Sat.Jun 22, 2024 - Fri.Jun 28, 2024

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These microscopic tunnels are a goldmine for new medicines

BioPharma Drive: Drug Pricing

A growing cohort of biotechs, from Biohaven to Neurocrine to Jazz, hope research on ion channels will bring them new drugs and big business — much like it has done for Vertex.

Research 138
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CDC Advises Updated COVID Vaccine for Everyone Over 6 Months of Age

Drugs.com

FRIDAY, June 28, 2024 -- As a summer wave of COVID infections rolls across the country, U.S. health officials have recommended that all Americans over the age of 6 months get one of the updated COVID vaccines when they become available this.

Vaccine 124
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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 125
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Hero, Villain, or Victim? Stories that Sabotage

Perficient: Drug Development

In 1968, psychiatrist Stephen Karpman modeled what he called the Drama Triangle. With this, he illustrated dysfunctional mindsets that can derail social interactions. The three roles defined in this model are the rescuer (hero), persecutor (villain), and victim. This is another view of the lies we tell ourselves. Since the dawn of history, we’ve loved stories.

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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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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

BioPharma Drive: Drug Pricing

Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

Treatment 125
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Cholesterol Med, Fenofibrate, Might Slow Vision Loss in People With Diabetes

Drugs.com

TUESDAY, June 25, 2024 -- A well-established cholesterol-lowering drug appears to significantly slow the progression of a diabetes-related eye disease, a new trial shows. Fenofibrate (Tricor) has been approved since 2004 as a means of lowering.

Trials 111

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How to Configure ServiceNow Catalog Items for Microsoft Search

Perficient: Drug Development

If you are using ServiceNow as your IT service management platform, you might want to make your catalog items searchable in Microsoft Search. Microsoft Search is a unified search experience that helps you find what you need across your organization, including files, sites, people, and more. By connecting your ServiceNow catalog items to Microsoft Search, you can enable your users to find and request them directly from the Microsoft 365 apps.

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First-of-its-kind Intellia data suggest CRISPR drug could be given more than once

BioPharma Drive: Drug Pricing

The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.

Therapies 113
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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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Analysis suggests 2021 Texas abortion ban resulted in increase in infant deaths in state in year after law went into effect

Science Daily: Pharmacology News

Researchers use statistical modeling to estimate infant deaths expected if one of the country's most stringent state abortion laws had not been enacted. The study estimates that infant deaths in Texas increased more than expected in the year following the state's 2021 ban on abortion in early pregnancy, especially among infants with congenital anomalies.

Research 123
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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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CRISPR to Reveal How “Water Bears” (Tardigrades) Survive Extreme Environments

PLOS: DNA Science

Tardigrades are among the weirdest of animals. Also known as “water bears” or “moss piglets,” the 1,300 recognized species are the only members of phylum Tardigrada, a term that means “slow stepper” for their somewhat waddling gait. German zoologist Johann August Ephraim Goeze first described the tardigrades in 1773.

DNA 98
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Supreme Court overturns Chevron doctrine, limiting reach of federal agencies

BioPharma Drive: Drug Pricing

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

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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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First case of Down syndrome in Neanderthals documented in new study

Science Daily: Pharmacology News

A new study documents the first case of Down syndrome in Neanderthals and reveals that they were capable of providing altruistic care and support for a vulnerable member of their social group.

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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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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.

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Exsilio debuts with $82M, pitching a ‘leap’ forward for genetic medicine

BioPharma Drive: Drug Pricing

The company claims it can address some of the field’s limitations with medicines delivered via messenger RNA and lipid nanoparticles.

RNA 117
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Slow-Release Ketamine Pill Eases Depression: Study

Drugs.com

TUESDAY, June 25, 2024 -- A new slow-release pill form of ketamine can quell hard-to-treat depression without producing psychedelic side effects normally associated with the drug, early research suggests. Patients on the strongest dose of ketamine.

