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.
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
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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.
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
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
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!
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
Rethinking Clinical Trials
JANUARY 6, 2025
In an upcoming session of the VA Spotlight on Pain Management Cyberseminars series curated by the Pain Management Collaboratory (PMC), Julie Fritz and Dan Rhon will present “Supporting Whole Person Pain Management in the Military Health System.” The session will be held on Tuesday, January 7, from 11:00 am to 12:00 pm eastern. Improving care for persons with chronic musculoskeletal pain is a priority in the Military Health System.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 10, 2025
Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.
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
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 6, 2025
Artificial intelligence (AI) and machine learning (ML) are poised to redefine the landscape of critical care medicine, offering innovative solutions to the challenges faced in intensive care units (ICUs). ICUs are high-stakes environments where every decision can mean the difference between life and death.
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.
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
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.
XTalks
JANUARY 7, 2025
The medical device and medtech industry has undergone significant mergers and acquisitions over the past decade. These strategic deals have reshaped the competitive landscape, spurred innovation and enabled companies to diversify their product offerings, expand into new markets and enhance operational efficiencies. This list highlights the top 10 largest mergers and acquisitions among companies in the medical device, medtech and diagnostics sector from the past decade.
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.
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.
Pharmaceutical Technology
JANUARY 7, 2025
Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.
Pharma Times
JANUARY 6, 2025
IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer
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.
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.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
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 9, 2025
Groundbreaking approval provides new hope for patients in England and Wales
Velocity Clinical Research
JANUARY 6, 2025
Robert Cupelo, MD, Principal Investigator in Syracuse, NY, shares his firsthand insights into the evolving landscape of Alzheimer’s treatment. Nearly two years after the FDA’s approval of lecanemab (Leqembi), and with the subsequent approval of donanemab (Kisunla), researchers are making crucial steps forward in the fight against disease progression and for disease prevention.
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.
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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.
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 8, 2025
Investment to support RNA therapeutics for epilepsy and neurological disorders
pharmaphorum
JANUARY 7, 2025
The life sciences industry is in a position to help humanity, perhaps more than ever, with the introduction of generative AI (GenAI).
Bio Pharma Dive
JANUARY 6, 2025
The stage is set for JPM 2025—don't miss expert reactions following 2025’s principal catalyst event!
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.
Pharmaceutical Technology
JANUARY 10, 2025
GlobalData analysis suggests that China will lead with the highest number of prevalent cases of Alzheimers disease in 2033.
Pharma Times
JANUARY 6, 2025
EpiSwitch PSE shows promise in reducing unnecessary procedures
Drug Discovery World podcast
JANUARY 9, 2025
This is the latest episode of the free DDW narrated podcast, titled Where are the global breakthroughs, opportunities and developments in cancer research?, which covers three articles written for DDW Volume 24 Issue 2, Spring 2023 of DDW. They are called: Global breakthroughs in cancer drug discovery , The Achilles heel of cancer , and Immunotherapy is here to stay .
Bio Pharma Dive
JANUARY 9, 2025
The biotech will stop developing two drugs and lay off nearly three-quarters of its staff after its lead therapy wasn’t as potent in early testing as the company expected.
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