Shots:
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…
Shots:
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…
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Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US
Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
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Supernus to acquire Sage Therapeutics, strengthening its neuropsychiatry product portfolio with Zurzuvae (zuranolone), & a novel CNS discovery platform
As per the deal, Sage’s shareholders will receive $8.5/share in an all-cash transaction totaling ~$561M, along with one non-tradeable CVR of $3.50/share (~$234M) tied to Zurzuvae milestones: $1 each for US sales allocable to Supernus reaching $250M (by…
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Biogen has collaborated with City Therapeutics to develop novel RNAi therapies, leveraging the former’s drug delivery tech & City’s RNAi engineering tech
As per the deal, City will receive $46M incl. $16M upfront + $30M investment in exchange for its convertible note, also eligible to receive ~$1B as development & commercial milestones, with high…
Shots:
The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA states
Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…

