Unsafe and unregulated cell therapies being sold in Europe
Pharmaceutical Technology
MARCH 14, 2025
The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European Union.
March, 2025
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March 12, 2025: In This Week’s PCT Grand Rounds, Spillover as a Potential Source of Bias in Pragmatic Trials
Rethinking Clinical Trials
MARCH 12, 2025
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
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HHS to cut 10,000 staff in major restructuring under RFK Jr.
Bio Pharma Dive
MARCH 27, 2025
The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not be affected.
Calcium channel inhibition promotes cardiac regeneration, offering hope for heart failure treatment
Medical Xpress
MARCH 7, 2025
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.
Bridging Innovation & Patient Care: The Growing Role of AI
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!
Beverage & Food IPOs in 2025: Companies Taking the Public Leap
XTalks
MARCH 26, 2025
After a strong showing in 2024, leading packaged foods company BBB Foods saw their stocks rise from $17.50 to over $28 per share, followed by a successful secondary offering this year. Moreover, Guzman y Gomezs, a renowned Australian fast-casual chain known for a fresh, made-to-order Mexican food experience, whose shares surged 37% on debut, now has its very first location in Illinois.
Do Ice Baths Really Work? Here’s What The Science Says
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 19, 2025
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.
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March 19, 2025: Use of Generative AI in Clinical Trials, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
MARCH 19, 2025
Dr. Alexander “AJ” Blood In this Friday’s PCT Grand Rounds, Alexander J. “AJ” Blood of Harvard Medical School and Brigham and Women’s Hospital will present “Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care.” The Grand Rounds session will be held on Friday, March 21, 2025, at 1:00 pm eastern.
First Prader-Willi drug to reduce hunger approved by FDA
Bio Pharma Dive
MARCH 26, 2025
Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.
Researchers develop new DNA test for personalized treatment of bacterial vaginosis
Medical Xpress
MARCH 29, 2025
Roughly one out of three women ages 14-49 in the United States develop a vaginal bacterial imbalance known as bacterial vaginosis (BV) during their lifetime. BV is characterized by unpleasant odors, and potentially painful side effects, as well as the risk of associated health issues later in life. More than half of the patients who seek medical care do not respond to the first-line treatment, the antibiotic metronidazole, leading to recurrence.
Innovating Treg Therapies for ALS and Alzheimer’s with Coya Therapeutics CEO Dr. Arun Swaminathan — Episode 200
XTalks
MARCH 19, 2025
Join us as we celebrate a major milestone the 200th episode of the Xtalks Life Science Podcast! From groundbreaking biotech innovations to exclusive interviews with life science industry innovators and leaders, we’ve covered it all. Thank you for tuning in each week! We look forward to continuing to bring the latest and greatest across the pharma, biotech and medical industries!
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
Inside the Russian Pharma Industry: Key Players and Innovations
Drug Patent Watch
MARCH 18, 2025
Exploring the Russian Pharma Industry: Key Players and Innovations As we continue to navigate the complexities of the global pharmaceutical landscape, it's essential to stay informed about emerging markets and trends. Today, I want to take you on a journey to Russia, a country with a rich history of pharmaceutical innovation and a growing presence in the industry.
AstraZeneca and Ionis win EU approval for ATTR polyneuropathy
Pharmaceutical Technology
MARCH 10, 2025
AstraZeneca and Ionis are intensifying their competition with Alnylam by securing an EU approval for Wainzua.
Grand Rounds March 21, 2025: Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care (Alexander J. “AJ” Blood, MD, MSc)
Rethinking Clinical Trials
MARCH 27, 2025
Speaker Alexander J. AJ Blood, MD, MSc Associate Director, Accelerator for Clinical Transformation Research Group Instructor of Medicine at Harvard Medical School Cardiologist and Intensivist Brigham and Womens Hospital Slides Keywords Artificial Intelligence; Cost; Large Language Models; Enrollment; Eligibility; Recruitment Key Points The Accelerator for Clinical Transformation (ACT) is a research group that seeks to use emerging technology to try and expand access to
Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks
Bio Pharma Dive
MARCH 31, 2025
Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.
New Publication Shares Insights on Decentralized Clinical Trial Elements in Cancer Trials During the COVID-19 Pandemic
CTTI (Clinical Trials Transformation Initiative)
MARCH 19, 2025
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
CagriSema, Novo Nordisk’s Latest Obesity Drug Offering, Disappoints Investors with Trial Results
XTalks
MARCH 14, 2025
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.
