pharmaphorum
JANUARY 4, 2024
Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.
XTalks
DECEMBER 9, 2024
The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.
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ACRP blog
OCTOBER 10, 2024
The increased accessibility of generative artificial intelligence (Gen AI) models like OpenAI’s ChatGPT and DALL-E has captured the popular imagination. You’d be hard-pressed now to find any leadership team in any sector that isn’t at least considering ways to leverage Gen AI. The technology uses patterns learned from data to create new content. Most industries have applied it to routine back office or administrative tasks, such as note-taking, helping to increase the efficiency of everyday pr
Rethinking Clinical Trials
NOVEMBER 21, 2024
In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.
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
Bio Pharma Dive
JANUARY 2, 2024
A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.
Worldwide Clinical Trials
OCTOBER 14, 2024
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
FDA Law Blog
NOVEMBER 10, 2024
By Sarah Wicks & James E. Valentine — The U.S. Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market.
Bio Pharma Dive
OCTOBER 4, 2024
An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.
Pharmaceutical Technology
SEPTEMBER 13, 2024
Distribution of the self-amplifying mRNA vaccine Kostaive is set to align with a planned October 2024 Covid-19 vaccination campaign.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 12, 2024
(Rasi Bhadramani/Getty Images) Forever chemicals are falling in the rain, running through our waterways, and swimming in our bloodstreams, and now, initial research suggests these potentially harmful pollutants are ‘clogging up’ a crucial drainage system in our bodies.
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
NOVEMBER 12, 2024
On World Pneumonia Day 2024, observed on November 12, the focus shifts to one of the world’s most preventable and treatable diseases that remain a leading cause of death for children under five and a significant risk to vulnerable populations globally. Pneumonia is a lung infection that can be caused by viruses, bacteria or fungi and can result in millions of hospitalizations and deaths annually.
Rethinking Clinical Trials
DECEMBER 5, 2024
Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial. The results of the study were published online ahead of print in JAMA. Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety of text messaging strategies to
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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
Fierce Pharma
OCTOBER 28, 2024
Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.
Worldwide Clinical Trials
NOVEMBER 12, 2024
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. CGTs address rare and complex diseases at the root cause with increasing use in cancer, genetic disorders, and autoimmune diseases.
pharmaphorum
OCTOBER 28, 2024
Biogen has revealed encouraging phase 2 results with its anti-CD38 antibody felzartamab in rare kidney disease IgA nephropathy (IgAN), which it hopes could join a series of first-in-class therapies for the disorder.Data reported at the Kidney Week 2024 congress in San Diego showed that felzartamab was able to achieve "substantial" reductions in proteinuria and stabilised kidney function in the 54-subject IGNAZ study that extended for 18 months after the last dose of the antibody.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 21, 2024
Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 5, 2024
India has taken centre-stage in clinical trials for HIV/AIDS drug as there are several ongoing clinical trials in India focused on advancing HIV treatment. These trials are investigating new drug candidates, therapies, and approaches to manage HIV more effectively and potentially cure it.
Worldwide Clinical Trials
NOVEMBER 13, 2024
By; Brooke Kaplan, Director, People Partner- HR Compliance & Human Capital Initiatives In April 2007, at 19 years old, I was a sophomore at the University of Maryland. I had always been relatively healthy, exercised recreationally, and worked part-time at the campus gym. I’d just returned from spring break at Disney World with my boyfriend (now husband), Zak, and we were gearing up for the Jewish holiday of Passover.
Rethinking Clinical Trials
NOVEMBER 26, 2024
In an article published online this week , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities.
Rethinking Clinical Trials
NOVEMBER 25, 2024
Drawing on experiences from the NIH Collaboratory Trials, authors of a new article in Contemporary Clinical Trials describe the challenges they encountered when relying on data from the electronic health record (EHR) to monitor outcomes and deliver interventions in pragmatic clinical trials embedded in healthcare systems. “Teams need to be aware of—and perhaps proactively investigate—possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and saf
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.
Worldwide Clinical Trials
OCTOBER 14, 2024
Autoimmune diseases and bone health conditions are not just medical challenges – they’re personal battles that millions of people fight every day. From the unpredictability of lupus flare-ups to the silent progression of osteoporosis, patients face daily struggles that can significantly impact their quality of life. Fortunately, advances in clinical research are providing hope for better treatments and outcomes.
Rethinking Clinical Trials
NOVEMBER 13, 2024
In this Friday’s PCT Grand Rounds, Kit Delgado of the University of Pennsylvania will present “Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers.” The Grand Rounds session will be held on Friday, November 15, 2024, at 1:00 pm eastern. Delgado is an associate professor of emergency medicine and epidemiology at the University of Pennsylvania and the director of the Penn Medicine Nudge Unit, which “designs an
Rethinking Clinical Trials
NOVEMBER 5, 2024
A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study , and NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce t
Rethinking Clinical Trials
NOVEMBER 20, 2024
Dr. Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif and Mary-Lou Hanna Chair in Surgical Oncology Research, a joint appointment at the Sunnybrook Research
Rethinking Clinical Trials
DECEMBER 3, 2024
In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation. The article was published online ahead of print in Clinical Trials. There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants.
Bio Pharma Dive
OCTOBER 16, 2024
The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.
Bio Pharma Dive
OCTOBER 22, 2024
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
Pharmaceutical Technology
JUNE 17, 2024
Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.
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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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