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April 17, 2025: Researchers Illustrate Potential for Observational Studies of Real-World Data to Emulate Randomized Trials

Rethinking Clinical Trials

Researchers applied the “target trial emulation framework” to highlight important design considerations for observational studies that use real-world data to emulate randomized clinical trials. The work, which was supported by the NIH Pragmatic Trials Collaboratory’s Distributed Research Network and by a grant from the National Institute on Aging, was published this week in Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

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US launches probe that could set stage for pharma tariffs

Bio Pharma Dive

The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.

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Jobevne (Bevacizumab) Gains FDA Nod, Biocon Expands US Oncology Biosimilars Portfolio

XTalks

The FDA has approved Jobevne (bevacizumabnwgd) , a biosimilar to Avastin (bevacizumab). This marks BioconBiologics seventh biosimilar cleared for use in the US. Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). By preventing VEGF from binding its receptors on blood vessel linings, the drug cuts off tumors oxygen and nutrient supply.

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FDA to phase out animal testing with AI and lab-based models

Pharmaceutical Technology

The FDA has announced plans to phase out animal testing in the development of monoclonal antibodies and other drugs.

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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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The Vital Role of Biomarkers in Neurodegenerative Pathways Early Phase Unit, Worldwide Clinical Trials

Worldwide Clinical Trials

Early Phase Unit, Worldwide Clinical Trials Neurodegenerative diseases represent a diverse group of progressive disorders characterized by the loss of structure and function of neurons. Despite their clinical heterogeneity, these diseases often share overlapping pathological mechanisms, including protein misfolding and aggregation, synaptic dysfunction, neuroinflammation, and axonal degeneration.

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April 16, 2025: In This Week’s PCT Grand Rounds, Colchicine and Spironolactone After Myocardial Infarction

Rethinking Clinical Trials

Dr. Sanjit Jolly In this Friday’s PCT Grand Rounds, Sanjit Jolly of McMaster University will present “Colchicine and Spironolactone Post-MI: A Review of the Late-Breaking Results of the CLEAR OASIS 9 Trial.” The Grand Rounds session will be held on Friday, April 18, 2025, at 1:00 pm eastern. Jolly is an interventional cardiologist at Hamilton Health Sciences and the Stuart Connolly Chair in Cardiology and a professor of medicine at McMaster University.

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Top 10 Most Innovative Food Companies of 2025, According to Fast Company

XTalks

Fast Companys annual Most Innovative Companies list recognizes leaders across industries and in 2025, food once again stole the spotlight. This years honorees tackle the sectors biggest challenges: cutting waste, boosting nutrition and engineering better flavor without compromise. Fast Company also flagged four foodtech trends to likely define 2025: personalized nutrition powered by data, AIenabled product development, alternativeprotein scaleup and robotics in processing.

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ESCMID Global 2025: Climate-informed infectious disease risk management

Pharmaceutical Technology

At the ESCMID Global conference in Austria, the development of climate-informed infectious disease risk management systems was discussed.

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How to Ensure Compliance in Generic Drug Development

Drug Patent Watch

"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies. At DrugPatentWatch, we've seen firsthand the importance of staying on top of regulatory changes and maintaining a robust compliance program.

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April 15, 2024: TAICHIKNEE Randomizes First Cohort in Study to Improve Knee Osteoarthritis Pain

Rethinking Clinical Trials

The TAICHIKNEE study randomized its first cohort of participants this month, and the intervention group began tai chi classes this week. Congratulations to the TAICHIKNEE team for reaching this important milestone! TAICHIKNEE will compare the effects of web-based tai chi interventions versus routine care for individuals experiencing knee pain due to osteoarthritis.

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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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Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Bio Pharma Dive

Amid a funding drought for startups, the company is looking for a deal that can advance its liver cancer drug.

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GSK’s Blujepa Wins FDA Approval as First New Class of Antibiotic for UTIs

XTalks

The FDA has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. GSKs Blujepa represents the first new oral antibiotic in almost 30 years to address the growing challenge of antibiotic resistance in UTIs. uUTIs are the most common type of bacterial infection, affecting up to 16 million women in the US each year.

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AstraZeneca’s oral breast cancer drug Truqap greenlit for NHS use

Pharmaceutical Technology

The twice daily tablet represents a significant step forward for patients with advanced breast cancer.

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Leveraging Drug Patent Data for Strategic Investment Decisions: A Comprehensive Analysis

Drug Patent Watch

"Patent Expiration: The Secret to Unlocking $100 Billion in Pharmaceutical Value Did you know that patent expirations in the pharmaceutical industry are projected to unlock over $100 billion in new business opportunities? At Drug Patent Watch, we've analyzed the latest data to reveal the top 5 therapeutic areas poised for disruption. From oncology to cardiovascular disease, we've identified the key trends and insights you need to know to make informed investment decisions.

