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The Japanese PMDA has received NDA for Leqembi SC autoinjector to treat adults with early Alzheimer’s disease (AD)
NDA is supported by sub-studies from the P-III (Clarity AD) OLE study in pts with mild cognitive impairment due to AD or mild AD dementia, showing that Leqembi (500mg, SC: two 250mg injections) administered QW, provided exposure equivalent to Q2W IV…
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Biogen has entered into a research collaboration with Dayra Therapeutics to discover & develop oral macrocyclic peptides for priority targets in immunological conditions
Biogen & Dayra will jointly discover, validate, & optimize oral macrocycle candidates for key immunology targets, after which Biogen will lead development, manufacturing, & potential commercialization
As per the deal, Dayra will…
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Sandoz has launched Tyruko, a biosimilar version of Biogen’s Tysabri (natalizumab), for all indications of the reference product, incl. relapsing forms of multiple sclerosis (MS) & mod. to sev. active Crohn’s disease in adults
In 2019, Sandoz signed a global commercialization deal with Polpharma for Tyruko, with Polpharma responsible for development & manufacturing of…
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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 &…

