Sat.Mar 29, 2025 - Fri.Apr 04, 2025

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Study strengthens link between shingles vaccine and lower dementia risk

Science Daily: Pharmacology News

A new analysis of a vaccination program in Wales found that the shingles vaccine appeared to lower new dementia diagnoses by 20% -- more than any other known intervention.

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Reviewing the IDH1 Mutation‐Mediated Mechanism of Drug Resistance and Revisiting Its Overcoming Strategies

Chemical Biology and Drug Design

Isocitrate dehydrogenase (IDH) is a key metabolic enzyme that catalyzes the conversion of isocitrate to -ketoglutaric acid (-KG). At present, there are few studies on the drug resistance of mIDH1 inhibitors. Therefore, this article first summarizes terms of IDH1 function from the molecular mechanism of IDH1, the mechanism of mutation, and the metabolism of substances due to mutations.

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Covalent adduct Grob fragmentation underlies LSD1 demethylase-specific inhibitor mechanism of action and resistance

Covalent Modifiers

Amanda L. Waterbury, Jonatan Caroli, Olivia Zhang, Paloma R. Tuttle, Chao Liu, Jiaming Li, Ji Sung Park, Samuel M. Hoenig, Marco Barone, Airi Furui, Andrea Mattevi & Brian B. Liau Nat Commun 16 , 3156 (2025). [link] Chromatin modifiers often work in concert with transcription factors (TFs) and other complex members, where they can serve both enzymatic and scaffolding functions.

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Suzetrigine

New Drug Approvals

Suzetrigine CAS 2649467-58-1 Weight Average: 473.4 Monoisotopic: 473.137396951 Chemical Formula C 21 H 20 F 5 N 3 O 4 FDA 1/30/2025, Journavx To treat moderate to severe acute pain Press Release 2-Pyridinecarboxamide, 4-[[[(2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)tetrahydro-4,5-dimethyl-5-(trifluoromethyl)-2-furanyl]carbonyl]amino]- 4-[(2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5- dimethyl-5-(trifluoromethyl)oxolane-2- carboxamido]pyridine-2-carboxamide 4-[(2R,3S,4S,5R)-3-(3,4-difluor

FDA
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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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More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their Goals

FDA Law Blog: Biosimilars

By Dr. Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. According to reports, which were published before the most recent reports of HHS staff level reductions and tumultuous changes in leadership, FDA staff were missing minor deadlines.

FDA
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SAIAME: Semi‐Parameter Adaptation Information‐Assisted Multi‐Objective Evolutionary for Protein‐Ligand Docking

Chemical Biology and Drug Design

A multi-objective optimization algorithm incorporating the strategies of dynamic semi-parameter adaptation updating, gradient enhancement, and population size reduction is adopted to solve the problem of protein-ligand docking. ABSTRACT Molecular docking, which simulates the binding pose of a drug molecule to target proteins and predicts the binding affinity, is an important computational tool in structure-based drug discovery.

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Creating a Launch Checklist

Perficient: Drug Development

Are you a PM or BA who has been assigned a project or platform that is new to your company? If so, you may find that theres a learning curve for everything that needs to be executed, especially when it comes to the launch. Not all platforms are the same; they can require different steps to go live. Below is a list of steps I take when creating a launch checklist.

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While FDA Suffers Staffing Cuts, Nondelegation Case in SCOTUS Is Latest Legal Challenge to Curb Agency Powers

FDA Law Blog: Biosimilars

By John W.M. Claud & JP Ellison Last June, the United States Supreme Court issued four landmark decisions that curbed executive agency powers. Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Regardless your position on the correctness of the holdings or the reasoning behind them, Loper Bright , Jarkesy , EPA v.

FDA
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We know nanoplastics are a threat -- this new tool can help us figure out just how bad they are

Science Daily: Pharmacology News

While the threat that microplastics pose to human and ecological health has been richly documented and is well known, nanoplastics, which are smaller than one micrometer (1/50th the thickness of an average human hair), are far more reactive, far more mobile and vastly more capable of crossing biological membranes. Yet, because they are so tiny and so mobile, researchers don't yet have an accurate understanding of just how toxic these particles are.

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Twist Bioscience

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RNA
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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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Understanding and Implementing OAuth2 and OpenID Connect in.NET

Perficient: Drug Development

Authentication and authorization are two crucial aspects of web development. In modern applications, it’s essential to ensure that users are who they say they are (authentication) and have permission to access specific resources (authorization). OAuth2 and OpenID Connect are two widely used protocols that help achieve both goals. What is OAuth2?

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Market Analysis: The Impact of Biosimilars on the Generic Drug Industry in Europe

Drug Patent Watch

The Biosimilar Revolution: How Europe's Generic Drug Industry is Evolving As we navigate the ever-changing landscape of the pharmaceutical industry, one trend is clear: biosimilars are here to stay. In Europe, the generic drug industry is undergoing a significant transformation, driven by the increasing adoption of biosimilars. But what does this mean for the industry as a whole, and how will it impact the way we approach healthcare?

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World's smallest pacemaker is activated by light

Science Daily: Pharmacology News

Smaller than a grain of rice, new pacemaker is particularly suited to the small, fragile hearts of newborn babies with congenital heart defects. Tiny pacemaker is paired with a small, soft, flexible wearable patch that sits on the patient's chest. The wearable patch detects irregular heartbeats and automatically emits pulses of light. The light then flashes on and off at a rate that corresponds to the correct pacing.

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Inflation-Adjusted U.S. Brand-Name Drug Prices Fell for the Seventh Consecutive Year as a New Era of Drug Pricing Dawns (rerun)

Drug Channels

This week, Im rerunning some popular posts while I prepare for todays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Click here to see the original post from January 2025. It's time for Drug Channels annual examination of U.S. brand-name drug pricing. For 2024, average brand-name drugs list prices grew by only 2.3%.

