Latest From Alaric DeArment
The company announced it would withdraw the BLA for balstilimab monotherapy in cervical cancer following Keytruda’s full approval, but it plans to keep developing the drug.
The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.
The formal split between the companies had been in the works since January, with 2seventy set to take over oncology operations while bluebird focuses on gene therapies.
Execs told Scrip they hope to get Tyrvaya (varenicline) onto formularies and aim for pricing that would make its nasal spray competitive with Restasis and Xiidra.
Gilead looks set to expand its lead position in the triple-negative breast cancer (TNBC) market in Europe with a positive opinion for Trodelvy from the CHMP.
Although the label’s PD-L1 expression requirement could limit the addressable market, there is also potential for future combination with Seagen’s recently approved Tivdak.