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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. What is the FDA’s current thinking on the use of single-arm trials?

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China’s NMPA grants priority review status for Ocumension’s Zerviate NDA

Pharmaceutical Technology

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Nicox granted exclusive license to Ocumension to develop and commercialise Zerviate in China and most of the Southeast Asian markets.

Licensing 162
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What Drives Clinical Trial Costs? A Comprehensive Exploration

Cloudbyz

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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US FDA accepts Sandoz’s BLA for biosimilar denosumab

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The BLA submission is supported by a comprehensive analytical and clinical data package, including the Phase I/III ROSALIA trial data.

Packaging 130
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Should we be worried about pharma’s supply chain?

World of DTC Marketing

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. We can’t continue to develop drugs the same way as we have done before. We need a 21st-century approach that puts patient safety first.

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RedX Pharma CEO focuses on pipeline that found Lilly’s rising star

pharmaphorum

In an interview with pharmaphorum, Anson said asset fire-sales will no longer be necessary thanks to a $30 million financing package from Redmile Group and Sofinnova Partners in July, followed by a further $25 million investment round led by Polar Capital last month.

Sales 119
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CanSinoBIO developed a highly effective COVID vaccine with an inhalant version

pharmaphorum

Convidencia’s injectable version was granted World Health Organization (WHO) Emergency Use Listing (EUL), and its inhalant counterpart, currently in phase three clinical trials, has shown enormous promise. CanSinoBIO’s inhalant has finished phase three trials in China and is presently undergoing trials in several countries.

Vaccine 138