Fri.Sep 29, 2023

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Recent Highlights in Covalent Drug Discovery

Drug Hunter

In Wednesday’s Flash Talk webinar, we covered recent highlights in covalent drug discovery, with lots of great questions from the audience. The webinar and recording are available below to everyone thanks to our sponsor, Revvity Signals, and the slides are available for download to Premium members at the bottom. The talk covered: Covalent drugs that break the toxicity stigma Case studies from notable recent covalent molecules Covalent drugs to watch Some of the highlights mentioned in the talk i

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Long-lasting Control of LDL-Cholesterol Induces a Forty Percent Reduction in the Incidence of Cardiovascular Events: New Insights from a 7-year Study [Cardiovascular]

ASPET

Recent studies have yielded controversial results on the long-term effects of statin treatment on the risk of cardiovascular (CV) events. In order to fill this knowledge gap, we analyzed the relationship between LDL-C levels and CV events in hypertensive patients without previous CV events and naïve to antidyslipidemic treatment, within the "Campania Salute Network" in Southern Italy.

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PTC to lay off more staff following drug setback in Europe

BioPharma Drive: Drug Pricing

The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.

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New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

Within the field of Drug Discovery and Development the term “ New Alternative Methodologies ” (NAMs) refers to the use of new and innovative testing methods that come to replace traditional animal models. In addition to ethical constraints and animal welfare distress regarding the use of animals such as rodents in preclinical testing, there are a number of obstacles encountered in the traditional testing methods.

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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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Structure boosted by early data for experimental obesity drug

BioPharma Drive: Drug Pricing

Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug Structure is developing, reflecting investor enthusiasm for the weight loss medicines.

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More Than a Feeling: Five Key Challenges When Walking Away From Commercial/340B Duplicate Payments

Drug Channels

Today’s guest post comes from Micah Litow, Chief Operating Officer at Kalderos. According to Kalderos, at least 5% of commercial rebates are paid for prescriptions that also have discounts under the 340B Drug Pricing Program. Micah outlines why it's more than a feeling that manufacturers struggle to walk away from these duplicate payments. But as he explains, reliable data is crucial to avoid hearing that old song that PBMs play.

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More Trending

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New study will examine irritable bowel syndrome as long COVID symptom

SCIENMAG: Medicine & Health

Researchers with the ongoing Arizona CoVHORT research study at the University of Arizona Mel and Enid Zuckerman College of Public Health were awarded $3.2 million by the National Institute of Diabetes and Digestive and Kidney Diseases for a five-year study of gastrointestinal symptoms, specifically irritable bowel syndrome, as a condition of long COVID.

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Allergy study on 'wild' mice challenges the hygiene hypothesis

Science Daily: Pharmacology News

The notion that some level of microbial exposure might reduce our risk of developing allergies has arisen over the last few decades and has been termed the hygiene hypothesis. Now, an article challenges this hypothesis by showing that mice with high infectious exposures from birth have the same, if not an even greater ability to develop allergic immune responses than 'clean' laboratory mice.

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Innovative Clinical Trial Design: Commercial vs Open-Source Software? Why Not Both?

Cytel

In the ever-changing field of clinical trial design, there is often a need to evaluate design options quickly and efficiently. But when it comes to evaluating options, which is better: commercial or open-source software? And does it need to be a question of either-or?

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Article Periodic: E.U. chemical developments we’re expecting in October 2023

Agency IQ

E.U. chemical developments we’re expecting in October 2023 Welcome to AgencyIQ’s roundup of regulatory activities anticipated next month in the European Union chemicals sector. This ongoing feature compiles public information from across E.U. agencies and institutions to deliver insight into what chemicals-related regulatory actions are likely to happen in the month ahead, including planned legislation, consultations, webinars, meetings, and more.

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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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Did animal evolution begin with a predatory lifestyle?

Science Daily: Pharmacology News

Surprising findings on the development of sea anemones suggest that a predatory lifestyle molded their evolution and had a significant impact on the origin of their nervous system. The researchers were able to show that the young life stages (larvae) of the small sea anemone Aiptasia actively feed on living prey and are not dependent on algae. To capture its prey, the anemone larvae use specialized stinging cells and a simple neuronal network.

