Wed.Jul 02, 2025

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Regeneron bispecific approved for myeloma; Concentra to buy IGM

Bio Pharma Dive

Lynozyflic is one of two bispecific antibodies Regeneron hopes will lift its oncology business. Meanwhile, IGM is the latest struggling biotech to agree to a buyout deal from Concentra.

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July 2, 2025: Researchers Share Tips for Embedding Pragmatic Trials Into Primary Care Settings

Rethinking Clinical Trials

Although the need for pragmatic research in primary care settings is great, conduct of pragmatic clinical trials in these settings remains nascent. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Wendy Weber of the National Center for Complementary and Integrative Health (NCCIH) led a discussion about how to expand pragmatic research into primary care settings.

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Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline

Bio Pharma Dive

Industry veteran Catherine Owen Adams expects external innovation will be key to getting the brain-focused drug developer to “the next level.

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Insights into Brain Tumor Growth Patterns Could Enhance Patient Care Strategies

Scienmag

Brain tumors exhibit distinct growth behaviors that significantly influence patient outcomes and treatment approaches. Fundamentally, these tumors adopt one of two aggressive strategies to expand within the confined space of the skull: they either exert mechanical pressure by pushing against the surrounding brain tissue or infiltrate by sending invasive, finger-like projections that destroy neighboring neural structures.

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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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argenx Advances ARGX-119 for Congenital Myasthenic Syndromes

The Pharma Data

argenx Advances ARGX-119 into Registrational Study for Congenital Myasthenic Syndromes Following Positive Phase 1b Data argenx SE (Euronext & Nasdaq: ARGX), a global immunology company focused on improving outcomes for patients with severe autoimmune diseases, has announced plans to progress its investigational therapy ARGX-119 into a registrational clinical trial for congenital myasthenic syndromes (CMS).

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Delirium Risks Linked to Ultra-Brief ECT

Scienmag

In a groundbreaking study published in BMC Psychiatry , researchers explore the nuanced effects of ultra-brief pulse electroconvulsive therapy (ECT) on postoperative delirium in patients diagnosed with schizophrenia (SCZ). This investigation offers vital insights into how ultra-brief pulse (UBP) ECT compares to traditional brief pulse (BP) ECT in minimizing the cognitive side effects commonly associated with this psychiatric treatment.

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Tumor-to-Parenchyma PET Ratio Predicts Chemotherapy Response

Scienmag

In a groundbreaking multicenter study poised to reshape breast cancer treatment strategies, researchers have unveiled new insights into the capabilities of [18F]FLT PET/CT imaging in predicting tumor response to neoadjuvant chemotherapy (NAC). This retrospective analysis leverages a rich dataset from the ACRIN 6688 observational trial, offering a comprehensive examination of how the tumor to background parenchymal ratio (TBR) of standardized uptake values (SUV) can provide critical prognostic in

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Neumifil shows promise in treating influenza with positive phase 2 dat

Pharma Times

Subscribe Advertise About us Follow Follow Follow Follow GO Magazine PharmaTimes Magazine Archive Web Exclusives News Competitions Appointments Business Insights Webinars Thought Leadership Neumifil shows promise in treating influenza with positive phase 2 dat by John Pinching | 2nd Jul 2025 | News Pneumagen’s intranasal antiviral demonstrates reduced infection Pneumagen has announced the publication of phase 2 data showing its antiviral therapy, Neumifil, significantly reduced influenza infecti

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Lung Cancer Risk in Chinese CT-Detected Nodules

Scienmag

A groundbreaking study from China is reshaping the landscape of lung cancer screening, unveiling a novel predictive model that enhances the accuracy of malignancy assessments for pulmonary nodules detected via low-dose computed tomography (LDCT). Published in BMC Cancer , this research addresses crucial challenges inherent in lung cancer early detection programs, particularly the high rates of false positives and overdiagnosis that undermine the potential life-saving benefits of LDCT screening.

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GlucoModicum's non-invasive CGM nears first filing

pharmaphorum

Finland's GlucoModicum thinks it is in the lead in the race to bring a non-invasive continuous glucose monitor (CGM) to market.

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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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Scientists Outline Future Strategies to Reduce Animal Testing

Scienmag

In recent years, the scientific community and regulatory bodies across the European Union have been grappling with a significant challenge: how to effectively identify endocrine-disrupting substances (EDS) while minimizing the reliance on animal testing. Endocrine disruptors, compounds that interfere with hormone systems, pose substantial risks to human health, wildlife, and ecosystems by contributing to conditions such as cancers, reproductive dysfunctions, and developmental disorders.

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New passport 'will speed medtech rollout in NHS'

pharmaphorum

The UK has revealed a new 'innovator passport' designed to accelerate the rollout of proven medtech in the NHS.

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Muscle Rev-erb Drives Time-Based Exercise Adaptations

Scienmag

In a groundbreaking study published recently in Nature Communications , researchers have unveiled a crucial molecular mechanism by which skeletal muscle adapts to chronic exercise in a time-dependent manner. The team led by Liu, Xiao, and Choubey discovered that the nuclear receptor Rev-erbα, a pivotal component of the cellular circadian clock, orchestrates muscle’s physiological remodeling in response to prolonged exercise regimens in mice.

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An interview with Daniel Williams, DO on Velocity’s PIVOT program and training the next generation of Principal Investigators

Velocity Clinical Research

Very few physicians begin their careers with an eye on research. Moving into the role of Principal Investigator (PI) can be unexpectedly challenging, with demands that often take physicians by surprise. “Much of my experience with clinical research centered around reviewing journal articles for clinical practice,” explains Daniel Williams, DO, FAAEM , who transitioned from emergency medicine into clinical research.

