AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 21, 2024
Mouse cortical neurons. (ALol88/Wikimedia Commons/CC by 4.0) Our brain isn’t the only place memories form in our body. New York University (NYU) researchers have discovered learning through repetition may be fundamental to all of our cells. The process may also help explain why taking breaks is such a powerful learning tool.
Antidote
NOVEMBER 20, 2024
Being a caregiver is one of the most selfless and demanding roles you can take on. Whether you're looking after a parent, spouse, child, or loved one, juggling all of the daily responsibilities that come with it can quickly feel overwhelming. With so much focus on taking care of others, it’s easy to put yourself and your needs on the back burner. While your focus is understandably on your loved one, it’s important to remember that your own well-being matters too.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
NOVEMBER 18, 2024
The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.
Rethinking Clinical Trials
NOVEMBER 21, 2024
In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.
Advertisement
Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Medical Xpress
NOVEMBER 22, 2024
An international research team, led by the University of Wollongong (UOW), has found wearable organic X-ray sensors could offer safer radiotherapy protocols for cancer patients.
Pharmaceutical Technology
NOVEMBER 6, 2024
The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 14, 2024
BioNTech has signed a definitive agreement to acquire Biotheus to obtain complete worldwide rights to BNT327/PM8002, a programmed death-ligand 1 and vascular endothelial growth factor A-targeting bispecific antibody.
Bio Pharma Dive
NOVEMBER 6, 2024
Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.
Fierce Pharma
NOVEMBER 20, 2024
As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 12, 2024
(Rasi Bhadramani/Getty Images) Forever chemicals are falling in the rain, running through our waterways, and swimming in our bloodstreams, and now, initial research suggests these potentially harmful pollutants are ‘clogging up’ a crucial drainage system in our bodies.
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!
Worldwide Clinical Trials
NOVEMBER 12, 2024
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. CGTs address rare and complex diseases at the root cause with increasing use in cancer, genetic disorders, and autoimmune diseases.
Rethinking Clinical Trials
NOVEMBER 26, 2024
In an article published online this week , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities.
Pharmaceutical Technology
NOVEMBER 27, 2024
Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.
Bio Pharma Dive
NOVEMBER 15, 2024
At an event hosted by BioPharma Dive, drugmaker executives and investors discussed the importance of focus, smart spending and maintaining lines of sight to the clinic.
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
XTalks
NOVEMBER 6, 2024
LumiThera Inc. , a vision tech company focused on developing photobiomodulation (PBM) therapies for ocular diseases and disorders, has received US Food and Drug Administration (FDA) authorization for its Valeda Light Delivery System for patients with dry age-related macular degeneration (AMD), one of the most common causes of vision impairment in the aging population.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 21, 2024
Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.
Worldwide Clinical Trials
NOVEMBER 13, 2024
By; Brooke Kaplan, Director, People Partner- HR Compliance & Human Capital Initiatives In April 2007, at 19 years old, I was a sophomore at the University of Maryland. I had always been relatively healthy, exercised recreationally, and worked part-time at the campus gym. I’d just returned from spring break at Disney World with my boyfriend (now husband), Zak, and we were gearing up for the Jewish holiday of Passover.
Rethinking Clinical Trials
NOVEMBER 25, 2024
Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems. “Teams need to be aware of—and perhaps proactively investigate—possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and saf
Pharmaceutical Technology
NOVEMBER 18, 2024
The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.
Bio Pharma Dive
NOVEMBER 11, 2024
Negative drug results cost AbbVie billions of dollars in market value and convinced analysts that Bristol Myers had placed a better bet in buying Karuna Therapeutics.
XTalks
NOVEMBER 13, 2024
Merck KGaA recently shared positive results from its Phase III MANEUVER trial on pimicotinib, an investigational oral therapy for tenosynovial giant cell tumor (TGCT). TGCT is a rare, aggressive joint condition caused by overactive colony-stimulating factor 1 (CSF-1). A generally non-cancerous growth that forms in the tissue lining the joints, tendons or fluid-filled sacs around joints, TGCT often leads to abnormal joint tissue growth, painful swelling and stiffness.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 14, 2024
The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
Advertisement
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.
Fierce Pharma
NOVEMBER 1, 2024
With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.
Rethinking Clinical Trials
NOVEMBER 13, 2024
In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern. Delgado is an associate professor of emergency medicine and epidemiology at the University of Pennsylvania and the director of the Penn Medicine Nudge Unit, which “designs an
Pharmaceutical Technology
NOVEMBER 11, 2024
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.
Bio Pharma Dive
NOVEMBER 21, 2024
Howard Chang will take over as chief scientific officer and senior VP of research as the biotech searches for more ways to overcome the looming loss of exclusivity for some of its top-selling medicines.
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.
XTalks
NOVEMBER 14, 2024
PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency. This therapy, the first of its kind to be administered directly into the brain, addresses a rare genetic disorder that severely affects motor function and dopamine production.
Advarra
NOVEMBER 14, 2024
In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy. These independent committees are entrusted with the task of safeguarding study participant’s interests while ensuring the trial’s scientific integrity.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 26, 2024
(SciePro/Science Photo Library/Getty Images) Stem cells are special in the way they can keep on replicating, and turn themselves into many other types of cell. Now scientists have discovered how their superpowers get a remarkable boost when they’re grown in space.
Rethinking Clinical Trials
NOVEMBER 5, 2024
A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study , and NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce t
Advertisement
Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.
Expert insights. Personalized for you.
246 
Let's personalize your content