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FDA puts Novavax flu vaccine trials on hold

BioPharma Drive: Drug Pricing

The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.

Trials 102
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Accelerated Approval and Confirmatory Trials: Timing is Everything

The Premier Consulting Blog

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52
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Innovative Trials CEO named top Woman in Pharma at the Pharma Industry Awards UK

Drug Discovery Today

Kate Shaw, founder and CEO of Innovative Trials, a global clinical trial patient recruitment and retention company, has been crowned a top ‘Woman in Pharma’ at the Pharma Industry Awards UK. She was given the award at a ceremony in Birmingham on Wednesday 18th September.

Trials 113
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Drug Industry Taking Bigger Role in Clinical Cancer Trials

Drugs.com

1, 2024 -- Clinical trials sponsored by Big Pharma enrolled eight times as many patients as U.S.-government government trials did between 2018 and 2022, new research shows.The study -- conducted by researchers at Fred Hutch Cancer Center in. TUESDAY, Oct.

Trials 96
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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.

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How Clinical Trial Trends are Redefining Drug Development

Quanticate

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

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ACR Response Criteria in Rheumatoid Arthritis Clinical Trials

Quanticate

In rheumatoid arthritis (RA) clinical trials, accurately measuring the effectiveness of treatments is critical for determining their value in managing this chronic and debilitating condition.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

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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.