June, 2022

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CDCDB: A large and continuously updated drug combination database

Drug Patent Watch

This article was originally published by Guy Shtar, Louise Azulay, Omer Nizri, Lior Rokach & Bracha Shapira in Scientific Data volume 9, Article number: 263 under a Creative Commons Attribution…. The post CDCDB: A large and continuously updated drug combination database appeared first on DrugPatentWatch - Make Better Decisions.

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National Association of Specialty Pharmacy (NASP) 2022 Annual Meeting & Expo

Drug Channels

National Association of Specialty Pharmacy (NASP) 2022 Annual Meeting & Expo. September 19-22, 2022 | Gaylord Palms Resort & Convention Center | Orlando, FL. www.naspnet.org/annualmeeting. The National Association of Specialty Pharmacy (NASP) will host the NASP 2022 Annual Meeting & Expo September 19-22. NASP will celebrate their 10th Anniversary and welcome attendees to a new conference venue – the gorgeous Gaylord Palms Resort & Convention Center, located in Orlando, Florida.

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A Comprehensive Guide to Atopic Dermatitis

Olympian Clinical Research

Atopic dermatitis is a form of eczema and is the most common chronic inflammatory skin disease. While this condition is often seen in children, around 16.5 million Americans suffer from this itchy skin condition. Although there is no cure for this condition, with the proper knowledge, treatments, and lifestyle changes, those with eczema may manage their symptoms and lead happy, healthy lives.

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The Current issue of “The view from here” is concerned with Cancer

Drug Discovery Today

The topic of this month’s newsletter from Drug Discovery Today is “Cancer”.

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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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Optimizing the digitization of tech transfer and scale-up for Pharma 4.0

Pharma Manufacturing

Advanced digital thread and technology transfer capabilities can help pharma reap the benefits of its processes

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Beyond the pill | Moving towards value-added services

Altus Drug Development

A focus on customers has always been one of the main pillars of the pharmaceutical industry. However, this is often narrowed down to the creation of product-centric marketing strategies with a strong customer orientation. While this strategy is widely adopted by modern pharmaceutical companies, in recent years, its effectiveness has begun to wane. The integration of value-added services and strategies provides a new perspective on patient care.

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Pharmacist Job Market in 2021: Retail Pharmacy Slump, Hospital Boom

Drug Channels

Time for an update to the Drug Channels Institute (DCI) annual analysis of pharmacist salaries and employment. The retail pharmacy shakeout affected 2021 pharmacist employment. We found that retail pharmacies and drugstores employed fewer pharmacists, while hospitals and outpatient centers continued to add positions. As a result, the share of pharmacists who work in non-retail practice settings reached a new high.

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Oncology Bioequivalence Clinical Studies

ProRelix Research

According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, accounting for nearly 10 million deaths in 2020 (1). In addition, GLOBACAN estimated 19.3 […]. The post Oncology Bioequivalence Clinical Studies appeared first on ProRelix Research.

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The Progress of Precision Medicine in Immuno-Oncology

Crown Bioscience

Precision medicine and immunotherapy continue to top the list as two of the hottest areas in cancer research. In this blog post we explore how immuno-oncology can draw from precision medicine to create more personalized cancer therapies to enhance their safety and efficacy. Read on to review how ICIs, neoantigen vaccines and adoptive cell therapies, including CAR-T, CAR-NK, CAR-M, TCR-T and TIL therapies, are advancing this remarkable field of science and medicine.

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Common Pitfalls in Preparing an IND Application

Advarra

As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application (NDA) to the Food and Drug Administration (FDA). While it may seem like a straightforward process to some, there’s room for many elements to be missed as sponsors prepare for the application submission. Failure to Have a Pre-Investigational New Drug (IND) Meeting.

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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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What are the Symptoms of Prurigo Nodularis?

