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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Worldwide Clinical Trials

APRIL 29, 2025

On the last day of February every year is Rare Disease Day , a dedicated day to celebrate the rare disease community, including patients, families, caregivers, clinicians, researchers, regulators, and more. The day inspires multiple events, such as fundraisers and scientific symposia, to bring together all the critical stakeholders who tirelessly work to make life better for those affected by rare diseases.

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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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AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 30, 2025

In a significant leap towards advancing Indias capabilities in cancer research and personalized healthcare, the Indian Council of Medical Research (ICMR)-National Institute of Cancer Prevention and Research (NICPR) under the Department of Health Research (DHR) has announced a DHR-sponsored intensive training course titled Advent of Omics Technologies in Precision Diagnostics and Targeted Therapeutics.

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Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.

Compliance

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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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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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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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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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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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

Trials

ACRP blog

APRIL 29, 2025

Signature Series speakers took on more of the clinical research enterprises big picture topics at ACRP 2025 on Saturday (April 26), focusing in the morning on the implications for clinical trials teams of the recently updated ICH E6(R3) Guideline for Good Clinical Practice (GCP) from the International Council for Harmonization , and in the afternoon on how seasoned professionals are enacting meaningful change in their organizations for the betterment of trial implementation and management.

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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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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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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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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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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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Pharmaceutical Technology

APRIL 23, 2025

The agreement gives Boehringer access to Tessellates novel approach targeting ALT-dependent tumours.

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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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Rethinking Clinical Trials

APRIL 30, 2025

In this Friday’s PCT Grand Rounds, Roland RJ van Kimmenade will present “Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake: The FRESH-UP Study.” The Grand Rounds session will be held on Friday, May 2, 2025, at 1:00 pm eastern. Van Kimmenade is a cardiologist at Radboud University Medical Center in Nijmegen, Netherlands.

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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 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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Clinical Supply

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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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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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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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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Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

Compliance

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 28, 2025

Pharmaceutical companies are turning to integrated RWD approaches to overcome challenges in rare disease research.

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ACRP blog

APRIL 30, 2025

From the moment one begins immersing oneself in the full education, networking, and workforce development advocacy experience that an Association of Clinical Research Professionals (ACRP) conference encompasses, theres almost limitless possibilities for meeting and learning from the new and exciting personalities one may encounter. Did you know that at ACRP 2025 (going on right now in New Orleans), you could meet such attendeeswhether they are ACRP members, certificants, presenters, leaders, ex

Clinical Research 101

Clinical Research Clinical Trials Clinical Trials Life Science 101

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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