Wed.Oct 18, 2023

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Novel blood test identifies Alzheimer’s risk with 97% accuracy

Drug Discovery World

A new blood test has been shown to identify biomarkers for Alzheimer’s disease, providing an early warning of cognitive decline. Early results from PharmaKure, a pharmaceutical company spun out from The University of Manchester, UK, shows a novel whole blood test (ALZmetrix) developed by the company can quantify Alzheimer’s disease biomarkers. The test may enable the development of a screening system to catch Alzheimer’s before any major memory problems become apparent, allowing treatments to be

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Synthesis and anti?tumor activity evaluation of 1H?pyrrolo[2,3?b]pyridine?2?carboxamide derivatives with phenyl sulfonamide groups as potent RSK2 inhibitors

Chemical Biology and Drug Design

A series of 1H-pyrrolo[2,3-b]pyridine-2-carboxamide derivatives with phenyl sulfonamide substitutions were synthesized, among them compounds B1 - B3 exhibited a potent RSK2 inhibitory potency, and compound B3 showed 54.6% of TGI in dosing of 30 mg/kg in MDA-MB-468 xenograft model. Abstract Ribosome S6 Protein Kinase 2 (RSK2) is involved in many signal pathways such as cell growth, proliferation, survival and migration in tumors.

Research 100
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How to advance AAV-based gene therapies

Drug Discovery World

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies. Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas. We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal mus

Therapies 163
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BrainStorm, after setbacks, withdraws approval application for ALS drug

BioPharma Drive: Drug Pricing

A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.

FDA 113
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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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Researchers reverse prostate cancer drug resistance by targeting myeloid cells

Drug Discovery World

Prostate cancer’s resistance to treatment can be reversed in some patients by stopping hijacked white blood cells from being ‘pulled into’ tumours, according to new research published in Nature. In an early clinical trial, researchers showed that blocking the messages cancer uses to hijack white blood cells can re-sensitise a subset of advanced prostate cancers to treatment – shrinking tumours or halting their growth.

Research 163
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Getting COVID Raises Odds for Guillain-Barre Syndrome, Vaccination Lowers Risk

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- COVID infection can raise the risk of a rare immune system attack on the body's nerves -- but vaccination might protect against it, a large new study suggests. The study, of more than 3 million Israeli adults and.

Vaccine 111

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Adults With ADHD May Face Higher Dementia Risk

Drugs.com

TUESDAY, Oct. 17, 2023 -- Adults with attention-deficit/hyperactivity disorder (ADHD) are nearly three times more likely to develop dementia than other adults, a new study suggests. The results also indicate that treatment with ADHD medication may.

Treatment 111
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Early adopters get access to new microcarrier platform

Drug Discovery World

Semarion, a University of Cambridge spin-out company from the Cavendish Laboratory, has opened the Early Adopter Programme for its SemaCyte Microcarrier Platform. The platform aims to overcome the limitations associated with adherent cell culture and assaying workflows by enabling small colonies of cells to be moved and frozen in their adherent state, increasing the volume of data collected per experiment and reducing the resource demands of in vitro drug discovery.

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Serotonin May Play Big Role in Long COVID

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- New research has uncovered evidence that remnants of the COVID-19 virus may remain in some patients' guts for months, contributing to the lingering symptoms known as long COVID. The remnants appear to trigger a drop in.

Virus 111
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Ultragenyx to spin out new company around Alzheimer’s gene therapy

BioPharma Drive: Drug Pricing

CEO Emil Kakkis says the company's findings are too exciting to ignore, but the “high-risk, high-return” venture needs to be pursued outside the organization.

Therapies 109
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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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Commonly Used Drug Amitriptyline Might Be New Treatment Option for IBS

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- An inexpensive medication long used for depression and migraines now has a clinical trial to back up its off-label use for another condition that lowers quality of life: irritable bowel syndrome (IBS).

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The Impact of Real-World Evidence on Clinical Data Management

ProRelix Research

The increasing focus and acceptance of real-world data (RWD) in clinical decision making has led regulatory authorities and sponsors to understand its influence on data management that is an integral […] The post The Impact of Real-World Evidence on Clinical Data Management appeared first on ProRelix Research.

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Blood Pressure's Ups & Downs Could Harm Heart, Brain

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- Fluctuating blood pressure can be a harbinger for both dementia and heart disease, a new study finds. Ups and downs within 24 hours or even over several days or weeks were linked with impaired thinking, researchers from.

Disease 111
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The encounter between Neanderthals and Sapiens as told by their genomes

Science Daily: Pharmacology News

About 40,000 years ago, Neanderthals, who had lived for hundreds of thousands of years in the western part of the Eurasian continent, gave way to Homo sapiens, who had arrived from Africa. This replacement was not sudden, and the two species coexisted for a few millennia, resulting in the integration of Neanderthal DNA into the genome of Sapiens. Researchers have analyzed the distribution of the portion of DNA inherited from Neanderthals in the genomes of humans (Homo sapiens) over the last 40,0

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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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Americans Can Expect to Spend Half Their Lives Taking a Prescription Drug

Drugs.com

TUESDAY, Oct. 17, 2023 -- Americans born in recent years can likely count on taking prescription drugs for about half their life, according to new research. For males born in 2019, it’s about 48% of their lives. For women, it’s 60% of.

