Sat.Dec 14, 2024 - Fri.Dec 20, 2024

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The Importance of CDMO Flexibility: Adapting to the Ever-Changing Pharmaceutical Landscape

Drug Patent Watch

Flexibility has become more than just a buzzword it’s a necessity. Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. But what exactly makes flexibility so important for CDMOs, and how can they cultivate this essential trait? Let’s dive into the world of pharmaceutical outsourcing and explore why adaptability is the key to success.

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6 Clinical Study Blogs Not to Miss

Imperical Blog

Our blog team reviewed our 2024 clinical study blogs, and we selected these six worth re-reading. Check them out! 1. Sustainability in Business: Transparency and Keeping Score ESG: Environmental, social, and governance are factors that influence commercial success. Discover how Imperial achieved a sustainability rating… The post 6 Clinical Study Blogs Not to Miss appeared first on Imperial Clinical Research Services Blog.

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Google Patents: Why It’s a Risky Tool for Finding Drug Patents

Drug Patent Watch

When it comes to researching and navigating the complex world of drug patents, inventors and researchers often turn to various tools to find relevant information. Google Patents, with its user-friendly interface and vast database, might seem like an ideal resource. However, there are several reasons why relying solely on Google Patents can be risky, especially in the context of pharmaceutical patents.

Drugs 52
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After studies flag possible link between Novo's Ozempic and rare eye disorder, Danish agency calls for probe

Fierce Pharma

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

Medicine 109
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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.

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2025: Perspectives and Predictions From Advarra Thought Leaders

Advarra

2024 has been a year of growth and evolution in clinical research. The coming year is expected to be no different. As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, an

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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

Genetics 130

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Grand Rounds December 13, 2024: Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial (Gbenga Ogedegbe, MD, MPH, FACP)

Rethinking Clinical Trials

Speaker Gbenga Ogedegbe, MD, MPH, FACP Dr. Adolph & Margaret Berger Professor of Population Health NYU Grossman School of Medicine Director, Institute for Excellence in Health Equity (IEHE) NYU Langone Health Slides Keywords Hypertension; Racial Disparities; Case Management; Telemonitoring Key Points There are significant racial disparities when it comes to stroke outcomes in the U.S., with Black and Hispanic populations experiencing poorer outcomes than Caucasian

Nurses 100
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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 116
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MSD makes obesity play in up to $2bn deal for Hansoh’s GLP-1RA asset

Pharmaceutical Technology

MSD has entered an exclusive global licence agreement with Hansoh Pharma for a preclinical oral small molecule GLP-1RA.

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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.

Pharmacy 284
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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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Dissemination and Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research: AcademyHealth (December 2024)

Rethinking Clinical Trials

December 8, 2024 : The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.

Trials 130
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Psychiatry Clinical Trials: Inclusive, Patient-Centric Approaches for Mental Health Research

XTalks

Mental health problems represent a critical area of unmet need worldwide, affecting an estimated one in eight people globally, according to the World Health Organization (WHO). These issues carry substantial personal and societal costs, impacting daily life and productivity. In fact, mental health conditions are associated with a 10- to 25-year reduction in life expectancy , emphasizing the need for effective and accessible treatments.

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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.

Insulin 264
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Merck calls quits on two immunotherapies for cancer

Bio Pharma Dive

The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.

Drugs 284
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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December 16, 2024: Study Snapshot and Updated Ethics Documentation Available for I CAN DO Surgical ACP

Rethinking Clinical Trials

A new study snapshot and updated ethics and regulatory documentation are now available for the I CAN DO Surgical ACP trial. As part of the study’s transition from the planning phase to the implementation phase this fall, the investigators reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. Read the updated ethics and regulatory documentation See the study snapshot I CAN DO Surgical ACP, an NIH Collaboratory Trial, is testing a system-based ap

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HeartBeam’s Credit Card-Sized Cardiac Monitor Cleared for At-Home Use

XTalks

Imagine having a heart monitoring device small enough to fit in a purse or a wallet, ready to record critical heart data whenever symptoms arise. This device by HeartBeam, Inc. is a breakthrough in at-home cardiac care, allowing patients to capture high-quality electrocardiograms (ECGs) wherever they are. When symptoms occur, patients simply place the device on their chest and follow prompts from a companion app.

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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.

Vaccine 264
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Sanofi, Teva say study results show gut disease drug could be ‘best in class’

Bio Pharma Dive

Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

Medicine 274
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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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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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MindMed begins phase 3 study of MM120 for anxiety disorder

Pharma Times

First patient dosed in landmark trial for GAD treatment

Trials 139
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Novo Nordisk invests $1.2bn in new Denmark facility

Pharmaceutical Technology

Construction has already begun on the Ozempic-producers new Denmark production facility and 40,000m2 warehouse.

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Roche sticks with Parkinson’s drug despite second study failure

Bio Pharma Dive

Even with another mid-stage setback, Roche believes there were enough positive signs to “merit further exploration” of the drug, which it’s been developing with Prothena for more than a decade.

Drugs 261
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Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

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Clinical Trials For Drug That Replaces Missing Teeth Finally Underway

AuroBlog - Aurous Healthcare Clinical Trials blog

People with missing teeth may be able to grow new ones, say Japanese dentists testing a pioneering drug they hope will offer an alternative to dentures and implants.

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The Beatles Revolutionized the Music Industry by Using Recording Studios — Will AI Revolutionize the Medical Writing Industry Next?

XTalks

Maria Hopfgarten Head of Global Medical Writing PPD Clinical Research Business of Thermo Fisher Scientific Artificial intelligence (AI) is revolutionizing industries worldwide, and medical writing is no exception. With the integration of human intelligence (HI) with AI, the field is discovering new efficiencies and maintaining, or even improving, the rigor required for quality and compliance.

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Small cell lung cancer: Navigating the global clinical trial landscape

Pharmaceutical Technology

Discover the latest advancements in small cell lung cancer through Novotech CROs in-depth disease analysis.

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A Vertex partner — and potential rival — secures $100M to develop non-opioid pain drugs

Bio Pharma Dive

“Pain has really been out of favor in the industry up until very recently,” said John Mulcahy, SiteOne Therapeutics’ CEO. The company plans to use its new funds to get to “proof of concept” for its medicines.

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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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Study Reveals Major Drawback to The Health Benefits of Fasting

AuroBlog - Aurous Healthcare Clinical Trials blog

The human body can survive without food for some time before starvation risks causing significant harm to the body.

Research 241
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German cancer centre treats first patient with Elekta Evo

Pharma Times

New CT-guided radiotherapy system offers personalised cancer treatment

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Novo Nordisk takes a hit as CagriSema underperforms in weight loss

Pharmaceutical Technology

Novo Nordisk has announced positive results from its Phase III trial of CagriSema but fell short of a previously promised 25% weight loss.

Trials 162
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Merck targets 2025 RSV season with antibody now under FDA review

Bio Pharma Dive

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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