Key Considerations for Generic Drug Stability Testing
Drug Patent Watch
MARCH 12, 2025
The Unseen Heroes of Generic Drugs: Stability Testing 101 As a consumer, have you ever stopped to think about the rigorous process that goes into bringing a generic version of your favorite medication to market? It's not just a matter of copying a formula and slapping a new label on it. Behind the scenes, generic drug manufacturers are working tirelessly to ensure that their products are safe, effective, and identical to their branded counterparts.
AstraZeneca and Alteogen agree on ALT-B4 platform tech
Pharmaceutical Technology
MARCH 18, 2025
AstraZeneca has entered an exclusive licence agreement with Alteogen involving the latters ALT-B4 platform technology.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
March 18, 2025: ABATE Infection Analysis Explores Cost-Effectiveness of Strategies to Prevent Hospital-Acquired Infections
Rethinking Clinical Trials
MARCH 18, 2025
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.
Peter Marks, FDA’s top vaccine official, resigns
Bio Pharma Dive
MARCH 29, 2025
In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.
Down syndrome case challenges Alzheimer's assumptions with unexpected cognitive stability
Medical Xpress
MARCH 1, 2025
Studies reveal that people with Down syndrome (DS) have over a 90% lifetime risk of developing dementia caused by Alzheimer's disease (AD) as they age. Research from the University of Pittsburgh's Swanson School of Engineering aims could uncover why some people with DS develop dementia while others do not providing insight that could ultimately benefit the entire DS community.
Wholemeal or Wholegrain? An Expert Explains How to Choose Your Bread.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 12, 2025
(Laura Leyshon/Getty Images) If you head to the shops to buy bread, you’ll face a variety of different options. But it can be hard to work out the difference between all the types on sale. For instance, you might have a vague idea that wholemeal or wholegrain bread is healthy. But what’s the difference?
How Machine Learning Drives Clinical Trial Efficiency
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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.
Drug Patent Expirations: Unlocking Strategic Investment Opportunities
Drug Patent Watch
MARCH 19, 2025
Unlocking Strategic Investment Opportunities in the Pharmaceutical Industry As we navigate the ever-evolving landscape of the pharmaceutical industry, one thing remains constant: the expiration of patents on blockbuster medications. These expirations can have a significant impact on the market, creating opportunities for strategic investment and growth.
Machine learning adoption into supply chain management on the horizon
Pharmaceutical Technology
MARCH 4, 2025
Large-scale integration of AI into pharma supply chains is on the way as companies seek optimised ordering.
March 26, 2025: GPT-4–Based Plain Language Translation of Clinical Notes for Patients, in This Week’s PCT Grand Rounds
Rethinking Clinical Trials
MARCH 26, 2025
Dr. Matthew Engelhard and Anivarya Kumar In this Friday’s PCT Grand Rounds, Matthew Engelhard and Anivarya Kumar of Duke University will present “A Cross-Sectional Study of GPT-4Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management.” The Grand Rounds session will be held on Friday, March 28, 2025, at 1:00 pm eastern.
MeiraGTx spins Parkinson’s, obesity gene therapies into AI startup
Bio Pharma Dive
MARCH 13, 2025
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.
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.
Everyday physical activity does not slow bone loss during menopause, finds study
Medical Xpress
MARCH 28, 2025
According to a recent study from the University of Jyvskyl, Finland, the impacts of everyday physical activity do not attenuate the accelerated hormonal bone loss that occurs during menopause. Effective bone-loading impacts are rare in everyday life. Future research should explore whether more targeted exercise can slow menopausal bone loss. The study suggests that impacts accumulated during everyday life are not sufficient to slow hormonal bone loss during menopause.
Bridging the Gap in Patient Support: How GoodRx is Revolutionizing Access to Specialty Meds
Drug Channels
MARCH 7, 2025
Todays guest post is from Divya Iyer, SVP Go-to-Market (GTM) Strategy at GoodRx. Divya argues that patient support programs (PSPs) struggle with awareness and accessibility, preventing patients from fully benefiting from the financial and educational resources available to them. Divya discusses how integrating digital solutions from GoodRx can enhance engagement, streamline access to therapy, and improve patient outcomes.
The Advantages of Using a CDMO
Drug Patent Watch
MARCH 20, 2025
Unlock the Full Potential of Your Pharmaceutical Product: The Power of a CDMO As a pharmaceutical professional, you're constantly looking for ways to bring innovative products to market faster and more efficiently. One key strategy that can help you achieve this goal is partnering with a Contract Development and Manufacturing Organization (CDMO). But what exactly is a CDMO, and how can it benefit your business?
AstraZeneca director says AI must be a “thought partner” in drug discovery
Pharmaceutical Technology
MARCH 14, 2025
AstraZenecas senior director in oncology data science outlined how the company uses AI for drug discovery at a recent talk.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
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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