Drugs 111
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Ancient diamonds shine light on the evolution of Earth

Science Daily: Pharmacology News

Formed millions to billions of years ago, diamonds can shine light into the darkest and oldest parts of the Earth's mantle. The analysis of ancient, superdeep diamonds dug up from mines in Brazil and Western Africa, has exposed new processes of how continents evolved and moved during the early evolution of complex life on Earth. These diamonds that were formed between 650 and 450 million years ago on the base of the supercontinent Gondwana, were analysed by an international team of experts, and

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1 in 5 U.S. Adults Now Has Arthritis

Drugs.com

TUESDAY, Oct. 17, 2023 -- Arthritis is becoming a disease of the masses, striking 21% of U.S. adults, or over 53 million people, a new report shows. “It's important first to point out that arthritis is a general term that includes over a.

Disease 105
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Wearable device makes memories and powers up with the flex of a finger

Science Daily: Pharmacology News

Researchers have invented an experimental wearable device that generates power from a user's bending finger and can create and store memories, in a promising step towards health monitoring and other technologies.

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Are Trigger Warnings Useless? New Study Says Yes

Drugs.com

TUESDAY, Oct. 17, 2023 -- "Trigger warnings" are now widely accepted as away to help people avoid harm from disturbing content. Trouble is, they just don't work, according to new research. Trigger warnings seem like an obvious good: They alert.

Research 105
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You don't lose if you snooze

Science Daily: Pharmacology News

It is often claimed that using the snooze button can have negative effects on sleep and cognitive processes, but there has been no direct evidence to this effect. New research shows that snoozing may actually support the waking process for regular snoozers.

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Women Face Higher Odds of Depression After Head Injury Than Men

Drugs.com

TUESDAY, Oct. 17, 2023 -- Women are more likely to develop depression after suffering a traumatic brain injury (TBI), a new study shows. The analysis of nine published studies included nearly 700,000 people and found that the risk for depression.

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Researchers design gene therapy that can effectively target glioblastoma

Science Daily: Pharmacology News

Glioblastoma (GBM), an aggressive brain cancer, is notoriously resistant to treatment, with recurrent GBM associated with survival of less than 10 months. Immunotherapies, which mobilize the body's immune defenses against a cancer, have not been effective for GBM, in part because the tumor's surrounding environment is largely impenetrable to assaults from the body's immune system.

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U.S. Injuries From E-Bikes, E-Scooters Jumped 21% in One Year

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- E-bikes, e-scooters and hoverboards are everywhere -- and injuries related to their use are soaring. The U.S. Consumer Product Safety Commission (CPSC) issued a new report on Tuesday showing that injuries associated with.

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Milestone: Miniature particle accelerator works

Science Daily: Pharmacology News

Particle accelerators are crucial tools in a wide variety of areas in industry, research and the medical sector. The space these machines require ranges from a few square meters to large research centers. Using lasers to accelerate electrons within a photonic nanostructure constitutes a microscopic alternative with the potential of generating significantly lower costs and making devices considerably less bulky.

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FDA Proposes Ban on Formaldehyde in Hair Straighteners Over Health Dangers

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- The U.S. Food and Drug Administration has proposed a ban on the use of formaldehyde in hair relaxers over concerns about its link to respiratory problems and certain cancers. Right now, the FDA only discourages using.

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From a five-layer graphene sandwich, a rare electronic state emerges

Science Daily: Pharmacology News

When stacked in five layers in a rhombohedral pattern, graphene takes on a rare 'multiferroic' state, exhibiting both unconventional magnetism and an exotic electronic behavior known as ferro-valleytricity.

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Seniors, 18 Holes of Golf Might Make You Smarter

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- Want to do something to protect your thinking skills as you age? Swing that golf club or go for a walk. A new study found that walking about 3.7 miles or playing 18 holes of golf improved cognitive function. Nordic.

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Preparing Your Integrated Summaries of Safety and Effectiveness: Best Practices

Cytel

Written by Angelo Tinazzi and Florence Le Maulf Integrated Summaries of Safety (ISS) and Integrated Summaries of Effectiveness (ISE) bring together in one place data and analyses pertinent to assess the safety and efficacy of a new drug submitted to the regulatory authorities. Let’s take a closer look at these essential documents and important steps for planning the ISS and ISE.

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Dementia Diagnosis Takes Huge Toll on a Family's Finances

Drugs.com

WEDNESDAY, Oct. 18, 2023 -- Dementia can take a big bite out of an American's bank account, robbing 60% of a patient's net worth in the eight years after a diagnosis, a new study says. The average dementia patient will also see a doubling of.

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When Should a 510(k) Include Clinical Data?

FDA Law Blog: Biosimilars

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. Such data may be needed to demonstrate substantial equivalence to a previously-marketed predicate device or, less frequently, to show that new or modified indications for use fall within the same intended use as the predicate device.

FDA 64
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Non-White Kids With Recurrent Ear Infections Less Likely to Get Specialist Care

Drugs.com

TUESDAY, Oct. 17, 2023 -- Which U.S. kids see specialists for ear infections and have tubes placed to drain fluid and improve air flow differs significantly by race. Asian, Hispanic and Black children are much less likely than white kids to see.

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Intellia cleared by FDA to start Phase 3 test of gene editing treatment

BioPharma Drive: Drug Pricing

Developed with Regeneron, Intellia’s treatment is designed to inactivate a gene to treat an inherited disease called transthyretin amyloidosis.

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FDA Moves Closer to Banning Menthol Cigarettes, Flavored Cigars

Drugs.com

TUESDAY, Oct. 17, 2023 – A proposed rule from federal regulators that would ban menthol cigarettes and flavored cigars has been sent to the White House Office of Management and Budget for final review. The U.S. Food and Drug Administration.

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New patent expiration for Novartis drug VOTRIENT

Drug Patent Watch

Annual Drug Patent Expirations for VOTRIENT Votrient is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting… The post New patent expiration for Novartis drug VOTRIENT appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59