November, 2022

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UK fast tracks approval for life-extending prostate cancer drug

Drug Discovery World

England will become the first country in Europe to roll out darolutamide (Nubeqa) to patients whose prostate cancer has spread to other parts of the body. . The drug works by blocking androgen receptors in cancer cells, which in turn blocks the effect of testosterone that allows the cancer cells to survive and multiply. Studies show the chances of living longer are increased by one third in men who were previously left untreated. .

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Co-crystallization in drug development ~ Exploring the benefits of co-crystals ~

Drug Discovery Today

Over the last decade, co-crystallization has become an attractive alternative to improve the physiochemical properties of drugs without affecting their pharmacology. As a result of the pharmaceutical benefits co-crystals exhibit, industrial interest is on the rise. Here Dr. Thomas Kendall, application specialist at crystallization and solid-state specialist Technobis Crystallization Systems, gives a perspective on the benefits of co-crystals and explains how they can be screened.

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Talk of the Towne Episode 05: Diversity in research with Allison Kalloo

Antidote

Antidote’s podcast, Talk of the Towne , focuses on the ultimate sweet spot: that special place where science and patients converge. Our host, Dr. Rich Towne, was trained in pharmacy and currently works in Clinical Informatics at Antidote. In each episode, Rich welcomes a new guest from an Antidote partner organization, and takes an in-depth look at a particular area of interest, zeroing in on the story that Antidote's data is telling about how best to connect patients and research.

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

Drug Channels

Last week, GoodRx announced that it would become the exclusive prescription discount card provider for the commercial beneficiaries of Cigna’s Express Scripts. Links below. The rise of discount card pricing within pharmacy benefit plans is a positive development. Patients get access to market prices that can be lower than their PBM’s contracted rate.

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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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From U.S. Air Force Captain to CRO Leader: Karl D. Kendall Shares His Story

Conversations in Drug Development Trends

At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?

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In Silico in Action: A Case Study in Relapsing Remitting Multiple Sclerosis

The Premier Consulting Blog

Computer modeling and simulation of humans, both healthy and with diseases, is a powerful tool. It can augment preclinical and clinical research through mechanistic and predictive investigations that would otherwise be impossible. In recent years, regulatory agencies have begun to accept evidence obtained through modeling and simulation, and in silico clinical trials have emerged as an important approach for virtual testing of pharmacological therapies and medical devices.

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New tentative approval for Teva Pharms drug eltrombopag

Drug Patent Watch

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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The differences between osteoporosis and osteoarthritis

Antidote

Osteoporosis and osteoarthritis (OA) are conditions with different causes and symptoms, but because people are often diagnosed with both, the terms are frequently used interchangeably.

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Cell and Gene Therapy Roundup: What the Road to Success Looks Like

Drug Channels

Today’s guest post comes from Lung-I Cheng, Vice President of Cell & Gene Therapy at AmerisourceBergen. Lung-I discusses advancements in cell and gene therapy and explains how to tackle the challenges facing manufacturers, providers, and patients. Click here to learn about AmerisourceBergen’s Cell and Gene Therapy solutions for biopharma companies, providers, and patients.

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Raters & Therapists: Protecting the validity of your study’s data in a psychedelic trial

Conversations in Drug Development Trends

Psychiatry has long embraced treatment options other than pharmaceuticals. So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. This is called “psychedelic-assisted psychotherapy” (PAP). But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data?

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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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Applications of Genetically Engineered Organoids and Cell Lines

Crown Bioscience

This post explores applications of genetically engineered organoids and cell lines to expand and accelerate anti-cancer drug discovery and development. We first provide a brief overview of two major methods that are used to develop engineered organoids/cell lines (i.e., lentiviral transduction and PiggyBac), followed by typical workflows for generating these models.

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Why genomic healthcare data matters in the development of new therapies 

Drug Discovery World

Genomic healthcare data is critical to identify disease risk, ancestry, traits and response to medicines and aids in the development of new targeted therapies – precision medicines. DDW’s Megan Thomas observes developments of accessibility in this sector and the potential impact. . The origins . One might argue that this all started getting exciting with the launch of the Human Genome Project, which the National Human Genome Research Institute consider to be one of the greatest scientifi

Therapies 246
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New tentative approval for Amneal Pharms drug saxagliptin

Drug Patent Watch

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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What are the types of mitral valve regurgitation?

