Mon.Jun 24, 2024

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Phase II study in idiopathic pulmonary fibrosis completes enrolment

Drug Discovery World

Insilico Medicine has completed patient enrolment in a Phase IIa study in China, which is investigating the safety, tolerability, and preliminary efficacy of AI-designed TNIK inhibitor INS018_055 for idiopathic pulmonary fibrosis (IPF). The randomised, double-blind, placebo-controlled study is being conducted across 29 clinical centres in China and has completed enrolment of the planned target of 71 patients in four participant groups, including three experimental and one placebo.

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Myths about intermittent fasting, debunked

Science Daily: Pharmacology News

Research shows that the increasingly popular weight-loss strategy is safe. Intermittent fasting has become an increasingly popular way to lose weight without counting calories. And a large body of research has shown it s safe. Still, several myths about fasting have gained traction.

Research 117
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New DDW Highlights podcast: 24 June 2024

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. It’s been another busy week in the world of cell therapy, with the first use of CAR-T therapy for stiff-person syndrome, a study debunking the risk of secondary cancers from CAR-T and a number of cell therapy research findings revealed at EHA2024.

Therapies 147
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Carbon dioxide's heavy stamp on temperature: Doubling CO2 may mean 7 to 14 degree increase

Science Daily: Pharmacology News

A doubling of the amount of CO2 in the atmosphere could cause an increase in the average temperature on earth from 7 to even a maximum of 14 degrees. That is shown in the analysis of sediments from the Pacific Ocean off the coast of California.

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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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Clinical trial to repurpose HIV drugs to treat brain tumours

Drug Discovery World

Drugs developed to treat HIV and AIDS are being trialled for the first time in patients with multiple brain tumours. Scientists at the Brain Tumour Research Centre of Excellence at the University of Plymouth are conducting a clinical trial to see whether using anti-retroviral medications, ritonavir and lopinavir, could help people with Neurofibromatosis 2 (NF2).

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Facial recognition linked to close social bonds, not social butterflies

Science Daily: Pharmacology News

Do you have trouble recognizing faces, or do you never forget a face? The better you are at facial recognition, the more supportive relationships you are likely to have, regardless of your personality type.

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Researchers develop RNA-targeting technology for precisely manipulating parts of human genes

Science Daily: Pharmacology News

Researchers have harnessed a bacterial immune defense system, known as CRISPR, to efficiently and precisely control the process of RNA splicing. The technology opens the door to new applications, including systematically interrogating the functions of parts of genes and correcting splicing deficiencies that underlie numerous diseases and disorders.

RNA 113
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DDW Highlights: 24 June 2024

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. It’s been another busy week in the world of cell therapy, with the first use of CAR-T therapy for stiff-person syndrome, a study debunking the risk of secondary cancers from CAR-T and a number of cell therapy research findings revealed at EHA2024.

Therapies 130
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Twice-a-Year Injection Gives Women Full Protection Against HIV, Trial Finds

Drugs.com

MONDAY, June 24, 2024 -- Just two injections a year of a new HIV drug protected young women in Africa from infection with the sexually transmitted disease, new trial results show.In announcing the findings, Gilead Sciences Inc. said its HIV.

Trials 111
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The impact of therapeutic antibody discovery

Drug Discovery World

This eBook explores the challenges and opportunities in the therapeutic antibody market, the range of applications for these therapies and the move towards more targeted and effective next-generation antibody treatments. Download this exclusive eBook to learn more about: How artificial intelligence and machine learning are benefitting antibody discovery and design Methods to increase access to antigens and improve immunotherapy treatments The potential impact of bispecific antibodies and antibod

Treatment 130
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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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Texas' 2021 Abortion Ban Tied to Rise in Infant Deaths

Drugs.com

MONDAY, June 24, 2024 -- Following state legislation passed in 2021 that essentially banned abortion in Texas, the rate of infant deaths rose by almost 13%, compared to a much smaller 1.8% rise nationwide, a new study finds.The number of Texan.

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A hidden treasure in the Milky Way -- Astronomers uncover ultrabright x-ray source

Science Daily: Pharmacology News

Astronomers uncovered that a well-known X-ray binary, whose exact nature has been a mystery to scientists until now, is actually a hidden ultraluminous X-ray source.

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FDA's Move to OK First Menthol Vapes Is Big Mistake, Health Advocates Say

Drugs.com

MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration's decision to authorize the first menthol-flavored e-cigarettes has drawn the the ire of health advocates who say the decision undermines efforts to end the youth vaping epidemic in.

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Star clusters observed within a galaxy in the early Universe

Science Daily: Pharmacology News

The history of how stars and galaxies came to be and evolved into the present day remains among the most challenging astrophysical questions to solve yet, but new research brings us closer to understanding it. New insights about young galaxies during the Epoch of Reionization have been revealed. Observations with the James Webb Space Telescope (JWST) of the galaxy Cosmic Gems arc (SPT0615-JD) have confirmed that the light of the galaxy was emitted 460 million years after the big bang.

Research 100
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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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Leveraging 505(b)(2) to Innovate Beyond Existing Drug Patents

Drug Patent Watch

The 505(b)(2) regulatory pathway provides an attractive avenue for drug developers to bring new products to market by leveraging existing data on approved drugs. This pathway allows modifications and improvements to be made to existing drugs, while potentially reducing development costs and timelines compared to the traditional new drug application (NDA) route.

Drugs 106
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New study confirms forever chemicals are absorbed through human skin

Science Daily: Pharmacology News

A study of 17 commonly used synthetic 'forever chemicals' has shown that these toxic substances can readily be absorbed through human skin.

