Fri.Jun 20, 2025

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Gene therapy faces fresh uncertainty as two more top FDA officials depart

Bio Pharma Dive

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

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Morale at the FDA Has Hit Rock Bottom: What It Means for Pharma

World of DTC Marketing

Low morale within the Food and Drug Administration (FDA) is more than just an internal issue—it sends shockwaves through the pharmaceutical industry, affecting regulatory timelines, decision-making, innovation, and public trust. When morale within such a crucial organization dips significantly, pharma companies should brace for turbulence and prepare for strategic adjustments.

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A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups

Bio Pharma Dive

A dramatic pullback in public biotech investment catalyzed by economic and regulatory upheaval is putting even more stress on startups navigating a yearslong downturn.

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National Heart Centre Singapore and Mayo Clinic Join Forces to Propel Cardiovascular Care and Research

Scienmag

In a landmark advancement for cardiovascular science and patient care, the National Heart Centre Singapore (NHCS) and the Mayo Clinic have formalized a strategic partnership through a Memorandum of Understanding (MOU) aimed at catalyzing breakthroughs in cardiovascular research and innovation. This unprecedented collaboration seeks to leverage deep clinical insights and cutting-edge technologies to reshape the future landscape of cardiovascular medicine, with a particular emphasis on Asian popul

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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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STAT+: Off-the-shelf stem cell therapy for type 1 diabetes continues to show positive results

STAT News

Twelve people with type 1 diabetes who received an investigational off-the-shelf stem cell therapy were able to produce their own insulin and keep healthy blood glucose levels for at least one year, Vertex Pharmaceuticals said Friday. After three months, none of them suffered severe bouts of low blood sugar. After 12 months, out of the 12 participants, 10 no longer needed to inject insulin.

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Elevated Cancer Burden Linked to Increased Racial Diversity and Environmental Stress in Neighborhoods

Scienmag

A recent breakthrough cohort study published in JAMA Network Open has revealed critical insights into the intricate relationship between environmental burden and cancer incidence rates across diverse racial and ethnic populations. This comprehensive investigation emphasizes the pressing need for sustained and targeted community interventions, particularly in minoritized census regions characterized by elevated environmental stressors.

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Risk Factors for Plastic Bronchitis in Kids

Scienmag

A groundbreaking advancement in pediatric respiratory medicine has emerged with the recent development of a sophisticated predictive model aimed at identifying the risk factors for plastic bronchitis (PB) among children suffering from severe Mycoplasma pneumoniae pneumonia (SMPP). This condition, though uncommon, poses significant risks to young patients, as PB involves the formation of obstructive bronchial casts that can severely compromise pulmonary function and escalate clinical severity.

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Opinion: Six former CDC vaccine advisory committee chairs warn: U.S. risks losing access to life-saving immunizations

STAT News

As former chairs of the CDC’s Advisory Committee on Immunization Practices ( ACIP ), we are deeply alarmed by the growing politicization of vaccines — a public health innovation that has saved 154 million lives globally. While politicization of science is not new, the escalating distrust in science across the political spectrum, and its intrusion into the vaccine ecosystem, now threatens the very infrastructure that has long protected Americans from infectious diseases.

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Unraveling Kawasaki Disease Clusters Linked to Heart Issues

Scienmag

In a groundbreaking study published in the upcoming issue of Pediatric Research, researchers have unveiled novel insights into the heterogeneity of Kawasaki disease, particularly focusing on patients who develop coronary artery abnormalities. Utilizing advanced data-driven cluster analysis techniques, the team led by Sunaga, Hasebe, and Kikuchi has peeled back layers of complexity that obscure our understanding of this enigmatic pediatric vasculitis.

