Sat.Dec 21, 2024 - Fri.Dec 27, 2024

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Top 5 Things to Know Before Joining a Clinical Trial

Pharma Mirror

Have you ever wondered how life-saving treatments for cancer, Alzheimers, or chronic diseases come to life? Clinical trials are the foundation of medical innovation, paving the way for groundbreaking therapies. Yet for many, the idea of joining a trial can feel intimidating or unclear. Experts are here to demystify the clinical trial process, with Dr.

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Deupirfenidone Could Perform Better Than Standard IPF Therapy

XTalks

A new Phase IIb clinical trial, ELEVATE IPF, has delivered promising results for deupirfenidone ( LYT-100 ), an investigational drug being evaluated to slow lung function decline in patients with idiopathic pulmonary fibrosis (IPF). The trial involved 257 participants and tested two doses of deupirfenidone over 26 weeks, with participants taking the drug three times a day (TID).

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Your Sniffles Could Be a Sign of The Fungi Hidden in Your Nose

AuroBlog - Aurous Healthcare Clinical Trials blog

(Runstudio/Photodisc/Getty Images) If you find yourself sniffling at the merest hint of an irritant, you likely have a different set of microbes calling your nostrils home than everyone else. An international team of researchers has found a unique assortment of fungi up the noses of people who suffer from hayfever and asthma.

Research 246
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The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved

FDA Law Blog

By Mark A. Tobolowsky & Frank J. Sasinowski The Winter Solstice, signifying the shortest day of the year, was Saturday, December 21. Although the earliest sunset of the year was actually in early December, this day also marked another premature sunset the beginning of the end of the rare pediatric disease priority review voucher program. As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended.

Drugs 59
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

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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FDA approves flurry of drugs ahead of holiday season

pharmaphorum

The FDA has wrapped up a series of new approvals as 2024 draws to a close, with Novo Nordisk, Pfizer, Vertex, and Hikma among the beneficiaries.

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Novo gets the green light for once-daily haemophilia drug following setbacks 

Pharmaceutical Technology

The FDA initially rejected the marketing application for Alhemo in 2022, asking for additional data on dosing and monitoring.

Drugs 264

More Trending

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International Day of Epidemic Preparedness 2024: Amplifying Global Resilience

XTalks

The International Day of Epidemic Preparedness, observed annually on December 27 , underscores the necessity of global collaboration to address epidemic threats. Proclaimed by the United Nations (UN) in 2020, this day honors lessons from past crises like COVID-19, emphasizing the importance of readiness in safeguarding lives and economies. A recent World Health Organization (WHO) report revealed a troubling decline in health spending , threatening epidemic resilience by weakening critical system

Vaccine 52
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A public health emergency is waiting at the bottom of the antibiotic resistance cliff

Medical Xpress

The rise of antibiotic-resistant bacteria could lead to a catastrophic rise in infection-related deaths, according to new research led by Northern Arizona University.

Bacteria 144
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FDA approves Lilly’s obesity med Zepbound to treat obstructive sleep apnoea

Pharmaceutical Technology

Lillys Zepbound has become the first prescription medicine approved to treat adults with moderate to severe obstructive sleep apnoea (OSA) and obesity.

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Mysterious Finding Shows Healthy Tissue Can Resemble Invasive Cance

AuroBlog - Aurous Healthcare Clinical Trials blog

(Nemes Laszlo/Science Photo Library/Getty Images) How we classify cancer and spot it in its earliest stages could need an urgent rethink: researchers have found that even some healthy women carry cells with the key hallmarks of breast cancer. These cells are known as aneuploid cells, and have an abnormal number of chromosomes.

Research 245
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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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Gastro Concepts’ Air Assist Device: Improving Procedural Colonoscopy

XTalks

Gastro Concepts has achieved a milestone with US Food and Drug Administration (FDA) clearance for its Air Assist device , an innovation designed to transform colonoscopy procedures. By addressing a long-standing challenge in the field air and carbon dioxide (CO 2 ) leakage during colonoscopy Air Assist offers a more efficient and safer approach to maintaining colonic distension.

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New bird flu mutation discovered in US as cat infections cause alarm

Medical Xpress

The ongoing spread of bird flu in the United States has alarmed expertsnot just because of human cases causing severe illness, but also due to troubling new instances of infections in cats.

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XBiotech halts all rheumatology research after missing Phase II endpoints

Pharmaceutical Technology

XBiotech has said it will investigate the results of its rheumatoid arthritis trial after finding irregularities in its Phase II trial.

