Regeneron, J&J, AstraZeneca Pull Plug On NGF Inhibitors In Development For Pain Indications

The three companies' decisions were spurred by concerns about potential for the bone disorder avascular necrosis.

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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

ICH Modernizes Stability Testing Guideline

 
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.