Sat.Feb 04, 2023 - Fri.Feb 10, 2023

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Study shines a light on representation in clinical research

Drug Discovery World

A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. GSK’s retrospective study looked at clinical trial demographic data from 495 GSK and ViiV clinical trials involving US-based participants from the period 2002 to 2019.

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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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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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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 98
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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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Danish women’s network promotes diversity in life sciences

Drug Discovery World

A science-centric network for women in senior positions across industry and academia has launched in Denmark to strengthen the life sciences industry and promote talent, diversity and inclusiveness. Women in Life Science Denmark (WiLD) has received support from the Novo Nordisk Foundation, contributing €56,000 ($60,293) over the next three years.

Science 130
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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 expiration for Bayer Hlthcare drug NEXAVAR

Drug Patent Watch

Annual Drug Patent Expirations for NEXAVAR Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents… The post New patent expiration for Bayer Hlthcare drug NEXAVAR appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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This week in drug discovery (6-10 February)

Drug Discovery World

News round-up for 6-10 February by DDW Digital Content Editor Diana Spencer. Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed. There were two significant UK regulatory approvals based on key Phase III trial data, while an unusual ‘non-interventional’ study into geographic atrophy enrolled

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Informa Connect’s Access USA

Drug Channels

Informa Connect’s Access USA Hybrid Event | March 20-23, 2023, Philadelphia Marriott Downtown www.informaconnect.com/accessusa Exclusive Offer – Be sure to use your exclusive promo 23AUSA10 to save 10% off* of your registration We would like to introduce to you Access USA , industry’s resource for accelerating access, partnerships and collaboration to deliver superior patient outcomes.

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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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New patent for Chiesi drug CARDENE

Drug Patent Watch

Annual Drug Patent Expirations for CARDENE Cardene is a drug marketed by Chiesi and is included in three NDAs. It is available from two suppliers. There are five patents protecting… The post New patent for Chiesi drug CARDENE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Scandinavia: insight into opportunities for drug discovery

Drug Discovery World

DDW Editor Reece Armstrong explores the Scandinavian drug discovery sector and speaks to key players about Sweden’s place in the market. Scandinavia represents one of the most exciting but perhaps underrepresented markets for the discovery and development of pharmaceuticals. Though not without its challenges, the life sciences industry in Scandinavia is well represented and acts as a serious contender for R&D output.

Science 130
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Supercharging Quantitative Decision-Making with Simulation-Guided Trial Design

Cytel

Those familiar with simulation-guided design (SGD) know that it can be used for a wealth of clinical trial options: endpoint selection, number and timing of interim analyses, hitting recruitment targets, managing risk, and building in trial efficiencies. Recently, decision-makers have commented on SGD’s ability to “super-charge” quantitative decision-making for “productive evidence-based conversations.

Trials 52
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Trends & Insights: Spotlight Winter Edition

DrugBank

DrugBank is passionate about equipping leading researchers with the data they need for new discoveries. As a trusted partner to world-renowned researchers, we are proud to be contributing to groundbreaking research and aiding in solving some of the industry's most pressing issues. Our team is excited to spotlight a handful of impressive academic researchers, their work, and how they've used DrugBank to power their research.

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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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New patent for Chiesi drug CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

Drug Patent Watch

Annual Drug Patent Expirations for CARDENE+IN+0.86%25+SODIUM+CHLORIDE+IN+PLASTIC+CONTAINER Cardene In 0.86% Sodium Chloride In Plastic Container is a drug marketed by Chiesi and is included in one NDA. It is available from… The post New patent for Chiesi drug CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Breast cancer still top disease area for clinical studies

Drug Discovery World

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, despite a drop in activity, according to analysis from analytics company Phesi. The company’s global analysis of all clinical trials conducted in 2022 showed that Covid-19 came second. Three of the top five most-studied disease areas fell within oncology, with prostate cancer the third most-studied disease, solid tumours fourth, and stroke fifth.

Disease 130
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How Antidote uses database insights to drive lupus research [whitepaper]

Antidote

Lupus is a chronic autoimmune disease that causes the body to attack its own tissues and organs. For the 1.5 million people in the United States that live with the disease, it has severe implications — symptoms include pain, fatigue, hair loss, cognitive issues, physical impairments, and disfiguring rashes. An estimated 10-15% of lupus patients will die prematurely due to the condition.

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3 Reasons Why Business Model Matters When Selecting an eClinical Technology Partner

Crucial Data Solutions

The news surrounding recent mass layoffs has been hard to miss and may even have you taking a closer look at the companies you choose to do business with. When it comes to evaluating vendors for your eClinical solutions, here are a few positive attributes to look for that serve as a recipe for longevity and sustainability. The post 3 Reasons Why Business Model Matters When Selecting an eClinical Technology Partner appeared first on Crucial Data Solutions.

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New patent for Chiesi drug CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

Drug Patent Watch

Annual Drug Patent Expirations for CARDENE+IN+0.83%25+SODIUM+CHLORIDE+IN+PLASTIC+CONTAINER Cardene In 0.83% Sodium Chloride In Plastic Container is a drug marketed by Chiesi and is included in one NDA. It is available from… The post New patent for Chiesi drug CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Non-interventional geographic atrophy study launches

Drug Discovery World

Complement Therapeutics (CTx) has enrolled the first patient in its study of people diagnosed with geographic atrophy (GA). The research will support the clinical development of CTx001, CTx’s lead gene therapy asset for the treatment of GA, by enabling the identification of patients with complement-driven AMD for future interventional studies. Also called late dry age-related macular degeneration (AMD), GA is a disease which causes irreversible blindness and currently has no approved treatme

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The Facts in the Case of Subject X

Cytel

Over the past years, probably the entire last decade, there have been several discussions on how to handle multiple subjects’ enrollments in CDISC data packages. Members of the CDISC SDS Multiple Subject Instances (MSI) team also shared some previews of future possible modifications of the SDTM standard to handle multiple subjects’ enrollment, [i] and we might finally have something available with the upcoming future releases of the SDTM standard and Implementation Guidance (IG).

