Gilead Sciences Advances Lyvdelzi Toward Public Reimbursement in Canada
Gilead Sciences has concluded pricing negotiations with Canada’s pan-Canadian Pharmaceutical Alliance (pCPA) for Lyvdelzi (seladelpar), bringing patients with primary biliary cholangitis (PBC) closer to a publicly funded treatment option. The agreement clears a key national pricing milestone, allowing participating provincial, territorial, and federal drug plans to review the therapy for formulary listing and establish reimbursement criteria. PBC is a progressive autoimmune liver disease that damages bile ducts and can lead to severe liver damage. Some public drug plans could begin reimbursing eligible patients as early as 2027, depending on jurisdictional decisions. Patients enrolled in Gilead’s Momentum Support Program will transition to public coverage as agreements are reached. The move could reduce affordability barriers and expand access, although provincial listing decisions, eligibility requirements, and rollout timelines will shape Lyvdelzi’s uptake across Canada.
Astellas Presents Canadian Real-World Evidence on Biomarker-Guided Access to Zolbetuximab
Astellas Pharma Canada presented real-world evidence at ESMO 2026 highlighting how a national pathway supported CLDN18.2 biomarker testing and access to zolbetuximab plus chemotherapy for eligible patients with advanced gastric or gastroesophageal junction (GEJ) cancer. Between May 2025 and January 2026, 63 patients across eight provinces received treatment through the patient support program, regardless of PD-L1 CPS status, consistent with the Health Canada-authorized indication. By March 31, 2026, 13 validated centres had tested 1,576 samples, with a mean turnaround time of 6.1 days and a median CLDN18.2 positivity rate of 41%. The findings offer early insights into implementing biomarker-guided care in Canada ahead of public reimbursement. Continued collaboration, clinical research and real-world evidence will be important to expand patient identification and access to targeted treatment.
Biogen Welcomes Draft Recommendation to Expand Spinraza Reimbursement in Canada
Biogen Canada has welcomed a draft recommendation from Canada’s Drug Agency (CDA) supporting expanded public reimbursement of Spinraza (nusinersen) for Canadians with spinal muscular atrophy (SMA), including adults and patients historically facing access barriers. The recommendation covers patients with genetically confirmed 5q SMA and two, three, or four SMN2 gene copies, subject to specific conditions. Although Spinraza has been approved in Canada since 2017, public coverage has varied by province and patient age. The reassessment began in March 2026 under CDA’s Formulary Management Expert Committee pilot initiative, which reviews emerging evidence for previously approved treatments. Stakeholder feedback is open until October 29, 2026, with a final recommendation expected December 1. Provincial funding decisions will still be required before expanded coverage takes effect, potentially broadening access and Biogen’s reimbursed patient base.
Sanofi Expands Nuvaxovid Availability Across Canada for 2026–2027 Respiratory Season
Sanofi Canada will make Nuvaxovid, a protein-based, non-mRNA COVID-19 vaccine, available across all 10 provinces and Yukon for the 2026–2027 respiratory season through public programs and most private insurers. Indicated for individuals aged 12 and older, the vaccine provides an alternative to mRNA-based options, supporting individual vaccination preferences and healthcare provider recommendations. In pivotal Phase III clinical trials, Nuvaxovid demonstrated approximately 90% efficacy against symptomatic COVID-19 and showed a favourable tolerability profile for seasonal vaccination. Its expanded availability comes amid the continued disease burden in Canada, where the 2024–2025 respiratory season recorded more than 120,000 reported cases, 33,500 hospitalizations, and 2,300 deaths. The rollout strengthens Sanofi’s position in the seasonal vaccine market, with uptake likely to depend on public coverage, provider recommendations, and competition from mRNA vaccines.
Spektus Pharma and GEBRO Partner to Commercialize ActraFlex Globally
Spektus Pharma and GEBRO Holding have announced a global commercialization partnership for ActraFlex, a twice-daily extended-release tramadol/paracetamol formulation designed for pain management. ActraFlex combines Spektus’ patented AmyloFlex drug-delivery technology with GEBRO’s established Diliban brand, aiming to provide sustained drug release with convenient twice-daily dosing. Under the agreement, GEBRO will lead commercialization and supply across Europe and selected international markets, with Spain serving as its regional anchor. Spektus will oversee North and South America and selected Rest of World markets. The partnership brings together GEBRO’s pain management expertise and commercial presence with Spektus’ drug-delivery platform and global partner network. Financial terms were not disclosed. The collaboration strengthens both companies’ international commercialization strategies, while regulatory approvals, clinical differentiation, and competition from existing analgesics will influence ActraFlex’s market uptake.
