Sat.Oct 08, 2022 - Fri.Oct 14, 2022

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Webinar recap: Lung Cancer Initiative webinar featuring Rich Towne

Antidote

On October 4, Antidote’s Senior Clinical Informatics Manager Dr. Rich Towne participated in a community education webinar for the North Carolina chapter of Lung Cancer Initiative. This webinar was aimed at educating lung cancer patients and professionals in the lung cancer industry on clinical trials and recent advancements in the field.

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Mapping the Vertical Integration of Insurers, PBMs, Specialty Pharmacies, and Providers: A 2022 Update

Drug Channels

I conservatively estimate that I’ve created about 1,374,613 slides during my career. But there are two slides that people seem to appreciate the most. One is my chart showing the key channel flows within the entire U.S. pharmaceutical distribution, payment, and reimbursement system. The other is my mapping of the insurer/PBM/specialty pharmacy/provider organizations that now dominate U.S. drug channels.

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Which pharmaceutical companies have the most film dosed drugs?

Drug Patent Watch

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

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Organoid Biobanks: Living Predictive Models for Cancer Drug Development

Crown Bioscience

The need for more clinically relevant preclinical models has been identified as one of the areas that can help reduce the high attrition rate observed for anticancer drugs. Better models, such as Hubrecht Organoid Technology (HUB) tumor organoids , can drive better decisions in drug discovery by identifying agents that will have the best chances of succeeding in clinical trials.

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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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World Mental Health Day: A Q&A with NAMI

Antidote

October 10 is World Mental Health Day , a day aimed at raising awareness of mental health and wellness around the globe. For many mental health conditions , it can take a period of trial and error to find the right treatment plan for patients — but through clinical trials, discovering new and more efficient treatments can be made possible.

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What Pharma Companies Can Expect From the Influx of Humira Biosimilars

Drug Channels

Today’s guest post comes from Steve Callahan, Senior Manager of Market Research at MMIT. Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. To learn more, check out MMIT’s Strategic Launch Report & Evaluate Forecast solution. Read on for Steve’s insights. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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What Is An Investigational Device Exemption Application and Study?

DS in Pharmatics

An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval.

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Unpacking IRB Innovations for Decentralized Clinical Trials

Advarra

In the blink of an eye, the world has gone digital. So many tasks which used to require going to a place and seeing a live human can now be accomplished from an app on our phones. Even the terms “phone” and “watch” seem antiquated, when you consider that little computer in your pocket or attached to your wrist can continuously measure your blood pressure, check your circadian rhythms, or even record changes in mobility and oxygen saturation levels.

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Open Targets Genetics: version 8 is out!

The Open Targets Blog

The latest release of Open Targets Genetics — version 8 — is now available at genetics.opentargets.org. The L2G scores from this latest release have already been integrated into the Open Targets Platform in our most recent update — 22.09. Key points Integration of sQTLs from GTEx Update to GWAS Catalog studies and FinnGen R6 Implementation of a Forest plot in the variant page Creation of a new API page Additional notes and metrics are available on the Open Targets Community.

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New patent for Eyepoint Pharms drug YUTIQ

Drug Patent Watch

Annual Drug Patent Expirations for YUTIQ Yutiq is a drug marketed by Eyepoint Pharms and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent for Eyepoint Pharms drug YUTIQ appeared first on DrugPatentWatch - Make Better Decisions.

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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 Ultimate Guide to Help You Understand and Treat Urticaria (Hives)

Olympian Clinical Research

Urticaria, more commonly known as hives, is a condition characterized by raised, itchy, red welts on the skin. The welts can range from a few millimeters to several centimeters and often appear in groups. Hives may be accompanied by swelling of the surrounding skin. It is a relatively common condition and will usually resolve on its own without treatment within a few days to weeks.

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Successful Applications of Real-World Data and Real-World Evidence in Rare Disease Programs

The Premier Consulting Blog

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial. However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness.

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The Chemistry Clicked: Two NIH-Supported Researchers Win 2022 Nobel Prize in Chemistry

NIH Director's Blog: Drug Development

Through the years, NIH has supported a total of 169 researchers who have received or shared 101 Nobel Prizes. That’s quite a testament to the world-leading science that NIH pursues and its continued impact on improving human health and well-being. Those numbers include the news late last week that the 2022 Nobel Prize in Chemistry was shared by two long-time grantees for their work on a transformative scientific approach known as “click chemistry.

