CGMP concerns delay return of Valstar to market
This article was originally published in The Gold Sheet
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Nulibry obtains FDA approval weeks ahead of its action date. Although small patient base offers modest revenue opportunity, approval enables BridgeBio to get commercial operations underway.
Since raising $135m in 2017 to address rare, monogenic diseases, BridgeBio has launched or purchased 17 companies and built a pipeline of 30-plus candidates. Scrip checked in as the company nears commercialization.
The Medicare rule, which was delayed by 60 days under a broader regulatory freeze, is seen as critical to the reimbursement of innovative devices.