Fri.Mar 29, 2024

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This week in drug discovery (25-29 March) 

Drug Discovery World

News round-up for 25-29 March by DDW Digital Content Editor Diana Spencer. In another busy week for drug discovery and development, we have seen the FDA approval of a monoclonal antibody for emergency use in Covid-19, the launch of trials into innovative new treatments for urea cycle disorders and alcohol use disorder, and a significant acquisition for Novo Nordisk, as well as the discovery of a new way to target dormant cancer cells.

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High-Strength Lidocaine Skin Creams Can Cause Seizures, Heart Trouble, FDA Warns

Drugs.com

FRIDAY, March 29, 2024 -- Some pain-relieving skin products contain potentially harmful doses of the numbing agent lidocaine and should be avoided, the U.S. Food and Drug Administration warns.These creams, gels, sprays and soaps are marketed for.

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Japan becomes first country to approve Astellas’ gastric cancer mAb

Drug Discovery World

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Vyloy (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. Vyloy is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world. Gastric cancer is the third deadliest cancer in Japan, with 126,724 cases diagnosed in 2022.

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CDC Warns of Spike in Bacterial Illness That Can Cause Meningitis

Drugs.com

FRIDAY, March 29, 2024 -- There has been a troubling rise in cases of a rare bacterial illness that can cause meningitis, U.S. health officials warned Thursday.In an alert issued to doctors, the U.S. Centers for Disease Control and Prevention said.

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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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Bristol Myers says KRAS drug succeeds in key trial

BioPharma Drive: Drug Pricing

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

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Another Study Warns of Surgery Risks for Folks Taking Ozempic, Wegovy

Drugs.com

FRIDAY, March 29, 2024 -- People taking weight-loss drugs like Ozempic and Wegovy need to drop them in the days or weeks prior to surgery, a new study warns.Folks on one of these drugs -- known as GLP-1 receptor agonists -- have a 33% higher risk.

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More Trending

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Steady Rise in U.S. Suicides Among Adolescents, Teens

Drugs.com

FRIDAY, Match 29, 2024 -- U.S. rates of suicide by all methods rose steadily for adolescents between 1999 and 2020, a new analysis shows.During those two decades, over 47,000 Americans between the ages 10 and 19 lost their lives to suicide, the.

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Hevolution Foundation issues $115 million call for applications for geroscience research opportunities

SCIENMAG: Medicine & Health

BOSTON, United States — 29 March, 2024 — Based on the success of its 2023 HF-GRO program effort, Hevolution Foundation is issuing a call for applications for the 2024 iteration of the program. HF-GRO is an international effort to accelerate progress in healthy aging research.

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What Is 'Mindful Reading' and Can It Help Your Brain?

Drugs.com

FRIDAY, March 29, 2024 -- Ever immersed yourself in a book and lost all sense of the time and place you're currently in?That's how reading can meld with mindfulness, one neuropsychologist explains.The experience can bring real mental health.

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About Broadies

Broad Institute

About Broadies By Maria Nemchuk March 29, 2024 Breadcrumb Home About Broadies We call ourselves “Broadies” – a unique, collaborative community of faculty based at the Broad Institute and our partner institutions, professional scientists, fellows, early-career scientists, and members of our administrative team.

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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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U.S. TB Cases Reach Highest Level in a Decade

Drugs.com

FRIDAY, March 29, 2024 -- Tuberculosis cases are on the rise in the United States, with the number of reported infections in 2023 the highest seen in a decade.Forty states logged an increase in tuberculosis (TB) cases, and rates were up among.

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What we expect European regulators to do in April 2024

Agency IQ

BY CHELSEY MCINTYRE, PHARMD , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Eye's 'Microbiome' Could Give Clues to Better Dry Eye Treatments

Drugs.com

FRIDAY, March 29, 2024 -- Folks suffering from dry eyes might have a problem with the naturally occurring bacteria found on the surface of their eyes, a new study suggests.There are key differences in the microbes found on dye eye patients compared.

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National PFAS water regulations imminent

Agency IQ

BY WALKER LIVINGSTON, ESQ The White House Office of Information and Regulatory Affairs has cleared a final rule that will implement the first national drinking water regulations for per- and polyfluoroalkyl substances. The rule, once released, will set the tone for future PFAS regulation in the U.S. Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since the 1940s.

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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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Chat GPT Can Produce Medical Records Ten Times Faster Than Doctors

Drugs.com

FRIDAY, March 29, 2024 -- Artificial intelligence programs could be an effective way to relieve the paperwork burden that keeps doctors from seeing more patients, a new study finds.The AI program Chat GPT can write administrative medical notes up.

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What We Expect the FDA to do in April and May 2024

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months 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. Fill out the form to read the full article.

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Obesity in Childhood Doubles Odds for MS in Young Adulthood

Drugs.com

FRIDAY, March 29, 2024 -- Children who are obese face double the odds of developing multiple sclerosis later in life, a new study warns.The overall odds for any one child to develop the neurodegenerative illness remains very low. However, the.

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What we expect the EPA to do in April 2024

Agency IQ

BY WALKER LIVINGSTON, ESQ The top line: In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. A final herbicide strategy to help the EPA meet its Endangered Species Act (ESA) requirement. Fill out the form to read the full article.

