February, 2023

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Clinical Trial Regulations in the United States

ProRelix Research

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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How to find and take part in paid clinical trials

Antidote

Participating in a clinical trial has many benefits, including working with condition specialists, getting access to personalized medical care, and helping science move forward — but did you know that some clinical trials offer compensation, as well?

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The Effectiveness of DIY Air Filtration Units

NIOSH Science Blog: Drugs

Portable air filtration units, or air cleaners, remove airborne particles (called aerosols) from the air indoors. Air filtration units were widely used during large wildfire outbreaks in the western United States,[1] and their use surged nationwide during the COVID-19 pandemic as a way to reduce exposure to aerosols containing the SARS-CoV-2 virus. Homemade or Do-It-Yourself (DIY) air filtration units are an alternative to commercially produced products that can be made from supplies available a

Virus 97
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The Top Indicators That a Hub Launch Will Succeed: Discovery and Partnership

Drug Channels

Today’s guest post comes from ConnectiveRx’s Lauren Cole, Senior VP of Launch Excellence at ConnectiveRx. Lauren outlines key success factors when transitioning or launching a patient hub. To learn more, join Lauren on April 4th at 1:00 p.m. ET for a free online panel discussion: Lessons from the Edge—Six Things That Can Make a Hub Launch Go Wrong. Lauren will also be exploring hub launch excellence at Informa Connect’s Hub and Specialty Pharmacy Models East conference on March 20-22.

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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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Which pharmaceutical drugs have the most drug patents in France?

Drug Patent Watch

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

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

By Mark A. Tobolowsky & Charles G. Raver — Amongst the many provisions that Congress included in the recent Food and Drug Omnibus Reform Act (“FDORA”) were two subtle changes – one change to the Federal Food, Drug, & Cosmetic Act’s (“FD&C Act”) requirements for advancing an investigational new drug into clinical trials and another change to the Public Health Service Act’s (“PHS Act”) (as amended by the Biologics Price Competition and Innovation Act of 2009) requirements for developin

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What is triple-negative breast cancer?

Antidote

While breast cancer is often thought of as a singular diagnosis, it is actually an umbrella term that encompasses several subtypes of the disease — many of which have been discovered in recent years due to continual advancement in the oncology research space. Traditionally, breast cancers are grouped into subtypes according to the Tumor, Nodes, and Metastasis system of staging breast cancer, the reproductive status of the patient, and the types of biological markers that are found in the cancer

Disease 98
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Modern Coal Miners Have Higher Death Rates From Lung Diseases Than Their Predecessors

NIOSH Science Blog: Drugs

Coal mine dust causes a range of lung diseases, collectively called coal mine dust lung diseases. Examples include coal workers’ pneumoconiosis (CWP, a dust-induced scarring lung disease commonly called black lung), chronic obstructive pulmonary disease (COPD), and lung function impairment. All of these cause substantial morbidity (illness) and mortality (death) among affected coal miners.[1–5] Most attention in the U.S. has focused on CWP, especially its most severe stage called progressive mas

Disease 90
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Copay Accumulator and Maximizer Update: Adoption Plateaus as Insurers Battle Patients Over Copay Support

Drug Channels

Is the gold rush in copay accumulators and maximizers slowing down? Our latest update finds that for 2022, about 40% of commercial lives have adopted these benefit designs. Accumulator adoption has plateaued, while maximizer use has overtaken accumulators. Patients who take a single-source, brand-name specialty drug for autoimmune conditions, multiple sclerosis, and oncology increasingly face these benefit designs.

