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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…

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Alkem Laboratories launches Pertuza (Biosimilar, Perjeta) Across India for Treating HER2-Positive Breast Cancer 

Shots:  Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer   In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product   Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer  Ref: Alkem Laboratories | Image: Alkem Laboratories | Press Release Related News:- CuraTeQ Biologics Reports…

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KalVista Pharmaceuticals Reports EC and Swissmedic Approval of Ekterly (Sebetralstat) for Hereditary Angioedema (HAE) 

Shots:  The EC and Swissmedic have approved Ekterly to treat acute HAE attacks in pts (age≥12) across EEA states. Launch is expected in Germany in Q4’25 and in Switzerland in H2’26  Ekterly’s approval by the EC and Swissmedic was based on the P-III (KONFIDENT) trial. Published in NEJM (May 2024), results showed significantly faster symptom…

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Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC  

Shots:  Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara  The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis  Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…

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