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Which pharmaceutical drugs have the most drug patents in Poland?

Drug Patent Watch

This chart shows the drugs with the most patents in Poland. 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 Poland? appeared first on DrugPatentWatch - Make Better Decisions.

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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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The value of Antidote’s partner network [infographic]

Antidote

Reaching the right patients is frequently cited as one of the most difficult parts of medical research. Without clinical trial participants, it’s impossible for researchers to advance their studies — but with smart outreach strategies, there are options for increasing the visibility of a trial.

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NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before

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Gene Therapy Is Here To Stay: Should Bigger Companies Build, Buy, Or Partner?

LifeSciVC

By Deanna Petersen, CBO of AVROBio, as part of the From the Trenches feature of LifeSciVC Gene therapy’s tremendous potential to transform the treatment of both rare and common diseases has been understood for decades. But few may appreciate how imminently that revolution is upon us. This summer, approvals on both sides of the Atlantic – for beta thalassemia and cerebral adrenoleukodystrophy in the United States and for severe hemophilia A and aromatic L-amino acid carboxylase deficiency in Euro

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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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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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What Do You Need To Know About The EUA Consultant And CGMP Certification?

Pharmaceutical Development Group

EUA Consultant will help you determine if the EUA is the right path for your device. We will help you to prepare for EUA filing and help you explore the EUA filing process and meet regulatory requirements under the EUA and after the COVID-19 outbreak. Preparation and submission of the EUA: Implementing an Emergency Use Authorization (EUA) process can be challenging.

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DrugBank announces partnership with ASHP in continued efforts to improve health outcomes through data accessibility

DrugBank

EDMONTON, CANADA, October 12— DrugBank today announced their partnership with the American Society of Health-System Pharmacists (ASHP). This move will combine both organization’s strengths at delivering reliable, trusted data and open the door for product development collaborations to address industry gaps. DrugBank will integrate ASHP’s trusted products and data into its already expansive knowledgebase before making it all available through their industry leading API.

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Guest Post – Second Circuit Rejects Manufacturer’s Plan to Share Cost of Expensive Drug with Medicare Part D Beneficiaries

Drug & Device Law

Today’s guest post is from Reed Smith ‘s Micah Brown. He discusses a recent appellate decision that we think is counterproductive, in that it interprets the federal Anti-Kickback statute to preclude drug manufacturers from alleviating the high expense of breakthrough drugs that treat relatively rare medical conditions. As always our guest bloggers deserve 100% of the credit (and any blame) for what they have to say. *.

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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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New patent for Gw Res drug EPIDIOLEX

Drug Patent Watch

Annual Drug Patent Expirations for EPIDIOLEX Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. It is available from one supplier. There are twenty-three…. The post New patent for Gw Res drug EPIDIOLEX appeared first on DrugPatentWatch - Make Better Decisions.

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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 forty-four 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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New patent for Merck Sharp drug VERQUVO

Drug Patent Watch

Annual Drug Patent Expirations for VERQUVO Verquvo is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Merck Sharp drug VERQUVO appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Vifor Fresenius drug VELPHORO

Drug Patent Watch

Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.

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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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New patent for NOVO drug SAXENDA

Drug Patent Watch

Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-four patents protecting…. The post New patent for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.

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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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New patent for Dermavant Sci drug VTAMA

Drug Patent Watch

Annual Drug Patent Expirations for VTAMA Vtama is a drug marketed by Dermavant Sci and is included in one NDA. There are three patents protecting this drug. This drug has…. The post New patent for Dermavant Sci drug VTAMA appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Antares Pharma drug XYOSTED (AUTOINJECTOR)

Drug Patent Watch

Annual Drug Patent Expirations for XYOSTED+%28AUTOINJECTOR%29 Xyosted (autoinjector) is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Antares Pharma drug XYOSTED (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for NOVO drug OZEMPIC

Drug Patent Watch

Annual Drug Patent Expirations for OZEMPIC Ozempic is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-four patents protecting…. The post New patent for NOVO drug OZEMPIC appeared first on DrugPatentWatch - Make Better Decisions.

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Which pharmaceutical companies have the largest patent portfolios?

Drug Patent Watch

A strong patent portfolio is at the core of branded pharmaceutical firms. Accordingly, one way to assess the relative strength of pharmaceutical firms is to compare their patent-counts. This chart…. The post Which pharmaceutical companies have the largest patent portfolios? appeared first on DrugPatentWatch - Make Better Decisions.