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Pregnant People With Substance Use Disorders Need Treatment, Not Criminalization

National Institute on Drug Abuse: Nora's Blog

Pregnant People With Substance Use Disorders Need Treatment, Not Criminalization mfleming Wed, 02/08/2023 - 15:33 Nora's Blog February 15, 2023 Image ©Getty Images/ Caia Image This blog was also published in STAT on February 8, 2023. Though it may be hard for many to fathom, even pregnant people and new parents can have active substance use disorders.

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New patent for Chiesi drug CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Drug Patent Watch

Annual Drug Patent Expirations for CARDENE+IN+4.8%25+DEXTROSE+IN+PLASTIC+CONTAINER Cardene In 4.8% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. It is available from two… The post New patent for Chiesi drug CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Envision Pharma Group acquires OKRA.ai

Drug Discovery World

Envision Pharma Group has acquired OKRA.ai, a provider of artificial intelligence (AI) services for the pharmaceutical and life sciences industry. “We are delighted to welcome OKRA.ai into the Envision family,” said Meg Heim, CEO, Envision Pharma Group. “The combination of Envision’s leading technology, capabilities, and solutions with OKRA.ai’s artificial intelligence expertise enables us to strengthen our offerings to clients across the product life cycle, but more importantly support patients

Science 130
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Predictive Oncology looks to improve precision cancer Rx development with AI-driven platform

Predictive Oncology

As appeared in Precision Oncology News. NEW YORK – Predictive Oncology wants to ink more partnerships with biopharmaceutical companies and demonstrate the ability of its commercially available PEDAL platform to provide early insights that sponsors can use to prioritize drugs for development and identify biomarker-informed indications. Predictive Oncology’s Patient-centric Drug Discovery by Active Learning (PEDAL) platform uses artificial intelligence and a proprietary biobank to generate drug r

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Advancing Cancer Drug Discovery with Exclusive Organoid Technology Using Adult Stem Cells

Crown Bioscience

Advancements in organoid technology have led to novel stem cell–based models that reflect important structural and functional properties of the tissue from which the cells were derived in vivo. These models provide more clinically relevant platforms that can help researchers better select agents to advance to the clinic.

Drugs 52
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New patent for Chiesi drug CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Drug Patent Watch

Annual Drug Patent Expirations for CARDENE+IN+5.0%25+DEXTROSE+IN+PLASTIC+CONTAINER Cardene In 5.0% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. It is available from two… The post New patent for Chiesi drug CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Immunotherapy offers survival extension for brain tumour patients

Drug Discovery World

Why data from a Phase III clinical trial offers promise for patients with a deadly form of brain cancer. A Phase III clinical trial has produced promising results for a cancer vaccine targeting patients with a new or recurrent glioblastoma. The study, which involved 331 patients, wanted to assess whether or not the DCVax-L vaccine could improve the overall survival for patients with a newly diagnosed glioblastoma, and recurrent glioblastoma, compared to therapies used as the standard of care.

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Antidote Technologies and XpertPatient partner to empower newly-diagnosed cancer patients to take part in clinical research

Antidote

We’re excited to share that today, we announced a partnership with XpertPatient, an award-winning educational website that provides support to newly-diagnosed cancer patients. We are providing the XpertPatient community with access to Antidote Match™, our patient-friendly clinical trial search that currently powers clinical trial matching for 300+ patient organizations.

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OCT West Coast (March 1-2)

Precision for Medicine

Precision for Medicine will be exhibiting at booth 55 at OCT West Coast. Stop by out booth or schedule a meeting here. The post OCT West Coast (March 1-2) appeared first on Precision For Medicine.

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New patent for Bausch And drug LOTEMAX SM

Drug Patent Watch

Annual Drug Patent Expirations for LOTEMAX+SM Lotemax Sm is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. There… The post New patent for Bausch And drug LOTEMAX SM appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Nano technique reveals how drug molecules behave in cells

Drug Discovery World

Researchers have made it possible to see at the nano level where a medicinal drug ends up in the cells and how much of it is needed for optimum treatment. The technique enables the development of new pharmaceuticals and tailored treatments for diseases that have not previously been treatable. The advance also makes it necessary for drug designers to consider how their molecules behave inside the cell.

Drugs 130
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Delivering solutions to the next generation of cardiovascular medicines

Labcorp Drug Development

JB Flinders, Senior Director, CVMER, Operational Strategy and Planning and Peter Alfinito, Executive Director, CVMER, Operational Strategy and Planning February is American Heart Month, and we at Labcorp are dedicated to improve the cardiovascular health of patients worldwide, as part of Labcorp’s mission to improve health and improve lives. This … The post Delivering solutions to the next generation of cardiovascular medicines appeared first on Insights From Our Labs to Yours.

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To Share or Not to Share Failed Genetic Screening Results with Patients

Conversations in Drug Development Trends

When using genetic screening to identify clinical trial volunteers, a sponsor’s obligations for further testing and disclosure of results to patients and families are unclear, especially when the results have no impact on medical management. Guidance in this area is much needed. At Worldwide, this topic arises frequently in discussion with rare disease sponsors.