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Combination of Lunsumio and Polivy from Roche Significantly Extends Remission in R/R Large B-Cell Lymphoma

The Pharma Data

Roche’s Lunsumio and Polivy Combination Marks Major Advance in Relapsed or Refractory Large B-Cell Lymphoma with Significant Remission Durability Roche has announced promising results from its pivotal Phase III SUNMO study (NCT05171647), demonstrating that its novel subcutaneous combination therapy of Lunsumio® (mosunetuzumab) and Polivy® (polatuzumab vedotin) yields statistically significant and clinically meaningful improvements in key efficacy measures compared to the conventional chemotherap

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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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Innovative Method for Detecting “Aged” Cells Opens New Frontiers in Ageing Research

Scienmag

Researchers at Tokyo Metropolitan University have pioneered a groundbreaking label-free technique that allows for the precise differentiation of “aged” or senescent human cells from their younger counterparts through the application of alternating electric fields. Conventional methods for identifying senescent cells typically depend on biochemical labeling, such as fluorescent tags that bind to specific markers unique to aged cells.

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People With Severe Diabetes Are Cured in Small Trial of New Drug

NY Times

Most in a small group of patients receiving a stem cell-based infusion no longer needed insulin, but the drug may not suit those with more manageable type 1 diabetes.

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Uncovering the Mechanism Driving Life-Threatening Side Effects of Cancer Drugs

Scienmag

A groundbreaking new study reveals crucial immune system alterations in cancer patients undergoing treatment with immune checkpoint inhibitors, potentially paving the way for early identification of individuals at heightened risk for severe cardiac complications. These findings promise to revolutionize how clinicians monitor and manage the cardiovascular side effects associated with some of the most advanced cancer therapies available today.

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STAT+: Disagreements over Duchenne therapy, management style may have led to ouster of key FDA official

STAT News

The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has learned.  The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics.

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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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TBX4 Deficiency Causes Infant Lung Issues, Hypertension

Scienmag

In a groundbreaking study poised to reshape our understanding of pulmonary hypertension (PH), researchers have unveiled the critical role of the T-box transcription factor 4 (TBX4) in postnatal lung development and vascular health. While TBX4 has long been recognized as a genetic culprit behind various forms of PH, this latest research illuminates how disruptions to TBX4 signaling after birth trigger a cascade of developmental derangements culminating in severe pulmonary disease.

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DoH – Abu Dhabi and Sanofi link for vaccine development

Pharmaceutical Technology

Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh

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Geostationary Satellite Revolutionizes Access to Ultra-Remote Robotic Hepatectomy

Scienmag

In recent years, the issue of healthcare inequality has emerged as a significant global concern, presenting formidable challenges worldwide. Remote regions, particularly those situated in highlands and oceanic areas, suffer from a dearth of high-speed networks and specialized surgical expertise, rendering complex surgeries inaccessible. Traditional 5G telesurgery solutions exhibit limited coverage, typically constrained by a 5,000-kilometer radius that relies heavily on ground-based infrastructu

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Why MAHA wants whole milk back on the table

STAT News

At a Brooklyn coffeeshop one recent rainy afternoon, the barista explained that lattes came just one of two ways: with whole milk or almond. It didn’t make sense to stock skim or reduced-fat milk when requests for those varieties are few and far between, she said — though a few months ago, she did notice a curious surge of customers asking for raw milk.

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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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Human–AI Collaborations Achieve Breakthrough Accuracy in Medical Diagnoses

Scienmag

In an era where artificial intelligence (AI) continues to revolutionize various fields, medicine stands out as a domain ripe for transformation. Despite advances in technology, diagnostic errors remain a persistent and serious problem in medical practice globally, often resulting in adverse patient outcomes. Recently, an international research team led by the Max Planck Institute for Human Development has provided compelling evidence that hybrid diagnostic teams, consisting of both human experti

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Merck and oncology: A conversation with Dr Gregory Lubiniecki at ASCO 2025

pharmaphorum

Watch this insightful video interview with Dr Gregory Lubiniecki at ASCO 2025 as he discusses Merck's advancements in oncology. Learn about the latest innovations and treatments in the field.

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Cancer Patients Avoiding Radiation Gain More Time with Loved Ones, Study Finds

Scienmag

A groundbreaking clinical trial led by researchers at University College London (UCL) has unveiled the potential to fundamentally alter the standard treatment paradigm for low-risk thyroid cancer patients worldwide. This extensive study demonstrates that hundreds of thousands could safely avoid radioactive iodine therapy following thyroidectomy, sparing them from the treatment’s debilitating side effects and the isolating hospital stays traditionally mandated.

