Sat.May 03, 2025 - Fri.May 09, 2025

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The Investigator’s Purpose: Addressing the PI Shortage

ACRP blog

This is a sponsored message. If you’ve led a clinical development program, you likely know something all too well: theres a constrained pipeline of qualified principal investigators (PIs), and a high prevalence of “one-and-done” PIs. About half of all PIs conduct only a single clinical trial in their careers before walking away. This isn’t simply another negative byproduct of turnover.

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Prasad’s FDA appointment pressures cell and gene therapy stocks

Bio Pharma Dive

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.

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Solve FSHD to invest in Armatus Bio for ARM-201 development

Pharmaceutical Technology

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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Grand Rounds May 2, 2025: Fluid REStriction in Heart failure versus liberal fluid UPtake: The FRESH-UP Study (Roland RJ van Kimmenade, MD, PhD)

Rethinking Clinical Trials

Speaker Roland RJ van Kimmenade, MD, PhD Cardiologist, Radboud University Medical Center Nijmegen, the Netherlands Slides Keywords Heart Failure; Fluids; Cardiology Key Points We are facing a pandemic of heart failure (HF), with an incidence of 1 20 cases of heart failure per 1,000 people. The incidence of HF is stable if not declining but mortality remains high, at about 15 30% after one year.

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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

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.

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Skin-to-skin contact improves breastfeeding but not cognitive outcomes in very preterm infants: Clinical trial

Medical Xpress

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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AI specialist Recursion trims pipeline in latest shakeup

Bio Pharma Dive

The cuts to three advanced drug programs were “inevitable” given the company’s “unsustainable cash burn,” one analyst wrote in a note to investors.

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Zevaskyn Gets FDA Nod as First Cell Therapy for Rare, Debilitating Skin Disease

XTalks

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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May 6, 2025: Registration and Abstract Submissions Open for 2025 Nudges in Health Care Symposium

Rethinking Clinical Trials

The Nudge Unit at Penn Medicine opened registration and abstract submissions for the 2025 Nudges in Health Care Symposium. The event is “focused on exploring the application of behavioral economics principles and nudges in healthcare settings.” The Nudge Unit is supported by Center for Health Care Transformation and Innovation and thePenn Center for Health Incentives and Behavioral Economics.

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Deerfield secures more than $600M for its next biotech venture fund

Bio Pharma Dive

The firm, a prolific backer of drug startups, will use the cash to back companies working on therapeutics, medical devices and healthcare services.

Drugs 234
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FDA accepts Novo Nordisk’s NDA submission for weight management therapy

Pharmaceutical Technology

The US FDA has accepted Novo Nordisks new drug application (NDA) submission for the 25 mg oral formulation of Wegovy (semaglutide).

Drugs 244
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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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PharmaTimes Clinical Researcher of the Year – The Americas Awards

Pharma Times

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

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A comprehensive look at what happens in the brain when we're reading

Medical Xpress

Reading is a highly valuable skill that allows humans to acquire new knowledge, pursue an education and complete a wide range of real-world tasks.

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UK trumpets a trade deal with India - but pharma isn't happy

pharmaphorum

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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HLS Therapeutics and Esperion partner to commercialise oral cardiovascular medicines

Pharmaceutical Technology

HLS Therapeutics has signed an agreement with Esperion Therapeutics for commercialising Nexletol and Nexlizet in Canada.

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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!

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PTC stock slides on new data for Huntington’s drug

Bio Pharma Dive

While updated study results confirmed the drug lowers a target protein, the therapy's effect on clinical outcomes was less clear-cut.

Drugs 175
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Nitrites for Urinary Tract Infection

JAMA Internal Medicine

This Viewpoint examines the urinary nitrite test and questions its effectiveness and relevance in distinguishing between urinary tract infection and asymptomatic bacteriuria.

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How does consciousness work? Dueling scientists test two big theories but find no winner

Medical Xpress

"Theories are like toothbrushes," it's sometimes said. "Everybody has their own and nobody wants to use anybody else's.

