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In a cost-effectiveness analysis using data from the ABATE Infection trial, a strategy of chlorhexidine bathing and nasal decolonization targeted to hospitalized adults with medical devices in nonintensive care unit (ICU) settings was cost-effective in reducing hospital-acquired infections. The study results were published this month in JAMA Network Open.
A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.
Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.
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
A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic. DCT elementssuch as remote monitoring, telemedicine, and home delivery of investigational products were widely used in cancer trials to maintain patient safety an
Dr. Sara Singer, principal investigator for iPATH Researchers from iPATH, an NIH Collaboratory Trial, described key considerations for integrating artificial intelligence tools into analyses of qualitative data. The report was posted this month on the AcademyHealth Blog. The iPATH trial, led by principal investigator Sara Singer at Stanford University, will test the implementation of a practice transformation strategy for type 2 diabetes in federally qualified health centers in California, Massa
The joint venture with generative AI firm Hologen hands MeiraGTx $200 million up front as well as other financial perks — a “transformative” deal, according to the company’s CEO.
The joint venture with generative AI firm Hologen hands MeiraGTx $200 million up front as well as other financial perks — a “transformative” deal, according to the company’s CEO.
Consumers of popular culture in the 1960s and 1970s preferred their artificial intelligence (AI) to come with overtones of danger, if not outright world domination, judging by small- and large-screen science fiction artifacts ranging from episodes of the original Star Trek series to movies like 2001: A Space Odyssey and Colossus: The Forbin Project.
On March 7, 2025, Advanced Biomed Inc. raised $6.56 million in its IPO and began trading on Nasdaq under the ticker ADVB. The biotech firm, which develops semiconductor-based microfluidic technology for early cancer detection, issued 1.64 million shares at $4 each, with an option to purchase an additional 246,000 shares within 45 days. Current Share Price: Established in 2014, Advanced Biomed has developed a proprietary microfluidic platform that functions as a compact laboratory on a chip.
Speaker Sean Mann Senior Policy Analyst RAND Corporation Slides Keywords Development Economics; Spillover; Bias; Pragmatic Clinical Trials Key Points Individually randomized, parallel-group embedded pragmatic trials randomly assign patients to a new healthcare intervention or to a control group that receives some form of usual care.
The agency formulated its advice to manufacturers after coordinating with the CDC and Defense Department. An advisory meeting that's typically held was canceled last month.
By Sara W. Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.
The FDA has issued a letter addressed to healthcare providers warning that the ongoing shortage of hemodialysis bloodlines may extend into the autumn months. Also referred to as dialysis catheters, hemodialysis bloodlines are sets of tubes inserted into a vein during dialysis treatment. They connect the patients bloodstream to the dialysis machine, which filters the blood to remove waste and excess fluid in patients with impaired kidney function.
Speaker F. Perry Wilson, MD MSCE Associate Professor of Medicine and Public Health Director, Clinical and Translational Research Accelerator Yale University New Haven, CT Slides Keywords Electronic Alerts; Acute Kidney Injury; Action Team Key Points Acute Kidney Injury (AKI), or abrupt decline in kidney function, is common, affecting about 15% of hospitalized patients.
Ed Kaye, Stoke’s longtime leader, will be replaced by former Vertex executive Ian Smith. Elsewhere, all 12 drugmakers targeted for second round of Medicare price talks agreed to participate.
(Ippei Naoi/Getty Images) Simply looking at nature or even just digital pictures of it can relieve pain, according to new research which scanned the brains of people receiving electrical shocks. Nature’s many health benefits have been documented by decades of research.
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.
Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. Hidradenitis suppurativa affecting roughly 1% of the population is a chronic skin condition marked by painful boils and abscesses that can significantly disrupt daily life.
Study results showed Orca’s treatment, a purified mix of donor-derived T cells and stem cells, was safer than standard transplant in treating certain blood cancers.
The use of AI in drug discovery and development has been recognised, explored, and implemented throughout the last decade, with a notable acceleration in recent years.
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.
In our latest POV by Roberto Ascione, President of EVERSANA INTOUCHs Health Innovation, and Ferdinando Scala, Director of Strategic Planning, the evolving landscape of digital health and its implications for the life sciences industry are explored with an emphasis on the importance of understanding digital determinants of health, which include factors such as internet access, digital literacy, and the availability of digital devices.
In 2025, as market pressures intensify and companies refocus on core strategic priorities, medical device and medtech companies have been forced to make tough decisions regarding their workforces. These developments come amid a broader nationwide trend of workforce realignment, with both private and public entities, including the FDA’s recent rehires amid mass layoffs, adapting to ongoing pressures.
This is a sponsored message. To grow your business, negotiate and collect fair payment for your work by understanding its true costs before budget discussions. This includes all direct and indirect costs, and typically covers: Personnel costs: salaries, overtime, training, and additional staffing if needed. Facility costs: not only facility space, maintenance, utilities, and equipment, but also any additional space or modifications needed for the study.
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.
Monkeys infected with Ebola can be cured with a pill, according to a new study out Friday that could pave the way for more practical, affordable treatments in humans.
A 16-year-old patient died after treatment with Elevidys (delandistrogene moxeparvovec), Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy (DMD). The patient suffered acute liver failure several months after receiving the therapy in December. Liver injury is a known risk with Elevidys and other gene therapies that use adeno-associated viral (AAV) vectors.
Navigating the Complex World of Biosimilar Regulatory Agency Interactions As a biosimilar developer, you know that getting your product to market can be a long and arduous process. One of the most critical components of this journey is interacting with regulatory agencies. But how can you ensure that these interactions are effective and set your product up for success?
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