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Sean Mann In this Friday’s PCT Grand Rounds, Sean Mann of RAND will present “Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, March 14, 2025, at 1:00 pm eastern. Mann is a senior policy analyst at RAND. Join the online meeting. The post March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials appeared first on Rethink
Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest? Rigorous procedures to ensure that drugs are effective and safe.
The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinical trial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure.
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.
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
Researchers report a discovery in cardiac regeneration that offers new hope for the treatment of ischemic heart failure. Published in npj Regenerative Medicine, the study reveals a novel approach to promoting cardiomyocyte proliferation. The researchers are from the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and collaborating institutions.
Anteris Technologies Global Corp. (ATGC) has gone public with its initial public offering (IPO), marking a significant milestone in its journey to transform the heart valve market. The company offered 14.8 million shares of its common stock at an initial price of $6.00 per share. Trading began on the Nasdaq Global Market on December 13, 2024, under the ticker symbol “AVR,” with the offering closed on December 16, 2024.
Anteris Technologies Global Corp. (ATGC) has gone public with its initial public offering (IPO), marking a significant milestone in its journey to transform the heart valve market. The company offered 14.8 million shares of its common stock at an initial price of $6.00 per share. Trading began on the Nasdaq Global Market on December 13, 2024, under the ticker symbol “AVR,” with the offering closed on December 16, 2024.
By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate. However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated
As a provider of custom services, Creative Biolabs aims to support the entire process of drug discovery and development for the global pharmaceutical industry using its cutting-edge technology and wide-ranging experiences. It is no secret that the complexities associated with biopharmaceuticals are ever increasing, particularly regarding the development of antibody therapeutics.
When preparing for flu season, those with asthma may have concerns about how the virus can affect their respiratory health and breathing. While asthma is a manageable condition, it does require extra care when dealing with seasonal illnesses like the flu. In this blog, we'll explore how asthma and the flu interact, provide tips for managing both, and offer resources to help you stay informed and prepared.
Designing the Future of Biosimilars: Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are facing increasing pressure to develop high-quality, cost-effective treatments that meet the evolving needs of patients and healthcare systems. One key aspect of this journey is the clinical trial design and execution process a critical step that can make or break the success of a biosimilar product.
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.
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
A Parliamentary Panel has recommended implementation of a comprehensive, nationwide and phased Medicines Regulatory Maturity Enhancement Programme on the lines of World Health Organisation’s (WHO) vaccine benchmarking process to ensure a consistently high standard of drug regulation across the country.
Researchers from Mass General Brigham and collaborating institutions have developed a non-invasive approach to manipulate cardiac tissue activity by using light to stimulate an innovative ink incorporated into bioprinted tissue. Their goal is to develop a technique that can be used to repair the heart. Their findings in preclinical models, published in Science Advances, show the transformative potential of non-invasive therapeutic methods to control electrically active tissues.
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
By Julie Kim & Deborah L. Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).
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.
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
For 2025, the three largest pharmacy benefit managers (PBMs)Caremark (CVS Health), Express Scripts (Cigna), and Optum Rx (United Health Group)have again each excluded hundreds of drugs from their standard formularies. You can find our updated counting below. As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace.
The Latin American Pharmaceutical Market: Why Specialty Generics Are Poised for Growth As the pharmaceutical industry continues to evolve, one trend is becoming increasingly clear: the demand for specialty generics is on the rise, particularly in the Latin American market. But what exactly are specialty generics, and why are they gaining traction in this region?
Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications. The article was published online in Statistics in Medicine.
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.
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.
Do ice baths live up to the hype? (Diana Light/Unsplash) Ice baths have become increasingly popular over the past few years. Fitness enthusiasts and casual exercisers around the world are embracing this trend that was once reserved for elite athletes. Ice baths (also known as “cold water immersion“) are exactly what they sound like.
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.
New research details the subcellular structures in neurons that enable signals to be transmitted from where they are received at specific sites on dendrites to the decision-making cell body located hundreds of micrometers away. The new research finds that the endoplasmic reticulum and the plasma membrane form contact sites where specialized molecules control the release of calcium, which regulates the signals sent along the dendrite to the soma.
Known for its AI-driven diagnostic tools, IMVARIA, a Berkeley-based health tech company, recently earned the FDAs 510(k) clearance of ScreenDx, a first-of-its-kind algorithm designed to identify potential interstitial lung disease (ILD) cases. This follows their earlier success with Fibresolve , a tool for idiopathic pulmonary fibrosis (IPF) that became the first FDA Breakthrough-designated AI diagnostic for lung fibrosis.
By Richard A. Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.
Craig Koch has been appointed as Velocitys new Executive Vice President, Europe, to spearhead the next phase of growth across the region. His appointment underscores the companys long-term commitment to Europe. Previously serving as EVP, Global Head of Sales, Craig has been with Velocity since 2019. He is now relocating to Europe to provide hands-on leadership as Velocity scales its integrated site network model across the continent.
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
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