Olympian Clinical Research

Prurigo nodularis is a skin condition characterized by the development of small nodular lesions, which are often severely itchy. People afflicted with this disease may develop a few lesions or potentially over 200, all of which with varying sizes. Often confused with other skin conditions, prurigo nodularis symptoms may resemble eczema or psoriasis, making it challenging to diagnose and treat. .

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New patent expiration for Eisai Inc drug LUSEDRA

Drug Patent Watch

Annual Drug Patent Expirations for LUSEDRA Lusedra is a drug marketed by Eisai Inc and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent expiration for Eisai Inc drug LUSEDRA appeared first on DrugPatentWatch - Make Better Decisions.

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The Case for Data Unity, Sharing, and Usability

Drug Channels

Today’s guest post comes from Bonnie Briggs, Associate Director of Clinical Effectiveness at Wolters Kluwer, Health. Bonnie describes how pharmaceutical care would benefit from standard medical record identification. She then discusses the practical issues behind implementing and adopting such a system. To learn more, download the Wolters Kluwer free ebook: Drug Data Unity: Realistic and Idealistic Futures for Information Exchange.

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Open Targets Platform 22.06 has been released!

The Open Targets Blog

The latest release of the Platform — 22.06 — is now available at platform.opentargets.org. Key points We have included five additional studies in our Gene Burden widget, incorporating evidence from a number of different therapeutic areas The term “ medical procedure ” has been added to our ontology Users can now visualise subcellular locations of targets Key stats Metric Count Targets 61,524 Diseases 23,074 Drugs 12,854 Evidence strings 14,455,104 Associations 7,247,8

Disease 52
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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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Cancer Cell Line Screening: A Compass for Drug Discovery

Crown Bioscience

This article originally appeared on Labiotech.eu in July 2022 and is written by Alexander Burik. Large-panel cancer cell line screening can help find the right fit between a specific cancer cell and a therapeutic molecule, leading to the development of effective treatments. How can robust quality control, real-time screening methods, and a set of unique screening panels address current screening challenges?

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Vendor Audit: What It Is and What to Expect From It

EG Life Sciences

The pharmaceutical industry is one of the most highly regulated industries, and for good reason. These organizations are tasked with protecting the rights and well-being of subjects, along with the integrity of data and analysis. As a result, audits are a crucial part of our business.

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Four Questions to Ask When Establishing a Pharmacovigilance Organization

Advarra

Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with the priorities of bringing a new drug to market. However, asking the right questions before starting the journey can mitigate the risks of PV findings and ensure a successful PV function build for the organization.

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New patent for Abbvie Inc drug ORILISSA

Drug Patent Watch

Annual Drug Patent Expirations for ORILISSA Orilissa is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Abbvie Inc drug ORILISSA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels News Roundup, June 2022: Drug Spending in 2021, PBM Exclusions, Employers vs. Rebates, GoodRx Questions, and More Prior Authorization Humor

Drug Channels

I can’t recall any period in my life when our country has been so divided and polarized. Through the Drug Channels Institute, I strive to provide you with fact-based and balanced coverage—along with links to source materials so you can make up your own mind. So before you launch your July 4 festivities and/or a civil war, Drug Channels humbly offers some data fireworks for our troubled nation: More evidence of slow growth in drug spending for 2021 Fresh data on skyrocketing PBM formulary exclusi

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Novel drug combo activates natural killer cell immunity to destroy cancer cells

The Pharma Data

Most skin cancer drugs that activate the immune system work by triggering immune cells, called T cells, to attack tumors, but when T cells are activated for too long, they can wear out and cease to function. A new study led by Penn State College of Medicine scientists finds that another type of immune cell – natural killer cells – can be harnessed to pick up the slack when T cells no longer work and may also reinvigorate T cells to attack melanoma tumors.

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Making NGS library prep practical for low-throughput labs

Tecan

By Ashesh Saraiya NGS has transformed genomics research and contributed to breakthroughs in many areas of medical science. At the same time, making NGS robust, reliable and cost-effective can be challenging for many labs. In particular, generating libraries for sequencing is a common bottleneck, especially for labs that are processing low sample volumes or not running NGS on a regular basis.