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog: Biosimilars

By John W.M. Claud & Kalie E. Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. Inspections went down—way down—during the pandemic. In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections.

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FDA’s oncology advisory committee to consider MRD as a multiple myeloma endpoint

Agency IQ

BY RACHEL COE, MSC Yesterday, the FDA announced that its Oncologic Drugs Advisory Committee would weigh in on the potential use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials. Cancers of the blood and bone marrow can affect production and function of white blood cells, red blood cells, and platelets, all produced by hematopoietic stem cells.

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Simplifying Address Management with Apex Triggers in Salesforce

Perficient: Drug Development

Hello Trailblazers! In Salesforce, managing addresses can sometimes be a tedious task, especially when dealing with duplicate data or ensuring consistency across different records. However, with the power of Apex triggers, we can automate address management processes to streamline operations and improve data accuracy. In this blog, we’ll explore how to use an Apex trigger to automatically synchronize shipping and billing addresses on the Account object based on a checkbox field.

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New tentative approval for MYLAN drug efavirenz, emtricitabine and tenofovir alafenamide

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

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The Pharmacist in the Value-Based Care Era

Fierce BioTech

The Pharmacist in the Value-Based Care Era swheeler Fri, 03/29/2024 - 17:24 Wed, 05/15/2024 - 14:00 Resource Type Webinar Karen Silverblatt, RPh Promotion Start Wed, 04/03/2024 - 12:00 Promotion End Thu, 10/03/2024 - 12:00 Duration 60 minutes The role of the pharmacist is evolving to focus less on administrative tasks and more on playing an integral role in the care management journey and closing gaps in care to improve patient outcomes.

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Important Update for Oracle EPM Cloud

Perficient: Drug Development

Oracle’s release notes for the March update includes a very important feature for Oracle EPM Cloud customers. The Daily Maintenance can now be configured to any minute within any hour (i.e. HH:MM format). Previously, the window could only be configured to start at the top of the hour. This allows customers to have more control over the maintenance processes.

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Mutation Helps Even Carriers of 'Alzheimer's Gene' Avoid Alzheimer's

Drugs.com

FRIDAY, March 29, 2024 -- A genetic mutation that boosts cell function could protect people against Alzheimer’s disease, even if they carry another gene mutation known to boost dementia risk.The newly discovered mutation appears to protect people.

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Mobile Apps Accessibility Series: User Testing with Diverse Groups – 9

Perficient: Drug Development

Welcome to the last installment of our Mobile Apps Accessibility Series! In this segment, we’ll explore the importance of user testing with diverse groups and how it can significantly enhance the accessibility and inclusivity of your app. Let’s delve into why user testing with diverse groups matters and how you can ensure that your app meets the needs of all users.

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New patent for Slayback Pharma drug PREVDUO

Drug Patent Watch

Annual Drug Patent Expirations for PREVDUO Prevduo is a drug marketed by Slayback Pharma Llc and is included in one NDA. It is available from one supplier.

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Clear Signage in Public Spaces for Universal Accessibility Series: Guiding the Way – 1

Perficient: Drug Development

Welcome to the inaugural installment of our Clear Signage in Public Spaces for Universal Accessibility Series! In this series, we’ll explore the importance of clear signage in promoting accessibility and inclusivity in public spaces. Let’s begin by discussing the significance of clear signage and how it guides individuals of all abilities through their surroundings.

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New patent for Eli Lilly drug ZEPBOUND

Drug Patent Watch

Annual Drug Patent Expirations for ZEPBOUND Zepbound is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier.

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Storybook

Perficient: Drug Development

You may have never heard of Storybook or maybe that was just a glimpse leaving you a feeling Storybook is such an unnecessary tool – in that case, this article is for you. Previously, I could share this opinion, but since I played with Storybook in action when building JumpStart starter kit with Next.Js, it changed. Why With the advent of responsive design, the uniqueness of user interfaces has increased significantly – with the majority of them having bespoke nuances.

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New patent expiration for Vifor Pharma drug VELTASSA

Drug Patent Watch

Annual Drug Patent Expirations for VELTASSA Veltassa is a drug marketed by Vifor Pharma and is included in one NDA. It is available from one supplier.

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SQL: DML, DDL and DCL

Perficient: Drug Development

In the realm of databases, SQL (Structured Query Language) serves as the lingua franca, enabling users to interact with data stored in various systems effectively. While SQL encompasses a wide array of commands, understanding the distinctions between Data Manipulation Language (DML), Data Definition Language (DDL), and Data Control Language (DCL) is fundamental for wielding this powerful tool with finesse.

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New patent for Genentech Inc drug XOFLUZA

Drug Patent Watch

Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier.

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4 Crucial Benefits of Agile Project Management for Healthcare Providers and Payers

Perficient: Drug Development

H ealthcare organizations (HCOs) are doubl ing down on business resiliency, cost optimization, and better experiences for their consumers and employees. To operationalize the important tasks at hand , many of these team s are adopting more modern, A gile methods to streamline and speed that progress. And importantly, health plans and systems increasingly rally d igital , IT , and marketing teams as important partners in this transformation work.