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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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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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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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 7, 2025

Solid tumors present a significant challenge to clinical research due to their complex and heterogeneous nature. However, the emergence of precision medicine is revolutionizing the way we approach these tumors, offering new hope and innovative solutions. Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention?

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Rethinking Clinical Trials

APRIL 7, 2025

The study design paper for IMPACt-LBP has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! IMPACt-LBP is evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for low back pain. The study team is seeking to determine if initial contact with these “primary spine practitioners” will improve physical function and pain, decrease opioid prescripti

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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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Drug Patent Watch

APRIL 9, 2025

"Unlocking New Hope for Neurological Disorders As we continue to push the boundaries of medical innovation, I'm excited to share with you a game-changing development in the fight against neurological disorders. At the forefront of this revolution is AI-based drug repurposing. By leveraging cutting-edge technology, researchers are re-examining existing medications to identify new uses for treating conditions such as Alzheimer's, Parkinson's, and multiple sclerosis.

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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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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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Pharmaceutical Technology

APRIL 11, 2025

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

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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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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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Clinical Supply

XTalks

APRIL 8, 2025

In 2024, the healthcare industry made significant waves TIME spotlighted Laguna Health for its AI-powered patient-care platform, while The Healthcare Technology Report recognized 50 trailblazing women leading progress in digital health, AI and medical devices. AI also gained traction across the sector, with UK-based home healthcare company Cera earning a Health Tech Digital Award for its advanced AI tools that support clinical decision-making and enhance home care efficiency.

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Pharmaceutical Technology

APRIL 7, 2025

The European Commission (EC) has granted approval for AstraZeneca's Imfinzi plus chemotherapy for treating resectable NSCLC in adults.

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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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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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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

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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Pharmaceutical Technology

APRIL 8, 2025

Ethris has partnered Lonza for the development of room-temperature stable mRNA vaccine candidates targeting respiratory conditions.

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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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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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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

Medical Xpress

APRIL 5, 2025

University of New Mexico researchers studying the health risks posed by gadolinium, a toxic rare earth metal used in MRI scans, have found that oxalic acid, a molecule found in many foods, can generate nanoparticles of the metal in human tissues.

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Pharmaceutical Technology

APRIL 8, 2025

The European Commission (EC) has granted approval for the extension of indication for Janssen-Cilag Internationals Darzalex SC formulation.

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XTalks

APRIL 7, 2025

Optum Life Sciences expert provides insights on the latest trends. GLP-1s continue to dominate the rapidly evolving treatment landscape for patients who are obese and overweight. For manufacturers developing GLP-1s or in the market, its invaluable to understand the nuances of how real-world evidence (RWE) can be harnessed to demonstrate the clinical and economic value of weight loss medications.

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Bio Pharma Dive

APRIL 7, 2025

“We, like so many others, have been forced to take steps to extend our cash runway,” said Tango’s CEO, citing the “extremely challenging financial markets.

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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

Pharma Marketing Network

APRIL 11, 2025

In a highly regulated industry like pharmaceuticals, standing out online can feel like navigating a maze. Unlike retail or tech brands, pharma companies must balance compliance with creativity while communicating with multiple audiences. This is where SEO marketing strategies become essentialallowing brands to boost visibility, earn trust, and support both HCP and patient journeys without violating regulatory guidelines.

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Pharmaceutical Technology

APRIL 11, 2025

AI tools are faster at drafting clinical trial documents, but human writers remain indispensable for logical reasoning.

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XTalks

APRIL 9, 2025

Building on its rapidfire approvals in rare kidney diseases most recently Fabhalta (iptacopan) earning a third FDA nod , most recently for C3 glomerulopathy Novartis now adds Vanrafia (atrasentan) to its nephrology portfolio. Vanrafia is the first and only selective endothelin A receptor antagonist approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).

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Bio Pharma Dive

APRIL 11, 2025

The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.

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Advertiser: FourKites

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.

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