December, 2024

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What Influence Do CROs Have on Improving DEI Across the Healthcare Industry?

XTalks

Equal opportunity to healthcare is not just a topic of discussion it must be intentionally implemented and built into every aspect of healthcare. In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products.

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Reprieve for Chinese biotechs as BIOSECURE Act left out of key bill

Pharmaceutical Technology

Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.

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Novo’s next-gen obesity drug misses expectations in closely watched trial

Bio Pharma Dive

Novo shares lost nearly a quarter of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.

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December 5, 2024: Nudge Pragmatic Trial Finds No Improvement in Adherence to Cardiovascular Medications

Rethinking Clinical Trials

Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety of text messaging strategies to

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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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Top 5 Things to Know Before Joining a Clinical Trial

Pharma Mirror

Have you ever wondered how life-saving treatments for cancer, Alzheimers, or chronic diseases come to life? Clinical trials are the foundation of medical innovation, paving the way for groundbreaking therapies. Yet for many, the idea of joining a trial can feel intimidating or unclear. Experts are here to demystify the clinical trial process, with Dr.

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The Risk of Cancer Fades as We Get Older, And We May Finally Know Wh

AuroBlog - Aurous Healthcare Clinical Trials blog

Researchers studied cancer growth in mice. (Zhuang et al., Nature, 2024) Aging brings two opposing trends in cancer risk: first, the risk climbs in our 60s and 70s, as decades of genetic mutations build up in our bodies.

Genetics 205

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Novo gets the green light for once-daily haemophilia drug following setbacks 

Pharmaceutical Technology

The FDA initially rejected the marketing application for Alhemo in 2022, asking for additional data on dosing and monitoring.

Drugs 264
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Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial

Bio Pharma Dive

Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.

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December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Rethinking Clinical Trials

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation. The article was published online ahead of print in Clinical Trials. There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants.

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World Orphan Drug Congresses Europe vs. The US: Global Perspectives on Genetic Testing

Worldwide Clinical Trials

At the recent World Orphan Drug Congresses (WODC) in Europe and the United States, Worldwide Clinical Trials Derek Ansel , Vice President, Therapeutic Strategy Lead, Rare Disease, facilitated roundtable discussions to explore the operational challenges and ethical barriers surrounding genetic testing. While the agenda remained the same across both events, the conversations revealed key regional distinctions and global perspectives on how genetic testing, ethics, and operational challenges are ad

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Your Sniffles Could Be a Sign of The Fungi Hidden in Your Nose

AuroBlog - Aurous Healthcare Clinical Trials blog

(Runstudio/Photodisc/Getty Images) If you find yourself sniffling at the merest hint of an irritant, you likely have a different set of microbes calling your nostrils home than everyone else. An international team of researchers has found a unique assortment of fungi up the noses of people who suffer from hayfever and asthma.

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New bird flu mutation discovered in US as cat infections cause alarm

Medical Xpress

The ongoing spread of bird flu in the United States has alarmed expertsnot just because of human cases causing severe illness, but also due to troubling new instances of infections in cats.

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FDA approves Lilly’s obesity med Zepbound to treat obstructive sleep apnoea

Pharmaceutical Technology

Lillys Zepbound has become the first prescription medicine approved to treat adults with moderate to severe obstructive sleep apnoea (OSA) and obesity.

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Diabetes advocacy group discourages use of compounded GLP-1 drugs

Bio Pharma Dive

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

Pharmacy 301
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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December 2, 2024: NCI-Supported LungSMART Trial Joins the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

From left to right: Drs. David Wetter, Guilherme Del Fiol, and Ken Kawamoto, principal investigators for LungSMART The NIH Pragmatic Trials Collaboratory is pleased to welcome LungSMART (Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers) to its portfolio of innovative NIH Collaboratory Trials. Lung cancer is the leading cause of cancer-related deaths in the United States, but only 6.5% of eligible individuals were screened for lung cancer in 20

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RFK Jr. could 'cost lives in this country' if he pursues changes to US vaccine policy, Gottlieb says

Fierce Pharma

Robert F. Kennedy Jr.’s appointment last month to lead the U.S. Department of Health and Human Services immediately sent waves of speculation swirling throughout the biopharma industry. | The former FDA Commissioner pointed to the threat of measles if vaccination rates were to decline by 5%.

