Fri.Jun 07, 2024

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New project hopes to reduce the use of animals in drug research

Drug Discovery World

Charles River Laboratories has announced the launch of its Virtual Control Groups (VCG) initiative with Sanofi. The companies are working together to reduce animal usage by replacing selected control group animals with selected matched virtual control animals developed using retrospective datasets. The VCG collaboration is a project guided by Charles River’s Alternative Methods Advancement Project (AMAP), focused on reducing the use of animals in research.

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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

BioPharma Drive: Drug Pricing

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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This week in drug discovery (3-7 June) 

Drug Discovery World

News round-up for 3-7 June by DDW Senior Digital Content Editor Diana Spencer. With the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting concluding this week, the headline news has all focused on breakthrough cancer research shared at the event. The top stories: New drug represents a ‘remarkable advancement’ in lung cancer New data show that an unprecedented 60% of patients with advanced lung cancer given Lorbrena (lorlatinib) remain alive without disease progression after fiv

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1 in 6 Patients Who Quit Antidepressants Get 'Discontinuation Symptoms'

Drugs.com

FRIDAY, June 7, 2024 -- Roughly 1 in 6 people who stop taking an antidepressant will experience symptoms caused by discontinuing the drug, a new review finds.However, only 1 in 35 will experience severe symptoms after dropping their medication.

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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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Biopharma industry optimistic about growth in the next year

Drug Discovery World

The biopharmaceutical industry is revealing increasing optimism regarding its growth prospects over the next 12 months. While the upward trend is a positive sign, it remains below the levels of confidence seen in 2022, finds data and analytics company GlobalData. In a recent survey, ‘The State of the Biopharmaceutical Industry 2024 (mid-year update)’, 73% of surveyed healthcare industry professionals felt optimistic or very optimistic about the industry’s growth during the next 12 months.

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FDA Rescinds Ban on Juul E-Cigarettes

Drugs.com

FRIDAY, June 7, 2024 -- A ban on Juul e-cigarettes has been reversed, the U.S. Food and Drug Administration announced Thursday.Why? The agency said it needs to review both new court decisions and updated data from the vape maker. While the.

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With Bird Flu a Threat, FDA Asks Some States to Curb Sales of Raw Milk

Drugs.com

FRIDAY, June 7, 2024 -- The U.S. Food and Drug Administration on Thursday asked states to work harder to protect the public from the risks of raw milk as a bird flu outbreak continues to spread among dairy cows.In an open letter to state and local.

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Changes Upstream: RIPE team uses CRISPR/Cas9 to alter photosynthesis for the first time

Science Daily: Pharmacology News

Scientists used CRISPR/Cas9 to increase gene expression in rice by changing its upstream regulatory DNA. While other studies have used the technology to knock out or decrease the expression of genes, this study, is an unbiased gene-editing approach to increase gene expression and downstream photosynthetic activity. The approach is more difficult than transgenic breeding, but could potentially preempt regulatory issues by changing DNA already within the plant, allowing the plants to get in the ha

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Could Brain 'Overgrowth' Contribute to Autism?

Drugs.com

FRIDAY, June 7, 2024 -- Severe forms of autism could be linked to overgrowth of the brain’s outer layer that starts while a baby is in the womb, a new study finds.Toddlers with autism have cerebral cortexes -- often referred to as “gray matter” -- t.

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A T cell receptor immunotherapy against a novel target

Drug Target Review

How does Immunocore’s TCR technology differentiate itself from other approaches to targeted cancer therapy? Our proprietary ImmTAC (Immune Mobilizing Monoclonal TCRs Against Cancer) technology is comprised of a bispecific molecule where the effector end (anti-CD3) is designed to specifically activate the immune system (ie, T cells) against tumour cells to destroy them.

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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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Lifestyle Changes May Slow or Prevent Alzheimer's in People at High Risk

Drugs.com

FRIDAY, June 7, 2024 -- New research shows that a set of healthy lifestyle habits can help preserve brain function in folks with mild cognitive impairment or early dementia.About 71% of patients who ate healthy, exercised regularly and engaged in.

