Worldwide Clinical Trials

MAY 15, 2025

The Investigational New Drug (IND) application is a pivotal step in the drug development journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drug development plan? This blog highlights some of the key themes discussed in our white paper on the application process, From Concept to Market: The Strategic Role of an IND in Drug DevelopmentMoving Beyond “May Proceed.&

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Clinical Trials Clinical Trials Development Drugs 130

Bio Pharma Dive

MAY 15, 2025

A gene editing drug custom-made for a critically ill baby showed that, for some ultra-rare diseases, it’s possible to design and test a new CRISPR medicine in just a few months.

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Gene Editing Gene Medicine Drugs 305

Pharmaceutical Technology

MAY 22, 2025

Sanofi has agreed to acquire Vigil Neuroscience in a $470m deal, nearly a year after investing an initial $40m in the company.

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World of DTC Marketing

MAY 31, 2025

Each year, the American Society of Clinical Oncology (ASCO) meeting brings together the brightest minds in cancer research, pharmaceuticals, and patient care to share breakthroughs, data, and hope. And each year, one glaring topic remains conspicuously under-discussed: the brutal, life-altering cost of cancer treatment. We celebrate new therapies. We hear about remarkable survival data.

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Drugs Nurses Doctors Doctor 197

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

MAY 13, 2025

Dr. James Tulsky and Dr. Angelo Volandes, principal investigators for ACP PEACE A video decision aid for older patients with advanced cancer, coupled with communication skills training for clinicians, led to higher rates of documented advance care planning in oncology clinics, according to the ACP PEACE study. The results of the study were published online this month in JAMA Network Open.

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Clinical Trials Clinical Trials Trials Medicine 147

Medical Xpress

MAY 25, 2025

An interdisciplinary research team has demonstrated a durable and lasting response to a novel treatmentcombined locoregional therapy and immunotherapy (LRT-IO)for advanced liver cancer patients. The study marks the first investigation into the long-term outcomes for patients with locally advanced liver cancer receiving this treatment. The researchers identified key factors associated with a complete response, and found that this pioneering approach is safe, effective and sustainable.

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Research 135

Bio Pharma Dive

MAY 30, 2025

Ivonescimab helped cut the risk of lung tumor progression in half in a multi-country Phase 3 trial. But it hasn’t yet clearly extended survival, which will be necessary to support an FDA submission.

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Drugs Trials 293

Pharmaceutical Technology

MAY 7, 2025

Venture philanthropy organisation Solve FSHD has announced an investment of $3m in Armatus Bio to support the development of ARM-201.

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Development 233

ACRP blog

MAY 13, 2025

Addressing continuing disparities between observed and expected representation for racial and ethnic minorities in clinical trials will require a comprehensive, multifaceted approach from regulatory bodies, sponsors, and contract research organizations (CROs) aimed at prioritizing inclusivity at every stage of the trial processfrom design to recruitment and implementationaccording to the student creator of an award-winning poster presented at ACRP 2025.

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Clinical Trials Clinical Trials Trials Research 104

Rethinking Clinical Trials

MAY 12, 2025

In this Friday’s PCT Grand Rounds, Jeffrey Spaeder and Adrian Hernandez will present “Pivoting Clinical Trials Into a New and Evolving World.” The Grand Rounds session will be held on Friday, May 16, 2025, at 1:00 pm eastern. Spaeder is the chief medical and scientific officer at IQVIA. Hernandez, who serves as coprincipal investigator of the NIH Pragmatic Trials Collaboratory Coordinating Center, is a professor of medicine and vice dean in the Duke University School of Medicin

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Clinical Trials Clinical Trials Trials Clinical Research 162

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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

Trials

pharmaphorum

MAY 22, 2025

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity

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Vaccination Vaccine 136

Pharma Times

MAY 19, 2025

Regulator confirms safety and efficacy of new treatment option for patient

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Regulation 140

Bio Pharma Dive

MAY 12, 2025

The biotech has quickly turned a cell therapy approval into one of the more lucrative recent sales for a priority review voucher, which companies can use to fast track drug reviews.

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Drugs Sales 282

Pharmaceutical Technology

MAY 26, 2025

The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSKs Blenrep.

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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

Medical Xpress

MAY 3, 2025

Researchers led by the Trondheim University Hospital in Norway report that two hours of immediate skin-to-skin contact between mothers and very preterm infants after birth does not improve cognitive, motor, or language development by age 2 to 3 years. Infants receiving the intervention did show significantly improved breastfeeding outcomes.