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Analysis Life Sciences: What We Expect the FDA to do in October 2023

Agency IQ

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

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New patent for Cmp Dev drug LIQREV

Drug Patent Watch

Annual Drug Patent Expirations for LIQREV Liqrev is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from one supplier. There are two… The post New patent for Cmp Dev drug LIQREV appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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We Have an LDT Proposed Rule!

FDA Law Blog: Biosimilars

By McKenzie E. Cato & Allyson B. Mullen & Gail H. Javitt — It’s the moment we’ve all been waiting for , dreading , anticipating. Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. The proposed rule has a 60-day comment period for stakeholders.

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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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New patent for Avadel Cns drug LUMRYZ

Drug Patent Watch

Annual Drug Patent Expirations for LUMRYZ Lumryz is a drug marketed by Avadel Cns and is included in one NDA. It is available from one supplier. There are thirteen patents… The post New patent for Avadel Cns drug LUMRYZ appeared first on DrugPatentWatch - Make Better Decisions.

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Securing Your Salesforce Ecosystem: A Comprehensive guide to using Checkmarx

Perficient: Drug Development

Secure software development is critical for businesses today, and organizations that use Salesforce as their primary CRM platform must ensure that their Salesforce applications are secure and protected against potential threats. One of the best ways to enhance the security of Salesforce applications is by using Checkmarx – a software security tool that provides application security testing solutions.

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CDD Attending Biotech Networks Scientific Speed Networking Event: DC Area OCT 11 2023

Collaborative Drug

Biotech Networks Scientific Speed Networking: DC Area October 11th 2023

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Solving a sticky, life-threatening problem

Science Daily: Pharmacology News

Researchers have zeroed in on C. auris' uncanny ability to stick to everything from skin to catheters and made a startling discovery: it uses a protein similar to that used by barnacles and mollusks.

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NCE to CTM: Strategies to Bridge Discovery and Formulation

Fierce BioTech

NCE to CTM: Strategies to Bridge Discovery and Formulation pesurya Fri, 09/29/2023 - 10:34 Tue, 11/07/2023 - 10:00 Resource Type Webinar Dr. Firouz Asgarzadeh Duration 60 Minutes In the dynamic landscape of pharmaceutical development, a multitude of new chemical entities (NCEs) are discovered daily. This constant influx presents formulators with the ongoing challenge of addressing issues related to solubility and permeability, as well as the need for modified release delivery, often with only mi

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Study identifies new pathway to suppressing autoimmunity

SCIENMAG: Medicine & Health

Researchers at Stanford University School of Medicine, Yale University School of Medicine, and the Hospital for Special Surgery Research Institute have uncovered new details about how the immune system prevents the production of antibodies that can recognize and damage the body’s own, healthy tissues.

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Real-World Solutions for Life Sciences: Harnessing the Power of Innovative Technologies to Stay Competitive in a Dynamic Market

Fierce BioTech

Real-World Solutions for Life Sciences: Harnessing the Power of Innovative Technologies to Stay Competitive in a Dynamic Market dwunderlin Fri, 09/29/2023 - 16:20 Tue, 10/31/2023 - 10:00 Resource Type Webinar João Antunes Corinne Marsolier Ruud Nieuweboer Duration 60 Minutes This webinar will examine how life science organizations are harnessing the power of innovative technologies to drive growth, improve efficiency, and stay competitive.

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American Academy of Arts and Sciences to induct UVA’s Garcia-Blanco

SCIENMAG: Medicine & Health

The University of Virginia School of Medicine’s Mariano A. Garcia-Blanco, MD, PhD, will be inducted this weekend into the American Academy of Arts and Sciences (AAAS), one of the country’s oldest and most prestigious honorary societies, in recognition of his exceptional scientific contributions. Credit: UVA Health The University of Virginia School of Medicine’s Mariano A.

Science 52
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[Video] Watch and Smile – Our Canadian Team in Action

Alta Sciences

[Video] Watch and Smile – Our Canadian Team in Action Mika.Matsumura Fri, 09/29/2023 - 23:10 HTML Think Canada! If you have yet to visit our Montréal clinical facility to learn about the advantages of conducting trials in Canada or had the pleasure of meeting the friendly, uniquely talented, and experienced team working on your studies, you will want to watch our latest video.

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ASTRO 2023 Session shines spotlight on physician burnout

SCIENMAG: Medicine & Health

MIAMI, FLORIDA (EMBARGOED UNTIL SEPT. 29, 2023, AT 5 PM ET, 2023) – Physician burnout was already a trending topic within the medical community before 2020, when the COVID-19 pandemic brought national attention to the issue. Credit: Photo by Sylvester MIAMI, FLORIDA (EMBARGOED UNTIL SEPT.