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

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The 3 C’s for Cleaning up the Chaos at Research Sites

ACRP blog

This is a sponsored message. Technology has undeniably contributed to growing chaos at research sites. Seventy percent of sites report using more than six systems per trial, and for the first time, managing these systems is their top challenge. The impact is significant: 52% of sites are struggling to take on new studies, and sponsors are seeing a 45% increase in timelines from protocol approval to first-patient-first-visit.

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Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

Bio Pharma Dive

Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical institutional knowledge at the FDA.

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World Hemophilia Day 2025: Women and Girls Deserve Recognition Too

XTalks

This World Hemophilia Day 2025, the bleeding disorders community comes together under the theme Access for all: Women and girls bleed too, spotlighting the long-overlooked experiences of women and girls with inherited bleeding disorders. Hemophilia occurs when a clotting protein is missing or deficient, causing prolonged bleeding that can lead to joint damage and chronic pain.

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Kyowa Kirin constructs drug manufacturing facility in Japan

Pharmaceutical Technology

Kyowa Kirin has concluded the construction of its new drug substance (DS) manufacturing facility, the HB7 building in Japan.

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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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ASCA 2024 Performance Update: Can ASCA Improve Submission Predictability?

FDA Law Blog

By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV). As we previously blogged, under the FDA Reauthorization Act of 2017 (FDARA), FDA committed to establish an ASCA Program using FDA-recognized consensus standards.

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First treatment for common bladder cancer recommended by NICE

Pharma Times

Johnson & Johnsons Balversa was found to extend the lives of urothelial cancer patients with a genetic alteration

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New research kindles excitement around stem cell therapies for Parkinson’s

Bio Pharma Dive

Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain, but also show promising — albeit unproven — signs of efficacy.

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Vykat XR Approved as First Treatment for Excessive Appetite in Prader-Willi Syndrome

XTalks

Soleno Therapeutics has announced the FDA approval of Vykat XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia an intense, persistent hunger in patients with Prader-Willi syndrome (PWS). The approval marks the first FDA-approved therapy specifically targeting hyperphagia in this rare genetic disorder. After a series of failures in the indication, Soleno has achieved a breakthrough with the approval.

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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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Verve’s shares jump by more than 26% on Lilly-partnered gene therapy data

Pharmaceutical Technology

Phase Ib results show VERVE-102 reduced LDL-C levels with no serious safety issues, unlike Verves VERVE-101 programme.

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The Value of PPC Campaigns in Modern Pharma Marketing

Pharma Marketing Network

What if the next patient who needs your medication is already searching onlineand youre not there? In today’s competitive healthcare landscape, PPC campaigns (Pay-Per-Click advertising) have emerged as a critical lever for pharma marketers aiming to deliver timely, targeted, and measurable impact. Gone are the days when print ads and in-person detailing alone could carry a brand.

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Yoga is as effective as strengthening exercises for knee osteoarthritis pain relief, study finds

Medical Xpress

Exercise therapy is suggested as a first-line treatment to improve joint pain and loss of function caused by osteoarthritis (OA), a musculoskeletal disorder that affects more than 595 million people worldwide. Yoga and strengthening exercises are both known to be effective ways of managing knee OA, but is one better than the other?

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Pharma bosses face down investor angst on tariffs, HHS chaos

Bio Pharma Dive

As first quarter earnings begin, executives are confronting market turmoil, regulatory instability and the threat of U.S. tariffs on their products.

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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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FDA Animal Testing Phase-Out Targets Monoclonal Antibodies

XTalks

On April 10, 2025, the FDA unveiled a new plan to phase out its animal testing requirements, refocusing the FDAs animal testing policy towards other methods. The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. For years, drug makers have relied on animal studies using rodents, dogs or primates to flag safety concerns, even though these models often fall short in pred

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Sandoz challenges Amgen’s Enbrel patents in US antitrust lawsuit

Pharmaceutical Technology

Sandoz is suing Amgen over alleged patent abuse delaying the US launch of a biosimilar to the autoimmune drug Enbrel.

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Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025

FDA Law Blog

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). This letter, dated March 21, 2025, cites Taihos false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act.

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Why Pharma’s Digital Ad Spend Will Surge Amid Tariff Fears and TV Ad Uncertainty

Pharma Marketing Network

What do you do when the traditional pillars of your marketing strategy start to crumble? For many pharmaceutical companies in 2025, the answer is clear: pivot aggressively toward digital. With geopolitical volatility sparking new tariff threats and mounting legislative scrutiny over pharmaceutical television ads, pharma digital ad spend is experiencing a noticeable surge.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time