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CHMP Recommends Third Indication for Bayer’s Nubeqa in Advanced Prostate Cancer Patients

The Pharma Data

CHMP Recommends Expanded Use of Bayer’s Nubeqa™ (Darolutamide) for Advanced Prostate Cancer Following Positive ARANOTE Trial Results The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending Bayer ’s oral androgen receptor inhibitor, darolutamide (marketed as Nubeqa™), for a third indication in the treatment of prostate cancer.

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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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Humeral Rotation Impacts Rotator Cuff Mechanics

Scienmag

The intricate mechanics of the shoulder have long fascinated biomechanical researchers and clinicians alike, owing to the joint’s remarkable range of motion and complex muscular interplay. Among the critical components contributing to shoulder function is the rotator cuff, a group of muscles and tendons that stabilize the humeral head within the glenoid cavity.

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London Biotechnology Show 2025: Novo Nordisk harnesses AI/ML to accelerate drug development landscape

Pharmaceutical Technology

Skip to site menu Skip to page content Switch language: translate --> PT Menu Search Sections Home News Analysis Features Comment & Opinion Projects Data Insights Sectors Clinical Trials Drug Manufacturers Therapy Area Cardiovascular Central Nervous System Immunology Infectious Disease Oncology Respiratory Pricing and Market Access Themes Artificial Intelligence Corporate Governance Cloud Cybersecurity Environmental Sustainability Internet of Things Robotics Social Responsibility Covid-19 Insigh

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Racial Disparities Impact Neonatal Hypoxic-Ischemic Outcomes

Scienmag

In a groundbreaking new study published in the Journal of Perinatology, researchers have unearthed unsettling evidence pointing to stark racial disparities in the incidence, severity, treatment, and outcomes of hypoxic-ischemic encephalopathy (HIE) among neonates in the United States. HIE, a devastating form of brain injury caused by oxygen deprivation and limited blood flow shortly before or during birth, remains a leading cause of neonatal morbidity and mortality worldwide.

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Omada Health IPO Targets Musculoskeletal and Obesity Care with Digital-First Model

XTalks

Omada Health went public with its initial public offering (IPO), pricing 7.9 million shares at $19 each. The offering is expected to raise $150.1 million, with the potential to increase to $172.6 million if underwriters exercise their option for additional shares. Omada began trading under the ticker “OMDA” on the Nasdaq Global Select Market on June 6.

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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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AI Diagnoses Vocal Cord Paralysis Severity

Scienmag

In a groundbreaking advancement at the crossroads of artificial intelligence and clinical otolaryngology, researchers have unveiled an innovative platform that automatically assesses the severity of unilateral vocal cord paralysis (UVCP) using state-of-the-art deep learning techniques. This pioneering research leverages Mel-spectrograms—a sophisticated audio representation technique—paired with convolutional neural networks (CNN) to dissect subtle vocal characteristics, offering a precise, non-i

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FDA blocks trials that send US cells to 'hostile' countries

pharmaphorum

The FDA says it will review clinical trials that send US citizens' cells to 'hostile countries' as leadership at the agency in this area is sidelined.

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How UV/Sulfite Breaks PFAS via Hydrated Electrons

Scienmag

In the relentless battle against environmental pollutants, few challenges loom as large as the persistent contamination caused by per- and polyfluoroalkyl substances, commonly known as PFAS. These synthetic chemicals, lauded for their resistance to heat, water, and oil, have found widespread use in countless consumer products, industrial applications, and firefighting foams.

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FDA Approves Dupixent as First and Only Targeted Therapy for Bullous Pemphigoid in the US

The Pharma Data

FDA Approves Dupixent as the First and Only Targeted Therapy for Adults with Bullous Pemphigoid In a groundbreaking development for patients suffering from a rare and debilitating autoimmune skin disease, the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). This approval marks the first and only targeted therapy available for this condition and brings renewed hope to thousands of patients—primarily elderly

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