Pharma Mirror
DECEMBER 23, 2024
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.
XTalks
DECEMBER 23, 2024
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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AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 23, 2024
(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.
FDA Law Blog
DECEMBER 23, 2024
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.
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
pharmaphorum
DECEMBER 24, 2024
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.
Pharmaceutical Technology
DECEMBER 24, 2024
The FDA initially rejected the marketing application for Alhemo in 2022, asking for additional data on dosing and monitoring.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Medical Xpress
DECEMBER 27, 2024
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.
pharmaphorum
DECEMBER 27, 2024
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
Pharmaceutical Technology
DECEMBER 23, 2024
Lillys Zepbound has become the first prescription medicine approved to treat adults with moderate to severe obstructive sleep apnoea (OSA) and obesity.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 24, 2024
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.
Medical Xpress
DECEMBER 27, 2024
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.
pharmaphorum
DECEMBER 24, 2024
Sanofi has moved ahead with plans to challenge Pfizer and MSD for a piece of the market for pneumococcal vaccines.
Pharmaceutical Technology
DECEMBER 24, 2024
XBiotech has said it will investigate the results of its rheumatoid arthritis trial after finding irregularities in its Phase II trial.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 26, 2024
(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.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Medical Xpress
DECEMBER 27, 2024
A study from Tel Aviv University could reshape our scientific understanding of how humans learn and form memories, particularly through classical and operant conditioning.
pharmaphorum
DECEMBER 22, 2024
Novo Nordisk data on obesity candidate CagriSema falls short of expectations, wiping around $94 billion off its market valuation.
Pharmaceutical Technology
DECEMBER 23, 2024
Pfizer has gained accelerated approval from the US FDA for BRAFTOVI in conjunction with cetuximab and mFOLFOX6 for treating mCRC.
Drug Patent Watch
DECEMBER 26, 2024
The biopharmaceutical sector has made significant strides in developing and delivering effective drugs to improve health and combat diseases. However, the high cost of prescription drugs remains a significant barrier to access for many patients. One key solution to this issue lies in the role of generic drugs, which are significantly cheaper than branded products and can help reduce the financial burden on patients and the healthcare system.
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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.
Medical Xpress
DECEMBER 27, 2024
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.
pharmaphorum
DECEMBER 22, 2024
Ionis Pharma's Tryngolza (olezarsen) has become the first FDA-approved drug therapy for adults with rare disease familial chylomicronaemia syndrome
Pharmaceutical Technology
DECEMBER 24, 2024
This seed funding comes after GEMMABio secured $100m in October through a partnership with Brazilian supplier Fiocruz.
XTalks
DECEMBER 23, 2024
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
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.
Medical Xpress
DECEMBER 27, 2024
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.
pharmaphorum
DECEMBER 24, 2024
AstraZeneca and Daiichi Sankyo have decided to voluntarily withdraw their EU marketing application for Dato-DXd in lung cancer.
Pharmaceutical Technology
DECEMBER 24, 2024
RAPT Therapeutics and Shanghai Jemincare Pharmaceutical have signed an exclusive agreement for RPT904 to treat various allergic conditions.
XTalks
DECEMBER 27, 2024
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.
Medical Xpress
DECEMBER 27, 2024
Starting this spring, the University of Washington will try a new approach to helping students and employees in mental health crises, based on a philosophy that's become increasingly mainstream: Mental health professionals are better equipped than police to respond to some emergencies.
pharmaphorum
DECEMBER 24, 2024
AstraZeneca's EGFR inhibitor Tagrisso has become the first drug in the class to be approved in the EU for a form of early-stage lung cancer.
Pharmaceutical Technology
DECEMBER 24, 2024
AstraZeneca has gained approval from the European Commission for its oral therapy, Tagrisso (osimertinib), to treat adults with NSCLC.
XTalks
DECEMBER 26, 2024
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.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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