Trending Articles

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April 2, 2025: The Greenlight Plus Trial and Preventing Childhood Obesity, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Bill Heerman of Vanderbilt University will present “A Digital Health Behavior Intervention to Prevent Childhood Obesity: The Greenlight Plus Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, April 4, 2025, at 1:00 pm eastern. Heerman is an associate professor of internal medicine and pediatrics, the William K.

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Peter Marks, FDA’s top vaccine official, resigns

Bio Pharma Dive

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.

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March 26, 2025: GPT-4–Based Plain Language Translation of Clinical Notes for Patients, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

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.

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HHS to cut 10,000 staff in major restructuring under RFK Jr.

Bio Pharma Dive

The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not be affected.

Drugs 329
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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!

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Researchers develop new DNA test for personalized treatment of bacterial vaginosis

Medical Xpress

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.

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Blockbuster potential drugs ruled the 2024 pipeline with 53% rise over 2023

Pharmaceutical Technology

GLP-1RAs were the big game changer, boosting average forecast sales and return on investment rates.

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First Prader-Willi drug to reduce hunger approved by FDA

Bio Pharma Dive

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

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Researchers identify mutations that can lead to resistance to some chemotherapies

Medical Xpress

Investigators at Mass General Brigham have uncovered how resistance to chemotherapies may occur in some cancers. Researchers focused on a pathway that harnesses reactive oxygen species (ROS) to kill cancer cells. The study found that mutations to VPS35, a key player in this pathway, can prevent chemotherapy-induced cell death. These results, published in Nature, could help pinpoint treatment-resistant tumors.

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FDA fast tracks Sanofi’s mRNA vaccine for chlamydia

Pharmaceutical Technology

Sanofi will commence a Phase I/II trial with its vaccine candidate in the next few days to start generating immunogenicity data.

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Purple Day 2025: Innovation for Epilepsy

XTalks

Purple Day 2025, celebrated on March 26, has set sail with the theme Power In Purple, honoring the strength and resilience of individuals living with epilepsy. Organized in collaboration between the Epilepsy Foundation and The Anita Kaufmann Foundation, this years Purple Day highlights the importance of solidarity, visibility and education. Epilepsy is characterized by recurrent, unprovoked seizures caused by irregular brain activity.

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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

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The role of biosimilars in population health management initiatives

Drug Patent Watch

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives. But what exactly are biosimilars, and how can they make a meaningful impact on population health?

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Everyday physical activity does not slow bone loss during menopause, finds study

Medical Xpress

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.

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Macau approves IASO Bio’s multiple myeloma therapy

Pharmaceutical Technology

The Macau Special Administrative Region (ISAF) Pharmaceutical Administration Bureau has approved IASO Bio's NDA for equecabtagene autoleucel.

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Sanofi’s Qfitlia Gets FDA Approval as First siRNA Therapy for Hemophilia

XTalks

The FDA has approved Sanofis Qfitlia (fitusiran), making it the first approved siRNA therapy for hemophilia A or B, and the first for the conditions with or without inhibitors. It is indicated to prevent or reduce bleeding episodes in patients aged 12 and older, with or without factor VIII or IX inhibitors. Qfitlia is also the first antithrombin-lowering therapy approved for routine prophylaxis in hemophilia A or B.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Transforming Biopharma Intelligence: Moving from Traditional Analysts to Direct Raw Data Platforms

Drug Patent Watch

The Future of Biopharma Intelligence: Why Direct Data Platforms are Revolutionizing the Industry As a biopharma professional, you're likely no stranger to the challenges of staying ahead in a rapidly evolving market. From navigating complex regulatory landscapes to keeping pace with the latest scientific breakthroughs, it's easy to get overwhelmed by the sheer volume of information at your fingertips.

