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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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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

More from R&D

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.