XTalks
DECEMBER 12, 2024
Equal opportunity to healthcare is not just a topic of discussion it must be intentionally implemented and built into every aspect of healthcare. In clinical research, this includes designing trials that elevate the patient voice, reduce barriers to participation, and represent the diverse populations who will ultimately use these medical products.
Pharmaceutical Technology
DECEMBER 9, 2024
Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.
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Bio Pharma Dive
DECEMBER 20, 2024
Novo shares lost nearly a quarter of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.
Rethinking Clinical Trials
DECEMBER 5, 2024
Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety of text messaging strategies to
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
Pharma Mirror
DECEMBER 23, 2024
Have you ever wondered how life-saving treatments for cancer, Alzheimers, or chronic diseases come to life? Clinical trials are the foundation of medical innovation, paving the way for groundbreaking therapies. Yet for many, the idea of joining a trial can feel intimidating or unclear. Experts are here to demystify the clinical trial process, with Dr.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 5, 2024
India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
DECEMBER 9, 2024
The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.
Bio Pharma Dive
DECEMBER 4, 2024
Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.
Rethinking Clinical Trials
DECEMBER 3, 2024
In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation. The article was published online ahead of print in Clinical Trials. There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants.
Fierce Pharma
DECEMBER 3, 2024
Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight.
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!
Advarra
DECEMBER 17, 2024
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
Pharmaceutical Technology
DECEMBER 24, 2024
The FDA initially rejected the marketing application for Alhemo in 2022, asking for additional data on dosing and monitoring.
XTalks
DECEMBER 18, 2024
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
Bio Pharma Dive
DECEMBER 2, 2024
The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.
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
Rethinking Clinical Trials
DECEMBER 11, 2024
Dr. Gbenga Ogedegbe In this Friday’s PCT Grand Rounds, Gbenga Ogedegbe of the NYU Grossman School of Medicine will present “Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, December 13, 2024, at 1:00 pm eastern.
Drug Patent Watch
DECEMBER 9, 2024
Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 29, 2024
(Dave & Les Jacobs/DigitalVision/Getty Images) We know that too much sitting is bad for us, but a new study adds an important detail: if you spend more than 10-and-a-half hours a day sitting or lying down, regular exercise might not be enough to prevent an increased risk of serious heart issues.
Pharmaceutical Technology
DECEMBER 19, 2024
MSD has entered an exclusive global licence agreement with Hansoh Pharma for a preclinical oral small molecule GLP-1RA.
XTalks
DECEMBER 4, 2024
Jupiter Neurosciences, a clinical-stage pharma company specializing in neuroinflammation, made its public market debut with an initial public offering (IPO) on the Nasdaq Capital Market under the symbol “JUNS.” The company priced 2,750,000 shares of common stock at $4.00 per share, expecting gross proceeds of $11 million. Trading began on December 3, 2024, with the IPO set to close the following day, subject to customary conditions.
Bio Pharma Dive
DECEMBER 3, 2024
While early and from a small trial, the findings suggest Janux’s method of “masking” T cell engagers could lead to differentiated results, some analysts said.
Rethinking Clinical Trials
DECEMBER 18, 2024
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
Fierce Pharma
DECEMBER 2, 2024
The FDA is investigating reports of patients develo | The FDA is investigating reports of patients developing blood cancer after receiving bluebird bio’s gene therapy Skysona and is evaluating the need for “further regulatory action,” the U.S. agency said last week. The FDA notification came seven weeks after the New England Journal of Medicine (NEJM) published a report that seven of 67 children who received Skysona during clinical trials had developed blood cancer.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 25, 2024
Researchers studied cancer growth in mice. (Zhuang et al., Nature, 2024) Aging brings two opposing trends in cancer risk: first, the risk climbs in our 60s and 70s, as decades of genetic mutations build up in our bodies.
Pharmaceutical Technology
DECEMBER 18, 2024
Eli Lilly and EVA Pharma have announced approval from the Egyptian Drug Authority for the human insulin glargine injection.
XTalks
DECEMBER 19, 2024
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.
Bio Pharma Dive
DECEMBER 19, 2024
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.
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.
Rethinking Clinical Trials
DECEMBER 17, 2024
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.
Drug Patent Watch
DECEMBER 3, 2024
In the ever-evolving landscape of pharmaceutical research and development, a revolutionary force is reshaping the way we approach drug discovery and repurposing. This force is none other than Artificial Intelligence (AI) and Machine Learning (ML).
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 23, 2024
(Runstudio/Photodisc/Getty Images) If you find yourself sniffling at the merest hint of an irritant, you likely have a different set of microbes calling your nostrils home than everyone else. An international team of researchers has found a unique assortment of fungi up the noses of people who suffer from hayfever and asthma.
Pharmaceutical Technology
DECEMBER 18, 2024
Abera and Orexo have entered a partnership to develop and test the powder formulations of the formers vaccine candidates.
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