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Tiny new species of great ape lived in Germany 11 million years ago

Science Daily: Pharmacology News

Ancient apes in Germany co-existed by partitioning resources in their environment, according to a new study.

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Texas Rancher Developed Anthrax From Butchered Lamb Meat

Drugs.com

FRIDAY, June 7, 2024 -- Anthrax disease in humans is rare and when it does occur, it's usually during hot, dry summers.That's why the case of a Texas rancher who developed anthrax in January of this year piqued the interest of investigators at the.

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Geron wins long-sought drug approval; Califf talks China, GLP-1s at BIO

BioPharma Drive: Drug Pricing

After 34 years, Geron finally has an approved medicine in Rytelo. Elsewhere, Shionogi disclosed disappointing obesity drug data and AbbVie got some good trial news.

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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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Have High Blood Pressure? Weekly Workout May Lower Risk to Your Brain

Drugs.com

FRIDAY, June 7, 2024 -- Vigorous exercise more than once a week can lower the risk of dementia for people with high blood pressure, a new clinical trial shows.People who engaged each week in vigorous physical activity had lower rates of mild.

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The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Agency IQ

BY CHELSEY MCINTYRE, PHARMD Since the passage of the Dietary Supplement Health and Education Act (DSHEA) 30 years ago, the U.S. dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Over the years, the retroactive structure of DSHEA has encouraged the influx of bad actors who have identified the dietary supplement sector as a venue for the introduction of unapproved drugs into the U.S. market.

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Extended Course of Paxlovid Adds No Benefit for Those With Long COVID

Drugs.com

FRIDAY, June 7, 2024 -- An extended course of the antiviral drug Paxlovid won’t ease a person’s Long COVID symptoms, a new study finds. People who took Paxlovid for 15 days -- three times as long as it’s prescribed for an initial.

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EPA proposes risk management actions for NMP

Agency IQ

BY WALKER LIVINGSTON, ESQ The Environmental Protection Agency (EPA) has proposed a suite of actions for n-methylpyrrolidone (NMP), including capping concentrations at 45% and implementing a series of bans for consumer, commercial, and industrial uses. Under the Toxic Substances Control Act (TSCA), the EPA is required to conduct risk evaluations of chemicals.

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Younger Kids in Class Might Be Misdiagnosed With ADHD, Autism

Drugs.com

FRIDAY, June 7, 2024 -- If your child is among the youngest in their school grade, it's more likely they'll be mistakenly identified by teachers as having ADHD or autism, a new study confirms."Adults involved in identifying or raising concerns over.

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FDA’s new guidance explains what to do during a BIMO inspection

Agency IQ

BY LAURA DIANGELO, MPH Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. After a Congressional directive, the agency has now released new draft guidance on the processes and practices on BIMO inspections. The new draft guidance comes as there is a major overhaul of the Office of Regulatory Affairs (ORA) in the works, and new authorities on Remote Regulatory Assessments (RRAs) are being implemented.

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Career Perspectives: A Conversation with Karl Karu

Cytel

In this latest edition of the Career Perspectives series, we are excited to introduce our readers to Karl Karu, Senior Statistical Programmer in Functional Service Provider (FSP) at Cytel. Karl is based in Estonia and joined Cytel in September 2023. Join us as we delve into his refreshing and enthusiastic perspective on statistical programming and the skills it requires, the importance of communication with sponsors, and a work-life balance when working from home.

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The devil is in the details: a deep dive into the state of Notified Body designations

Agency IQ

BY COREY JASEPH, MS, RAC While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations. While designation numbers are up, there are still concerns that manufacturers need to be aware of.

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Risk-Based Quality Management in Clinical Data Management

Quanticate

Discover how Risk-Based Quality Management (RBQM) optimizes clinical data management for improved safety, efficiency, and regulatory compliance in clinical trials

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European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

BY SCOTT STEPHENS, MPA The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU. Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances.