Antidote

Mitral valve regurgitation, also known as mitral regurgitation, mitral insufficiency, or mitral incompetence, is the most common type of heart valve disease , affecting more than 2% of the population. Though mild mitral valve regurgitation does not usually cause issues, it is a condition that can worsen with time and lead to more severe symptoms. Below, we will be looking at what this condition is, what the common causes are, and some symptoms of mitral valve regurgitation that are helpful to kn

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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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Innovate4Outcomes: Collaborating to Solve Antimicrobial Resistance

Drug Channels

Today’s guest post comes from Matthew Balogh, Head of Digital Marketing at Melinta Therapeutics. Matt discusses the ongoing global problem of antimicrobial resistance (AMR). He suggests that lessons learned from the COVID-19 pandemic can inform both innovation in AMR therapies and our understanding of AMR. To learn more about the global challenge of AMR and brainstorm solutions, request an invitation to Innovate4Outcomes ®.

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Bayesian Adaptive Clinical Trial Designs: INLA vs. MCMC

Cytel

Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as oncology and rare diseases, and in addressing clinical development challenges for COVID-19 drugs, devices, and biologics. From early-phase trials to late-phase development, utilizing Bayesian tools can expedite and/or de-risk trials, even when used to augment a Frequentist framework.

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Protein Assays | BMG LABTECH

BMG Labtech

What are proteins? Next to carbohydrates, lipids and nucleic acids, proteins are one of the main macromolecule building blocks of life. On a molecular basis, they can be described as complex polymers of amino acids, connected via a peptide bond backbone (fig.1). There are 20 different types of amino acids available as possible residues of individual subunits of a protein.

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Can Europe become a major player in cell and gene therapy?

Drug Discovery World

With European life sciences R&D investment at a 20-year low, biopharmaceutical associations and MEPs are calling on the EU to modernise its policies. DDW’s Diana Spencer asks what will be needed for Europe to compete in the growing global market for advanced therapies. . A new report by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA has revealed that Europe is falling behind the US and Asia in its pharmaceutical R&D investment,

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New patent for Guerbet drug ELUCIREM

Drug Patent Watch

Annual Drug Patent Expirations for ELUCIREM Elucirem is a drug marketed by Guerbet and is included in one NDA. It is available from two suppliers. The generic ingredient in ELUCIREM…. The post New patent for Guerbet drug ELUCIREM appeared first on DrugPatentWatch - Make Better Decisions.

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Lung Cancer Awareness Month: Helping patients through research

Antidote

Lung Cancer Awareness Month occurs every November with the purpose of increasing general knowledge of lung cancer and the treatment options available to patients who have been diagnosed. While lung cancer is still a prevalent disease, there have been many advancements in the lung cancer treatment space over the years, and medical research studies are consistently underway to find better solutions for patients.

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Preferred Pharmacy Networks in 2023’s Medicare Part D Plans: Cigna, CVS Health, Humana, UnitedHealthcare, WellCare, and More

Drug Channels

Open enrollment is under way for the 2023 Medicare Part D plans. Our exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that preferred cost sharing pharmacy networks will maintain their dominance as an established component of Part D benefit design. For 2023: 98% of stand-alone Medicare Part D prescription drug plans (PDP) will have a preferred network. 52% of Medicare Advantage prescription drug (MA-PD) plans will have a preferred network.

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Regulatory Trends in Cell and Gene Therapies

Advarra

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. There have been recent signals indicating the Food and Drug Administration (FDA) plans to provide greater support for CGT, addressing key issues continuing to impede their development.

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Open Targets Platform 22.11 has been released!

