Keeping Track Of Rolling Submissions: Gamida Cell, Roche, Lilly And Reata Are Latest To Use Fast Track
Applications are underway for omidubicel, mosenutuzumab, pirtobrutinib and omaveloxolone.
You may also be interested in...
RWE On The Runway: Trio Of Upcoming Approval Decisions Will Test US FDA’s Thinking On RWE For Efficacy
Real-world evidence provides external controls for bluebird bio’s eli-cel and Ipsen’s palovarotene, while Reata used RWE to address FDA concerns about the pivotal single-arm study of omaveloxolone. In the post-market, Intercept is gearing up to seek full approval of Ocaliva relying in part on claims database.
Roche has enjoyed decades-long success with its string of CD20-targeting drugs – and thanks to a legacy opt-in, so has Biogen.
With funding drying up for biotechs as sentiment continues to turn against the sector, Israel-headquartered Gamida Cell is cutting jobs and putting out feelers for potential partners to take its promising cell therapy to market.