Drugs 92
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Which pharmaceutical companies have the most drug patents in Serbia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Serbia. 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 Serbia? 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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Predictive Oncology partners with Cvergenx to create new genomics-based A.I. radiation therapy

Predictive Oncology

Proactive Investor’s Natalie Stoberman met with Raymond F. Vennare, CEO of Predictive Oncology, and Javier Torres-Roca, MD, Co-Founder and CEO of Cvergenx, Inc., to discuss a strategic partnership to create the first-ever genomics-based approach to precision radiation therapy and drug discovery using artificial intelligence. Click here to view the interview and learn more about how this powerful collaboration will leverage Predictive Oncology’s drug discovery, artificial intelligence and machin

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Development of a Covalent Inhibitor of c-Jun N-Terminal Protein Kinase (JNK) 2/3 with Selectivity over JNK1

Covalent Modifiers

Wenchao Lu, Yao Liu, Yang Gao, Qixiang Geng, Deepak Gurbani, Lianbo Li, Scott B. Ficarro, Cynthia J. Meyer, Dhiraj Sinha, Inchul You, Jason Tse, Zhixiang He, Wenzhi Ji, Jianwei Che, Audrey Y. Kim, Tengteng Yu, Kenneth Wen, Kenneth C. Anderson, Jarrod A. Marto, Kenneth D. Westover, Tinghu Zhang, and Nathanael S. Gray Journal of Medicinal Chemistry 2023 DOI: 10.1021/acs.jmedchem.2c01834 The c-Jun N-terminal kinases (JNKs) are members of the mitogen-activated protein kinase (MAPK) family, which inc

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A closer look at resistant hypertension for American Heart Month

Antidote

Did you know that February is American Heart Month ? This month is dedicated to raising awareness for and providing education on heart health, high blood pressure, and cardiovascular disease.

Disease 98
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Violence Against Public Health Workers

NIOSH Science Blog: Drugs

Many workers who were on the frontlines during the COVID-19 pandemic experienced increased physical and mental stress. One study found that 70% of U.S. workers felt more stressed at work during COVID-19 than at any other point in their professional careers [1]. Public health workers, including epidemiologists, contact tracers, laboratory scientists, community health workers, and data analysts, served on the front lines of the pandemic delivering information, providing services, and conducting re

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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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Improve Access, Affordability, and Brand Performance With GoodRx’s Point-of-Sale Rebate Programs

Drug Channels

Today’s guest post comes from Jim Longley, Head of Commercial, Pharma Manufacturer Solutions at GoodRx. Jim discusses GoodRx Assist , a point-of-sale (POS) rebate program designed to help cash-paying patients start and stay on brand-name medication. Click here to learn more about GoodRx Assist. Read on for Jim’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Which pharmaceutical companies have the most drug patents in Mexico?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Mexico. 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 Mexico? appeared first on DrugPatentWatch - Make Better Decisions.

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Accelerating Cancer Drug Development for Children and Adolescents

Crown Bioscience

Significant progress has been made in the treatment of pediatric cancers, with the 5-year survival rate for children with cancer overall in high-income countries currently at ~80%. Despite this progress, there are still major unmet needs in this patient population. The 5-year survival rate for children with cancer in middle- and low-income countries are ~55% and ~40%, respectively, and survival prospects for several pediatric cancers are still very poor.

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Honoring Clinical Trailblazers: 2023 Video Series

Advarra

This February, Advarra’s “Honoring Clinical Trailblazers” video series paid tribute to the outstanding achievements of four pioneering African American physicians who defied the odds to make significant contributions to the field of medicine. These physicians faced enormous challenges due to their race, gender, and societal barriers, but their passion for helping others and their unwavering commitment to advancing medical knowledge led to groundbreaking discoveries and changes,

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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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COPD resources: Where to find the information and support you need

Antidote

Chronic obstructive pulmonary disease, known commonly as COPD, is a condition that impacts more than 16 million Americans. COPD is a chronic, inflammatory lung disease that obstructs the airflow to and from the lungs, and common symptoms include a continual cough, shortness of breath, excess mucus, and chest tightness.For those living with COPD, their loved ones, and their care partners, we’re sharing some helpful resources to gain information and build community.