The Open Targets Blog

The latest release of the Platform — 22.11 — is now available at platform.opentargets.org. Key points In addition to continuous updates from our data providers, we have introduced the following new features: Gene burden data for Parkinson’s disease Updated classifications for clinical trial stop reasons Variant functional consequences, available to browse in the Gene2Phenotype and Orphanet widgets Key stats Metric Count Targets 62,678 Diseases 22,274 Drugs 12,854 Evidence 14

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Polymer-based drug delivery system for mRNA wins Excellence Award

Drug Discovery World

A new polymer-based drug delivery system for mRNA and other nucleic acids has won the CPHI Excellence in Pharma Award in the category “Packaging and Drug Delivery”. . The system was developed by Evonik Health Care together with researchers at Stanford University. . Developed together with Professors Robert Waymouth, Paul Wender and Ronald Levy from the University of Stanford in the US, the prize-winning polymer-based platform complements Evonik’s existing portfolio of lipid-based drug de

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New patent expiration for Viatris drug NEURONTIN

Drug Patent Watch

Annual Drug Patent Expirations for NEURONTIN Neurontin is a drug marketed by Viatris and is included in three NDAs. It is available from two suppliers. There is one patent protecting…. The post New patent expiration for Viatris drug NEURONTIN appeared first on DrugPatentWatch - Make Better Decisions.

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The holiday season and mental health: Tips for managing stress and staying healthy

Antidote

While the holiday season can be a time filled with joy and cheer, for many, these are not the only emotions associated with this time of year. In fact, a 2021 survey found that 3 in 5 Americans feel that their mental health is negatively impacted by the holidays.

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The Consolidated Drug Channel and Cash-Pay Drugs: My Podcast with a16z's Julie Yoo

Drug Channels

I recently joined Julie Yoo on Bio Eats World , a podcast from legendary venture capital firm Andreessen Horowitz (also known as "a16z"). Julie is a General Partner at Andreessen Horowitz. We chatted about the current state of the U.S. drug channel, the roles and controversies around pharmacy benefit managers (PBMs), GoodRx, Mark Cuban’s cost-plus pharmacy, the 340B Drug Pricing Program, and much more.

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Biosimilar Clinical Trials and US FDA Guidance

ProRelix Research

Biological products have unlocked the potential for the management of several diseases such as cancers and autoimmune diseases for which treatment with small molecule, chemically synthesized drug molecules remain suboptimal. […]. The post Biosimilar Clinical Trials and US FDA Guidance appeared first on ProRelix Research.

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Five Medical Communication Preferences, According to Patients

PPD

The medical communication experts at Thermo Fisher Scientific ’s PPD clinical research business were not satisfied with basic patient satisfaction data to inform our clients’ medical communication strategies. So, we went straight to the source: In December 2021, we directly surveyed 400 European and United States patients on their preferences for medical communications.

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Hope for drug that slows neurodegenerative disease

Drug Discovery World

Scientists have found a new drug treatment that can slow the progression of neurodegenerative disease in mice. The breakthrough research may offer fresh hope in tackling currently untreatable conditions such as Alzheimer’s disease (AD). . The study was led by researchers at the University of Glasgow’s new Advanced Research Centre (ARC) and published in Science Signaling.

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New patent for AADI drug FYARRO

Drug Patent Watch

Annual Drug Patent Expirations for FYARRO Fyarro is a drug marketed by Aadi and is included in one NDA. There are four patents protecting this drug. This drug has one…. The post New patent for AADI drug FYARRO appeared first on DrugPatentWatch - Make Better Decisions.

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Alzheimer's vs. dementia: An overview for National Alzheimer's Disease Awareness Month

Antidote

While there are many conditions that can cause memory loss , dementia and Alzheimer’s disease are probably two of the most well-known terms associated with cognitive decline. However, while these two terms are often used interchangeably, they actually refer to different kinds of memory loss diseases. In honor of November being National Alzheimer’s Disease Awareness Month , we wanted to take a few moments to address some important considerations when comparing Alzheimer’s and dementia.

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Drug Channels Outlook 2023 (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2023. Friday, December 16, 2022 12:00 p.m. to 1:30 p.m. ET. This page describes the event and explains how to purchase a registration to the live event. The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

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Everything we know about resistance arteries

Reprocell

Resistance arteries are a group of blood vessels that regulate up to 90% of peripheral vascular resistance. 1 There are three types of resistance vessels in humans: precapillary sphincters, arterioles, and small arteries. 2 They are important for controlling blood flow to vital organs, such as the heart (coronary arteries) and the brain (cerebral resistance arteries) so are often considered in cardiovascular safety studies. 1,3 In the following article, we have summarized the physiology of resis