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Older Americans in Senior Housing Have Better Health Than Those Living at Home

Drugs.com

MONDAY, June 21, 2024 -- Independent living is important for seniors, but a new study shows it might not be the best thing for their health.Older adults living in senior housing tended to have better health than those who remain in their own homes.

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Geologists expect Chang'e-6 lunar surface samples to contain volcanic rock and impact ejecta

Science Daily: Pharmacology News

On June 25, China's Chang'e-6 (CE-6) lunar probe is set to return to Earth, carrying the first surface samples collected from the farside of the Moon. In anticipation of this historic event, scientists are publishing their predictions for the unique materials that may be found in the CE-6 samples.

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Inhaled Insulin Could Help Folks With Type 1 Diabetes Avoid Needles

Drugs.com

MONDAY, June 24, 2024 -- Inhaled insulin could be a better option than injections or pumps for some patients with type 1 diabetes, a new clinical trial shows.Patients using inhaled insulin (Afrezza) plus long-lasting insulin degludec injections had.

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The Next Generation of Vaccine Mega Trials

PPD

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19. The landscape of these trials is evolving, influenced by technological advancements, changing industry standards and innovative clinical trial designs.

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Timing of Chemo Could Be Key to Pancreatic Cancer Outcomes

Drugs.com

MONDAY, June 24, 2024 -- Giving people with pancreatic cancer chemotherapy both before and after a tumor-removing surgery brought better outcomes than if they got the drugs only after the surgery, new research shows.Researchers at the Yale Cancer.

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CDD Vault Update (June 2024 #2)

Collaborative Drug

Learn about the latest update in CDD Vault's Sample Management feature, allowing you to track samples, manage inventory, and create hierarchies of locations. Find out how to create, edit, and delete samples and events, and get helpful hints for managing multiple samples. Discover how to import assay data and maintain compatibility with legacy batch-level inventory features.

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U.S. Supreme Court Agrees to Hear Case on Medical Care for Transgender Youth

Drugs.com

MONDAY, June 24, 2024 -- The U.S. Supreme Court announced Monday that it would hear a case on a Tennessee law that bans transgender minors from receiving certain medical treatments in that state.The banned treatments include puberty-blocking drugs.

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Part one: what can scientists do with LLMs today?

Drug Target Review

LLMs, or deep learning models, have been around since the 1990s, but it wasn’t until the 2010s that their use became more popular. They have been used as the basis for AI assistants like Apple’s Siri and ChatGPT. Because of their ability to process vast sets of data there have been attempts to use them to accelerate progress across a range of industries.

Science 69
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Medication Abortion Without Ultrasound Is Safe: Study

Drugs.com

MONDAY, June 24, 2024 -- Women don’t need an ultrasound to have a safe medication abortion, a new study says.Women who received abortion pills by mail without getting an ultrasound first did just as well as those who were examined and given the d.

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Novo fills in positive picture for preventive hemophilia drug

BioPharma Drive: Drug Pricing

Phase 3 trial results should support an approval application for the drug, which analysts view as a potential competitor to Roche’s blockbuster medicine Hemlibra.

Drugs 62
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Anti- Seizure Meds Are Crucial, But Can Trigger Severe Reactions

Drugs.com

MONDAY, June 24, 2024 -- Specific steps can be taken to reduce the risk of potentially fatal reactions to anti-seizure medications, researchers report in a new review.Performing blood tests, asking patients about risk factors and modifying dosages.

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Obesity drugs from Altimmune, Hengrui show potential; Lilly details Zepbound sleep apnea data

BioPharma Drive: Drug Pricing

The American Diabetes Association’s annual meeting provided a forum for early trial results on several would-be weight loss drug competitors.

Drugs 62
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AWS Systems Manager (SSM)

Perficient: Drug Development

It provides a unified interface for viewing and controlling your infrastructure, automating tasks, and managing configurations. Here are some key features and components of AWS Systems Manager AWS Systems Manager Core Components : Run Command : Executes commands on instances. State Manager : Maintains desired state configurations. Parameter Store : Stores configuration data and secrets.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs. There are three patents protecting this compound. Drug patent litigation for DABIGATRAN ETEXILATE MESYLATE. Nine suppliers are listed for this compound.

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HPM Director Dara Katcher Levy to Present Webinar on AMCP Format for Formulary Submissions v5.0

FDA Law Blog: Biosimilars

This afternoon Hyman, Phelps & McNamara, P.C. (HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.

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New patent for Gilead Sciences drug VEKLURY

Drug Patent Watch

Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. The generic ingredient in VEKLURY is remdesivir. One supplier is listed for this compound.

Science 52
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Advanced API Testing Part 1: Payloads & Rest Assured Framework

Perficient: Drug Development

Introduction to Rest Assured Framework In today’s API-driven development landscape, testing RESTful APIs is a critical aspect of ensuring application functionality and performance. The Rest Assured framework is a powerful and easy-to-use Java library that simplifies testing REST APIs. Leveraging a fluent API allows developers to write readable and maintainable tests.

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Cathinones

Common Sense for Drug Policy Blog

Cathinones "The phenomenon of new psychoactive substances (NPS) is an ongoing problem in modern forensic toxicology. One of the most important groups among NPS are synthetic cathinones, which are derivatives of cathinone, a natural alkaloid found in the shrub Catha edulis. This substance has been shown to have psychoactive properties, with a widespread centuries-old tradition among the Arabian Peninsula population of chewing the leaves of this plant for recreational purposes [ 1 , 2 , 3 ].