Pfizer and BioNTech Receive Health Canada Authorization for XFG-Adapted Comirnaty
Pfizer and BioNTech received Health Canada authorization for their XFG variant-adapted Comirnaty COVID-19 vaccine for active immunization of individuals aged 6 months and older during the 2026–2027 season. The updated formulation targets the Omicron XFG lineage and is supported by cumulative clinical, non-clinical, and real-world evidence. Pfizer has secured sufficient inventory to meet contractual commitments with federal and provincial vaccination programs and is managing distribution across Canada, with the updated vaccine expected to become available through various channels, including participating pharmacies, in the coming days and weeks.
Sandoz Canada Receives Health Canada Approval for Generic Semaglutide
Sandoz Canada received Health Canada authorization for PrSandoz Semaglutide, a generic version of Ozempic (semaglutide), for once-weekly treatment of adults with type 2 diabetes alongside lifestyle changes and other antidiabetic medicines. The approval covers 0.25 mg, 0.5 mg, and 1 mg doses delivered subcutaneously through two pen presentations. Sandoz describes the product as pharmaceutically equivalent to the reference product and says it could support greater affordability and access amid growing demand for semaglutide in Canada. Following the Notice of Compliance, Sandoz is preparing for commercialization and developing educational resources for patients and healthcare professionals.
Blair Health Raises CAD $4.24M to Scale Specialist-Level Care
Blair Health raised CAD $4.24 million in pre-seed funding, bringing its total capital to CAD $4.5 million, in a round co-led by BDC’s Thrive Venture Fund, Accelia Capital, and Ogaei, with participation from OCI’s LSIF and angel investors. The company will use the funding to accelerate product development, clinical operations, provider-network growth, and commercial expansion across Canada and the U.S. Blair’s platform encodes specialist-designed clinical pathways into software to help generalist providers deliver specialist-level care, with its menopause pathway reporting 98.7% clinical accuracy and newer offerings spanning urology, pelvic health, nutrition, and weight management. Since launching in May 2025, Blair has grown to more than 2,300 Canadian users, while employer contracts now generate roughly half of its revenue.
Rhythm Pharmaceuticals’ Imcivree Approved in Canada for Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals announced that Health Canada has approved Imcivree (setmelanotide) for weight management in adults and children aged 4 years and older with acquired hypothalamic obesity. The approval makes Imcivree the first targeted therapy authorized in Canada for this rare condition caused by hypothalamic injury and associated with sustained weight gain and hyperphagia. The decision was supported by the Phase 3 TRANSCEND trial in 142 patients, which demonstrated an 18.8% placebo-adjusted reduction in BMI. Imcivree was previously approved in Canada for patients aged 6 years and older with obesity associated with Bardet-Biedl syndrome and certain genetic deficiencies.
Signia Launches MaX Hearing Aid Platform in Canada
Signia introduced its Multi-adaptive Xperience (MaX) platform in Canada, powered by Acoustic Intelligence and four Deep Neural Networks designed to analyze speech, noise, environment, and the wearer’s own voice. The new MaX chip delivers 54x more processing power, 50% greater energy efficiency, and twice the memory for continuous, real-time sound processing. Signia reports that 97% of wearers performed better in noisy group conversations versus key competitors, while the first device, Pure C&G MaX, features Bluetooth Classic, LE Audio, Telecoil, and Auracast connectivity, with full Auracast functionality expected through a firmware update by March 2027.
GSK Seeks Health Canada Review of Jemperli for Locally Advanced Rectal Cancer
GSK announced that Health Canada has accepted its submission for Jemperli (dostarlimab) for previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer under the NOC/c policy and Project Orbis pathway. The submission is supported by the Phase II AZUR-1 trial, which demonstrated a sustained clinical complete response at 12 months in patients with no detectable cancer for at least one year after treatment. If approved, Jemperli could offer an immunotherapy-based treatment approach that may allow some eligible patients to avoid or delay chemotherapy, radiation, and surgery. Jemperli is not currently approved in Canada for this indication, and its safety and efficacy in this setting remain under investigation.
AbbVie’s Epkinly Gains Health Canada Approval for Follicular Lymphoma
AbbVie announced that Epkinly (epcoritamab), in combination with lenalidomide and rituximab, has received Health Canada approval for adults with relapsed or refractory Grade 1, 2, or 3a follicular lymphoma after at least one prior systemic therapy. The approval is supported by the Phase 3 EPCORE FL-1 study of 488 patients, in which the combination reduced the risk of disease progression or death by 79% versus lenalidomide and rituximab alone. Follicular lymphoma accounts for approximately 20%–25% of non-Hodgkin lymphoma diagnoses in Canada, with around 2,400–3,000 new cases annually, and the new indication expands Epkinly’s role as a treatment option for patients with relapsed or refractory disease.
Milestone Advances Phase 3 Trial of Etripamil in Canada
Milestone Pharmaceuticals enrolled the first Canadian patient in the Phase 3 ReVeRA-301 trial evaluating etripamil nasal spray for atrial fibrillation with rapid ventricular rate (AFib-RVR). The Montreal Heart Institute is the first Canadian clinical trial site, contributing to the multinational study targeting 150 patients with treated AFib-RVR events. ReVeRA-301 is evaluating a 70 mg repeat-dose regimen of etripamil, the same regimen approved by the FDA for paroxysmal supraventricular tachycardia as Cardamyst. The Canadian expansion builds on Phase 2 data and will assess whether self-administered etripamil can rapidly treat AFib-RVR outside the emergency department.
