AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 7, 2025
Still from Breath of the Wild. (Nintendo) Many modern video games fall into the open-world category, giving players vast, detailed worlds to explore and a new study shows these expansive digital playgrounds have benefits for our mental health.
Worldwide Clinical Trials
JANUARY 6, 2025
With 20-25% of the global population affected by metabolic problems, finding effective treatments is crucial for cardiovascular and metabolic (CVM) conditions. Traditional study designs feature predetermined sample sizes, assessments, and analyses that must remain in place over long treatment durations. Although formal protocol amendments are possible, this process is time-consuming and complex.
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Rethinking Clinical Trials
JANUARY 9, 2025
The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic Clinical Trials. A keynote presentation will address the state of healthcare delivery in the United States and the constraints on healthcare systems that are important for researchers to understand. Day 1 of the workshop will develop participants understanding of the landscape for pragmatic research, including stressors on the healthcare system and barriers and opp
Bio Pharma Dive
JANUARY 8, 2025
The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 9, 2025
CMV-infected human placental cell. (Nephron/CC BY-SA 3.0/Wikimedia Commons) Researchers have discovered a link between a chronic gut infection caused by a common virus and the development of Alzheimer’s disease in some people. Most people encounter cytomegalovirus (CMV) during childhood, and after the initial infection the virus remains in the body for life, usually dormant.
Worldwide Clinical Trials
JANUARY 6, 2025
Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential? BioA plays a pivotal role in therapeutic development, facilitating progress in our understanding and treatment of complicated diseases through PK/PD, immunogenicit
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JANUARY 7, 2025
Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.
XTalks
JANUARY 7, 2025
In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. Dr. Rishi Kundi, a clinical investigator at the University of Maryland Medical System, believes Symvess holds the potential to transform vascular trauma care by overcoming longstanding challenges like infection control and graft failure that have plagued traditional r
Pharmaceutical Technology
JANUARY 10, 2025
Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.
Rethinking Clinical Trials
JANUARY 8, 2025
In this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.” The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern. FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among pati
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Bio Pharma Dive
JANUARY 7, 2025
The three-year partnership is another example of Vertex’s interest in improving on Casgevy, its CRISPR medicine for sickle cell and beta thalassemia.
XTalks
JANUARY 9, 2025
The FDAs new draft guidance for developers of AI-enabled medical devices marks a critical milestone in addressing the complexities of transparency, bias and safety throughout the lifecycle of these advanced technologies. Tailored for manufacturers and stakeholders, it outlines strategies to ensure devices meet high standards of efficacy and inclusivity.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 8, 2025
(SDI Productions/E+/Getty Images) The right therapy can dramatically boost the self-healing capabilities of the human heart after heart failure, a new study has found giving the vital organ regenerative powers even beyond those of a healthy heart.
FDA Law Blog
JANUARY 9, 2025
By Anne K. Walsh & Hyman, Phelps & McNamara, P.C. & Douglas B. Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind
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!
Bio Pharma Dive
JANUARY 6, 2025
The startup is developing a kind of macrocyles, which share strengths of both small molecules and biologics, as oral medicines against “validated blockbuster biologic targets.
XTalks
JANUARY 6, 2025
The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation. This approval marks a significant milestone for Vertex Pharmaceuticals, making Alyftrek their fifth CFTR modulator to secure FDA approval, offering hope
ACRP blog
JANUARY 9, 2025
Many current trends in clinical research will likely continue regardless of the upcoming changes in the White House. The need to incorporate technology into our clinical trials processes, alongside a continued emphasis on the power of artificial intelligence ( AI) , will remain a priority for both the U.S. Food and Drug Administration (FDA) and the rest of government in 2025.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 8, 2025
The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.
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
Bio Pharma Dive
JANUARY 10, 2025
The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change.
XTalks
JANUARY 10, 2025
The FDA has granted clearance to Heidelberg Engineerings Epithelial Thickness Module (ETM) integrated into the companys Cornea App, which is a part of the Anterion ocular imaging platform. The new module is expected to enhance precision in corneal health assessment, offering ophthalmologists a robust tool for more comprehensive and accurate evaluation of the corneal epithelium.
Pharmaceutical Technology
JANUARY 7, 2025
Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.
ACRP blog
JANUARY 6, 2025
This is sponsored content. While the U.S. Department of Justice (DOJ) continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity in the U.S. Department of Health and Human Services recently released its Final Rule on regulations governing Public Health Service Policies on Research Misconduct, which takes effect January 1, 2025.
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?
Bio Pharma Dive
JANUARY 6, 2025
The stage is set for JPM 2025—don't miss expert reactions following 2025’s principal catalyst event!
XTalks
JANUARY 7, 2025
Eli Lillys obesity drug Zepbound (tirzepatide) has become the first approved medication for obstructive sleep apnea (OSA). At the end of December, the US Food and Drug Administration (FDA) approved Zepbound for the treatment of moderate to severe OSA in adults with obesity, for use in combination with a reduced-calorie diet and increased physical activity.
Pharmaceutical Technology
JANUARY 10, 2025
Light Horses CEO said the biotechs initial focus will be on high-value and historically challenging oncology targets.
Pharma Times
JANUARY 6, 2025
IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer
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Bio Pharma Dive
JANUARY 7, 2025
The startup, which has already raised more than half a billion dollars, released Phase 2 results that could position its drug as a future threat to weight loss medicines from Novo Nordisk and Eli Lilly.
XTalks
JANUARY 8, 2025
The US Food and Drug Administrations (FDAs) new draft guidance , Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products , provides a roadmap for integrating artificial intelligence (AI) into regulatory decisions for drug and biological product development. It targets sponsors, manufacturers and stakeholders, aiming to enhance the credibility of AI models in generating data for evaluating safety, effectiveness and quality.
Pharmaceutical Technology
JANUARY 8, 2025
GSK has gained US FDA breakthrough therapy designation for GSK'227 to treat adults with relapsed or refractory osteosarcoma.
Pharma Times
JANUARY 9, 2025
Groundbreaking approval provides new hope for patients in England and Wales
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