Thu.Aug 08, 2024

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Lenacapavir Exhibits Atropisomerism - Mechanistic Pharmacokinetics and Disposition Studies of Lenacapavir Reveal Intestinal Excretion as a Major Clearance Pathway [Metabolism, Transport, and Pharmacogenetics]

ASPET

Lenacapavir (LEN), a long-acting injectable, is the first approved human immunodeficiency virus type 1 capsid inhibitor and one of a few FDA-approved drugs that exhibit atropisomerism. LEN exists as a mixture of two class 2 atropisomers that interconvert at a fast rate (t 1/2 <2 hours) with a ratio that is stable over time and unaffected by enzymes or binding to proteins in plasma.

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More Evidence That an Artificial Sweetener Poses Heart Risk

Drugs.com

THURSDAY, Aug. 8, 2024 -- There's more evidence to suggest that the common artificial sweetener erythritol might pose dangers to consumers' hearts.The new study, involving 20 healthy adult volunteers, found that at doses commonly found in an.

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Early mammals lived longer

Science Daily: Pharmacology News

What distinguishes the growth and development patterns of early mammals of the Jurassic period? Paleontologists have been able to gauge the lifespan and growth rates of these ancient animals, and even when they reached maturity, by studying growth rings in fossilized tooth roots.

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Lilly boosts outlook on rising Zepbound revenue

BioPharma Drive: Drug Pricing

Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.

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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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Many Doctors Underestimate the Pain of IUD Insertion for Women. The CDC Wants to Change That

Drugs.com

THURSDAY, Aug. 8, 2024 -- Plenty of women know that having an IUD inserted in their uterus can be an excruciating experience, but new government guidance issued Thursday may soon make the experience less painful for many.For the first time, updated.

Doctors 111
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Zepbound shortages ease, but Lilly cautions pharmacy availability may remain ‘choppy’

BioPharma Drive: Drug Pricing

After months of supply strains, Lilly has begun to catch up with demand. Consumers may still need to wait for their prescriptions to be filled, however.

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Artificial compound eye to revolutionize robotic vision at lower cost but higher sensitivity

Science Daily: Pharmacology News

A research team has recently developed a novel artificial compound eye system that is not only more cost-effective, but demonstrates a sensitivity at least twice that of existing market products in small areas. The system promises to revolutionize robotic vision, enhance robots' abilities in navigation, perception and decision-making, while promoting commercial application and further development in human-robot collaboration.

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Fish Oil Might Help Keep Cholesterol in Check

Drugs.com

THURSDAY, Aug. 8, 2024 -- People with a genetic predisposition for high cholesterol can lower their levels by taking fish oil supplements, a new study shows.The results indicate that lifestyle can be a powerful influence on artery-clogging.

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Breakthrough in molecular control: New bioinspired double helix with switchable chirality

Science Daily: Pharmacology News

The control of artificial double-helical structures, which are essential for the development of high-order molecular systems, remains difficult. In a new study, researchers have developed novel double-helical monometallofoldamers that exhibit controllable helicity inversion and chiral information transfer, in response to external stimuli. These monometallofoldamers can lead to novel artificial supramolecular systems for molecular information transmission, amplification, replication, and other ex

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Another Listeria Death, Dozens of Hospitalizations in Outbreak Tied to Boar's Head Deli Meats

Drugs.com

WEDNESDAY, July 31, 2024 -- The death toll from listeria linked to tainted Boar's Head deli meats has risen to three, with nine more cases of the bacterial illness reported in the outbreak, an update issued Thursday by the U.S. Centers for Disease.

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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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Using PROC SQL: Creating Macro Variables with the INTO Statement & Other Applications

Quanticate

Explore PROC SQL's INTO statement for creating macro variables & enhancing data manipulation in SAS programming to streamline data analysis processes.

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Hardy Bacteria Are Surviving in Your Microwave

Drugs.com

THURSDAY, Aug. 8, 2024 -- Bacteria can adapt to a wide range of hostile environments, surviving and even thriving in marine oil spills, ocean-borne plastic trash, industrial brownfields and even the interior of the International Space Station.Now.

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Chemists develop new sustainable reaction for creating unique molecular building blocks

Science Daily: Pharmacology News

Polymers can be thought of like trains: Just as a train is composed of multiple cars, polymers are made up of multiple monomers, and the couplings between the train cars are similar to the chemical bonds that link monomers together. While polymers have myriad applications -- from drug delivery to construction materials -- their structures and functions are restricted by the chemically similar monomer building blocks they're composed of.

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Cheap, High-Tech 'Electric Bandage' Speeds Wound Healing

Drugs.com

FRIDAY, Aug. 9, 2024 -- Newly developed battery-powered electric bandages could help wounds heal more quickly, a new study reports.In animal testing, wounds treated with electric bandages healed 30% faster than wounds treated with conventional.

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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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Sarepta reveals lower Elevidys sales, but points to ‘massive’ opportunity ahead

BioPharma Drive: Drug Pricing

Company executives claimed “unprecedented demand” for the Duchenne gene therapy will soon cause a sales surge, countering a dip in quarterly sales and financial projections that raised concerns among investors.

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Painkiller Misuse Common Among People Battling Chronic Pain

Drugs.com

THURSDAY, Aug. 8, 2024 -- Nearly 1 in every 10 chronic pain patients treated with prescription opioids winds up addicted to the painkillers at some point, a new review finds.Further, nearly 1 in 3 will show symptoms of opioid addiction, researchers.