Research 111
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Microrobot-packed pill shows promise for treating inflammatory bowel disease in mice

Science Daily: Pharmacology News

Engineers have developed a pill that releases microscopic robots, or microrobots, into the colon to treat inflammatory bowel disease (IBD). The experimental treatment, given orally, has shown success in mice. It significantly reduced IBD symptoms and promoted the healing of damaged colon tissue without causing toxic side effects.

Disease 120
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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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2seventy slims down with sale of hemophilia assets to Novo

BioPharma Drive: Drug Pricing

Novo will pay $38 million in cash under the deal, which will also see 2seventy employees working on the program transfer to the Danish drugmaker.

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Migraine Prevention Med, Quilipta, Might Stop 'Rebound' Headaches, Too

Drugs.com

THURSDAY, June 27, 2024 -- It's a nasty cycle: Chronic migraine sufferers who use too much pain medication sometimes get smacked with rebound headaches. But new research suggests that a medication commonly used to prevent migraines may also help.

Research 111
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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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A Guide to CDISC ADaM Standards in 2024

Quanticate

Clinical Data Interchange Standards Consortium (CDISC) defines and manages industry level data standards that are widely used during the analysis, reporting and the regulatory submission of clinical data. There are three key CDISC standards which are vital for efficient data processing and analysis of clinical trial data known as CDASH , SDTM and ADaM.

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Best Practices for Drug Patent Portfolio Management

Drug Patent Watch

Introduction Patent portfolios are critical assets for pharmaceutical companies, providing market exclusivity and protecting revenue streams for drug products. Effective management of drug patent portfolios requires strategic planning, ongoing evaluation, and adaptation to the evolving pharmaceutical landscape. This article explores key best practices for optimizing drug patent portfolios to maximize value and maintain competitive advantage.

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Supreme Court Rejects Purdue Pharma Opioid Settlement

Drugs.com

FRIDAY, June 28, 2024 -- The U.S. Supreme Court on Thursday struck down a controversial settlement that drug maker Purdue Pharma had reached with victims of the opioid epidemic.The ruling threatens a massive bankruptcy plan that would have.

Drugs 105
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Non-stop flight: 4,200 km transatlantic flight of the Painted Lady butterfly mapped

Science Daily: Pharmacology News

In October 2013 a researcher made a surprising discovery of Painted Lady Butterflies on the Atlantic beaches of French Guiana -- a species not typically found in South America. This unusual sighting prompted an international study to investigate the origin of these butterflies.

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Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

BioPharma Drive: Drug Pricing

The failure of a Phase 3 trial led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

Trials 96
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Introducing DrugChatter: Revolutionizing Information Access

Drug Patent Watch

DrugChatter is an innovative AI-powered search and answer engine designed to revolutionize how we access and comprehend information. Harnessing the power of advanced natural language processing, DrugChatter provides concise, accurate, and contextually relevant answers to a wide array of questions, making information retrieval faster and more intuitive than ever before.

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Summer COVID Cases Are Rising Across America

Drugs.com

TUESDAY, June 25, 2024 -- As scorching summer temperatures drive Americans indoors and millions travel for vacations and family gatherings, COVID infections are again climbing, U.S. health officials warned Monday.In evidence that suggests a COVID.

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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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PRIDICT: Predicting Efficiencies of Prime Editing Guide RNAs

addgene Blog

Prime editing is a versatile genome editing technology that allows precise modifications of DNA (replacements, small insertions, and deletions) without introducing DNA double-strand breaks (Anzalone et al., 2019; Chen & Liu, 2023). This method uses a prime editor (typically a Cas9 H840A nickase fused to a reverse transcriptase) together with a prime editing guide RNA (pegRNA).

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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.

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Listeria Fears Spur Nationwide Ice Cream Recall

Drugs.com

TUESDAY, June 25, 2024 -- Check your freezer for multiple brands of ice cream that are being recalled by the maker, Totally Cool Inc., due to worries over listeria contamination. The full list of brands and recalled products can be found online.

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How do our memories last a lifetime? New study offers a biological explanation

Science Daily: Pharmacology News

A new study by a team of international researchers has uncovered a biological explanation for long-term memories. It centers on the discovery of the role of a molecule, KIBRA, that serves as a 'glue' to other molecules, thereby solidifying memory formation.