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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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What Salad Dressing Reveals About the Inner Workings of Cells: Insights from Biological Emulsions

Scienmag

In the intricate world of cellular biology, the organization within a cell is far from random. Much like a finely tuned, multi-compartmentalized factory, cells have distinct regions where specific tasks are performed with remarkable precision. These compartments can be broadly divided into two categories: membrane-bound organelles, such as mitochondria that generate energy and the nucleus that safeguards our genetic blueprint, and membrane-less structures known as biomolecular condensates.

RNA 75
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Asahi Kasei Pharma Launches Global Phase III Trial of ART-123 for CIPN Prevention

The Pharma Data

Asahi Kasei Pharma Initiates Phase III Clinical Trial of ART-123 to Combat Chemotherapy-Induced Peripheral Neuropathy Asahi Kasei Pharma Corporation has officially commenced drug administration in a pivotal Phase III clinical trial of ART-123, a recombinant human thrombomodulin (rTM), in Japan. Marketed domestically under the brand name Recomodulin™ Injection, ART-123 is being investigated for its potential to prevent chemotherapy-induced peripheral neuropathy (CIPN)—a debilitating side effect c

Trials 40
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Perceived Social Status Linked to Cardiovascular Risk in Women, Not Men

Scienmag

A groundbreaking new study led by researchers at McGill and Concordia universities has unveiled compelling evidence linking women’s subjective perceptions of their social status to early indicators of cardiac stress, potentially setting the stage for future heart disease. This research sheds light on a critical, yet understudied, dimension of cardiovascular risk—how social and psychological factors uniquely influence women’s heart health, underscoring the necessity for a paradigmatic shift in ca

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FDA Grants Accelerated Approval to Lynozyfic™ for Relapsed or Refractory Multiple Myeloma

The Pharma Data

FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S. Food and Drug Administration’s (FDA) accelerated approval of Lynozyfic™ (linvoseltamab-gcpt), a first-in-class BCMAxCD3 bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) multiple myeloma (MM).

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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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Organon drug for endometriosis falls short in mid-stage study

Bio Pharma Dive

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Drugs 240
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WuXi Biologics Unveils WuXiHigh™ 2.0 for Ultra-Concentrated Biologics

The Pharma Data

WuXi Biologics Launches WuXiHigh™ 2.0 to Advance High-Concentration Biologic Formulations WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has announced the official launch of WuXiHigh™ 2.0 , a next-generation, high-throughput formulation development platform specifically engineered for high-concentration biologics.

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Shionogi puts up to $600m behind BioVersys antibiotics

pharmaphorum

Shionogi has added to its antibiotics pipeline by taking an option on a preclinical-stage candidate from BioVersys for non-tuberculous mycobacteria.

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Analysis shows Yeztugo approval a ‘momentous step’ for HIV prevention

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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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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The OTC Fee Fallout: Are Hundreds of Companies Ignoring FDA’s User Fee Requirements?

FDA Law

By Charles D. Snow — Since the U.S. Food and Drug Administration (FDA) launched the Over-the-Counter Monograph User Fee Program (OMUFA) in 2020, the Agency has been pushing for modernization and self-funding of its regulatory oversight for over-the-counter (OTC) products. But five years in, the Agency’s OMUFA Facility Arrears List paints a concerning picture: nearly 1,400 businesses—foreign and domestic—appear to have either ignored or fallen behind on their facility registration payments.

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Robert Holton Dies at 81; His Potent Chemo Drug Saved Lives — and Trees

NY Times

His method of producing the drug Taxol, now used widely to treat various cancers, eliminated the need to source its active compound from endangered trees.

Drugs 56
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Biogen Launches Phase 3 Trial of Felzartamab for Primary Membranous Nephropathy

The Pharma Data

Biogen Launches Global Phase 3 PROMINENT Trial Evaluating Felzartamab in Primary Membranous Nephropathy Biogen Inc. (Nasdaq: BIIB) has announced the initiation of dosing in its global Phase 3 clinical trial, known as PROMINENT, to assess the safety and efficacy of its investigational anti-CD38 antibody, felzartamab , in adults with primary membranous nephropathy (PMN).

Trials 40
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Cell and gene therapy: The vital role of logistics

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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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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FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. and Canada, has announced a significant regulatory milestone for its pulmonary arterial hypertension (PAH) treatment, WINREVAIR™ (sotatercept-csrk).

Trials 52
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Why this activist is putting her body on the line for Americans with disabilities

STAT News

Flanked by her friends as lawmakers debated the future of a 60-year-old health care plan, Latoya Maddox raised her voice, shouting, “No cuts to Medicaid! No cuts to Medicaid!” The chanting, during a meeting of the House Energy and Commerce Committee on May 13, quickly earned her and her fellow disabled activists in the room a rough escort out by Capitol Police.

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WHO-backed testing model boosts mpox, HIV, and syphilis response

The Pharma Data

As mpox cases surge once again in parts of Central Africa, the Democratic Republic of the Congo (DRC) is leading a bold, innovative strategy by integrating HIV and syphilis testing into its national mpox management framework. This approach, supported by the World Health Organization (WHO), represents a crucial advancement in public health aimed at addressing overlapping vulnerabilities and improving patient outcomes.

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Social Media Marketing Strategies Working in Pharma

Pharma Marketing Network

In the digital-first era, social media marketing strategies are reshaping how pharmaceutical companies engage with healthcare professionals, patients, and caregivers. These strategies are no longer optional; they are essential. From awareness campaigns to real-time engagement, pharma brands that embrace digital transformation are seeing meaningful results across platforms.

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