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Radiopharm Specialist Navidea Steps Up Licensing Activity, Opens Boston Office In Anticipation Of Key Approval Decision

 
• By Michael Goodman

In the past year, Navidea has struck two licensing deals, expanded its geographic footprint, filed for its lead candidate Lymphoseek in the U.S. and has plans to file in Europe, and refocused into a commercial-ready biopharma specializing in radiopharmaceutical diagnostic products.

Navidea Biopharmaceuticals, headquartered in Dublin, Ohio specializes in the development and commercialization of radiopharmaceutical products that assist in the diagnosis of cancers and neurodegenerative diseases. In 2011, following the sale of its gamma detection systems business to Devicor Medical Products Inc, the company changed its name from Neoprobe to Navidea Biopharmaceuticals Inc.[See Deal]. In so doing, it focused on its radiopharmaceutical business, which at the time consisted of its lead candidate Lymphoseek (tilmanocept), currently submitted for approval in the U.S. and eligible for filing in Europe, and a Phase III radio-labeled antibody called RigScan.

In December 2011, Navidea (still doing business as Neoprobe) licensed exclusive worldwide rights to AstraZeneca PLC’s mid-stage fluorine-18-labeled agent...

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AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

More from R&D

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By Vibha Sharma

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.