FDA Law

FEBRUARY 27, 2025

By Julie Kim & Deborah L. Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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ACRP blog

FEBRUARY 25, 2025

[ Editors Note: In recognition of Rare Disease Day being observed on February 28, ACRP is pleased to present this, the second of two blogs contributed by subject matter experts offering insights on how rare diseases are being focused on by the clinical research enterprise. The first blog highlights how Net Treatment Benefit assessments may be used to support rare disease research. ] Randomized controlled clinical trials are considered the gold standard for understanding treatment safety and eff

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XTalks

FEBRUARY 5, 2025

Celltrions Actemra (tocilizumab) biosimilar Avtozma (tocilizumab-anoh) has received FDA approval for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) as well as COVID-19. The approval encompasses both intravenous (IV) and subcutaneous (SC) formulations, offering flexibility in administration.

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Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. These highly similar versions of biologic medications offer a more affordable alternative to their reference products, but their development requires careful consideration of regulatory requirements.

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

Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.

Compliance

Rethinking Clinical Trials

FEBRUARY 6, 2025

Speakers Richard L. Skolasky, ScD Professor, Johns Hopkins School of Medicine Department of Orthopaedic Surgery Kevin H. McLaughlin, DPT Assistant Professor, Johns Hopkins School of Medicine Department of Physical Medicine and Rehabilitation Slides Keywords Back Pain; Rural Health; Telehealth Key Points Low back pain (LBP) is the most common cause of disability globally and in the U.S.

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Medicine Clinical Trials Clinical Trials Research 100

Advarra

FEBRUARY 4, 2025

At a busy research site, a clinical trial is ready to launch but its stuck in limbo over a single paragraph in the informed consent form (ICF). The issue? Language relating to the potential cost of participation. One sites language on what they will pay for differs from anothers, and the contradictory wording needs to be reviewed and agreed to by the sponsor before the IRB can proceed.

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ACRP blog

FEBRUARY 5, 2025

As many as 20% to 50% of clinical trials do not accrue participants at the site level, leading to wasted time and financial resources. This waste can be minimized by early selection of trials most likely to succeed. The protocol feasibility review process informs this selection by offering a way to evaluate logistical elements of a clinical trial before the activation process is started.

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XTalks

FEBRUARY 5, 2025

Metsera, Inc., a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 per share, raising $275 million in gross proceeds. Current Share Price: The offering, which includes 15,277,778 shares of common stock, is set to close on February 3, 2025, after beginning trading on the Nasdaq under the ticker sy

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Drug Patent Watch

FEBRUARY 5, 2025

The Latin American Pharmaceutical Market: Why Specialty Generics Are Poised for Growth As the pharmaceutical industry continues to evolve, one trend is becoming increasingly clear: the demand for specialty generics is on the rise, particularly in the Latin American market. But what exactly are specialty generics, and why are they gaining traction in this region?

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Medical Xpress

FEBRUARY 8, 2025

New evidence from a large population-based cohort analysis indicates an increased risk of both attempted and completed suicide among individuals diagnosed with headache disorders. Researchers at Aarhus University in Denmark found that individuals diagnosed with migraine, tension-type headache, posttraumatic headache, and trigeminal autonomic cephalalgia face an increased risk of suicide.

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Research 104

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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

Trials

Rethinking Clinical Trials

FEBRUARY 12, 2025

In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).” The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.

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FDA Law

FEBRUARY 13, 2025

By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

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ACRP blog

FEBRUARY 4, 2025

Taking an average of around eight months, study start-up can be subject to a wide variety of delays that impact study costs and timelines. In effort to reduce this average, HCA Healthcare Research Institute, a site management organization with around 40 sites and 275 open trials, has a centralized approach to reducing start-up timelines. We pride ourselves on being a watchdog, for example, by making sure that operational elements of the protocol do not over-burden study participants and lead to

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Compliance Clinical Research Clinical Trials Clinical Trials 59

XTalks

FEBRUARY 28, 2025

Medtronic has received FDA approval for its BrainSense Adaptive Deep Brain Stimulation (aDBS) system. Medtronic says the technology represents the worlds first closed-loop deep brain stimulation (DBS), brain-computer interface (BCI) technology that adjusts therapy in real-time based on an individuals brain activity, offering a more personalized approach to managing Parkinsons symptoms.

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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

Drug Patent Watch

FEBRUARY 19, 2025

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.

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Medical Xpress

FEBRUARY 8, 2025

New research details the subcellular structures in neurons that enable signals to be transmitted from where they are received at specific sites on dendrites to the decision-making cell body located hundreds of micrometers away. The new research finds that the endoplasmic reticulum and the plasma membrane form contact sites where specialized molecules control the release of calcium, which regulates the signals sent along the dendrite to the soma.