Disease 98
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Highly Pathogenic Avian Influenza (HPAI) in the Agricultural Community

NIOSH Science Blog: Drugs

Avian influenza (bird flu) is caused by infection with avian influenza (flu) Type A viruses. These viruses routinely spread among wild aquatic birds worldwide and can infect domestic poultry and other bird and animal species. Sporadic human infections with bird flu viruses have occurred. Avian influenza A viruses are classified into the following two categories: Highly pathogenic avian influenza (HPAI) virus strains are extremely infectious, often fatal to chickens, and can spread rapidly from f

Virus 64
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Exclusive Report: Manufacturers Identify the Three Critical Drivers of Hub Success

Drug Channels

Today’s guest post comes from Matt Hall, President of Patient Solutions at CareMetx. Matt shares three key findings from CareMetx’s exclusive new survey on patient support services for specialty pharmaceuticals. To learn more, download CareMetx’s free 2022 Report - Patient Services Trends. Read on for Matt’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Which pharmaceutical companies have the most drug patents in Cyprus?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Cyprus. 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 Cyprus? appeared first on DrugPatentWatch - Make Better Decisions.

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Before Clinical Trials: The Long Game of Rare Disease Research

Conversations in Drug Development Trends

95% of rare diseases don’t have a treatment approved and won’t anytime soon. Uplifting Athletes (UA) is on a mission to change that. Back in 2010, Rob Long was a 22-year-old football player at Syracuse University on the path towards his dream career of becoming a punter in the NFL. But just a few months before his college graduation and the start of his career, Rob’s dreams fell to pieces.

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NIH 2023 Data Management and Sharing Policy: What you Need to Know

Advarra

In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized Data Management and Sharing (DMS) policy , effective January 25, 2023. The policy is fundamentally intended to promote and expedite the “translation of research results into knowledge, products, and procedures to improve human health.

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World Cancer Day cancer research roundup

Antidote

The statistics about the prevalence of cancer can be disheartening. Over 10 million people die each year from cancer , making it one of the leading causes of death — and unfortunately, researchers have yet to find a cure for many cancers.

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Psychosocial Hazards Often Overlooked in Construction Industry

NIOSH Science Blog: Drugs

Why Do Psychosocial Factors of Work Matter? The construction industry has considerable safety and health hazards that result in high rates of injury, illness, and fatality. Common hazards include noise, fall, electrical, and chemical hazards. Approximately 60% of all construction fatalities each year can be attributed to the ‘focus four’ hazards of falls, struck-by, caught in and between, and electrocutions.1 Construction occupational safety and health (OSH) has traditionally focused on eliminat

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

Drug Channels

As you've surely heard, Amgen has just launched Amjevita, the first non-interchangeable biosimilar of Humira. Our crazy drug channel led Amgen to launch both a high-list/high-rebate and a low-list/low-rebate version of the drug. Its strategy echoes the pricing of the first interchangeable insulin biosimilars— as I predicted in 2021. Unfortunately, we should expect most PBMs and plan sponsors to embrace the high-list/high-rebate version.

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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 86
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How Drug Development CMC Works 

DS in Pharmatics

When pharmaceutical companies develop a new drug product for the market, there are many different steps a potential product must go through to determine and control its safety, manufacturability, effectiveness and reliability. These processes, and all activities within, are known as chemistry, manufacturing, and controls (CMC).

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Demystifying Synthetic Control Arms

Cytel

Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of trials incorporating an external control group, sometimes known as a synthetic control arm. But what are synthetic control arms and what are the potential benefits to this clinical trial design?

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Antidote's curated journey capabilities [one-pager]

Antidote

When matching individuals to medical research opportunities, patient centricity is at the heart of the process for Antidote. Through our best-in-class clinical trial matching software, we provide a streamlined, user-friendly experience for any individual searching for a trial — and now, through our curated journeys, we’re able to refine this process even more.

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Precision Medicine World Conference 2023

DrugBank

As the snow was falling on us at the end of January a handful of our team packed their bags and flew down to the sun in Silicon Valley for the 2023 Precision Medicine World Conference. In addition to extra sunscreen, we brought down our bright pink booth to show off everything we love about DrugBank. As a distributed team these in-person conferences are highly cherished opportunities for us to engage with our customers and industry leaders, and soak up valuable insights.

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Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. This report—our fourteenth edition—remains the most comprehensive, fact-based tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system. 12 chapters, 480+ pages, 241 exhibits, 900+ endnotes: There is nothing else available that comes close to this valuable resource.