Antidote
APRIL 3, 2024
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.
Bio Pharma Dive
APRIL 1, 2024
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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Pharmaceutical Technology
APRIL 4, 2024
Download our comprehensive list of leading specialist companies offering clinical trials and development services for free today.
Worldwide Clinical Trials
APRIL 3, 2024
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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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
Cloudbyz
MARCH 31, 2024
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.
Worldwide Clinical Trials
APRIL 4, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 3, 2024
This critical year for drug discount management includes changes to the 340B programme, implications for Medicare, and updates on the Inflation Reduction Act.
Drug Discovery World
APRIL 4, 2024
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.
Antidote
APRIL 2, 2024
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.
Bio Pharma Dive
APRIL 5, 2024
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
APRIL 1, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 2, 2024
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.
Rethinking Clinical Trials
APRIL 3, 2024
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.
Bio Pharma Dive
APRIL 3, 2024
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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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.
Pharmaceutical Technology
APRIL 5, 2024
MiNA Therapeutics has entered into an agreement with Nippon Shinyaku to develop RNAa therapeutics for rare neurodegenerative ailments.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 4, 2024
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.
Rethinking Clinical Trials
APRIL 4, 2024
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.
Bio Pharma Dive
APRIL 1, 2024
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.
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.
Pharmaceutical Technology
APRIL 1, 2024
FDA has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of PSC.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 2, 2024
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.
Worldwide Clinical Trials
APRIL 5, 2024
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.
Bio Pharma Dive
APRIL 4, 2024
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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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
APRIL 4, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 3, 2024
Evidence does not support the use of cannabidiol (CBD) products as a treatment for chronic pain, a new review found.
BioPharma Reporter
APRIL 2, 2024
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.
Bio Pharma Dive
APRIL 2, 2024
Stalking horse bidder Merz Therapeutics could get rights to Acorda’s three marketed drugs if its $185 million proposal holds.
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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.
Pharmaceutical Technology
APRIL 4, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 3, 2024
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, […]
Fierce Pharma
APRIL 5, 2024
After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma. | After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers’ CAR-T therapy Abecma into the earlier treatment of multiple myeloma.
Bio Pharma Dive
APRIL 2, 2024
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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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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