Sat.Mar 25, 2023 - Fri.Mar 31, 2023

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2023 IS the Year for OTC Naloxone!

FDA Law Blog: Biosimilars

By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n

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Molecular targets of metformin against ovarian cancer based on network pharmacology

Chemical Biology and Drug Design

In this study, 255 drug targets of metformin were obtained from the BATMAN, Drugbank, PharmMapper, SwissTargetPrediction, and TargetNet databases. Meanwhile, 10,463 differentially expressed genes (DEGs) in OC were screened from GSE29450, GSE10971, GSE18520, GSE14407, and TCGA + GTEx datasets. A total of 95 common targets were obtained by deintersection of drug targets of metformin and DEGs in OC.

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Webinar recap: Kidney Action Week webinar featuring Antidote’s Rich Towne, PharmD

Antidote

The annual Kidney Action Week is a virtual event put on by the American Kidney Fund designed to bring the entire kidney health community together for a week of amazing and informative content on all things related to kidney health. The event is filled with discussions, Q&As, webinars, and more — and this year, Antidote was thrilled to be involved!

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The Big Three PBMs’ 2023 Formulary Exclusions: Observations on Insulin, Humira, and Biosimilars (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies.

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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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Which pharmaceutical companies have the most drug patents in Ukraine?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Ukraine. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is… The post Which pharmaceutical companies have the most drug patents in Ukraine? appeared first on DrugPatentWatch - Make Better Decisions.

More Trending

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National Kidney Month: What to know about IgA nephropathy

Antidote

Each year in March, the National Institute of Diabetes and Digestive and Kidney Diseases puts on National Kidney Month , a month dedicated to raising awareness about kidney health and conditions. Chronic kidney disease, a grouping of conditions that damage the kidneys , impacts around 37 million Americans, and millions of others are considered to be at an increased risk.

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Behind the GoodRx-Express Scripts Partnership: How PBMs Profit from Discount Cards in Pharmacy Benefits (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Friday's webinar will include my latest thoughts on a key trend discussed in todays rerun: how plan sponsors are incorporating patient-paid prescriptions—cash-pay prescriptions and discount cards—within pharmacy benefits.

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Cream dosed drug patent expirations by year

Drug Patent Watch

This chart shows the patent expirations for cream dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from… The post Cream dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 96
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Looking back at Women’s History Month

BenchSci

As Women’s History Month comes to a close, I wanted to share some of the events and takeaways we learned on behalf of the BenchShe+ leadership team. We had the honor of putting together programming not just for members of the BenchShe+ employee resource group (ERG), but also hosting events company-wide to help educate and inspire our team throughout the month.

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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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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.

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CVS, Walgreens, and Walmart Keep Position in 2023 Part D Preferred Networks—While Kroger Bails Over its Express Scripts Blowup (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. One follow-up to this rerun: Kroger’s participation as a preferred pharmacy declined significantly due to its Express Scripts relationship. Based on early 2023 enrollment data, Kroger is preferred in plans that enrolled only 11.8 million people—a decline of 33% from the 2022 figure.

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Which pharmaceutical companies have the most capsule dosed drugs?

Drug Patent Watch

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

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Electronic Data Capture – The Basics

Crucial Data Solutions

In a time with lots of hype surrounding decentralized clinical trial (DCT) solutions, let's not lose sight of the importance of a dependable and secure electronic data capture (EDC) system. This blog post walks you through the basics to keep in mind when selecting an EDC platform for your studies. The post Electronic Data Capture – The Basics appeared first on Crucial Data Solutions.

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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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The New Fungus Among Us, Candida auris

PLOS: DNA Science

In “The Last of Us,” a video game and recently-wrapped HBO series , giant mutant fungi turn much of humanity into zombies. In real life, another fungus, the yeast Candida auris , is spreading, just as COVID finally fades. Candida auris is the first multi-drug resistant fungus identified. It is deadlier than familiar relative Candida albicans , which lies behind common vaginal and throat infections.

