April, 2025

article thumbnail

April 22, 2025: New Report Highlights Value of Informing Participants About Research Conducted Under a Waiver of Consent

Rethinking Clinical Trials

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.

Research 147
article thumbnail

Novo says it’s submitted obesity pill for FDA approval

Bio Pharma Dive

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog

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

article thumbnail

Indian pharma poised to enhance affordability & accessibility of CAR-T cell therapy to combat cancer

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

article thumbnail

Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

article thumbnail

Understanding Challenges in Early Parkinson’s Research: Critical Insights from Dr. Tom Babic

Worldwide Clinical Trials

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.

Research 124
article thumbnail

Insights and Inspirations On and About the Clinical Research Workforce

ACRP blog

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.

More Trending

article thumbnail

US risks losing biotech edge to China, report warns

Bio Pharma Dive

“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.

317
317
article thumbnail

Daiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers

Pharmaceutical Technology

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

274
274
article thumbnail

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.

Antibody 109
article thumbnail

Valuation of Pharma Companies: 5 Key Considerations

Drug Patent Watch

"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.

article thumbnail

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!

article thumbnail

“Where Does Clinical Research Go from Here?” and Foundational Lessons for the Workforce

ACRP blog

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

article thumbnail

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.

Trials 147
article thumbnail

Biohaven stock slides on withdrawal of European marketing application

Bio Pharma Dive

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.

Genetics 267
article thumbnail

Eli Lilly sues Mochi Health and others for ‘deceptive’ tirzepatide marketing

Pharmaceutical Technology

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

Marketing 240
article thumbnail

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

article thumbnail

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.

Protein 93
article thumbnail

How to Ensure Patient Safety with Generic Drugs

Drug Patent Watch

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.

article thumbnail

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.

article thumbnail

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.

Trials 147
article thumbnail

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

article thumbnail

FDA plans to phase out animal testing for some drugs

Bio Pharma Dive

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

Antibody 284
article thumbnail

Roche announces $50bn US investment in pharma and diagnostics

Pharmaceutical Technology

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.

239
239
article thumbnail

Enhancing Access and Retention in Global, Cross-Border Rare Disease Clinical Trials

XTalks

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

article thumbnail

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.

article thumbnail

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.

article thumbnail

Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog

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

Drugs 64
article thumbnail

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.

article thumbnail

RFK Jr. won’t appear before Senate panel this week

Bio Pharma Dive

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.

284
284
article thumbnail

Biogen’s Friedreich’s ataxia treatment authorised in UK

Pharmaceutical Technology

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

Marketing 233
article thumbnail

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.

article thumbnail

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.

article thumbnail

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.

article thumbnail

Lab-grown lung cancer cells show potential to revolutionise treatment

Pharma Times

The model could lead to more targeted treatments for the disease

Research 150
article thumbnail

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.

article thumbnail

White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.