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.
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Oncology Market Trends: Predictive Biomarkers, New IO Targets And Tougher Competition
Higher success rates in rare cancers, where biomarkers can better direct therapy, characterize the oncology treatment landscape. Deal-making is favoring alliances over acquisitions as drugmakers focus on establishing the clinical benefit of new targets, particularly for rare indications.
Janssen/Legend Plan Phased US Launch For BCMA-Targeting CAR-T Carvykti
Janssen priced the one-time autologous treatment at $465,000, well above the $419,500 list price for Bristol’s first-to-market CAR-T, but expects broad commercial and Medicare coverage.
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.