pharmaphorum
FEBRUARY 21, 2024
Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.
XTalks
FEBRUARY 21, 2024
Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. This lack of diversity can lead to skewed results that may not accurately reflect the efficacy of medical interventions across all populations. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.
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ACRP blog
FEBRUARY 22, 2024
When the ACRP Certified Professional (ACRP-CP®) certification launched in 2017, it made available to the clinical research field a rigorously developed and validated test leading to a credential highlighting the skills of professionals whose job roles do not easily stay within the boundaries of traditional clinical research coordinators (CRCs), clinical research associates (CRAs), or principal investigators.
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.
Rethinking Clinical Trials
FEBRUARY 22, 2024
An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials. The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems in the conduct of pragmatic trials, and special ethical and regulatory considerations.
Pharma Times
FEBRUARY 20, 2024
The new programme will engage with children and young people under the age of 18 years
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 20, 2024
The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.
Rethinking Clinical Trials
FEBRUARY 21, 2024
In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.
Bio Pharma Dive
FEBRUARY 21, 2024
The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.
Pharmaceutical Technology
FEBRUARY 22, 2024
US patients are travelling to avoid abortion bans, but a new study has found telehealth prescriptions to be safe and effective.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 22, 2024
Some form of brain injury could be behind the symptoms reported by those with long COVID, according to a new study, and adapting tests and treatments to match could aid progress in tackling the condition.
pharmaphorum
FEBRUARY 23, 2024
Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.
Bio Pharma Dive
FEBRUARY 20, 2024
The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes.
Pharmaceutical Technology
FEBRUARY 22, 2024
The company will evaluate an IMC-F106C/Opdivo combination treatment in a Phase III registrational study called PRISM-MEL-301.
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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
FEBRUARY 18, 2024
If you ask 50 different people how long the effects of cannabis last, you’re likely to get 50 different answers. This can be a problem for figuring out how long a patient using the drug for medical purposes is going to remain impaired. A meta-analysis of 80 papers published in 2021 narrowed down this timeframe.
Drug Discovery World
FEBRUARY 21, 2024
DDW Editor Reece Armstrong speaks to Dr Paul Song , MD, NKGen and Dr Vince DeOrchis , clinician, to find out more about the investigational natural killer therapy SNK01 and the benefit of using a patient’s own cells to treat Alzheimer’s. In October 2023, pharmaceutical company NKGen Biotech released data from its Phase I clinical trial on the use of its investigational natural killer therapy, SNK01, to treat patients with Alzheimer’s disease.
Bio Pharma Dive
FEBRUARY 22, 2024
The startup’s Series C round will support a clinical-stage drug the company thinks could address some of the weaknesses of other KRAS-targeting medicines.
Pharmaceutical Technology
FEBRUARY 23, 2024
The FDA Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 22, 2024
In its efforts to streamline and rationalise the sampling procedure and maintain a centralised monthly database the Central Drugs Standard Control Organisation (CDSCO) has released the final version of the regulatory guidelines for sampling of drugs, cosmetics and medical devices by drugs inspectors of the Central and State drug authorities.
Fierce Pharma
FEBRUARY 21, 2024
On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.
Bio Pharma Dive
FEBRUARY 23, 2024
The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.
Pharmaceutical Technology
FEBRUARY 22, 2024
The FDA has accepted Regeneron’s biologics licence application (BLA) for linvoseltamab to treat multiple myeloma for priority review.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 21, 2024
Approximately 1 in 26 people develop epilepsy, a condition in which someone experiences recurring and unprovoked seizures. But experiencing a seizure does not always mean a person has epilepsy. Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.
Fierce Pharma
FEBRUARY 23, 2024
Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.
Bio Pharma Dive
FEBRUARY 21, 2024
One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.
Pharmaceutical Technology
FEBRUARY 20, 2024
Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 19, 2024
A detailed look at minute differences in the levels of specific proteins in blood has allowed researchers to identify potential early warning signs of dementia.
Fierce Pharma
FEBRUARY 23, 2024
A narrow miss in a confirmatory trial has | Along with host of other positive recommendations, European drug regulators rendered a positive opinion on Travere's Filspari for full approval in Berger’s disease.
Bio Pharma Dive
FEBRUARY 23, 2024
European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.
Pharmaceutical Technology
FEBRUARY 19, 2024
Almirall has signed a licensing agreement for the acquisition of worldwide rights to Novo Nordisk’s IL21-hindering antibody NN-8828.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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