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Apellis plans FDA filing after drug success in kidney trial

BioPharma Drive: Drug Pricing

Analysts at Evercore ISI called pegcetacoplan’s data in two kidney conditions a “left-field hit” that compare favorably to results for a Novartis treatment.

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Dementia May Not Be as Common Among Parkinson's Patients as Thought

Drugs.com

THURSDAY, Aug. 8, 2024 -- Many people with Parkinson's disease may fear dementia as a common consequence of the disease.But new research suggests dementia is not inevitable with Parkinson's, and in fact is less common than presumed. If dementia.

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An Addgene Summer Internship

addgene Blog

I never would have imagined that my summer before high school senior year would have been spent within a lovable community that has allowed me to expand my knowledge more than ever before. Before joining Addgene, I had spent most of my junior year stressed out applying for summer programs. I spent one day at Addgene last summer, through the La Vida Scholars summer program.

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U.S. Deaths Dropped 6% Last Year, as COVID Fell From 3rd to 10th Leading Killer

Drugs.com

THURSDAY, Aug. 8, 2024 -- Deaths among Americans dropped by a significant 6.1% between 2022 and 2023, a new government tally finds.Much of this was due to COVID-19's ebbing effect on deaths.During the pandemic, over a million Americans lost their.

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Recursion to absorb Exscientia in ‘techbio’ deal

BioPharma Drive: Drug Pricing

The two AI drug discovery firms, which have each lost most of their value since going public, believe their complementary skills can better speed the development of new medicines.

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New Strain of Mpox Spreading in Africa Has CDC Concerned

Drugs.com

THURSDAY, Aug. 8, 2024 -- U.S. doctors should be on the lookout for a more severe strain of mpox that is spreading widely in parts of Africa, federal health officials warned Wednesday.The alert, issued by the U.S. Centers for Disease Control and.

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Merck TIGIT drug fails another trial; Intellia therapy succeeds in HAE study

BioPharma Drive: Drug Pricing

Merck stopped a Phase 3 TIGIT study for futility. Elsewhere, shares in Cabaletta Bio sank on safety worries and Vertex secured Casgevy reimbursement in England.

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Kids Worldwide Are Consuming More Sugary Drinks

Drugs.com

THURSDAY, Aug. 8, 2024 -- Kids and teens around the world are consuming more sugary drinks, increasing their risk of future health problems, a new study finds.Young people consumed nearly 23% more sugar-sweetened beverages in 2018 compared to 1990.

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The Risk and Reward of Connected Cars 

Perficient: Drug Development

Connected vehicles are no longer the future. They have become the present. This year, our team is conducting connected products research in which we are collecting insights from consumers, commercial end users, and manufacturers. The reason? Almost every manufacturer is working on providing connected products and solutions for both their consumers and their businesses operations.

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Supporting Clinical Trials with Early Detection Biomarker Testing

Fierce BioTech

Supporting Clinical Trials with Early Detection Biomarker Testing swheeler Thu, 08/08/2024 - 13:31 Tue, 10/01/2024 - 11:00 Resource Type Webinar Mingwei Zhao, Ph.D. Duration 60 minutes The clinical trial landscape continues to evolve at a rapid pace. New biomarker detection technologies are driving breakthroughs to earlier discoveries and more sensitive diagnostics.

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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.

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Completing the patient journey: using AI and RWD to see the unseen

Fierce BioTech

Completing the patient journey: using AI and RWD to see the unseen dwunderlin Thu, 08/08/2024 - 10:52 Tue, 09/24/2024 - 11:00 Resource Type Webinar Joseph Zabinski, PhD, MEM Promotion Start Fri, 08/09/2024 - 06:29 Promotion End Sun, 02/09/2025 - 06:29 Duration 60 Minutes Examine applications of AI to existing RWD to answer persistently challenging patient journey questions Explain how patients can be scored, ranked, and highlighted for diagnosis, treatment response, and risk Explore why tagging

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Increasing the probability of technical success in drug development using AI and patient heterogeneity

Predictive Oncology

A recent white paper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment. In addition to the unpredictable costs associated with late-stage clinical trials, the typical timeline for moving from exhaustive basic research to regulatory approval is anywhe

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Text Messaging Can Help Teens Kick the Vaping Habit

Drugs.com

THURSDAY, Aug. 8, 2024 -- An interactive text-message support program can help teenagers quit vaping, a groundbreaking new clinical trial finds.Teens who subscribed to the anonymous program, called This Is Quitting, were 35% more likely to report.

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Shervin Tabrizi

Broad Institute

Shervin Tabrizi By Rose Circeo August 8, 2024 Shervin Tabrizi, M.D. Postdoctoral scholar Shervin Tabrizi is a physician-scientist and postdoctoral scholar at the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard, and a radiation oncologist at Massachusetts General Hospital. He is co-advised by Chris Love at the Koch Institute at MIT.

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Are Vape Makers Using Dubious Nicotine 'Mimics' to Bypass Regulations?

Drugs.com

THURSDAY, Aug. 8, 2024 -- That vape pen might contain something even worse than nicotine, new research warns.Tobacco companies may be trying to duck federal restrictions on vaping products by replacing nicotine with “nicotine analogs” -- related che.

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Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. As outlined in the table below, application fee rates, such as for a New Drug Application (NDA) or Biologics License Application (BLA), will increase by almost $300,000 in FY2025 (effective October 1, 2024).

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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The European Parliament recently adopted the Artificial Intelligence Act (AI Act), marking a significant regulatory step in the oversight of AI technologies. This landmark legislation aims to create a comprehensive framework for AI development and deployment, ensuring ethical use, safety, and transparency for European Union (EU) residents.