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April 7, 2025: Study Design Paper Published for IMPACt-LBP

Rethinking Clinical Trials

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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Roche halts testing of Sarepta Duchenne gene therapy in Europe

Bio Pharma Dive

The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.

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Daiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers

Pharmaceutical Technology

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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Breaking Barriers in Solid Tumor Research: Precision Medicine & Strategic Operations

Worldwide Clinical Trials

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?

Medicine 100
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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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Itolizumab Shows Positive Phase III Results in First-Line Treatment of Acute GVHD

XTalks

Equillium announced encouraging topline results from its Phase III EQUATOR study evaluating itolizumab in combination with corticosteroids as a first-line treatment for patients with acute graft-versus-host disease (aGVHD). The randomized, double-blind, placebo-controlled global trial assessed itolizumab in patients with newly diagnosed grade II-IV aGVHD.

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April 2, 2025: The Greenlight Plus Trial and Preventing Childhood Obesity, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

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.

Trials 147

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Streeting promises UK pharma quick action on VPAG frustration

Pharmaceutical Technology

Streeting said his June 10-year plan will address drug sale clawbacks, NICE regulation, and the abolition of NHS England.

Sales 246
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AMMOI general secretary Dr Ramanathan elected as director board member of Ayushexcil

AuroBlog - Aurous Healthcare Clinical Trials blog

The Kerala based Ayurveda Medicine Manufacturers Organisation of India (AMMOI) has got a chair in the administrative committee of the Ayush Export Promotion Council (Ayushexcil ) with the election of its general secretary Dr. D Ramanathan as one of the board of directors.

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AZmed’s AZchest Receives Two FDA Clearances for AI-Powered Software Applications

XTalks

European AI med tech company AZmed received two new FDA clearances for its AI-powered chest X-ray tool, AZchest. The FDA approved AZchest applications to detect lung nodules and triage cases involving pneumothorax and pleural effusion. The applications offer radiologists improved interpretation and detection of these chest X-ray abnormalities. AZchest, a clinically validated AI radiology solution, automatically identifies, classifies and generates reports on key cardiac and pulmonary abnormaliti

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Scientists discover how nanoparticles of toxic metal used in MRI scans infiltrate human tissue

Medical Xpress

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.

Scientist 145
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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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‘A cruel April Fool’s joke’: HHS layoffs characterized by confusion, errors

Bio Pharma Dive

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

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Amneal and Shilpa introduce Boruzu in US for cancer treatment

Pharmaceutical Technology

Amneal Pharmaceuticals, along with Shilpa Medicare, has launched the new presentation of bortezomib, Boruzu.

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The role of biosimilars in population health management initiatives

Drug Patent Watch

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives. But what exactly are biosimilars, and how can they make a meaningful impact on population health?

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Sanofi’s Qfitlia Gets FDA Approval as First siRNA Therapy for Hemophilia

XTalks

The FDA has approved Sanofis Qfitlia (fitusiran), making it the first approved siRNA therapy for hemophilia A or B, and the first for the conditions with or without inhibitors. It is indicated to prevent or reduce bleeding episodes in patients aged 12 and older, with or without factor VIII or IX inhibitors. Qfitlia is also the first antithrombin-lowering therapy approved for routine prophylaxis in hemophilia A or B.

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

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Scientists cast new light on how fasting impacts the immune system

Medical Xpress

New research from The University of Manchester may reshape our understanding of what happens to the immune system when we fast. The study on mice shows that the brain's hypothalamus controls how the immune system adapts during fasting, through a handful of highly specialized neurons responsible for making animals hungry.

Scientist 132
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Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

Bio Pharma Dive

Sarepta and Roche will share the monitors' findings with EMA to resolve a temporary hold. Elsewhere, Allakos agreed to a buyout and high-dose Ocrevus missed a study goal.

Trials 184
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UK life sciences venture capital funding lags behind

Pharmaceutical Technology

At the BioTrinity Conference, experts champion government funding programmes to bridge gap the in UK venture capital financing.

