January, 2025

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FDA adds warning to RSV shots from GSK, Pfizer

Bio Pharma Dive

The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

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FDA CDER director Patrizia Cavazzoni announces resignation

Pharmaceutical Technology

Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.

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Artificial intelligence and machine learning transforming ICU decision-making: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

Artificial intelligence (AI) and machine learning (ML) are poised to redefine the landscape of critical care medicine, offering innovative solutions to the challenges faced in intensive care units (ICUs). ICUs are high-stakes environments where every decision can mean the difference between life and death.

Medicine 186
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January 9, 2025: NIH Pragmatic Trials Collaboratory Will Hold Virtual Workshop on Emerging Issues in February

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on February 5 and 6, 2025, on Digging Into Dilemmas of Pragmatic Clinical Trials. A keynote presentation will address the state of healthcare delivery in the United States and the constraints on healthcare systems that are important for researchers to understand. Day 1 of the workshop will develop participants understanding of the landscape for pragmatic research, including stressors on the healthcare system and barriers and opp

Trials 173
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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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Adaptive Trial Designs in Cardiovascular Metabolism Studies

Worldwide Clinical Trials

With 20-25% of the global population affected by metabolic problems, finding effective treatments is crucial for cardiovascular and metabolic (CVM) conditions. Traditional study designs feature predetermined sample sizes, assessments, and analyses that must remain in place over long treatment durations. Although formal protocol amendments are possible, this process is time-consuming and complex.

Trials 173
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Amgen’s lung cancer treatment gets conditional approval

Pharma Times

IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer

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More Trending

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Tirzepatide outpacing Wegovy in the obesity space

Pharmaceutical Technology

Eli Lilly and Novo Nordisk have been competing in the obesity market for the past year, making it an opportune time to review the benefits of the two most prominent obesity medications.

Marketing 255
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Damaged Hearts May Have Hidden Self-Healing Powers, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

(SDI Productions/E+/Getty Images) The right therapy can dramatically boost the self-healing capabilities of the human heart after heart failure, a new study has found giving the vital organ regenerative powers even beyond those of a healthy heart.

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January 6, 2025: Fritz and Rhon to Present Strategies for Pain Management in the Military Health System

Rethinking Clinical Trials

In an upcoming session of the VA Spotlight on Pain Management Cyberseminars series curated by the Pain Management Collaboratory (PMC), Julie Fritz and Dan Rhon will present “Supporting Whole Person Pain Management in the Military Health System.” The session will be held on Tuesday, January 7, from 11:00 am to 12:00 pm eastern. Improving care for persons with chronic musculoskeletal pain is a priority in the Military Health System.

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Worldwide Clinical Trials

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential? BioA plays a pivotal role in therapeutic development, facilitating progress in our understanding and treatment of complicated diseases through PK/PD, immunogenicit

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

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EC approves Rybrevant with Lazcluze for advanced lung cancer

Pharma Times

New chemotherapy-free treatment shows promise for EGFR-mutated NSCLC

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Orbis raises $93M to turn popular biologics into pills

Bio Pharma Dive

The startup is developing a kind of macrocyles, which share strengths of both small molecules and biologics, as oral medicines against “validated blockbuster biologic targets.

Medicine 293
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Variant Bio and Novo Nordisk to identify targets for metabolic disease treatment

Pharmaceutical Technology

Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.

Research 173
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Open-World Games Like Zelda Can Boost Your Mental Health, Study Says

AuroBlog - Aurous Healthcare Clinical Trials blog

Still from Breath of the Wild. (Nintendo) Many modern video games fall into the open-world category, giving players vast, detailed worlds to explore and a new study shows these expansive digital playgrounds have benefits for our mental health.

Research 170
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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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January 8, 2025: In This Week’s PCT Grand Rounds, Community Engagement Methods in the FM-TIPS Trial

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Heather Schacht Reisinger and Dana Dailey of the University of Iowa will present “FM-TIPS Community Engagement Methods for Recruitment.” The Grand Rounds session will be held on Friday, January 10, 2025, at 1:00 pm eastern. FM-TIPS, an NIH Collaboratory Trial, is examining whether the addition of transcutaneous electrical nerve stimulation to routine physical therapy improves movement-evoked pain compared with physical therapy alone among pati

Trials 182
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Cambodian man dies from bird flu

Medical Xpress

A 28-year-old Cambodian man died from bird flu on Friday after eating sick chickens, the health ministry said.

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NICE recommends olaparib for BRCA-mutated breast cancer treatment

Pharma Times

Groundbreaking approval provides new hope for patients in England and Wales

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Vertex, startup Orna to partner on gene editing research

Bio Pharma Dive

The three-year partnership is another example of Vertex’s interest in improving on Casgevy, its CRISPR medicine for sickle cell and beta thalassemia.

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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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FDA awards GSA breakthrough status for relapsed osteosarcoma treatment

Pharmaceutical Technology

GSK has gained US FDA breakthrough therapy designation for GSK'227 to treat adults with relapsed or refractory osteosarcoma.

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Scientists Discover Common Virus Could Be Causing a Type of Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

CMV-infected human placental cell. (Nephron/CC BY-SA 3.0/Wikimedia Commons) Researchers have discovered a link between a chronic gut infection caused by a common virus and the development of Alzheimer’s disease in some people. Most people encounter cytomegalovirus (CMV) during childhood, and after the initial infection the virus remains in the body for life, usually dormant.

Scientist 169
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Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

XTalks

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. Dr. Rishi Kundi, a clinical investigator at the University of Maryland Medical System, believes Symvess holds the potential to transform vascular trauma care by overcoming longstanding challenges like infection control and graft failure that have plagued traditional r

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Early cancer diagnoses reach record level in NHS

pharmaphorum

Early cancer diagnoses have risen to record levels in England, says NHS, but long waiting times for treatment threaten to undermine the gains.

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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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Angelini Ventures co-leads Series A financing in Neumirna Therapeutics

Pharma Times

Investment to support RNA therapeutics for epilepsy and neurological disorders

RNA 115
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Galapagos, after research struggles, will split in two and revamp Gilead deal

Bio Pharma Dive

Alongside plans to spin out a new company, the Belgian drugmaker said it will cut some 300 positions, or about 40% of its current workforce.

Research 278
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IIT Guwahati and Bose Institute develop injectable hydrogel for cancer

Pharmaceutical Technology

The Indian Institute of Technology (IIT) Guwahati and the Bose Institute Kolkata research team have developed an advanced injectable hydrogel

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CDSCO brings clinical trial site addition and change of PI applications to online mode

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinical trial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure.

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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.

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Brain study challenges long-held views about Parkinson's movement disorders

Medical Xpress

University of Arizona researchers have revealed new insights into one of the most common complications faced by Parkinson's disease patients: uncontrollable movements that develop after years of treatment.

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FDA issues first guidance on AI in medicine development

pharmaphorum

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area

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New prostate cancer test cuts biopsies by 50% in US

Pharma Times

EpiSwitch PSE shows promise in reducing unnecessary procedures

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Bayer says menopause drug succeeds in breast cancer study

Bio Pharma Dive

The results suggest Bayer’s elinzanetant may help a broader group of women with vasomotor symptoms, which are associated with menopause as well as a common breast cancer therapy.

Drugs 269
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g