Rethinking Clinical Trials

APRIL 22, 2025

Even in minimal-risk studies that do not use the standard consent process, there may be value in informing participants about the research. Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory. The open-access article was published online ahead of print this week in Learning Health Systems.

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Bio Pharma Dive

APRIL 21, 2025

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.

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FDA Law Blog

APRIL 8, 2025

By Kurt R. Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, generally, this blogger wanted to call out one particular division in the Office of Generic Drugs (OGD), funded by user fees under the Generic Drug User Fee Amendments (GDUFA), that was eradicated and what t

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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2025

The Indian pharmaceutical industry is at the forefront of a transformative effort to make CAR-T cell therapy more affordable and accessible, offering renewed hope to cancer patients nationwide. This cutting-edge treatment, particularly effective against blood cancers such as leukaemia and lymphoma, has remained prohibitively expensive due to its complex manufacturing process and high international pricing.

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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

Trials

Worldwide Clinical Trials

APRIL 8, 2025

In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research. Although clinical research in PD began more than 25 years ago, there have been no significant updates in the last decade.

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ACRP blog

APRIL 25, 2025

At the latest meeting of the Association of Clinical Research Professionals (ACRP)-led Partners Advancing the Clinical Research Workforce (PACRW) consortium, the focus for these extraordinary times in human subjects research was on what levers need to be pulled by the consortiums members to bend the curve toward a better future for stakeholders in what is often an under-recognized and under-resourced segment of the larger healthcare workforce.

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Bio Pharma Dive

APRIL 8, 2025

“There will be a ChatGPT moment for biotechnology,” a bipartisan commission wrote in the new report, which calls for the U.S. to invest at least $15 billion into the sector over the next five years.

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Pharmaceutical Technology

APRIL 4, 2025

The EC has approved Daiichi Sankyo and AstraZenecas Enhertu for use as a single agent to treat adults with certain breast cancers.

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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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Drug Patent Watch

APRIL 8, 2025

"5 Key Considerations for Valuing Pharma Companies As the pharmaceutical industry continues to evolve, accurately valuing pharma companies has become increasingly complex. At DrugPatentWatch, we've identified 5 key considerations that can help you make informed investment decisions. Patent Portfolio Strength : A strong patent portfolio can significantly impact a company's valuation.

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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

ACRP blog

APRIL 26, 2025

With recent federal actions upending business as usual for many stakeholders in the clinical research enterprise, some of its thought leaders pondered the big question of Where does clinical research go from here? during Fridays (April 25) first Signature Series gathering at ACRP 2025 in New Orleans. After the heartfelt session closed with a Big Easy-style second line jazz band sendoff, an expert lineup of educational session presenters held forth on an array of vital topics for members of the i

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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 25, 2025

The drug, being developed for a rare genetic disorder and currently under review in the U.S., is seen by some investors as critical to Biohaven’s future.

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Pharmaceutical Technology

APRIL 23, 2025

The lawsuit filings are the latest turn in a long-running legal saga between GLP-1RAs makers and compounders.

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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

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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Drug Patent Watch

APRIL 8, 2025

Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts. At DrugPatentWatch, we've seen firsthand the impact that generic drugs can have on patients.

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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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Rethinking Clinical Trials

APRIL 2, 2025

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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Clinical Supply

Bio Pharma Dive

APRIL 11, 2025

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

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Pharmaceutical Technology

APRIL 22, 2025

Roche is set to invest $50bn in pharmaceuticals and diagnostics in the US over the coming five years to bolster its presence in the country.

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XTalks

APRIL 8, 2025

There are over 10,000 rare diseases affecting an estimated 300 million people worldwide where 80% are genetic , 95% lack approved treatments and nearly half begin in childhood. Global rare disease clinical trials face unique challenges due to small patient populations, complex logistics, diverse regulatory environments and cultural differences. Reflecting on these challenges, Michelle Petersen, MS, Vice-President of Clinical Trial Management at Medpace, noted, When its rare, its personal every

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Drug Patent Watch

APRIL 2, 2025

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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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

FDA Law Blog

APRIL 21, 2025

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a

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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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Bio Pharma Dive

APRIL 7, 2025

HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later.

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Pharmaceutical Technology

APRIL 24, 2025

Biogen Netherlands has received marketing authorisation from the UK MHRA for its Skyclarys to treat Friedreich's ataxia.

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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 1, 2025

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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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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Pharma Times

APRIL 10, 2025

The model could lead to more targeted treatments for the disease

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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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