Taiwan-based biopharmaceutical company PharmaEssentia (TWSE: 6446) announced on Monday that its subsidiary FORUS Therapeutics has received a Notice of Compliance from Health Canada for BESREMi (ropeginterferon alfa-2b) for the treatment of adults with polycythaemia vera (PV).
BESREMi is a next-generation interferon therapy for PV, a rare chronic blood cancer characterised by overproduction of blood cells that can increase the risk of thrombosis, stroke, myocardial infarction and progression to myelofibrosis or acute myeloid leukaemia.
The approval allows the treatment to become commercially available in Canada in the coming weeks and adds to existing regulatory authorisations in more than 40 countries, including the US, European Union and Japan.
PharmaEssentia said the approval strengthens its global commercial footprint in haematology and oncology as it continues to expand its biologics portfolio.
Novartis to acquire Myricx Bio in deal worth up to USD1.5bn
Genentech reports positive Phase III results for divarasib in KRAS G12C lung cancer
Alligator Bioscience reports first patient dosed in early-stage breast cancer study
Abbisko Therapeutics and AstraZeneca collaborate to conduct combination clinical trial for NSCLC
Caris Life Sciences introduces Caris Detect multi-cancer early detection blood test
SciBase submits FDA filing to expand Nevisense use to non‑melanoma skin cancers
Biovica secures Japanese patent for immuno-oncology TKa application
Zelluna awarded NOK16m research grant for Phase 1 cancer study