XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research. Patients offer invaluable perspectives on their own needs, wishes and important concerns. Their input can guide the development of treatments that address their unique challenges, enhancing their overall care experience.

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Clinical Trials Clinical Trials Trials Clinical Development 87

ACRP blog

NOVEMBER 1, 2023

Following its discovery in 1799, the Rosetta stone, which features the same message in three different languages, became an invaluable tool for deciphering the previously untranslatable hieroglyphic style of Ancient Egyptian script because the other languages used on the stone were already known to linguists. Today, clinical researchers can take advantage of a new tool offering something akin to the Rosetta stone’s breakthrough gift—a way to take feedback from clinical trial participants that is

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Clinical Trials Clinical Trials Trials Research 59

Pharmaceutical Technology

OCTOBER 30, 2023

Lowering barriers to participation could boost the diversity of patients in clinical trials. We analyze gender, race and ethnicity data to understand the differences that mobile visits from a certified mobile research nurse can make.

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Clinical Trials Clinical Trials Trials Nurses 130

Bio Pharma Dive

OCTOBER 30, 2023

PrwS studies can reach beyond the limitations of today’s RWE studies and expand the role of RWD across the entire drug development cycle.

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Clinical Research Research Development Drugs 279

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

Medicine

Rethinking Clinical Trials

OCTOBER 31, 2023

       Speaker Harlan M. Krumholz, MD, SM Harold H. Hines, Jr. Professor of Medicine Department of Internal Medicine Section of Cardiovascular Medicine Yale University School of Medicine Director, Yale-New Haven Hospital Center for Outcomes Research and Evaluation Slides Keywords Decentralized Trial, Digital Trial, Yale PaxLC Trial, Long COVID Key Points The PaxLC Trial is a decentralized Phase 2, 1:1 randomized double-blind superiority placebo-controlled study on non-hospitalized high sy

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Trials Medicine Research Clinical Trials 177

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 30, 2023

The risk of Alzheimer’s disease and depression differs significantly between male and female bodies, and yet the vast majority of research on the human brain does not reflect that. Instead, male anatomy is too often considered ‘the norm’ against which all other human brains are measured.

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WCG Clinical

OCTOBER 30, 2023

Sponsors, CROs, sites, and anyone else involved in running clinical trials must consider the risk of suicidality. But deep-rooted misconceptions get in the way. Each year, 703,000 people die by suicide. [1] The rate is rising, especially in the US. In fact, more people died from suicide in the US in 2022 than in any year on record, according to CDC data.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Worldwide Clinical Trials

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. However, with a greater number of trials, sponsors and CROs face an increased risk of operational challenges, and sites continue to feel the widespread effects of the COVID-19 pandemic. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Trials Clinical Trials Clinical Trials Clinical Development 189

BioSpace

OCTOBER 31, 2023

Optimizing Biomarker Assays to Bridge the Clinical Trial Participation Gap - read this article along with other careers information, tips and advice on BioSpace

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Clinical Trials Clinical Trials Trials 80

Bio Pharma Dive

OCTOBER 31, 2023

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

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Gene Editing Gene 338

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Clinical Supply

Pharmaceutical Technology

NOVEMBER 2, 2023

Memo’s fast track-designated candidate is currently in a Phase II trial for BKV infection, with a data readout expected in 2024.

Trials 278

Trials 278

AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 31, 2023

After a bump, we can expect a bruise. But what if we find ourselves bruising without any noticeable cause? What might be behind it? Should we worry? Around 18 percent of adults report easy bruising. As hematologists (blood doctors), we are often asked for advice when people are worried they might bruise too easily.

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Rethinking Clinical Trials

OCTOBER 31, 2023

The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects, which will extend the program’s mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.

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Trials Nurses Clinical Trials Clinical Trials 162

Bio Pharma Dive

OCTOBER 31, 2023

Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.

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Gene Editing Gene Medicine 334

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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

Clinical Trials

Pharmaceutical Technology

NOVEMBER 1, 2023

The US FDA has granted approval for Novartis’ Cosentyx to treat adult patients with moderate to severe hidradenitis suppurativa (HS).

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AuroBlog - Aurous Healthcare Clinical Trials blog

OCTOBER 29, 2023

For those with stubbornly resistant forms of severe depression, ketamine was looking more and more like a solution. Years of research has hinted at the dissociative anesthetic’s treatment potential where other medications failed, promising the benefits of electroshock therapy with far fewer risks.

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Research Clinical Trials Clinical Trials Clinical Research 245

Pharma Times

NOVEMBER 3, 2023

Since 2022, an estimated 17,000 strokes and 4,000 deaths have been prevented - News - PharmaTimes

Drugs 152

Drugs 152

Bio Pharma Dive

NOVEMBER 3, 2023

The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.

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Vaccine Vaccination Manufacturing 317

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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.

Clinical Trials

Pharmaceutical Technology

NOVEMBER 1, 2023

Pfizer has posted a net loss of $2.38bn in Q3 2023 compared to a net income of $8.61bn during the same period of 2022.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

Scientists have developed a new tool for determining the age of eye cells without sampling regenerative tissue, which could make treatments for eye disease more personalized and better targeted. The team, led by researchers from Stanford University, adapted a technique used for analyzing eye fluid.

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Protein Scientist Research Development 238

Pharma Times

OCTOBER 31, 2023

Around 400,000 eligible patients are set to benefit from the travel offer - News - PharmaTimes

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Bio Pharma Dive

NOVEMBER 2, 2023

The rival companies reported strong quarterly sales growth for their latest products, which could face off as weight loss treatments next year.

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Sales Production Drugs 305

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.

Clinical Research

Pharmaceutical Technology

OCTOBER 31, 2023

ArriVent Biopharma has received the US FDA's breakthrough therapy designation for furmonertinib to treat non-small cell lung cancer.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 2, 2023

If you have hay fever, you’ve probably been sneezing a lot lately. Sneezing is universal but also quite unique to each of us. It is a protective reflex action outside our conscious control, to remove irritants from inside our nose.

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Clinical Trials Clinical Trials Clinical Research Trials 236

Rethinking Clinical Trials

NOVEMBER 1, 2023

In this Friday’s PCT Grand Rounds, Jonathan Moyer of the NIH Office of Disease Prevention will continue our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “The Perils and Pitfalls of Complex Clustering in Pragmatic Trials.” The session will be held on Friday, November 3, at 1:00 pm eastern and will be moderated by Andrea Cook.

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Trials Clinical Trials Clinical Trials Research 147

Bio Pharma Dive

OCTOBER 30, 2023

Yet Sarepta said it still plans to ask the FDA to expand regulatory clearance of Elevidys, which was granted an accelerated approval by the FDA in June.

Gene Therapy 296

Gene Therapy Gene 296

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Clinical Supply

Pharmaceutical Technology

NOVEMBER 2, 2023

The UK MHRA authorises Pfizer’s Litfulo (ritlecitinib), to treat severe alopecia areata in people aged 12 years and above.

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 1, 2023

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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Fierce Pharma

OCTOBER 30, 2023

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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Bio Pharma Dive

NOVEMBER 2, 2023

The gene therapy company will move headquarters and reduce its workforce by 40%, while seeking partners for its Fabry and cell therapy research.

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Gene Therapy Gene Research 289

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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.

Clinical Trials