Sat.Mar 30, 2024 - Fri.Apr 05, 2024

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7 essential clinical trial patient recruitment tips

Antidote

There are many options for clinical trial patient recruitment — digital advertising, in-person campaigns, and doctor’s office flyers are just a few. However, regardless of which avenue a study uses to find eligible individuals, there are a few basic tips that can help create effective outreach.

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5 FDA decisions to watch in the second quarter

Bio Pharma Dive

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

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Clinical trials and development services

Pharmaceutical Technology

Download our comprehensive list of leading specialist companies offering clinical trials and development services for free today.

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Strategies for Successful Navigation of Complex Radiopharmaceutical Trials

Worldwide Clinical Trials

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Transforming Clinical Trial Management: The Shift from Point Systems to Platform Solutions

Cloudbyz

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. At the heart of this change is a move away from traditional point systems—discrete tools designed for specific tasks within a trial—to comprehensive platform solutions that offer a unified approach to managing all aspects of a trial.

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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Worldwide Clinical Trials

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. However, with varying national regulatory agencies each requiring their own unique specifications, this process can be remarkably perplexing. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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A critical year for drug discount management

pharmaphorum

This critical year for drug discount management includes changes to the 340B programme, implications for Medicare, and updates on the Inflation Reduction Act.

Drugs 110
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Microbiome drug to be tested in IBS clinical trial

Drug Discovery World

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS). The Phase II study, named ‘TrIuMPH’ (treating IBS with an intestinal microbiota product for health) will initially enrol 60 patients with IBS and constipation across sites in the UK.

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How to reach the right patients in clinical trial advertising

Antidote

Digital advertising, which encompasses social media, online channels, streaming content, and more can be a powerful way to reach patients. One of the biggest avenues of reaching potential clinical trial participants through digital advertising is social media — and from the statistics, it is clear why. Not only does Facebook boast more than 3 billion users every month, but 80% of social media users are searching for health information.

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Bristol Myers CAR-T therapy approved by FDA for earlier myeloma use

Bio Pharma Dive

The FDA’s clearance comes three weeks after a panel of advisers endorsed expanded use of Abecma despite safety concerns raised by the agency.

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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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Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

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IPC’s Pharmacovigilance Programmes complements CDSCO & Pharmexcil initiatives to fortify patient safety

AuroBlog - Aurous Healthcare Clinical Trials blog

In a concerted effort to bolster patient safety measures within the healthcare landscape, the Indian Pharmacopoeia Commission (IPC) is set to roll out its Skill Development Programmes on Pharmacovigilance.

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April 3, 2024: In This Week’s PCT Grand Rounds, a New Look at P Values for Randomized Trials

Rethinking Clinical Trials

Dr. Erik van Zwet In this Friday’s PCT Grand Rounds, Erik van Zwet of Leiden University Medical Center will present “A New Look at P Values for Randomized Clinical Trials.” The Grand Rounds session will be held on Friday, April 5, 2024, at 1:00 pm eastern. Dr. van Zwet is an associate professor in the Department of Biomedical Data Sciences at Leiden University Medical Center in the Netherlands.

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Diagonal starts up with $128M to make better ‘activator’ antibody drugs

Bio Pharma Dive

The startup claims to have a more efficient way to develop biologic drugs that treat disease by turning on cellular pathways, rather than blocking them.

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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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MiNA and Nippon Shinyaku enter RNAa therapeutics deal

Pharmaceutical Technology

MiNA Therapeutics has entered into an agreement with Nippon Shinyaku to develop RNAa therapeutics for rare neurodegenerative ailments.

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Hand Sanitizers Could Damage Critical Supporting Cells In The Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Chemicals found in common household disinfectants, glues, and furniture textiles could damage supporting cells in the brain during critical stages of their development, a new study based on human cell cultures and mice has found.

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April 4, 2024: ICD-Pieces Trial Sees No Reduction in Hospitalization for Patients With Chronic Kidney Disease

Rethinking Clinical Trials

Dr. Miguel Vazquez, principal investigator for ICD-Pieces A primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care, according to the ICD-Pieces study. The results of the study were published this week in the New England Journal of Medicine.

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Breaking barriers: Advances and challenges in therapeutic cancer vaccines

Bio Pharma Dive

The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.

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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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US FDA grants fast track status to LISCure’s LB-P8 drug for PSC

Pharmaceutical Technology

FDA has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of PSC.

Drugs 246
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The Hidden Cause of Alzheimer’s May Have Been Identified a Century Ago

AuroBlog - Aurous Healthcare Clinical Trials blog

Alzheimer’s disease is commonly associated with clumps and tangles of proteins building up in brain cells. Yet for more than a century, accumulations of a completely different material have also been linked with the neurodegenerative condition.

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A Reflection on Shared Moments of Strength and Progress in the Rare Disease Communities

Worldwide Clinical Trials

For many people, February 29th is simply Leap Day, an extraordinary date that appears only once every four years. For others, this rare day is aptly the day we honor rare disease communities. Observed annually on the last day of February since 2008, Rare Disease Day has grown into a global movement for raising awareness, promoting research, and advocating for improved access to rare disease treatments and support services.

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Merck puts KRAS cancer drug competitor to the test

Bio Pharma Dive

A Phase 3 study will compare Merck’s experimental KRAS inhibitor together with its immunotherapy Keytruda against Keytruda alone in lung cancer.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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F. Hoffmann-La Roche gets grant for system for identifying nucleic acid bases using nanopore technology

Pharmaceutical Technology

Discover how F. Hoffmann-La Roche's patented system uses nanopores to identify nucleic acid bases, increasing confidence in base identification. Explore the innovative approach in genomics and personalized medicine.

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Large Review Finds CBD Products Don’t Relieve Chronic Pain After All

AuroBlog - Aurous Healthcare Clinical Trials blog

Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.

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FDA settles ivermectin lawsuit, removes contentious COVID-19 posts

BioPharma Reporter

The FDA has agreed to permanently remove several social media posts urging people not to take ivermectin for the treatment of COVID-19, after a lawsuit brought by three doctors accused the regulatory body of interfering with their ability to practice medicine.

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Acorda files for bankruptcy, reveals asset sale plan

Bio Pharma Dive

Stalking horse bidder Merz Therapeutics could get rights to Acorda’s three marketed drugs if its $185 million proposal holds.

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The New Age of Decentralized Clinical Trials

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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Chiesi Farmaceutici gets grant for pharmaceutical formulation for intraduodenal administration with melevodopa and carbidopa

Pharmaceutical Technology

Discover Chiesi Farmaceutici's innovative patent for a specialized pharmaceutical formulation aimed at enhancing drug delivery efficiency for Parkinson's disease treatment. Learn about the unique composition and processes involved in this groundbreaking intraduodenal administration solution.

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DCC asks SLAs to set deadline for manufacturers to add product details to Sugam portal

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, […]

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AACR 2024: What Cancer Researchers Are Talking About

BioSpace

The American Association for Cancer Research (AACR)’s annual conference runs April 5 through April 10. BioSpace will have all the key data and news out of San Diego.

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Verve pauses base editing study after treatment side effect

Bio Pharma Dive

Lab test abnormalities in one study participant led the company to halt enrollment and prioritize a different version of its gene editing therapy for heart disease.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.