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Overcoming challenges in orphan drug development: From clinical trials to market

Pharmaceutical Technology

Developing orphan drugs involves navigating intricate regulatory landscapes, financial risks, and limited clinical data. To rise to these challenges, the biopharma industry continues to develop innovative strategies to bring vital therapies swiftly to rare disease patients.

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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

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Viatris’ new form of old pain drug scores in large trials

Bio Pharma Dive

A version of meloxicam designed to work faster has beat out a placebo in two late-stage studies focused on post-surgical acute pain. Viatris now plans to file for approval this year.

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New data could move Enhertu into early breast cancer

pharmaphorum

AstraZeneca and Daiichi Sankyo's Enhertu has been shown to provide a benefit in a phase 3 trial in early-stage breast cancer for the first time

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US researchers seek to legitimize AI mental health care

Medical Xpress

Researchers at Dartmouth College believe artificial intelligence can deliver reliable psychotherapy, distinguishing their work from the unproven and sometimes dubious mental health apps flooding today's market.

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GLP-1 receptor agonists poised to redefine treatment paradigms beyond diabetes and obesity

Pharmaceutical Technology

Glucagon-like peptide-1 receptor agonists (GLP-1RAs), once focused on treating diabetes and obesity, are now emerging as potential treatments for a broader range of chronic conditions, including metabolic dysfunction-associated steatohepatitis and Alzheimers disease.

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Can Your Organization Spot a Conflict Before It’s a Crisis?

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?

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Gilead, bracing for tariffs, joins peers in US drug production push

Bio Pharma Dive

The company added to a recent flurry of pledges by pharmaceutical companies, promising $11 billion in new capital and operational investments in U.S. drug manufacturing.

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AI trained on NHS data 'may predict ill health in advance'

pharmaphorum

An AI model is being piloted at a national scale for the first time, but will it be able to predict future health risks reliably?

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Top 100 US Hospitals in 2025: Standouts from Fortune – Premier Rankings

XTalks

Fortune, in collaboration with Premier, Inc., has unveiled its 2025 list of the 100 Top Hospitals in the United States. This ranking evaluates hospitals based on clinical outcomes, patient experience, operational efficiency and financial health. You can explore this table to view the top 100 hospitals in the US according to Fortune Premier Rankings, with 20 in each category: major teaching hospitals, teaching hospitals, large community hospitals, medium community hospitals and small community h

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Novo Nordisk cuts 2025 outlook due to compounding-hit Wegovy demand

Pharmaceutical Technology

Novo Nordisk has cut its sales and profits forecasts for 2025 due to lower demand in the US for blockbuster weight loss and diabetes drugs.

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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.

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The Big Picture: Healthcare Data and Interoperability

Rethinking Clinical Trials

The Big Picture: Healthcare Data and Interoperability Description In this video, Dr. Lesley Curtis explores how data flow into EHRs and move between systems, the role of data standards, and the barriers to building a more streamlined and connected healthcare system. Speaker Lesley Curtis, PhD Professor of Population Health Sciences and Medicine, Duke University Duke Clinical Research Institute Collaboratory Steering Committee Chair Related Electronic Health RecordsBased Phenotyping The post The

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GSK reveals data behind linerixibat for PBC 'relentless itch'

pharmaphorum

GSK reveals the data behind its linerixibat for itching associated with autoimmune liver disease PBC as it anticipates first approvals for the drug.

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Innovating Gastrointestinal Therapeutics: Science, Strategy and Insight

XTalks

Gastrointestinal (GI) disorders pose major challenges in modern healthcare. In the US, nearly 45 million adults suffer from nonerosive gastroesophageal reflux disease (GERD) , while more than 15 million receive prescription treatments for its erosive form. Nonerosive GERD shows typical reflux symptoms without visible esophageal damage, whereas erosive GERD causes clear injury to the esophageal lining.

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FDA approves Selarsdi injection as interchangeable with Stelara

Pharmaceutical Technology

Teva and Alvotech have announced receipt of the US FDA approval to Selarsdi injection for use as an interchangeable with Stelara.

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