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Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

Bio Pharma Dive

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

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Study reveals how Chagas parasite invades human cells

Medical Xpress

Researchers from Auburn University, in a landmark collaboration with Brazil's Oswaldo Cruz Foundation (FIOCRUZ), the world's leading research institution on Chagas Disease, have published a significant study in the journal Biochemistry. The study sheds new light on how the Chagas Disease parasite invades human cellsa crucial step towards developing effective treatments for this neglected tropical disease.

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Google-backed Isomorphic Labs raises $600m to advance AI drug discovery

Pharmaceutical Technology

The funding is set to accelerate the development of Isomorphics AI drug design engine and advance clinical programmes.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Itolizumab Shows Positive Phase III Results in First-Line Treatment of Acute GVHD

XTalks

Equillium announced encouraging topline results from its Phase III EQUATOR study evaluating itolizumab in combination with corticosteroids as a first-line treatment for patients with acute graft-versus-host disease (aGVHD). The randomized, double-blind, placebo-controlled global trial assessed itolizumab in patients with newly diagnosed grade II-IV aGVHD.

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AI in Pharma Marketing: Innovation or Compliance Nightmare?

Pharma Marketing Network

Artificial intelligence (AI) is no longer a futuristic concept in healthcareits here, embedded in nearly every touchpoint of modern pharma marketing. From generative AI tools that draft emails to predictive algorithms that segment target audiences, the speed and scale of innovation are staggering. But as pharma marketers race to adopt these tools, a central question looms: Is AI fueling smarter engagement, or setting the stage for a compliance disaster?

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Lilly hits same Alzheimer’s roadblock in Europe as Eisai, Biogen

Bio Pharma Dive

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.

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Poor blood flow in the brain linked to postural orthostatic tachycardia syndrome

Medical Xpress

In what is believed to be a world-first study, researchers from the University of Adelaide's Australian Dysautonomia and Arrhythmia Research Collaborative (ADARC) have used brain scans to identify blood flow problems in people with postural orthostatic tachycardia syndrome (POTS).

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Saving shelved ultra-rare therapies through unorthodox funding

Pharmaceutical Technology

Non-profit organisations provide an alternative to rescue stalled orphan drugs for biotechs struggling against a lethargic investment climate.

Drugs 147
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Compliance Challenges in Generic Drug Development: Lessons Learned

Drug Patent Watch

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. Generic drugs have long been a vital part of this equation, offering a more accessible alternative to brand-name medications. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Four Revelations from Minnesota’s First 340B Transparency Report (rerun)

Drug Channels

This week, Im rerunning some popular posts while I prepare for Fridays live video webinar: PBM Industry Update: Trends, Challenges, and Whats Ahead. Click here to see the original post from December 2024. Its time to pay attention to the money behind the 340B curtain. Minnesota just released the industrys first ever mandated financial report on the 340B Drug Pricing Program.

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Wave to seek approval of Duchenne drug after mid-stage study data

Bio Pharma Dive

The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.

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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.

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New study reveals protector protein that supports hair regrowth in adults

Medical Xpress

Alopecia is an autoimmune disorder that causes non-scarring hair loss on the scalp and body that is experienced by almost 2% of the global population at some point in their lifetime.

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Big pharma faces headwinds in China as vaccine sales decline

Pharmaceutical Technology

Multinational companies in Chinas vaccine market face headwinds amid an anti-corruption crackdown and rising competition.

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Innovation enabled by new drug discovery technologies

Drug Discovery World podcast

This is the latest episode of the free DDW narrated podcast, titled Innovation enabled by new drug discovery technologies, which covers two articles written for DDW Volume 24 Issue 3, Summer 2023. They are called: CRISPR breakthroughs: New solutions for common diseases and Re-assessing the risks of drug-induced arrhythmias during drug discovery .

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5 Ways Thought Leaders Are Shaping the Future of Clinical Research

XTalks

In the fast-evolving field of clinical research, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. True thought leadership is achieved by consistently providing valuable insights, challenging the status quo and offering innovative solutions that address the fields most pressing challenges. Businesses that establish themselves as trusted voices not only gain credibility but also attract key partnerships and position themselves as pioneers.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.