Clinuvel’s Scenesse (afamelanotide) approved in Canada for erythropoietic protoporphyria
Health Canada has approved Clinuvel’s Scenesse (afamelanotide) for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP). SCENESSE is the first approved treatment for EPP in Canada and is designed to increase patients’ tolerance to light, helping reduce phototoxic reactions and improve daily quality of life.
Dexcom’s G7 15 Day Continuous Glucose Monitoring System receives Health Canada authorization
Dexcom announced that Health Canada has authorized the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for adults aged 18 years and older living with diabetes. The system provides real-time glucose monitoring for up to 15.5 days, reducing the number of monthly sensor changes while improving continuity of glucose management. The authorization expands access to longer-lasting CGM technology for Canadians and offers a more convenient option for diabetes care.
Novartis’ VANRAFIA (atrasentan) approved in Canada for primary IgA nephropathy
Novartis Canada announced that Health Canada has approved VANRAFIA (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. The once-daily oral therapy was approved based on Phase III ALIGN trial results demonstrating a significant reduction in proteinuria. The approval expands treatment options for Canadians with IgAN and aims to help slow disease progression.
Médunik Canada becomes exclusive distributor of INCRELEX (mecasermin) in Canada
Médunik Canada announced that it has become the exclusive Canadian distributor of INCRELEX (mecasermin) for the treatment of children and adolescents with severe primary insulin-like growth factor-1 deficiency (SPIGFD). Through its partnership with ESTEVE, Médunik will ensure uninterrupted product supply and continue providing patient support services, strengthening access to this rare disease therapy for patients across Canada.
Skyhawk Therapeutics expands FALCON-HD clinical trial for SKY-0515 to Canada
Skyhawk Therapeutics announced the expansion of its global Phase 2/3 FALCON-HD clinical trial of SKY-0515 for Huntington’s disease to Canada, the United States, and the United Kingdom following regulatory clearances. The pivotal study is now active across more than 20 sites in over 10 countries and has enrolled more than 175 patients. The expansion is expected to broaden patient access to the investigational oral therapy and support its global clinical development for Huntington’s disease.
Meridian Bioscience’s Alethia CMV Assay receives Health Canada license
Meridian Bioscience announced that Health Canada has granted a license for its Alethia CMV assay, expanding the company’s Alethia molecular diagnostic portfolio in Canada. The assay enables rapid detection of congenital cytomegalovirus (CMV) using saliva samples, providing results in less than an hour to support early diagnosis and timely clinical decision-making for newborns. The approval broadens Meridian’s molecular diagnostic offerings and strengthens access to rapid congenital CMV testing in the Canadian market.
Zoetis launches Lenivia (izenivetmab injection) in Canada
Zoetis announced the launch of Lenivia (izenivetmab injection) in Canada for the management of osteoarthritis (OA) pain in dogs. The long-acting monoclonal antibody is administered as a single subcutaneous injection every three months and is designed to provide sustained pain relief while improving mobility and quality of life in dogs with OA. The launch expands treatment options for veterinarians and pet owners, offering a longer-lasting approach to managing this chronic condition.
Septa Pharmaceuticals acquires CeeNU (lomustine) from Bristol Myers Squibb Canada
Septa Pharmaceuticals Inc. announced the acquisition of CeeNU (lomustine) from Bristol Myers Squibb Canada, strengthening its specialty oncology portfolio. CeeNU is an oral chemotherapy indicated for the treatment of certain brain tumors and Hodgkin lymphoma. The acquisition is expected to ensure continued availability of the medicine for Canadian patients while expanding Septa’s oncology offerings and reinforcing its commitment to improving access to essential cancer therapies.