Research 162
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Surprise Hair Loss Breakthrough: A Sugar Gel Triggers Robust Regrowth

AuroBlog - Aurous Healthcare Clinical Trials blog

Earlier this year, scientists stumbled upon a potential new treatment for hereditary-patterned baldness, the most common cause of hair loss in both men and women worldwide. It all started with research on a sugar that naturally occurs in the body and helps form DNA: the ‘deoxyribose‘ part of deoxyribonucleic acid.

DNA 246
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Obicetrapib Lowers LDL-C as Monotherapy and with Ezetimibe in Phase III Trials

XTalks

Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. These trials aim to address a major challenge in cardiovascular disease: managing elevated low-density lipoprotein cholesterol (LDL-C) levels in patients at risk of heart disease.

Trials 52
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Detailed study reveals how cells coordinate to heal human wounds

Medical Xpress

A new study from Karolinska Institutet maps the cellular and molecular dynamics of human wound healing in exceptional detail. The study was published in Cell Stem Cell.

Research 124
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Investors optimistic about continued biotech and medtech IPO resurgence in 2025

Pharmaceutical Technology

Though still below boom levels seen a few years ago, 2024 compares favourably to 2023, and signs suggest that growth will continue into 2025.

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Generative AI in pharma: Moving beyond hype and into widespread adoption

pharmaphorum

Discover how Generative AI is revolutionising the pharmaceutical industry and moving beyond hype towards widespread adoption in drug discovery and development. Learn more about the impact of GenAI.

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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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Cloudbyz Achieves Dual Recognition for CTMS and EDC Solutions in Everest Group’s 2024 PEAK Matrix®

Cloudbyz

Cloudbyz Earns Dual Recognition in Everest Groups 2024 PEAK Matrix for CTMS and EDC Solutions Driving Innovation in Clinical Trial Management Cloudbyz is proud to announce its dual recognition in Everest Groups 2024 PEAK Matrix assessments for both Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) solutions. This achievement solidifies Cloudbyzs position as a trusted partner in advancing clinical research through cutting-edge, cloud-based technologies.

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Brain's 'tug-of-war': Choosing between classical and operant conditioning

Medical Xpress

A study from Tel Aviv University could reshape our scientific understanding of how humans learn and form memories, particularly through classical and operant conditioning.

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Pfizer’s colorectal cancer combo therapy gains accelerated approval from FDA

Pharmaceutical Technology

Pfizer has gained accelerated approval from the US FDA for BRAFTOVI in conjunction with cetuximab and mFOLFOX6 for treating mCRC.

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Diversity in STEM in 2024: A reflection and a path forward

pharmaphorum

This article reflects on the current state of diversity in Science, Technology, Engineering, and Mathematics (STEM) fields in 2024 and outlines a path forward for creating a more inclusive and equitable environment.

Engineer 113
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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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Variation in Emergency Department Physician Admitting Practices and Subsequent Mortality

JAMA Internal Medicine

This cross-sectional study using Veterans Affairs data from more than 2 million patient emergency department visits over 8 years examines the variation in physicians admission propensities and how those may relate to mortality outcomes.

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Sustained visual improvements in LHON patients treated with AAV gene therapy

Medical Xpress

A multinational study led by the LHON Study Group has revealed sustained visual improvements and a favorable safety profile five years following lenadogene nolparvovec gene therapy in patients with Leber hereditary optic neuropathy (LHON) caused by the MT-ND4 gene mutation.

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GEMMABio raises $34m to advance gene therapy programmes 

Pharmaceutical Technology

This seed funding comes after GEMMABio secured $100m in October through a partnership with Brazilian supplier Fiocruz.

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Being loud

pharmaphorum

Explore the concept of being loud in local, regional, and global life sciences with Oliver Stohlmann's Corporate Survival Hacks. Find practical tips and strategies to thrive in the industry.

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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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Our Top 5 Social Media Posts of 2024

Pharmaceutical Commerce

Check out our top five most engaged social media posts from the year 2024.

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New genetic mutation found to suppress cancer growth

Medical Xpress

UT Southwestern Medical Center researchers have identified a genetic mutation that slows the growth of melanoma and potentially other cancers by harnessing the power of the immune system. Their findings, published in the Journal of Experimental Medicine, could lead to new treatments that improve outcomes from existing cancer immunotherapies.

Genetics 109
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RAPT Therapeutics and Shanghai Jemincare sign anti-IgE antibody agreement

Pharmaceutical Technology

RAPT Therapeutics and Shanghai Jemincare Pharmaceutical have signed an exclusive agreement for RPT904 to treat various allergic conditions.

Antibody 147
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Amid BIOSECURE Act speculation, WuXi AppTec sells unit

pharmaphorum

WuXi AppTec has agreed to sell a business unit serving the cell and gene therapy (CGT) sector to private equity firm Altaris for an undisclosed sum

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time