November, 2024

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Memory Is Not Confined to Our Brains, Scientists Discover

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Scientist 205
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Caring for Yourself While Caring for Others: Practical Tips for Caregivers

Antidote

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.

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FDA endorses speedy approval path for Regenxbio Duchenne gene therapy

Bio Pharma Dive

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.

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November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

Rethinking Clinical Trials

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.

Trials 316
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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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Printable organic X-ray sensors may transform treatment for cancer patients

Medical Xpress

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.

Research 114
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Top 20 biopharmas’ market cap rises 2% in Q3 2024 amid flurry of drug approvals

Pharmaceutical Technology

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.

Marketing 263

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BioNTech signs agreement to acquire Biotheus

Pharmaceutical Technology

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.

Antibody 246
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An RNAi renaissance is creating a new generation of startups

Bio Pharma Dive

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.

RNA 346
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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

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.

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Forever Chemicals May Damage Kidney Function, Evidence Shows

AuroBlog - Aurous Healthcare Clinical Trials blog

(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.

Research 223
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Worldwide Clinical Trials

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.

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November 26, 2024: Hybrid Methods Improve Collection of Patient-Reported Outcome Measures in Rural and Underserved Populations

Rethinking Clinical Trials

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.

Trials 147
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Digital transformation expected to shorten drug development timelines

Pharmaceutical Technology

Pharmaceutical professionals expect digital solutions to solve drug development headaches, with AI already proving disruptive.

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Surviving in biotech’s new normal: 5 tips from industry VCs and CEOs

Bio Pharma Dive

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.

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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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The pink elephant test: What your visual imagination predicts about your ability to control your thoughts

Medical Xpress

"Tell a man he shouldn't think of a pink elephant and he can't get that beast out of his mind!

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Osteoporosis Is a ‘Silent Killer’. Here’s How to Avoid It.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Taokinesis/Canva) Because there are typically no symptoms until the first fracture occurs, osteoporosis is considered a silent disease. Some call it a silent killer. Osteoporosis is a bone disease characterized by decreased bone density and strength, leading to fragile, brittle bones that increase the risk of fractures, especially in the spine, hips and wrists.

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Running Through Life with Type 1 Diabetes

Worldwide Clinical Trials

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.

Insulin 162
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November 25, 2024: NIH Collaboratory Trial Investigators Share Lessons From Using Electronic Health Records in Pragmatic Trials

Rethinking Clinical Trials

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

Trials 147
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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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AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

Drugs 264
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On Wall Street, ‘flat out’ failure of AbbVie schizophrenia drug leaves analysts stunned

Bio Pharma Dive

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.

Drugs 318
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Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Fierce Pharma

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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Study Finds Eggs Might Protect Brain Health And Lower Cholesterol

AuroBlog - Aurous Healthcare Clinical Trials blog

(SimpleImages/Getty Images) A high-cholesterol animal product eaten by billions of people worldwide is not as bad for your health as it’s often cracked up to be. It might even be good for you.

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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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FDA Guidance on Decentralized Clinical Trials

Deltaclinical

In September 2024, the FDA released a document regarding the conduct of clinical trials with decentralized elements.

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November 13, 2024: Pragmatic Trial of Smartphone Nudges to Prevent Distracted Driving, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

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

Trials 173
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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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Amgen picks prolific biotech founder Chang as new top scientist

Bio Pharma Dive

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.

Scientist 308
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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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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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Stem Cells Grown in Space Turn Out to Have a Surprise Advantage

AuroBlog - Aurous Healthcare Clinical Trials blog

(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.

Scientist 198
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New study to assess mpox vaccine in pregnant women and infants

Pharma Times

Trial to evaluate safety and efficacy of MVA-BN vaccine

Vaccine 129
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November 21, 2024: JAMA Commentary Highlights Need for Virtual Vigilance in Decentralized Clinical Trials

Rethinking Clinical Trials

In a JAMA Viewpoint published online this week , coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices. In a decentralized clinical trial, some or all of the trial-related activities take place at locations other than the trial site, which can result in decrease in travel, time, and burden for patien

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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