pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

FDA 91

FDA Marketing Safety Patients 91

pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

Medicine 52

Medicine FDA Recruitment Patients 52

pharmaphorum

DECEMBER 23, 2022

Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers. CellCentric, a U.K-based Of these patients, seven have been treated at the recommended phase II dose (RP2D) and regimen.

Side effects 52

Side effects Patients Medical Medicine 52

European Pharmaceutical Review

DECEMBER 27, 2023

Currently CAR T-cell therapy is approved for three indications: acute lymphoblastic leukaemia (ALL), non-hodgkin lymphoma (NHL), and multiple myeloma (MM) – and the strongest correlation between CAR T-cell efficacy and persistence has been demonstrated in ALL. This is in addition to its considerable price tag. Asghar N, et al.

Manufacturing 83

Manufacturing Food and Drug Administration Patients Pharma 83