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Clinical Trials Clinical Trials Trials Development 97

Rethinking Clinical Trials

MAY 14, 2025

Pragmatic clinical trials embedded in healthcare systems rely on partnerships between investigators and healthcare system leaders to conduct research. As the end of a pragmatic trial approaches, research teams and their partners often face uncertainties around this undefined phase when researchers are waiting on results. End-of-trial decision-making, including whether to sustain an intervention, has implications for research teams, healthcare systems, and patients.

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Trials Clinical Trials Clinical Trials Research 147

XTalks

MAY 9, 2025

The FDA has granted approval to Abeona Therapeutics Zevaskyn (prademagene zamikeracel, also known as pz-cel), marking it as the first and only cell-based gene therapy approved for the rare skin disease recessive dystrophic epidermolysis bullosa (RDEB). The therapy is described as an autologous cell sheet-based gene therapy that acts as a skin graft.

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Gene Therapy Gene FDA Approval Dermatology 90

Pharma Times

MAY 7, 2025

Demonstrate your skill and prowess by entering this year's awards!

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Clinical Research Research 128

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

Bio Pharma Dive

MAY 14, 2025

The new acquisition from Boston Pharmaceuticals adds to a wave of dealmaking undertaken by GSK to build its liver disease franchise.

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Drugs 260

Pharmaceutical Technology

MAY 16, 2025

The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) was terminated in April.

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Medical Xpress

MAY 17, 2025

A pharmaceutically produced cannabidiol formulation had a good overall safety profile, including cardiac safety, according to research presented at Heart Failure 2025.

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Manufacturing Research Cardiology 122

Rethinking Clinical Trials

MAY 28, 2025

The NIH Pragmatic Trials Collaboratory has launched a new learning module, Healthcare Data Interoperability and Standardization for Research , exploring the complexities of collecting, storing, and transforming healthcare data in the electronic health record to achieve optimal patient and research outcomes. The learning module, which was developed by members of the NIH Collaboratory’s Electronic Health Records Core Working Group, comprises 2 new learning topic videos, “The Big Pictur

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Clinical Trials Clinical Trials Trials Research 147

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XTalks

MAY 2, 2025

New data for Boehringer Ingelheims investigational oncology candidate, zongertinib, shows sustained clinical benefits in non-small cell lung cancer (NSCLC) patients with HER2 mutations in the tyrosine kinase domain (TKD). Updated findings from the Phase Ib Beamion LUNG-1 trial included durability of response, building on the clinical evidence supporting zongertinibs efficacy.

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FDA Approval Trials Drugs Clinical Trials 98

pharmaphorum

MAY 7, 2025

Various industries have welcomed news of a trade deal between the UK and India, but Britain's pharma sector isn't among them

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Bio Pharma Dive

MAY 19, 2025

The biotech, which has for years invested in genetics research, plans to acquire "substantially all" of testing firm 23andMe's assets for $256 million.

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Genetics Research 289

Pharmaceutical Technology

MAY 28, 2025

Merck KGaA is filing for global regulatory approvals of pimicotinibafter it met primary and secondary endpoints in a Phase III TGCT trial.

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Trials Drugs 165

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

Medical Xpress

MAY 25, 2025

Neuropathy, a disorder in which damage to nerves can impair sensation and movement, has many causes, including infection. Now, researchers from the UK have identified distinct genetic changes in a newly-discovered neuropathy and believe that their work will provide insights into the causal mechanism and why some previously healthy people develop neuropathies after infection whereas others do not.

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Genetics Development Research 111

Rethinking Clinical Trials

MAY 30, 2025

In this Friday’s Rethinking Clinical Trials Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial.” The Grand Rounds session will be held on Friday, May 30, 2025, at 1:00 pm eastern.

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Vaccination Vaccine Clinical Trials Clinical Trials 150

XTalks

MAY 28, 2025

On Sunday, June 1, 2025, communities will observe the 38th annual National Cancer Survivors Day a day to recognize the 18,060,100 cancer survivors in the US and the over 53.5 million cancer survivors worldwide in the last five years. This years official theme of National Cancer Survivors Day 2025, Celebrating Life, Raising Awareness and Inspiring Hope for the Future, acknowledges the ongoing challenges survivors face long after treatment ends.

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Clinical Trials Clinical Trials Trials Research 97

pharmaphorum

MAY 16, 2025

In a medical breakthrough, a child diagnosed with a rare genetic disorder has received a bespoke CRISPR gene editing therapy to correct the mutation

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Gene Editing Genetics Gene 98

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