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By Steven J. Gonzalez On March 31, 2025, U.S. District Judge Sean D. Jordan ordered that FDAs Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests.
Achieving end-to-end lineage in Databricks while allowing external users to access raw data can be a challenging task. In Databricks, leveraging Unity Catalog for end-to-end lineage is a best practice. However, enabling external users to access raw data while maintaining security and lineage integrity requires a well-thought-out architecture. This blog outlines a reference architecture to achieve this balance.
The Future of Healthcare: Unpacking the Global Generic Drug Market As we navigate the ever-changing landscape of the pharmaceutical industry, one thing is clear: the demand for affordable, high-quality medications is on the rise. The global generic drug market is at the forefront of this trend, with its growth projected to reach new heights in the coming years.
Threes still company in the world of pharmacy benefit managers. For 2024, nearly 80% of all equivalent prescription claims were processed by three familiar companies: the CVS Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group. The names havent changed, but shifting relationships and contract shakeups have altered the plot, with Express Scripts stepping into a new lead role.
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!
Today in our “We Are Perficient” series, we explore how businesses can take their digital experience to the next level through mobile optimization. In an exclusive conversation with Jonathan Crockett, Managing Director of Go-To-Market, Sales, and Solutions at Perficient , we dive into key strategies to ensure brands deliver seamless, high-impact experiences on mobile devices.
A newly developed blood test for Alzheimer's disease not only aids in the diagnosis of the neurodegenerative condition but also indicates how far it has progressed, according to a new study.
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Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
A newly developed blood test for Alzheimer's disease not only aids in the diagnosis of the neurodegenerative condition but also indicates how far it has progressed, according to a new study.
MONDAY, March 31, 2025 -- Use of cutting-edge weight-loss drugs like Ozempic and Zepbound has increased dramatically among people with type 1 diabetes, raising safety concerns among experts, a new study says.Both adults and children with type 1.
New research reveals that lower proportions of specific sleep stages are associated with reduced brain volume in regions vulnerable to the development of Alzheimer's disease over time.
MONDAY, March 31, 2025 -- A new drug may help protect millions of people from heart attacks and strokes by lowering a little-known risk factor in the blood.The drug, made by Eli Lilly and called lepodisiran, lowered levels of a tiny particle called.
One of the ocean currents in the Arctic Ocean is at risk of disappearing this century because of climate change, according to a new study. As a result, the North Atlantic could be flooded with freshwater which would weaken the global ocean circulation.
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
MONDAY, March 31, 2025 -- A top vaccine official at the U.S. Food and Drug Administration (FDA) is stepping down, warning that vaccine misinformation is coloring the countrys top health decisions.Dr. Peter Marks, director of the FDAs Center for Bi.
MONDAY, March 31, 2025 -- Breast-conserving therapy for breast cancer might not conserve as much as previously thought, a new study suggests.Womens breasts can shrink considerably after theyve undergone radiation therapy and lumpectomy for their e.
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.
MONDAY, March 31, 2025 -- Certain stages of sleep deep sleep and dream sleep appear to contribute to brain health in ways that affect risk of Alzheimers disease, a new study says.People who get less deep sleep or dream sleep have smaller volum.
Researchers have uncovered a complete Quina technological system in the Longtan site in southwest China. The discovery challenges the widely held perception that the Middle Paleolithic period was mostly static in East Asia.
Drugs from Novartis, Amgen and now Lilly have proven powerfully effective at reducing Lp(a). Whether that will translate to a cardioprotective benefit won’t be answered until Phase 3 tests read out.
A new study warns that global climate change may have a devastating effect on butterflies, turning their species-rich, mountain habitats from refuges into traps. Think of it as the 'butterfly effect' -- the idea that something as small as the flapping of a butterfly's wings can eventually lead to a major event such as a hurricane -- in reverse. The new study also suggests that a lack of comprehensive global data about insects may leave conservationists and policymakers ill-prepared to mitigate b
Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
MONDAY, March 31, 2025 -- Surgery might not be needed to treat as many as 60% of early-stage breast cancers, a new study says.Breast cancers that have been completely wiped out by chemotherapy and radiation treatment are not likely to come back.
A study presents a striking example of cooperative organization among cells as a potential force in the evolution of multicellular life. The study is based on the fluid dynamics of cooperative feeding by Stentor, a relatively giant unicellular organism.
The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and predict molecular structures.
Inhaling dust particles from the Red Planet over long periods of time could put humans at risk of developing respiratory issues, thyroid disease and other health problems.
Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
MONDAY, March 31, 2025 -- The U.S. Food and Drug Administration has approved cabozantinib (Cabometyx), an oral tyrosine kinase inhibitor, for patients with previously treated advanced neuroendocrine tumors, offering a new standard of care for this.
| Project Optimus is changing the landscape of oncology drug development by redefining dose optimization standards. Learn how sponsors can align with FDA expectations and implement more precise dose-finding strategies. Watch the full interview with Alex MacDonald now!
MONDAY, March 31, 2025 -- Wearing a smartwatch might do more than track steps (or your texts) -- it could be a powerful tool for helping people with type 2 diabetes stay active, a new study says.Participants were more likely to start and maintain.
Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the increasing complexity of clinical research.
MONDAY, March 31, 2025 -- The U.S. Food and Drug Administration (FDA) has recalled ground coffee sold in 15 states after finding it may have been wrongly labeled as decaffeinated.Hundreds of 12-ounce bags of Our Family Traverse City Cherry Decaf.
Beyond the Science: Accelerating Biotech Success dwunderlin Mon, 03/31/2025 - 16:17 Wed, 05/14/2025 - 11:00 Resource Type Webinar Vik Chawla Paul Holmes Biotech success isnt just about great scienceits about building a compelling commercial narrative from day one. In todays challenging funding landscape, investors and partners demand more than regulatory milestones; they need a clear path to market differentiation and value creation.
James J. Collins Research Group at MIT - The Collins lab focuses on synthetic biology and systems biology, with an emphasis on infectious diseases and antibiotic resistance.
By Alexander Gaffney, MS, RAC MARTY MAKARY has been confirmed by the Senate as the next commissioner of the FDA. But Makary will almost immediately face challenges that will make his tenure as commissioner especially difficult. Here, AgencyIQ identifies and explores five of the biggest hurdles the new commissioner will face. Fill out the form to read the full article.
James J. Collins Research Group at MIT - The Collins lab focuses on synthetic biology and systems biology, with an emphasis on infectious diseases and antibiotic resistance.
MONDAY, March 31, 2025 -- COVID-19 and influenza burned through the U.S. during this years cold and flu season, and deadly measles outbreaks have sickened people in 19 states.So what does it take to get people vaccinated against these preventable d.
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