The 2017 FDA approval of Luxturna (voretigene neparvovec-rzyl, Roche Holding AG) spurred a race to create the next gene therapy for the eye. The organ is very amenable to gene therapy given that it's a confined space with post-mitotic cells that has immune privilege and requires substantially smaller amounts of viral vector compared to systemic treatments.
In the opening panel of the BIO CEO & Investor digital conference BIO president and CEO Michelle McMurry-Heath explored some of the key issues that are currently impacting the sector with Adena Friedman, president and CEO of Nasdaq, which, this month, marks the 50th anniversary of its launch in 1971.
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020.
January is historically the weakest month of the year for FDA approvals and 2021 is following that trend. With only nine approvals tracked by BioWorld during the month, it falls short of the 12 approvals during the same month in 2020, and it is the lowest amount in a single month since January of 2019, which also recorded nine.
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