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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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Delayed CDC meeting on vaccines is rescheduled to April

Bio Pharma Dive

A panel of CDC advisers, who had been set to meet in February, will discuss the current measles outbreak as well as guidelines for several types of shots.

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Alnylam drug gets long-awaited FDA approval in deadly heart disease

Bio Pharma Dive

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a competitive and fast-changing market.

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Panel recommends programme for uniform high standard drug regulation nationwide

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

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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Oxford BioTherapeutics and Roche link on antibody cancer treatments

Pharmaceutical Technology

OBT has entered a multi-year partnership with Roche to discover antibody-based therapeutics for cancer treatment.

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Drug Patent Expirations: Unlocking Strategic Investment Opportunities

Drug Patent Watch

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.

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Do Ice Baths Really Work? Here’s What The Science Says

AuroBlog - Aurous Healthcare Clinical Trials blog

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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Innovating Treg Therapies for ALS and Alzheimer’s with Coya Therapeutics CEO Dr. Arun Swaminathan — Episode 200

XTalks

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!

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AstraZeneca to invest $2.5bn in R&D centre in China

Pharmaceutical Technology

AstraZeneca has announced a $2.5bn investment to establish the companys sixth worldwide strategic R&D centre in China.

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Grand Rounds March 14, 2025: Spillover Due to Constraints on Care Delivery: A Potential Source of Bias in Pragmatic Clinical Trials (Sean Mann)

Rethinking Clinical Trials

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.

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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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Accelerate oncology drug development: A data-driven approach to clinical decisions

Bio Pharma Dive

Speed vs. success in oncology trials: Discover data-driven strategies to accelerate drug development.

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New Publication Shares Insights on Decentralized Clinical Trial Elements in Cancer Trials During the COVID-19 Pandemic

CTTI (Clinical Trials Transformation Initiative)

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

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Sarepta’s Gene Therapy Elevidys Under Scrutiny After Patient Death

XTalks

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.

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Just 5 Days of Junk Food Can Trigger Obesity’s Hold on Your Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

After a long, stressful day at work, or when pressed for time, the temptation to have a quick, satisfying snack like crisps or a chocolate bar can be strong.

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

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J&J boosts US operations with $55bn investment

Pharmaceutical Technology

J&J is the latest pharma company to announce a major US investment, committing to a $55bn influx in the next four years.

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J&J boosts US manufacturing as big pharma reshores

Bio Pharma Dive

Following big announcements from Lilly and Merck, J&J is pledging $55 billion over the next four years to open new plants.

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The End of the Blockbuster Era: Unlocking Growth with Direct-to-Patient Commercialization

Drug Channels

Todays guest post comes from Greg Skalicky, President of EVERSANA. Greg discusses some of the challenges manufacturers face with product commercialization, patient access and adherence, and negotiating partnerships with pharmacy benefit managers (PBMs). He introduces us to EVERSANA DIRECT Commercialization, a direct-to-patient change/model. To learn more about EVERSANA DIRECT Commercialization and how the direct-to-patient model can help you, meet with EVERSANA at the Asembia Summit in Las Vegas

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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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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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ICMR to establish Centre for Advanced Research in Aging to explore India-specific biomarkers

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) is working to set up a Centre for Advanced Research in Aging, marking a significant move in India’s efforts to address the challenges of aging and age-related diseases.

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Menarini to enhance BPDCN detection with VisualDx’s link

Pharmaceutical Technology

Menarini Group has announced a partnership with VisualDx to enhance the diagnosis of individuals with BPDCN.

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Character Biosciences raises $93M with an eye on vision loss drugs

Bio Pharma Dive

The startup is bringing into Phase 1 testing an experimental treatment it says could be more effective than marketed geographic atrophy medicines.

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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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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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Beverage & Food IPOs in 2025: Companies Taking the Public Leap

XTalks

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.

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Medical Device Notification Warns of Continued Data Integrity Concerns

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. This was followed last September with warning letters issued to two Chinese firms performing biocompatibility testing, citing violations of 21 C.F.R.

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FDA approves Johnson & Johnson’s Tremfya to treat Crohn’s disease

Pharmaceutical Technology

J&J has received US FDA approval for Tremfya (guselkumab), to treat moderately to severely active Crohn's disease (CD) in adults.

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Novartis builds case for new SMA gene therapy

Bio Pharma Dive

To Novartis, fresh late-stage data support the idea that its intrathecal drug, which has the same active ingredient as Zolgensma, could be approved for a broad range of spinal muscular atrophy patients.

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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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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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Top Pharma and Biotech Companies to Work for in the US in 2025, According to Forbes

XTalks

The pharmaceutical and biotechnology industries offer some of the most rewarding career opportunities in the US. Find out the top pharma and biotech companies to work for in the US in 2025. Whether youre a scientist developing life-saving treatments, a regulatory expert ensuring drug safety or a business professional driving strategic growth, the right workplace makes a difference.

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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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Global funding cuts reversing decades of tuberculosis progress, WHO says

Pharmaceutical Technology

Ahead of World Tuberculosis Day on 24 March, the WHO has said that global funding cuts are curtailing efforts to fight the disease.

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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.