Rethinking Clinical Trials

APRIL 17, 2025

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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Bio Pharma Dive

APRIL 14, 2025

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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XTalks

APRIL 11, 2025

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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Pharmaceutical Technology

APRIL 11, 2025

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

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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!

Clinical Trials

Worldwide Clinical Trials

APRIL 15, 2025

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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Clinical Trials Clinical Trials Trials Protein 100

Rethinking Clinical Trials

APRIL 16, 2025

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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XTalks

APRIL 10, 2025

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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Pharmaceutical Technology

APRIL 15, 2025

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

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Development 240

Drug Patent Watch

APRIL 14, 2025

"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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Rethinking Clinical Trials

APRIL 15, 2025

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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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

Medicine

Bio Pharma Dive

APRIL 10, 2025

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

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Trials Drugs 238

XTalks

APRIL 15, 2025

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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Pharmaceutical Technology

APRIL 11, 2025

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

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Drugs 236

Drug Patent Watch

APRIL 16, 2025

"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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ACRP blog

APRIL 14, 2025

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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Bio Pharma Dive

APRIL 10, 2025

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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Development Drugs 228

XTalks

APRIL 15, 2025

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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Gene Therapy Gene Clinical Trials Clinical Trials 66

Pharmaceutical Technology

APRIL 14, 2025

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

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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

Clinical Trials

FDA Law Blog

APRIL 14, 2025

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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Containment 59

Pharma Times

APRIL 10, 2025

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

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Genetics 137

Bio Pharma Dive

APRIL 16, 2025

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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XTalks

APRIL 15, 2025

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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FDA Approval Clinical Trials Clinical Trials Trials 59

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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.

Clinical Trials

Pharmaceutical Technology

APRIL 14, 2025

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

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Gene Therapy Gene 189

Pharma Marketing Network

APRIL 10, 2025

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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Marketing Branding Compliance Pharma Companies 52

Medical Xpress

APRIL 13, 2025

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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Bio Pharma Dive

APRIL 14, 2025

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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Production Marketing 184

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.

Clinical Research

XTalks

APRIL 14, 2025

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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Antibody Drugs Development Medicine 59

Pharmaceutical Technology

APRIL 14, 2025

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

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Drugs 165

FDA Law Blog

APRIL 13, 2025

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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Branding Drugs Trials Marketing 52

Pharma Marketing Network

APRIL 17, 2025

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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