largest magnetic storms ever recorded, almost covering the entire night sky with colourful aurorae in both hemispheres.

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Biotech Consolidation: Not Really Happening

LifeSciVC

After the bursting of the pandemic biotech bubble, talk of industry consolidation was ubiquitous. The sector had pushed out too many IPOs during the go-go years, leading to too many public biotech companies, with sub-scale enterprises, and wasteful crowding in lots of therapeutic categories. And too many inexperienced management teams leading those newly-minted public companies.

Marketing 112
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Let’s talk neuroscience with Michelle Sidor at SFN

Drug Target Review

As the Director of Neuroscience Alchemab Therapeutics, how do you navigate neuroscientific research to propel the company’s future objectives? Michelle: The key is keeping up-to-date on research advancements and technological innovations, while keeping an eye on the therapeutic landscape. By doing this, we ensure we are well-positioned to take advantage of the latest findings and technologies that can help propel our research and development efforts forward, with the ultimate goal of deliv

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Advancements in upstream CLD for enhanced biotherapeutics production

Drug Discovery World

This article is sponsored by Revvity. By Anis H Khimani , PhD, Senior Strategy Leader, Life Sciences strategy group, Revvity, Inc. Across the biotherapeutics workflow The landscape of large molecule drug development has evolved significantly in recent decades. As the significance of large molecules continues to broaden across diverse modalities, emphasis on bispecific and multispecific antibodies to treat various disorders such as rheumatologic diseases, cancer, diabetes, anaemia, and infectious

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An astronomical waltz reveals a sextuplet of planets

Science Daily: Pharmacology News

Astronomers have found a key new system of six transiting planets orbiting a bright star in a harmonic rhythm. This rare property enabled the team to determine the planetary orbits which initially appeared as an unsolvable riddle.

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Whole Grain Foods Could Help Black Seniors Avoid Alzheimer's

Drugs.com

MONDAY, Nov. 27, 2023 -- Whole grains could be the key to Black people protecting their brains against aging and dementia, a new study reports.Black folks who ate more foods with whole grains appeared to have a slower rate of memory decline than.

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Revolutionizing the clinical trial patient experience with IQVIA

Fierce BioTech

What if clinical trial sites could focus entirely on research? | IQVIA’s new technologies are changing clinical trials, reducing the administrative burden on staff and improving insights for sponsors.

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This week in drug discovery (27 Nov – 1 Dec) 

Drug Discovery World

News round-up for 27 November – 1 December by DDW Digital Content Editor Diana Spencer. The key drug discovery news this week focuses on experimental approaches to the treatment of some of the most challenging diseases, including a mathematical model that can simulate Alzheimer’s progression and using CRISPR gene editing to ‘shred’ tumours. The top stories: Potential disease-modifying therapy for Parkinson’s disease An experimental drug has shown potential as a disease-modifying therapy fo

Therapies 130
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Solar activity likely to peak next year

Science Daily: Pharmacology News

Researchers have discovered a new relationship between the Sun's magnetic field and its sunspot cycle, that can help predict when the peak in solar activity will occur. Their work indicates that the maximum intensity of solar cycle 25, the ongoing sunspot cycle, is imminent and likely to occur within a year.

Research 109
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After Salmonella Cases Double in a Week, Cantaloupe Recall Expanded

Drugs.com

MONDAY, Nov. 27, 2023 (Healthday News) -- Three more brands of cantaloupe have been recalled by U.S. health officials after salmonella infections linked to the fruit more than doubled in just a week.The case count now includes nearly 100 people in.

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New technology optimises mesenchymal stem cell extraction

Drug Target Review

A groundbreaking new technology that can extract mesenchymal stem cells (MSCs) directly from pure bone barrow, known as bone marrow aspirate (BMA) without dilution has been developed by researchers from the Critical Analytics for Manufacturing Personalised-Medicine (CAMP) Interdisciplinary Research Group (IRG) of Singapore-MIT Alliance for Research and Technology (SMART).

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CatSci adds cGMP analytical development services

Drug Discovery World

UK-based CatSci have expanded their offering to now include cGMP analytical capabilities for both small molecule and oligonucleotides. The new cGMP analytical capability will be led by Dr Sam Whitmarsh and Duncan Thompson, CatSci’s Director of Analytical Science and Digital Transformation, and Head of Dagenham site respectively. Dr Nigel Richardson, CatSci’s Director of New Modalities, will lead the analytical development of oligonucleotides.

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SQL Server Space Monitoring

Perficient: Drug Development

On Operational projects that involves heavy data volume load on a daily basis, there’s a need to monitor the DB Disk Space availability. Over a period of time, the size grows occupying the disk space. While there are best practices to handle the size by adopting strategies of Purge for outdated data and add buffer/temp/data/log space to address the growing needs, it is necessary to be aware of the Disk space and consistently monitor for further actions.

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Internet Poses No Threat to Mental Health, Major Study Finds

Drugs.com

TUESDAY, Nov. 28, 2023 -- It might seem that surfing the web could cause a person’s mental health to suffer, but a landmark new study has concluded that internet use poses no major threat to people’s psychological well-being.Researchers.

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