Zolgensma: Bumpy Japan Review Holds Lessons For Applicants
‘Numerous And Extensive’ Problems
Product review report reveals multiple delays and missteps on route to market, holding valuable lessons for other gene therapy developers but also evidencing an ultimately welcoming environment.
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The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.
F-star's novel bispecific technology attracts Sino Biopharma-affiliated acquisition, Shionogi agreement with GARDP brings antibiotic cefiderocol to 135 countries, deal with WinHealth covering Greater China expands Quoin’s licensing of Netherton syndrome candidate to 60 nations, Kyorin and CellGenTech team up in Fabry disease.
After months of speculation and anticipation, Shionogi’s once-daily oral antiviral for the treatment of COVID-19 has stumbled after receiving an unexpected preliminary decision on its emergency approval from an advisory committee in Japan.