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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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Log Framework Integration in Azure Functions with Azure Cosmos DB

Perficient: Drug Development

Introduction Logging is an essential part of application development, especially in cloud environments where monitoring and debugging are crucial. In Azure Functions, there is no built-in provision to log application-level details into a centralized database, making it challenging to check logs every time in the Azure portal. This blog focuses on integrating NLog into Azure Functions to store all logs in a single database (Cosmos DB) , ensuring a unified logging approach for better monitoring an

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The role of biosimilars in population health management initiatives

Drug Patent Watch

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives. But what exactly are biosimilars, and how can they make a meaningful impact on population health?

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Federal District Court Vacates FDA’s Laboratory Developed Tests Final Rule

FDA Law Blog: Biosimilars

By Steven J. Gonzalez On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDAs Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests.

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The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars (rerun)

Drug Channels

This week, Im rerunning some popular posts while I prepare for Fridays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Click here to see the original post from January 2025. For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies.

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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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Tips for building top performer teams

Perficient: Drug Development

There’s no doubt that every Director or Manager wants a high-performance team that delivers the best results and allows them to focus on building new business opportunities. Come on, let’s face it! If we were comparing a work team with a sports team, who wouldn’t want to have a Barcelona Soccer Club, the Dodgers baseball team, or the Philadelphia Eagles in American football?

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Transforming Biopharma Intelligence: Moving from Traditional Analysts to Direct Raw Data Platforms

Drug Patent Watch

The Future of Biopharma Intelligence: Why Direct Data Platforms are Revolutionizing the Industry As a biopharma professional, you're likely no stranger to the challenges of staying ahead in a rapidly evolving market. From navigating complex regulatory landscapes to keeping pace with the latest scientific breakthroughs, it's easy to get overwhelmed by the sheer volume of information at your fingertips.

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Highly accurate blood test diagnoses Alzheimer's disease, measures extent of dementia

Science Daily: Pharmacology News

A newly developed blood test for Alzheimer's disease not only aids in the diagnosis of the neurodegenerative condition but also indicates how far it has progressed, according to a new study.

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Four Revelations from Minnesota’s First 340B Transparency Report (rerun)

Drug Channels

This week, Im rerunning some popular posts while I prepare for Fridays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Click here to see the original post from December 2024. Its time to pay attention to the money behind the 340B curtain. Minnesota just released the industrys first ever mandated financial report on the 340B Drug Pricing Program.

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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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End-to-End Lineage and External Raw Data Access in Databricks

Perficient: Drug Development

Achieving end-to-end lineage in Databricks while allowing external users to access raw data can be a challenging task. In Databricks, leveraging Unity Catalog for end-to-end lineage is a best practice. However, enabling external users to access raw data while maintaining security and lineage integrity requires a well-thought-out architecture. This blog outlines a reference architecture to achieve this balance.

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The Global Generic Drug Market: Trends, Opportunities, and Challenges

Drug Patent Watch

The Future of Healthcare: Unpacking the Global Generic Drug Market As we navigate the ever-changing landscape of the pharmaceutical industry, one thing is clear: the demand for affordable, high-quality medications is on the rise. The global generic drug market is at the forefront of this trend, with its growth projected to reach new heights in the coming years.

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Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

BioPharma Drive: Drug Pricing

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

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The Top Pharmacy Benefit Managers of 2024: Market Share and Key Industry Developments

Drug Channels

Threes still company in the world of pharmacy benefit managers. For 2024, nearly 80% of all equivalent prescription claims were processed by three familiar companies: the CVS Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group. The names havent changed, but shifting relationships and contract shakeups have altered the plot, with Express Scripts stepping into a new lead role.

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Deena Piquion from Xerox on Data, Disruption, and Digital Natives

Perficient: Drug Development

In the new episode of the “What If? So What?” podcast, Jim Hertzfeld and Deena Piquion, chief growth and disruption officer at Xerox , discuss how disruption and digital transformation can position companies to succeed in a rapidly changing technology landscape. Deena is leading Xerox on a unique and pivotal reinvention journey as the company undergoes a significant transformation, expanding beyond its traditional print and copy services.

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Shingles Vaccine Protects Against Dementia

Drugs.com

TUESDAY, April 2, 2025 -- The shingles vaccine can do more than protect seniors from painful, blistering rashes. It also appears to protect older folks from dementia, researchers say. Seniors who got the shingles vaccine when it became available.

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Peter Marks, FDA’s top vaccine official, resigns

BioPharma Drive: Drug Pricing

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.

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Western diet causes inflammation, traditional African food protects

Science Daily: Pharmacology News

A switch of just two weeks from a traditional African diet to a Western diet causes inflammation, reduces the immune response to pathogens, and activates processes associated with lifestyle diseases. Conversely, an African diet rich in vegetables, fiber, and fermented foods has positive effects. This study highlights the significant impact of diet on the immune system and metabolism.

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We Are Perficient: Transforming the Digital Strategies with Adobe

Perficient: Drug Development

Today in our “We Are Perficient” series, we explore how businesses can take their digital experience to the next level through mobile optimization. In an exclusive conversation with Jonathan Crockett, Managing Director of Go-To-Market, Sales, and Solutions at Perficient , we dive into key strategies to ensure brands deliver seamless, high-impact experiences on mobile devices.

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FDA Delays Final Approval of Novavax COVID Vaccine

Drugs.com

FRIDAY, April 4, 2025 -- The U.S. Food and Drug Administration (FDA) has delayed the full approval of Novavaxs COVID-19 vaccine. The decision had been expected by April 1, but the agency now says it needs more information before moving forward.The.