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Transforming Biopharma Intelligence: Moving from Traditional Analysts to Direct Raw Data Platforms

Drug Patent Watch

The Future of Biopharma Intelligence: Why Direct Data Platforms are Revolutionizing the Industry As a biopharma professional, you're likely no stranger to the challenges of staying ahead in a rapidly evolving market. From navigating complex regulatory landscapes to keeping pace with the latest scientific breakthroughs, it's easy to get overwhelmed by the sheer volume of information at your fingertips.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA Layoffs: Bird Flu Response in Jeopardy

XTalks

According to the American Veterinary Medical Association (AVMA), as reported by Reuters , the FDA layoffs initiated last week included personnel directly involved in avian influenza monitoring and response efforts. Many employees found out about the layoffs after trying to enter office buildings on Tuesday, April 1, and being denied access. A Center for Veterinary Medicine (CVM) employee said the FDA let go almost all of the administrative staff.

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Does Added Protein Really Enhance The Nutrition of Your Food?

AuroBlog - Aurous Healthcare Clinical Trials blog

We don’t all need extra protein in our diet. (OKrasyuk/Getty Images) Protein intake dominates fitness advice. Whether you want to build muscle, improve your fitness or watch your weight, the common advice handed out by everyone from fitness influencers to doctors is that we need more protein.

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FDA misses approval deadline for Novavax’s COVID-19 vaccine

Bio Pharma Dive

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter Marks.

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Large pharma drug licensing from China hits high at 28% in 2024

Pharmaceutical Technology

Total deal value of innovator drug licensing agreements involving Chinese biopharma licensors has risen 66% to $41.5 billion in 2024.

Licensing 147
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How Machine Learning Drives Clinical Trial Efficiency

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.

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How the brain uses context boundaries to guide decision-making in both spatial and abstract environments

Medical Xpress

The DAM-Decision and Memory group at Universitat Jaume I in Castell, led by Raphael Kaplan and composed of researchers from Spain, Italy and the United States, has recently published the results of two studies that provide new insights into human brain behavior in everyday activities such as decision-making and social interaction.

Research 123
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Lilly’s Lepodisiran Achieves Over 90% Reduction in Heart Disease Marker in Phase II Trial

XTalks

Eli Lilly shared new Phase II trial data showing that its experimental siRNA therapy, lepodisiran, leads to reductions in levels of lipoprotein(a) (Lp(a)) a genetically inherited risk factor for heart disease in adults with elevated levels of the marker. In the Phase II ALPACA trial, a single 400 mg dose of lepodisiran led to an average decrease of 93.9% in Lp(a) levels over the 60- to 180-day period after treatment compared to placebo, meeting the trials primary endpoint.

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The Ultimate Guide to CDMO Pricing

Drug Patent Watch

"Unlocking the Secrets of CDMO Pricing: A Game-Changer for Life Sciences As a seasoned professional in the life sciences industry, I've seen firsthand the impact of Contract Development and Manufacturing Organization (CDMO) pricing on the bottom line. But with so many variables at play, it can be daunting to navigate the complex world of CDMO pricing.

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Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs

Bio Pharma Dive

More than three-quarters of private biotech investment tracked by BioPharma Dive between January and March was distributed via rounds worth at least $100 million, which experts believe reflects a strategic shift.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Rhythm seeks market expansion for Imcivree following Phase III victory

Pharmaceutical Technology

Rhythm's Imcivree has shown benefit in a Phase III trial in patients with acquired hypothalamic obesity, leading to 19.8% weight loss.

Marketing 130
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Velocity and Merck are Collaborating to Enhance Trial Data Exchange and Insights

Velocity Clinical Research

Velocity is collaborating with Merck to enhance the way trial insights are shared within Merck and across Velocity sites worldwide. Through fast-response data exchange, weve developed the Velocity Insight Platform (VIP), a dynamic dashboard that provides actionable metrics to optimize site activities. A huge thank you to the data team at Merck for their dedication to this groundbreaking project.

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What’s the Latest Research in Weight Loss Medications Telling Us?

XTalks

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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Antiviral chewing gum shows promise in reducing influenza and herpes spread

Medical Xpress

In today's interconnected world, infectious diseases pose an escalating threat, as demonstrated by the coronavirus pandemic and outbreaks of H1N1, SARS, Ebola, Zika, and H5N1 (bird flu) virusesall of which have had significant global health and economic impacts.

Research 118
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.