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The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment
Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…
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Samsung Bioepis has entered an asset purchase agreement with Biogen to acquire its ophthalmology assets, Byooviz & Opuviz, biosimilar versions of Lucentis (ranibizumab) & Eylea (aflibercept), in the EU
Samsung Bioepis will assume full responsibility for the commercialization of Byooviz following the transfer of rights from Biogen, effective January 2026
Byooviz was approved by…
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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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Biogen has entered into a definitive agreement to acquire Alcyone Therapeutics, building on its partnership to advance ThecaFlex DRx
As per the deal, Biogen will acquire Alcyone Therapeutics for $85M upfront + potential milestone payments tied to the development & approval of ThecaFlex DRx with nusinersen & other products. The deal gives Biogen full…
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The EC has approved Zurzuvae (zuranolone) for the treatment of postpartum depression in adults following MHRA’s approval in Aug 2025
Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression
Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…
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ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
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Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025
Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…
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Stoke Therapeutics & Biogen have dosed their first patient with zorevunersen in global P-III (EMPEROR) trial for the treatment of Dravet syndrome; Trial has initiated in the US, UK, & Japan, with an EU study planned
Trial will assess zorevunersen (70mg on Day 1 & Wk. 8, then 45mg at Wks. 24 & 40) vs sham…
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The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25
Opinion was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression
Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…
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Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes
In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…

