US FDA Extends Roche’s Risdiplam Decision Date
Move Triggered By Roche’s Submission Of Added Trial Data
The submission of more trial data from Roche has prompted the US FDA to extend by three months its decision on whether to approve risdiplam for spinal muscular atrophy.
You may also be interested in...
Roche’s Evrysdi Approved For SMA, Priced Below Competitors
Risdiplam’s efficacy across two clinical trials and oral dosing made it a credible threat before its US FDA approval, but its weight-based pricing falls below Biogen’s Spinraza and Novartis’s Zolgensma.
Finance Watch: With Four More IPOs, July May Match Or Exceed June’s 14
Public Company Edition: iTeos, Annexon, Nurix and Inozyme went public on 23 July and now CureVac has added its name to the IPO queue for what could be a large offering. Also, BioNTech raises $511.5m as COVID-19 vaccine progresses and PTC gets $650m from sale of risdiplam royalties.
Roche Warns Of Bigger Negative Impact From COVID-19 And Biosimilars
Biosimilar competitors to Avastin, Herceptin and Rituxan and headwinds from COVID-19 are expected to have a CHF4.7bn negative impact in 2020, higher than the CHF4bn previously projected.