Keeping Track Of Rolling Submissions: Gamida Cell, Roche, Lilly And Reata Are Latest To Use Fast Track
Executive Summary
Applications are underway for omidubicel, mosenutuzumab, pirtobrutinib and omaveloxolone.
You may also be interested in...
Biogen’s Opt-In On Roche’s CD20 Drugs Is Gift That Keeps On Giving
Roche has enjoyed decades-long success with its string of CD20-targeting drugs – and thanks to a legacy opt-in, so has Biogen.
Gamida Cell Gears Up For Omidubicel Submission
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.
Broader Horizons For Advanced Biotech In 2022: New Targets, Settings For IO, Cell And Gene Therapy
US FDA’s user fee goal calendar for 2022 already contains 45 applications for novel agents featuring a wide array of biologics, from cell therapy in cancer and hematology to bispecifics and new immuno-oncology targets that could move the field beyond PD-1/L1.