DNA 52
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Brand-Name Drug Prices Fell for the Fifth Consecutive Year—And Plummeted After Adjusting for Inflation (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2023. Time for the Drug Channels annual reality check on drug pricing. The data once again tell a different story than you might read in your favorite politician’s Twitter feed or misleading news reports.

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New patent for Xellia Pharms drug VANCOMYCIN

Drug Patent Watch

Annual Drug Patent Expirations for VANCOMYCIN Vancomycin is a drug marketed by Xellia Pharms Aps, Akorn, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Alkem… The post New patent for Xellia Pharms drug VANCOMYCIN appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Episode 14: The Medical Affairs Learning Journey: Navigating Unapproved Content with Marie-Josee Toutounji

ACTO

Listen on In this episode, Marie-Josee Toutounji, Medical affairs professional with over 20 years of experience in the pharmaceutical industry, discusses the pressing issue of unapproved content in the medical and regulatory field. The episode covers the potential risks of using unapproved content and tools in healthcare. Marie-Josee explores the challenges of implementing a continuous learning culture in the industry, with a focus on stakeholder engagement, compliance, and documentation to deve

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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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Electronic Data Capture – The Basics

Crucial Data Solutions

With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. Yet, this is not the case. While most clinical researchers have embraced the use of specialized software platforms to help stay on top of study data, there are still some who continue to collect, store, access and analyze data using old-school pen and paper or with software (like spreadsheets) that are not fit for purpo

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The Warped Incentives Behind Amgen’s Humira Biosimilar Pricing–And What We Can Learn from Semglee and Repatha (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version. In February, AbbVie stated that U.S. Humira sales would be decline by about 37% in 2023—which is at the lower end of its previous erosion projection of 35% to 55%.

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Which pharmaceutical drugs have the most drug patents in Japan?

Drug Patent Watch

This chart shows the drugs with the most patents in Japan. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Japan? appeared first on DrugPatentWatch - Make Better Decisions.

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Predictive Oncology announces collaboration to advance gene therapy

Predictive Oncology

Predictive Oncology announces it is partnering with Integra Therapeutics, a company focused on engineering the next generation of gene writing tools to cure diseases. The collaboration was created to pursue a novel method to enhance Integra Therapeutics’ ability to use gene editing for future cancer therapies. Read about the news here. The post Predictive Oncology announces collaboration to advance gene therapy appeared first on Predictive Oncology.

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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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DARPA Neurotechnology: The Deep Dive

Codon

You’re reading Codon, a newsletter about biology, technology, and the future. View our database of DARPA neurotechnology projects online. “I am a brain, Watson. The rest of me is a mere appendix.” — Arthur Conan Doyle Ted Berger was running out of money. In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall.

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Quality vs Quantity: Strategies For Device Manufacturers to Succeed in the Current Marketplace

H1 Blog

The United States devotes roughly $200 billion to national health expenditures on medical devices every year. In fact, the global medical devices market is projected to grow from $495.46 billion in 2022 to $718.92 billion by 2029. Medical device companies historically have operated under the assumption that if they built it, physicians would buy it.

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New patent for Msd Sub drug ISENTRESS

Drug Patent Watch

Annual Drug Patent Expirations for ISENTRESS Isentress is a drug marketed by Msd Sub Merck and is included in three NDAs. It is available from eight suppliers. There are six… The post New patent for Msd Sub drug ISENTRESS appeared first on DrugPatentWatch - Make Better Decisions.

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Drug warning update: withdrawn drugs and drugs that carry a black box warning

The ChEMBL-og

The drug warning information in ChEMBL has been updated for version 32. In particular, the withdrawn drug data has been fully reviewed and, to assist the manual curation process, our rules have been updated, clarified and formally written. In ChEMBL, a withdrawn drug is an approved drug (ie Phase 4) that has subsequently been withdrawn for toxicity reasons.

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How Single IRB Review Mandates Help Research Sponsors

Advarra

The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater efficiencies and consistencies when conducting multisite research. This change has the potential for a substantial impact on sponsors and contract research organizations (CROs), as well as institutions conducting multisite research.