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NEWS

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots:Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative optionsApproval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
August 20, 2025

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Merck new
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Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots:Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1)Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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CSL Receives Health Canada’s Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: Health Canada has approved Andembry (garadacimab) for HAE pts (≥12yrs)Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean; data was published in The LancetInterim analysis of the ongoing OLE…
August 11, 2025

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Bavarian Nordic
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Bavarian Nordic Reports the Health Canada’s NDS Acceptance of CHIKV VLP to Prevent Chikungunya

Shots:Health Canada has accepted NDS of CHIKV VLP for active immunization against CHIKV disease in individuals (≥12yrs.); decision is anticipated in H1’26NDS was based on 2 P-III trials (n>3,500) that met their 1EP, with 97.8% of subjects aged 12–64yrs. & 87.3% aged >65yrs. developing neutralizing antibodies by day 21 post vaccination; seroresponse rates…
July 22, 2025

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NEWS

Ultragenyx Reports the Health Canada’s Approval of Evkeeza (evinacumab) to Treat Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots:Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFHApproval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children…
July 15, 2025

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Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)   

Shots: Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab) Ref: PRNewsWire | Image:…
July 2, 2025

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