Fri.Jun 07, 2024

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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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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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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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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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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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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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Pan AMPK Activation Protects Tubules in Rat Ischemic Acute Kidney Injury [Cardiovascular]

ASPET

Acute Kidney Injury (AKI) is characterized by an abrupt decline in kidney function and has been associated with excess risks of death, kidney disease progression, and cardiovascular events. The kidney has a high energetic demand with mitochondrial health being essential to renal function and damaged mitochondria has been reported across AKI subtypes. 5' adenosine monophosphate-activated protein kinase (AMPK) activation preserves cellular energetics through improvement of mitochondrial function a

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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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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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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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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Discovery of Aurovertin B as a Potent Metastasis Inhibitor against Triple-Negative Breast Cancer: Elucidating the Complex Role of the ATF3-DUSP1 Axis [Drug Discovery and Translational Medicine]

ASPET

Triple-negative breast cancer (TNBC) is characterized by high mortality rates primarily due to its propensity for metastasis. Addressing this challenge necessitates the development of effective antimetastatic therapies. This study aimed to identify natural compounds with potential antimetastatic properties mainly based on the high-throughput phenotypic screening system.

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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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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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REPROCELL USA Inaugurates New GMP Laboratory

Reprocell

In his opening remarks during a welcome reception at the 27 th annual meeting of the American Society of Gene & Cell Therapy , Maryland Secretary of Commerce Kevin Anderson touted the most recent accomplishments of biotech companies including Regenexbio, MaxCyte, and AstraZeneca. What these companies have in common is that they are all in the heart of Maryland’s biotech corridor in Montgomery County and their successes contribute to Maryland’s mission to make the state a biotech hub.

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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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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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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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Which pharmaceutical companies have the most SPCs in Norway?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Norway.

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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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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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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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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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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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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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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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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.