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From Lead Optimization to Drug Candidate Triage: A Data-Driven Approach to Drug Discovery

Fierce BioTech

From Lead Optimization to Drug Candidate Triage: A Data-Driven Approach to Drug Discovery Embark on an in-depth journey through the pivotal Make-Test-Decide Workflow, where collaboration and data-driven decisions play a paramount role in the intricate landscape of drug discovery. Watch now to learn how cloud implementation fosters accessibility and collaboration, revolutionizing research across locations and companies. lpastoria Fri, 09/29/2023 - 16:18 Embark on an in-depth journey through the p

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Oracle’s Updates Cloud EPM Data Integration UI

Perficient: Drug Development

If you’ve been following Oracle’s monthly updates for Cloud EPM, then you are aware that they had previously announced that the Data Management user interface was slowly being replaced with the newer Oracle Data Integration screen (found under the Data Exchange tile). The move does not mean the deprecation of functionality overall, but rather an enhancement to the user experience overall.

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Real-World Solutions for Business Challenges: Harnessing the Power of Innovative Technologies to Stay Competitive in a Dynamic Market

Fierce BioTech

Real-World Solutions for Business Challenges: Harnessing the Power of Innovative Technologies to Stay Competitive in a Dynamic Market dwunderlin Fri, 09/29/2023 - 16:20 Tue, 10/31/2023 - 10:00 Resource Type Webinar Corinne Marsolier Ruud Nieuweboer João Antunes Duration 60 Minutes Through real-world case studies, we will examine how life science organizations are harnessing the power of innovative technologies to drive growth, improve efficiency, and stay competitive.

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Women in Digital Virtual Panel Presented by Perficient and Adobe

Perficient: Drug Development

We’re thrilled to announce the next exciting installment in our Women in Digital series, brought to you by Perficient and Adobe. Following the success of our last in-person event in Cincinnati , we’re continuing our mission to empower and connect women. Date: October 10, 2023 Location: Virtual Event | Register Here Meet Our Panelists Our upcoming virtual panel discussion promises to be an inspiring and insightful experience, featuring accomplished women who have made their mark in th

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Genome study reveals 30 years of Darwin's finch evolution

Science Daily: Pharmacology News

An international team of researchers has released a landmark study on contemporary evolutionary change in natural populations. Their study uses one of the largest genomic datasets ever produced for animals in their natural environment, comprising nearly 4,000 Darwin's finches. The study has revealed the genetic basis of adaptation in this iconic group.

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Headless is out of this world, let’s dive in!

Perficient: Drug Development

I previously wrote about Sitecore Content Hub ONE and its place in the market as a new pure play headless CMS. One of the key differentiators of a pure play headless CMS is the lack of any presentation or visual rendering of content. They focus on managing content in its purest form in a repository to then syndicate it out to any channel. While many organizations still leverage pure play headless CMS’s to build traditional web experiences, a good fit use case is to provide physical world a

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Insights into early snake evolution through brain analysis

Science Daily: Pharmacology News

Recent study sheds new light on the enigmatic early evolution of snakes by examining an unexpected source: their brains. The results emphasize the significance of studying both the soft parts of animals’ bodies and their bones for understanding how animals evolved.

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Navigating FDA User Fee Updates for Fiscal Year 2023

thought leadership

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices. In this context, ProPharma would like to bring attention to these updates for our clients, colleagues, and contacts.

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Sensitive Quantitation of Antisense Oligonucleotides Using Capitainer® qDBS Microsampling Device Coupled With Hybridization LC-MS/MS

Alta Sciences

Sensitive Quantitation of Antisense Oligonucleotides Using Capitainer® qDBS Microsampling Device Coupled With Hybridization LC-MS/MS lperez Fri, 09/29/2023 - 09:30 Publication Altasciences_APA_2023_Sensitive_Quantitation_of_Antisense_Oligonucleotides_Using_Capitainer_qDBS_Microsampling_Device_Coupled_With_Hybridization_LC_MS_MS.

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Which pharmaceutical companies have the most aerosol dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most aerosol dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most aerosol dosed drugs… The post Which pharmaceutical companies have the most aerosol dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.