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Too Much Sitting Can Still Be Harmful Even if You Exercise, Study Warns

AuroBlog - Aurous Healthcare Clinical Trials blog

(Dave & Les Jacobs/DigitalVision/Getty Images) We know that too much sitting is bad for us, but a new study adds an important detail: if you spend more than 10-and-a-half hours a day sitting or lying down, regular exercise might not be enough to prevent an increased risk of serious heart issues.

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FDA Refines Accelerated Approval Pathway with New Draft Guidance

XTalks

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.

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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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Egyptian Drug Authority approves Lilly and EVA’s insulin injection

Pharmaceutical Technology

Eli Lilly and EVA Pharma have announced approval from the Egyptian Drug Authority for the human insulin glargine injection.

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Zepbound, Mounjaro shortages are resolved, FDA confirms

Bio Pharma Dive

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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December 11, 2024: Home Blood Pressure Telemonitoring in Black and Hispanic Patients With Stroke, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, December 13, 2024, at 1:00 pm eastern.

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Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance

Pharma Mirror

CPHI Milan the worlds largest pharma event hosted last month in Milan saw a new record attendance of 59,000 pharma executives buoyed by returning confidence and increased deal-making on site. The post Pharma prepares for CDMO growth in 2025 as CPHI Milan reports record attendance appeared first on Pharma Mirror Magazine.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Mysterious Finding Shows Healthy Tissue Can Resemble Invasive Cance

AuroBlog - Aurous Healthcare Clinical Trials blog

(Nemes Laszlo/Science Photo Library/Getty Images) How we classify cancer and spot it in its earliest stages could need an urgent rethink: researchers have found that even some healthy women carry cells with the key hallmarks of breast cancer. These cells are known as aneuploid cells, and have an abnormal number of chromosomes.

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Brain's 'tug-of-war': Choosing between classical and operant conditioning

Medical Xpress

A study from Tel Aviv University could reshape our scientific understanding of how humans learn and form memories, particularly through classical and operant conditioning.

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Abera and Orexo partner for vaccine powder formulations

Pharmaceutical Technology

Abera and Orexo have entered a partnership to develop and test the powder formulations of the formers vaccine candidates.

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Janux impresses Wall Street with new prostate cancer drug results

Bio Pharma Dive

While early and from a small trial, the findings suggest Janux’s method of “masking” T cell engagers could lead to differentiated results, some analysts said.

Drugs 292
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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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December 12, 2024: Another Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups , and results from the NIH Collaboratory Trials.

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Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

Fierce Pharma

Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight.

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Abnormal Patterns in Brain Waves May Indicate ADHD, Expert Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Children with attention deficit hyperactivity disorder ( ADHD) do not have a behavioural disorder, nor are they lazy, or lacking in manners and boundaries. Their brains mature in a different way, with different patterns of neurological activity and a number of neurochemical differences. For this reason, ADHD is considered to be a neurodevelopmental disorder.

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Neurocrine Biosciences’ Crenessity Approved as First New Treatment in Decades for Rare Genetic Disorder CAH

XTalks

Neurocrine Biosciences Crenessity (crinecerfont) has been given the green light by the US Food and Drug Administration (FDA) as a new treatment for congenital adrenal hyperplasia (CAH). The approval marks a significant step in addressing a condition that has historically relied on decades-old therapies. The therapy is approved to be used in combination with glucocorticoid replacement therapies (steroids) to control androgen levels in adults and pediatric patients four years of age and older with

Genetics 113
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g