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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

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JHL Becomes Eden And Announces Denosumab Progress

Taiwan’s JHL Biotech has rebranded itself as Eden Biologics at the same time as it has announced progress on clinical trials for its denosumab biosimilar candidate.

Australia’s Starpharma Plans To Launch COVID-Killing Nasal Spray In Europe

Starpharma's COVID-busting Viraleze antiviral nasal spray will soon be available across Europe, included the UK. But will it fall foul of local evidence requirements, for example in France, where the country's medicines agency has halted the sale of Pharma & Beauty (P&B) Group's COV-Defense spray until its efficacy against COVID has been confirmed by human-based studies?

Coronavirus Update: Moderna’s Variant-Targeting Vaccine Moves Into Trial, J&J Looks Set For US Authorization

A round up of COVID-19 developments, also including news on the EMA beginning a rolling review of Celltrion's antibody therapy, and progress for Novavax and Moderna in Japan.

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