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Regulation Research 124

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 13, 2025

Identifying a significant gap in the Ministry’s actions in addressing the funding and resource challenges in the premier mental health institutions, the Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended various measures including development of a comprehensive long-term strategic plan for mental healthcare, research and infrastructure development.

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Rethinking Clinical Trials

FEBRUARY 24, 2025

Updated study snapshots and ethics and regulatory documentation are now available for the AIM-CP, ARBOR-Telehealth, and RAMP trials. The 3 NIH Collaboratory Trials, all supported through the NIH HEAL Initiative, or Helping to End Addiction Long-Term Initiative, reflect a special emphasis on developing strategies for the management of chronic pain in rural and remote populations. “There are many known disparities between urban and rural populations,” said Karen Kehl, a program directo

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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

ACRP blog

FEBRUARY 19, 2025

A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides. Clinical research associate (CRA) competencies are key to creating and nurturing this relationship under all circumstances.

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XTalks

FEBRUARY 25, 2025

A recent survey by 9amHealth has revealed a significant trend in employee health benefits: employer-sponsored GLP-1 drug coverage is emerging as a pivotal factor in attracting and retaining top talent. As the competitive landscape for skilled professionals intensifies, companies are re-evaluating their health benefits packages to include innovative treatments that go beyond traditional healthcare offerings.

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Pharma Mirror

FEBRUARY 21, 2025

As a provider of custom services, Creative Biolabs aims to support the entire process of drug discovery and development for the global pharmaceutical industry using its cutting-edge technology and wide-ranging experiences. It is no secret that the complexities associated with biopharmaceuticals are ever increasing, particularly regarding the development of antibody therapeutics.

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Medical Xpress

FEBRUARY 1, 2025

Prolonged illnesses like cancer and chronic infections often leave the immune system in a state of exhaustion, where its frontline defendersT cellslose their ability to function effectively. Research, led by the Peter Doherty Institute for Infection and Immunity (Doherty Institute) and the Peter MacCallum Cancer Center (Peter Mac), have identified a rare type of immune cells, called stem-like T cells, that holds the key to maintaining powerful, long-term immune responses.

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Immune Response Research 81

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Clinical Supply

Drug Patent Watch

FEBRUARY 11, 2025

The Dark Side of Innovation: How Companies Use Drug Patents to Block Competitors As we celebrate the breakthroughs in medical research and the development of life-saving treatments, it's essential to acknowledge the complex landscape of pharmaceutical innovation. Behind the scenes, companies are employing clever tactics to protect their intellectual property and block competitors from entering the market.

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Rethinking Clinical Trials

FEBRUARY 4, 2025

A workshop summary, videocast recordings, and other materials are now available from the NIH Pragmatic Trials Collaboratory’s 2024 virtual workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues. “ The 2-day workshop, hosted by the NIH, featured a keynote address by Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.

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ACRP blog

FEBRUARY 11, 2025

People who are entering the clinical research profession can come from many other fields and with very diverse backgrounds. No matter their role, everyone acknowledges project management as an essential and invaluable skill set. Project management requires leadership, communication, and management skills that can be applied in any role across clinical research.

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Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

FEBRUARY 18, 2025

Healthcare organizations have long used workforce adjustments to respond to changing market dynamics, regulatory pressures and the need to refocus on core patient care. In this blog, we detail the healthcare layoffs in 2025, examining the underlying factors and potential ramifications for the industry. In 2024, major players like CVS Health and BioRad Laboratories made headlines by trimming their staff.

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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

Bio Pharma Dive

FEBRUARY 24, 2025

Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.

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Drugs 363

Medical Xpress

FEBRUARY 7, 2025

Researchers at the University of Lige (Belgium) have uncovered a previously unknown mechanism that regulates the immune response against parasites. During a parasitic infection, specific immune cells, known as virtual memory T cells, become activated and express a surface molecule called CD22, which prevents an excessive immune reaction. This discovery could help in better-controlling inflammation and improving immune responses to infections.

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Immune Response Regulation Research 124

Pharmaceutical Technology

FEBRUARY 24, 2025

With Novo Nordisks blockbuster drugs Wegovy and Ozempic back in stock, copycat versions are no longer allowed for now.

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Drugs 279

Rethinking Clinical Trials

FEBRUARY 5, 2025

Dr. Lillian Sung In this Friday’s PCT Grand Rounds, Lillian Sung of the Hospital for Sick Children will present “Improving Symptom Control in Pediatric Cancer Patients With SSPedi and SPARK.” The Grand Rounds session will be held on Friday, February 7, 2025, at 1:00 pm eastern. The Symptom Screening in Pediatrics Tool (SSPedi) is a validated approach to measuring bothersome symptoms in pediatric patients receiving cancer treatments.

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Clinical Trials Clinical Trials Scientist Trials 147

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

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

Compliance