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Clinical Research Opportunity for Patients with Migraines

Olympian Clinical Research

Do you or someone that you care about suffer from migraines? Are you wondering what options you may have? Consider the PRECLUDE study – a clinical research study for patients with episodic migraines. About Migraines. Migraines are headaches of moderate to severe intensity and may also include symptoms of nausea, vomiting, and sensitivity to light or sound.

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A Checklist for Optimizing Clinical Trial Study Startup Activities

Advarra

Study startup is a complicated, multi-faceted, and time-consuming component of the clinical research lifecycle, one notoriously prone to delays. The key challenge of successful, timely study startup requires careful coordination across multiple constituencies within and external to a research organization. As a result, it is easy to lose track of all the various steps necessary to activate a study efficiently and compliantly. .

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New patent for Jazz Pharms drug XYREM

Drug Patent Watch

Annual Drug Patent Expirations for XYREM Xyrem is a drug marketed by Jazz Pharms and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Jazz Pharms drug XYREM appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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A New JAMA Study Misleads About Drug Prices—And Launches a New Attack on Patients with Ultra-Rare Diseases

Drug Channels

Last week, the authors of a new JAMA study claimed that “prices for new drugs are skyrocketing.” Their research, along with a simultaneously released New York Times op-ed, received widespread media coverage. Links below. But as I explain, the study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations.

Disease 98
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Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants

The Pharma Data

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The antibodies were effective against all SARS-CoV-2 variants of concern tested and could be used alone or in an antibody cocktail to diminish the risk of infection.

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Multi-Drug Combination Strategies in High Content Applications

Crown Bioscience

In this post, we explore multi-drug combination screening studies, including major design and analysis strategies, and how novel high content technologies are being used to identify promising multi-drug combination regimens more efficiently.

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SARS-CoV-2 Protease Inhibitors: An Attractive Approach for Treating COVID-19

PerkinElmer

The current SARS-CoV-2 pandemic has highlighted the substantial threat posed by pathogenic coronaviruses to humans. To date, over six million people have died from COVID-19 across the globe and more than 500 million cases have been reported. 1 Although effective COVID-19 vaccines have been developed, variants of SARS-CoV-2 have already emerged for which vaccines are less effective, and many people remain unvaccinated due to certain medical conditions, personal choice, or global access challenges

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Best Practices in Pre-Screening Includes Use of Technology

Advarra

Pre-screening potential participants for a clinical study is common practice at most research sites. It can save time by quickly identifying those who may qualify for a study prior to having them move on to the informed consent process. Pre-screens can be done in person, over the phone, or in some cases, even online. The role technology can play in this process is important not to overlook.

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New patent for Amicus Therap drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are thirty-five patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

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Five Ways Tech Can Transform Your Program Delivery

Drug Channels

Today’s guest post comes from Edward Hensley, Co-founder and Chief Commercial Officer at AssistRx. Edward offers five ways life sciences companies can use technology to transform their patient support services and thus differentiate their products. To learn more, sign up for AssistRx’s free webinar Specialty Pharma’s 2022 Patient Support Trends: Progress Check.

Science 98
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Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe. Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formul

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Warp Speed, Vaccines, and Agile Practices

EG Life Sciences

In his last talk at Bio-IT World, Dr. Terry Barnhart spoke of the potential of Agile practices in pharmaceutical innovation. At the most recent Bio-IT World conference , Barnhart shows how Agile practices not only bring products to market faster – they also save lives. As we have discussed in previous Lean Coffees about the intersections between Agile practices and Biopharma, organizations can incorporate Agile practices without using the "Agile" label or terminology , and a major example is Ope

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Using Tumor Organoids and 3D Ex Vivo Microtumors for Immuno-Oncology Applications

Crown Bioscience

Do you ever wonder how tumor organoids and ex vivo microtumors (i.e., patient tumor material) are being used in immuno-oncology (I/O)?

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