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Community Pharmacies and Harm Reduction

Common Sense for Drug Policy Blog

Community Pharmacies and Harm Reduction "Community pharmacies are essential healthcare destinations that serve as an optimal resource for addressing non-urgent inquiries, such as safe injecting practices, management of adverse drug reactions, and medication provision, thus reducing the burden on general practitioners (GPs) [ 1 , 2 ]. Pharmacists also have a role in addressing social determinants of health and promoting health equity, including the support of primary prevention strategies such as

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How clinical trial patient recruitment and retention work together

Antidote

Recruiting and retaining patients are two of the most challenging aspects of clinical trials. The average clinical trial must extend its recruitment timeline by 71%, and up to 30% of patients will eventually drop out. While patients can leave a trial if it is not a good fit for them, there are patient-centric approaches that can make enrolling and participating in a study a more enjoyable experience.

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Community Pharmacies and Anabolic-Androgenic Steroid Consumers

Common Sense for Drug Policy Blog

Community Pharmacies and Anabolic-Androgenic Steroid Consumers "With the growing availability of AAS [Anabolic-Androgenic Steroids] through online platforms [ 71 , 72 ] the traditional reliance on social networks and healthcare providers for access to injecting equipment and safer use information has diminished [ 73 – 76 ]. This unregulated supply of AAS and other PIEDs from online sources is accompanied by misleading information regarding the benefits and risks associated with their use [ 13 ,

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Choosing the Right Hub Partner: A Blueprint for Decision-Makers

Drug Channels

Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir highlights manufacturers' top objectives and vendor metrics from CareMetx’s recent survey of leaders and decision makers in the specialty pharmaceutical industry. He then outlines key questions to help manufacturers evaluate their potential hub partners. You can donwload CareMetx’s full 2024 Patient Services Report here: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

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New patent expiration for Harrow Eye drug ILEVRO

Drug Patent Watch

Annual Drug Patent Expirations for ILEVRO Ilevro is a drug marketed by Harrow Eye and is included in one NDA. It is available from two suppliers.

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Harnessing Functional Genomics to Revolutionize Inflammatory Bowel Disease Treatment

Reprocell

Discover how functional genomics is transforming IBD treatment with groundbreaking research on ETS2's role in inflammation.

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Proteomic Analysis of Signaling Pathways Modulated by FABP5 in Macrophages [Inflammation, Immunopharmacology, and Asthma]

ASPET

While acute inflammation serves essential functions in maintaining tissue homeostasis, chronic inflammation is causally linked to many diseases. Macrophages are a major cell-type that orchestrates inflammatory processes. During inflammation, macrophages undergo polarization and activation, thereby mobilizing pro-inflammatory and anti-inflammatory transcriptional programs that regulate ensuing macrophage functions.

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Analysis Life Sciences Thank You The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked.

Agency IQ

The FDA tried to call the dietary supplement industry’s bluff. It appears to have blinked. Since the passage of the Dietary Supplement Health and Education Act (DSHEA) 30 years ago, the U.S. dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Over the years, the retroactive structure of DSHEA has encouraged the influx of bad actors who have identified the dietary supplement sector as a venue for the introduction of unapproved drugs i

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Chronic activation of {beta}-adrenergic receptors leads to tissue water and electrolyte retention [Cardiovascular]

ASPET

Beta-adrenergic receptors (β-AR) are expressed on the membranes of various cell types and their activation affects body water balance by modulating renal sodium and water excretion, cardiovascular function and metabolic processes. However, β-AR-associated body fluid imbalance has not been well characterised. In the present study, we hypothesized that chronic β-AR stimulation increases electrolyte and water content at the tissue level.

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Article FDA Thank You FDA’s new guidance explains what to do during a BIMO inspection

Agency IQ

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. After a Congressional directive, the agency has now released new draft guidance on the processes and practices on BIMO inspections. The new draft guidance comes as there is a major overhaul of the Office of Regulatory Affairs (ORA) in the works, and new authorities on Remote Regulatory Assessments (RRAs) are being implemen

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